ISO9001 and IATF 16949 Combined - Reference

For reference and training purposes only
ISO 9001:2015 and

IATF 16949 Combined
This document in its current format is not copyrighted and is to be used for reference and training
purposes only. All text included in this document is copyrighted by either the International Organization
for Standardization (ISO) or the International Automotive Task Force (IATF.)
Text inside the box is ISO 9001:2015. Supplemental IATF 16949 text is
italicized and colored in blue.
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ISO 9001 & IATF 16949 Combined – For training and reference purposes only
Table of Contents
Introduction .................................................................................................................................... 1
0.1 General ...............................................................................................................................................1
0.2 Quality Management Principles ..........................................................................................................2
0.3 Process Approach ...............................................................................................................................2
0.3.1 General ...............................................................................................................................................2
0.3.2 Plan‐Do‐Check‐Act Cycle .....................................................................................................................3
0.3.3 Risk‐based thinking .............................................................................................................................4
0.4 Relationship with other Management System Standards ................................................................. 4
Quality Management Systems — Requirements ............................................................................ 5

1. Scope ........................................................................................................................................ 5
1.1 Scope – automotive supplemental to ISO 9001:2015 ........................................................................ 5
2. Normative References.............................................................................................................. 5
2.1 Normative and informative references ..............................................................................................5
3. Terms and Definitions .............................................................................................................. 6

3.1 Terms and Definitions for the Automotive Industry ............................................................................ 6
4. Context of the Organization ..................................................................................................... 9

4.1 Understanding the Organization and Its Context ............................................................................... 9
4.2 Understanding the Needs and Expectations of Interested Parties .................................................... 9
4.3 Determining the Scope of the Quality Management System ............................................................ 9
4.3.1 Determining the scope of the quality management system — supplemental ..................................10
4.3.2 Customer‐specific requirements .......................................................................................................10
4.4 Quality management system and its processes ............................................................................... 10
4.4.1 . .......................................................................................................................................................10
4.4.1.1 Conformance of products and processes ..........................................................................................10
4.4.1.2 Product safety ...................................................................................................................................10
4.4.2 To the extent necessary, the organization shall: .............................................................................. 11
5. Leadership .............................................................................................................................. 11
5.1 Leadership and commitment ............................................................................................................11
5.1.1 General .............................................................................................................................................11
5.1.1.1 Corporate responsibility ....................................................................................................................11
5.1.1.2 Process effectiveness and efficiency .................................................................................................12
5.1.1.3 Process owners..................................................................................................................................12
5.1.2 Customer focus .................................................................................................................................12
5.2 Policy .................................................................................................................................................12
5.2.1 Establishing the quality policy...........................................................................................................12
5.2.2 Communicating the quality policy ....................................................................................................12
5.3 Organizational roles, responsibilities and authorities ...................................................................... 12
5.3.1 Organizational roles, responsibilities, and authorities — supplemental...........................................13
5.3.2 Responsibility and authority for product requirements and corrective actions ................................13
6. Planning .................................................................................................................................. 13
6.1 Actions to address risks and opportunities .......................................................................................13
6.1.1 ........................................................................................................................................................13
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ISO 9001 & IATF 16949 Combined For training and reference purposes only
6.1.2 ........................................................................................................................................................13
6.1.2.1 Risk analysis ......................................................................................................................................14
6.1.2.2 Preventive action ..............................................................................................................................14
6.1.2.3 Contingency plans .............................................................................................................................14
6.2 Quality objectives and planning to achieve them. ........................................................................... 14
6.2.1 ........................................................................................................................................................14
6.2.2 .......................................................................................................................................... 15
6.2.2.1 Quality objectives and planning to achieve them — supplemental ................................................. 15
6.3 Planning of changes ..........................................................................................................................15
7. Support ................................................................................................................................... 15
7.1 Resources ..........................................................................................................................................15
7.1.1 General .............................................................................................................................................15
7.1.2 People ...............................................................................................................................................15
7.1.3 Infrastructure ....................................................................................................................................16
7.1.3.1 Plant, facility, and equipment planning ............................................................................................16
7.1.4 Environment for the operation of processes ....................................................................................16
7.1.4.1 Environment for the operation of processes — supplemental ......................................................... 16
7.1.5 Monitoring and measuring resources ...............................................................................................17
7.1.5.1 General .............................................................................................................................................17
7.1.5.1.1 Measurement systems analysis ........................................................................................................17
7.1.5.2 Measurement traceability ................................................................................................................17
7.1.5.2.1 Calibration/verification records ........................................................................................................17
7.1.5.3 Laboratory requirements ..................................................................................................................18
7.1.5.3.1 Internal laboratory ............................................................................................................................18
7.1.5.3.2 External laboratory ...........................................................................................................................18
7.1.6 Organizational knowledge ................................................................................................................19
7.2 Competence ......................................................................................................................................19
7.2.1 Competence — supplemental ...........................................................................................................19
7.2.2 Competence — on‐the‐job training ...................................................................................................20
7.2.3 Internal auditor competency .............................................................................................................20
7.2.4 Second‐party auditor compentency ..................................................................................................20
7.3 Awareness .........................................................................................................................................21
7.3.1 Awareness — supplemental..............................................................................................................21
7.3.2 Employee motivation and empowerment .........................................................................................21
7.4 Communication.................................................................................................................................21
7.5 Documented information .................................................................................................................21
7.5.1 General .............................................................................................................................................21
7.5.1.1 Quality management system documentation ...................................................................................21
7.5.2 Creating and updating.......................................................................................................................22
7.5.3 Control of documented information .................................................................................................22
7.5.3.1 ........................................................................................................................................................22
7.5.3.2 ........................................................................................................................................................22
7.5.3.2.1 Record retention ...............................................................................................................................22
7.5.3.2.2 Engineering specifications.................................................................................................................23
8. Operation ............................................................................................................................... 23
8.1 Operational planning and control .....................................................................................................23
8.1.1 Operational planning and control — supplemental ..........................................................................23
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8.1.2 Confidentiality ...................................................................................................................................24
8.2 Requirements for products and services ..........................................................................................24
8.2.1 Customer communication ................................................................................................................24
8.2.1.1 Customer communication — supplemental ......................................................................................24
8.2.2 Determining the requirements for products and services ............................................................... 24
8.2.2.1 Determining the requirements for products and services — supplemental. .................................... 24
8.2.3 Review of the requirements for products and services ....................................................................25
8.2.3.1 ........................................................................................................................................................25
8.2.3.1.1 Review of the requirements for products and services — supplemental ......................................... 25
8.2.3.1.2 Customer‐designated special characteristics ....................................................................................25
8.2.3.1.3 Organization manufacturing feasibility ............................................................................................25
8.2.3.2 ........................................................................................................................................................25
8.2.4 Changes to requirements for products and services ........................................................................25
8.3 Design and Development of Products and Services ......................................................................... 26
8.3.1 General .............................................................................................................................................26
8.3.1.1 Design and development of products and services — supplemental ............................................... 26
8.3.2 Design and development planning ...................................................................................................26
8.3.2.1 Design and development planning — supplemental ........................................................................26
8.3.2.2 Product design skills ..........................................................................................................................26
8.3.2.3 Development of products with embedded software .........................................................................27
8.3.3 Design and development inputs .......................................................................................................27
8.3.3.1 Product design input .........................................................................................................................27
8.3.3.2 Manufacturing process design input.................................................................................................27
8.3.3.3 Special characteristics .......................................................................................................................28
8.3.4 Design and development controls ....................................................................................................28
8.3.4.1 Monitoring ........................................................................................................................................28
8.3.4.2 Design and development validation..................................................................................................29
8.3.4.3 Prototype programme ......................................................................................................................29
8.3.4.4 Product approval process..................................................................................................................29
8.3.5 Design and development outputs .....................................................................................................29
8.3.5.1 Design and development outputs — supplemental ..........................................................................29
8.3.5.2 Manufacturing process design output ..............................................................................................30
8.3.6 Design and development changes ....................................................................................................30
8.3.6.1 Design and development changes — supplemental .........................................................................30
8.4 Control of externally provided processes, products and services ................................................... 31
8.4.1 General .............................................................................................................................................31
8.4.1.1 General — supplemental ..................................................................................................................31
8.4.1.2 Supplier selection process .................................................................................................................31
8.4.1.3 Customer‐directed sources (also known as “Directed–Buy”) ............................................................ 32
8.4.2 Type and extent of control................................................................................................................32
8.4.2.1 Type and extent of control — supplemental .....................................................................................32
8.4.2.2 Statutory and regulatory requirements ............................................................................................32
8.4.2.3 Supplier quality management system development .........................................................................32
8.4.2.3.1 Automotive product‐related software or automotive products with embedded software ...............33
8.4.2.4 Supplier monitoring ..........................................................................................................................33
8.4.2.4.1 Second‐party audits ..........................................................................................................................33
8.4.2.5 Supplier development .......................................................................................................................34
8.4.3 Information for external providers ...................................................................................................34
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8.4.3.1 Information for external providers — supplemental ........................................................................34
8.5 Production and Service Provision .....................................................................................................34
8.5.1 Control of Production and Service Provision ....................................................................................34
8.5.1.1 Control plan.......................................................................................................................................35
8.5.1.2 Standardised work — operator instructions and visual standards .................................................. 35
8.5.1.3 Verification of job set‐ups .................................................................................................................36
8.5.1.4 Verification after shutdown ..............................................................................................................36
8.5.1.5 Total productive maintenance ..........................................................................................................36
8.5.1.6 ........................................................................................................................................................36
8.5.1.7 Production scheduling .......................................................................................................................37
8.5.2 Identification and traceability ...........................................................................................................37
8.5.2.1 Identification and traceability — supplemental ................................................................................37
8.5.3 Property belonging to customers or external providers ...................................................................38
8.5.4 Preservation ......................................................................................................................................38
8.5.4.1 Preservation — supplemental ...........................................................................................................38
8.5.5 Post‐delivery activities ......................................................................................................................38
8.5.5.1 Feedback of information from service ..............................................................................................39
8.5.5.2 Service agreement with customer.....................................................................................................39
8.5.6 Control of changes ............................................................................................................................39
8.5.6.1 Control of changes — supplemental .................................................................................................39
8.5.6.1.1 Temporary change of process controls .............................................................................................39
8.6 Release of products and services ......................................................................................................40
8.6.1 Release of products and services — supplemental ...........................................................................40
8.6.2 Layout inspection and functional testing ..........................................................................................40
8.6.3 Appearance items .............................................................................................................................41
8.6.4 ........................................................................................................................................................41
8.6.5 Statutory and regulatory conformity ................................................................................................41
8.6.6 Acceptance criteria ...........................................................................................................................41
8.7 Control of nonconforming outputs ...................................................................................................41
8.7.1 ........................................................................................................................................................41
8.7.1.1 Customer authorization for concession ............................................................................................42
8.7.1.2 Control of nonconforming product — customer‐specified process .................................................. 42
8.7.1.3 Control of suspect product ................................................................................................................42
8.7.1.4 Control of reworked product .............................................................................................................42
8.7.1.5 Control of repaired product...............................................................................................................42
8.7.1.6 Customer notification .......................................................................................................................43
8.7.1.7 Nonconforming product disposition..................................................................................................43
8.7.2 ........................................................................................................................................................43
9. Performance Evaluation ......................................................................................................... 43

9.1 Monitoring, measurement, analysis and evaluation ........................................................................ 43
9.1.1 General .............................................................................................................................................43
9.1.1.1 Monitoring and measurement of manufacturing processes............................................................ 43
9.1.1.2 Identification of statistical tools........................................................................................................44
9.1.1.3 Application of statistical concepts ....................................................................................................44
9.1.2 Customer satisfaction .......................................................................................................................44
9.1.2.1 Customer satisfaction — supplemental ............................................................................................44
9.1.3 Analysis and evaluation ....................................................................................................................44
9.1.3.1 Prioritization .....................................................................................................................................45
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9.2 Internal audit ....................................................................................................................................45
9.2.1 ........................................................................................................................................................45
9.2.2 ........................................................................................................................................................45
9.2.2.1 Internal audit programme ................................................................................................................45
9.2.2.2 Quality management system audit ...................................................................................................46
9.2.2.3 Manufacturing process audit ............................................................................................................46
9.2.2.4 Product audit ....................................................................................................................................46
9.3 Management review .........................................................................................................................46
9.3.1 General .............................................................................................................................................46
9.3.1.1 Management review — supplemental ..............................................................................................46
9.3.2 Management review inputs ..............................................................................................................46
9.3.2.1 Management review inputs — supplemental ...................................................................................47
9.3.3 Management review outputs ...........................................................................................................47
9.3.3.1 Management review outputs — supplemental ................................................................................47
10. Improvement.......................................................................................................................... 47
10.1 General .............................................................................................................................................47
10.2 Nonconformity and corrective action ...............................................................................................47
10.2.1 ........................................................................................................................................................47
10.2.2 ........................................................................................................................................................48
10.2.3 Problem solving .................................................................................................................................48
10.2.4 Error‐proofing ...................................................................................................................................48
10.2.5 Warranty management systems.......................................................................................................48
10.2.6 Customer complaints and field failure test analysis .........................................................................49
10.3 Continual improvement ....................................................................................................................49
10.3.1 Continual improvement — supplemental .........................................................................................49
Annex A: Control Plan .........................................................................................................................................50

Annex B: Bibliography – supplemental automotive ...........................................................................................52
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Introduction
0.1 General
The adoption of a quality management system is a strategic decision for an organization that can help to improve its
overall performance and provide a sound basis for sustainable development initiatives.
The potential benefits to an organization of implementing a quality management system based on this International
Standard are:
a) the ability to consistently provide products and services that meet customer and applicable statutory and
regulatory requirements;
b) facilitating opportunities to enhance customer satisfaction;
c) addressing risks and opportunities associated with its context and objectives;
d) the ability to demonstrate conformity to specified quality management system requirements. This International
Standard can be used by internal and external parties.
It is not the intent of this International Standard to imply the need for:
• uniformity in the structure of different quality management systems;

• alignment of documentation to the clause structure of this International Standard;
• the use of the specific terminology of this International Standard within the organization.
The quality management system requirements specified in this International Standard are complementary to
requirements for products and services.
This International Standard employs the process approach, which incorporates the Plan‐Do‐Check‐Act (PDCA) cycle and
risk‐based thinking.
The process approach enables an organization to plan its processes and their interactions.
The PDCA cycle enables an organization to ensure that its processes are adequately resourced and managed, and that
opportunities for improvement are determined and acted on.
Risk‐based thinking enables an organization to determine the factors that could cause its processes and its quality
management system to deviate from the planned results, to put in place preventive controls to minimize negative effects
and to make maximum use of opportunities as they arise (see Clause A.4).
Consistently meeting requirements and addressing future needs and expectations poses a challenge for organizations in
an increasingly dynamic and complex environment. To achieve this objective, the organization might find it necessary to
adopt various forms of improvement in addition to correction and continual improvement, such as breakthrough change,
innovation and re‐organization.
In this International Standard, the following verbal forms are used:
• “shall” indicates a requirement;

• “should” indicates a recommendation;
• “may” indicates a permission;
• “can” indicates a possibility or a capability.
Information marked as “NOTE” is for guidance in understanding or clarifying the associated requirement.
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0.2 Quality Management Principles

This International Standard is based on the quality management principles described in ISO 9000. The descriptions include
a statement of each principle, a rationale of why the principle is important for the organization, some examples of
benefits associated with the principle and examples of typical actions to improve the organization’s performance when
applying the principle.
The quality management principles are:
• customer focus;
• leadership;
• engagement of people;
• process approach;
• improvement;
• evidence‐based decision making;
• relationship management.
0.3 Process Approach
0.3.1 General
This International Standard promotes the adoption of a process approach when developing, implementing and improving
the effectiveness of a quality management system, to enhance customer satisfaction by meeting customer requirements.
Specific requirements considered essential to the adoption of a process approach are included in 4.4.
Understanding and managing interrelated processes as a system contributes to the organization’s effectiveness and
efficiency in achieving its intended results. This approach enables the organization to control the interrelationships and
interdependencies among the processes of the system, so that the overall performance of the organization can be
enhanced.
The process approach involves the systematic definition and management of processes, and their interactions, so as to
achieve the intended results in accordance with the quality policy and strategic direction of the organization.
Management of the processes and the system as a whole can be achieved using the PDCA cycle (see 0.3.2) with an overall
focus on risk‐based thinking (see 0.3.3) aimed at taking advantage of opportunities and preventing undesirable results.
The application of the process approach in a quality management system enables:
a) understanding and consistency in meeting requirements;
b) the consideration of processes in terms of added value;
c) the achievement of effective process performance;
d) improvement of processes based on evaluation of data and information.
Figure 1 gives a schematic representation of any process and shows the interaction of its elements. The monitoring and
measuring check points, which are necessary for control, are specific to each process and will vary depending on the
related risks.
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0.3.2 Plan‐Do‐Check‐Act Cycle

The PDCA cycle can be applied to all processes and to the quality management system as a whole. Figure 2 illustrates how
Clauses 4 to 10 can be grouped in relation to the PDCA cycle.
NOTE: Numbers in brackets refer to the clauses in this International Standard.

Figure 2 — Representation of the structure of this International Standard in the PDCA cycle
The PDCA cycle can be briefly described as follows:
• Plan: establish the objectives of the system and its processes, and the resources needed to deliver results in
accordance with customers’ requirements and the organization’s policies, and identify and address risks and
opportunities;
• Do: implement what was planned;
• Check: monitor and (where applicable) measure processes and the resulting products and services against
policies, objectives, requirements and planned activities, and report the results;
• Act: take actions to improve performance, as necessary.
0.3.3 Risk‐based thinking

Risk‐based thinking (see Clause A.4) is essential for achieving an effective quality management system. The concept of
risk‐based thinking has been implicit in previous editions of this International Standard including, for example, carrying
out preventive action to eliminate potential nonconformities, analysing any nonconformities that do occur, and taking
action to prevent recurrence that is appropriate for the effects of the nonconformity.
To conform to the requirements of this International Standard, an organization needs to plan and implement actions to
address risks and opportunities. Addressing both risks and opportunities establishes a basis for increasing the
effectiveness of the quality management system, achieving improved results and preventing negative effects.
Opportunities can arise as a result of a situation favourable to achieving an intended result, for example, a set of
circumstances that allow the organization to attract customers, develop new products and services, reduce waste or
improve productivity. Actions to address opportunities can also include consideration of associated risks. Risk is the effect
of uncertainty and any such uncertainty can have positive or negative effects. A positive deviation arising from a risk can
provide an opportunity, but not all positive effects of risk result in opportunities.
0.4 Relationship with other Management System Standards

This International Standard applies the framework developed by ISO to improve alignment among its International
Standards for management systems (see Clause A.1).
This International Standard enables an organization to use the process approach, coupled with the PDCA cycle and risk‐
based thinking, to align or integrate its quality management system with the requirements of other management system
standards.
This International Standard relates to ISO 9000 and ISO 9004 as follows:
• ISO 9000 Quality management systems — Fundamentals and vocabulary provides essential background for the
proper understanding and implementation of this International Standard;
• ISO 9004 Managing for the sustained success of an organization — A quality management approach provides
guidance for organizations that choose to progress beyond the requirements of this International Standard.
Annex B provides details of other International Standards on quality management and quality management systems that
have been developed by ISO/TC 176.
This International Standard does not include requirements specific to other management systems, such as those for
environmental management, occupational health and safety management, or financial management.
Sector‐specific quality management system standards based on the requirements of this International Standard have
been developed for a number of sectors. Some of these standards specify additional quality management system
requirements, while others are limited to providing guidance to the application of this International Standard within the
particular sector.
A matrix showing the correlation between the clauses of this edition of this International Standard and the previous
edition (ISO 9001:2008) can be found on the ISO/TC 176/SC 2 open access web site at: w w w.iso.org/tc176/sc02/public.
Quality Management Systems — Requirements
1. Scope
This International Standard specifies requirements for a quality management system when an organization:
a) needs to demonstrate its ability to consistently provide products and services that meet customer and applicable
statutory and regulatory requirements, and
b) aims to enhance customer satisfaction through the effective application of the system, including processes for
improvement of the system and the assurance of conformity to customer and applicable statutory and
regulatory requirements.
All the requirements of this International Standard are generic and are intended to be applicable to any organization,
regardless of its type or size, or the products and services it provides.
NOTE 1: In this International Standard, the terms “product” or “service” only apply to products and services intended for,
or required by, a customer.
NOTE 2: Statutory and regulatory requirements can be expressed as legal requirements.
1.1 Scope – automotive supplemental to ISO 9001:2015

This Automotive QMS Standard defines the quality management system requirements for the design and development,
production and, when relevant, assembly, installation, and services of automotive‐related products, including products
with embedded software.
This Automotive QMS Standard is applicable to sites of the organization where manufacturing of customer‐specified
production parts, service parts, and/or accessory parts occur.
This Automotive QMS Standard should be applied throughout the automotive supply chain.
2. Normative References
The following documents, in whole or in part, are normatively referenced in this document and are indispensable for its
application. For dated references, only the edition cited applies. For undated references, the latest edition of the
referenced document (including any amendments) applies.
ISO 9000:2015, Quality management systems — Fundamentals and vocabulary
2.1 Normative and informative references

Annex A (Control Plan) is a normative part of this Automotive QMS standard.
Annex B (Bibliography – automotive supplemental) is informative, which provides additional information intended to assist
the understanding or use of this Automotive QMS standard.
3. Terms and Definitions

3.1 Terms and Definitions for the Automotive Industry
accessory part Customer‐specified additional component(s) that are either
mechanically or electronically connected to the vehicle or powertrain
before (or after) delivery to the final customer (e.g., custom floor mats,
truck bed liners, wheel covers, sound system enhancements, sunroofs,
spoilers, super‐chargers, etc.).
advanced product quality planning (APQP) Product quality planning process that supports development of a
product or service that will satisfy customer requirements; APQP serves
as a guide in the development process and also a standard way to share
results between organizations and their customers; APQP covers design
robustness, design testing and specification compliance, production
process design, quality inspection standards, process capability,
production capacity, product packaging, product testing and operator
training plan, among other items.
aftermarket part Replacement part(s) not procured or released by an OEM for service
part applications, which may or may not be produced to original
equipment specifications.
authorization Documented permission for a person(s) specifying rights and
responsibilities related to giving or denying permissions or sanctions
within an organization.
challenge (master) part Part(s) of known specification, calibrated and traceable to standards,
with expected results (pass or fail) that are used to validate the
functionality of an error‐proofing device or check fixtures (e.g., go / no‐
go gauging).
control plan Documented description of the systems and processes required for
controlling the manufacturing of product (see Annex A).
customer requirements All requirements specified by the customer (e.g., technical, commercial,
product and manufacturing process‐related requirements, general terms
and conditions, customer‐specific requirements, etc.).
customer‐specific requirements (CSRs) . Interpretations of or supplemental requirements linked to a specific
clause(s) of this Automotive QMS Standard.
design for assembly (DFA) Process by which products are designed with ease of assembly
considerations. (e.g., if a product contains fewer parts it will take less
time to assemble, thereby reducing assembly costs).
design for manufacturing (DFM) Integration of product design and process planning to design a product
that is easily and economically manufactured.
design for manufacturing and assembly Combination of two methodologies: Design for Manufacture (DFM),
(DFMA) which is the process of optimizing the design to be easier to produce,
have higher throughput, and improved quality; and Design for Assembly
(DFA), which is the optimization of the design to reduce risk of error,
lowering costs, and making it easier to assemble.
design for six sigma (DFSS) Systematic methodology, tools, and techniques with the aim of being a
robust design of products or processes that meets customer
expectations and can be produced at a six sigma quality level .
design‐responsible organization Organization with authority to establish a new, or change an existing,
product specification.
NOTE: This responsibility includes testing and verification of design
performance within the customer's specified application.

error proofing Product and manufacturing process design and development to prevent
manufacture of nonconforming products.
escalation process Process used to highlight or flag certain issues within an organization so
that the appropriate personnel can respond to these situations and
monitor the resolutions
fault tree analysis (FTA) deductive failure analysis methodology in which an undesired state of a
system is analysed; fault tree analysis maps the relationship between
faults, subsystems, and redundant design elements by creating a logic
diagram of the overall system.
laboratory Facility for inspection, test, or calibration that may include but is not
limited to the following: chemical, metallurgical, dimensional, physical,
electrical, or reliability testing.
laboratory scope - Specific tests, evaluations, and calibrations that a laboratory is
qualified to perform;
- A list of the equipment that the laboratory uses to perform the
above; and
- A list of methods and standards to which the laboratory performs
the above controlled document containing
manufacturing Process of making or fabricating
- production materials;
- production parts or service parts;
- assemblies; or
- heat treating, welding, painting, plating, or other finishing services
manufacturing feasibility An analysis and evaluation of a proposed project to determine if it is
technically feasible to manufacture the product to meet customer
requirements. This includes but is not limited to the following (as
applicable): within the estimated costs, and if the necessary resources,
facilities, tooling, capacity, software, and personnel with required skills,
including support functions, are or are planned to be available,
manufacturing services Companies that test, manufacture, distribute, and provide repair
services for components and assemblies.
multi‐disciplinary approach Method to capture input from all interested parties who may influence
how a process is administered by a team whose members include
personnel from the organization and may include customer and supplier
representatives; team members may be internal or external to the
organization; either existing teams or ad hoc teams may be used as
circumstances warrant; input to the team may include both organization
and customer inputs.
no trouble found (NTF) Designation applied to a part replaced during a service event that, when
analysed by the vehicle or parts manufacturer, meets all the
requirements of a “good part” (also referred to as “No Fault Found” or
“Trouble Not Found”).
outsourced process Portion of an organization’s function (or processes) that is performed by
an external organization.
periodic overhaul Maintenance methodology to prevent a major unplanned breakdown
where, based on fault or interruption history, a piece of equipment, or
subsystem of the equipment, is proactively taken out of service and
disassembled, repaired, parts replaced, reassembled, and then returned
to service.
predictive maintenance An approach and set of techniques to evaluate the condition of in‐
service equipment by performing periodic or continuous monitoring of
equipment conditions, in order to predict when maintenance should be
performed.
premium freight Extra costs or charges incurred in addition to contracted delivery.
NOTE: This can be caused by method, quantity, unscheduled or late
deliveries, etc.
preventive maintenance Planned activities at regular intervals (time‐based, periodic inspection,
and overhaul) to eliminate causes of equipment failure and unscheduled
interruptions to production, as an output of the manufacturing process
design.
product Applies to any intended output resulting from the product realization
process.
product safety Standards relating to the design and manufacturing of products to
ensure they do not represent harm or hazards to customers.
production shutdown Condition where manufacturing processes are idle; time span may be a
few hours to a few months.
reaction plan Action or series of steps prescribed in a control plan in the event
abnormal or nonconforming events are detected.
remote location Location that supports manufacturing sites and at which non‐production
processes occur.
service part Replacement part(s) manufactured to OEM specifications that are
procured or released by the OEM for service part applications, including
remanufactured parts.
site Location at which value‐added manufacturing processes occur.
special characteristic Classification of a product characteristic or manufacturing process
parameter that can affect safety or compliance with regulations, fit,
function, performance, requirements, or subsequent processing of
product.
special status Notification of a customer‐identified classification assigned to an
organization where one or more customer requirements are not being
satisfied due to a significant quality or delivery issue.
support function Non‐production activity (conducted on site or at a remote location) that
supports one (or more) manufacturing sites of the same organization.
total productive maintenance A system of maintaining and improving the integrity of production and
quality systems through machines, equipment, processes, and
employees that add value to the organization.
trade‐off curves Tool to understand and communicate the relationship of various design
characteristics of a product to each other; a product’s performance on
one characteristic is mapped on the Y‐axis and another on the x‐axis,
then a curve is plotted to illustrate product performance relative to the
two characteristics.
trade‐off process Methodology of developing and using trade‐off curves for products and
their performance characteristics that establish the customer, technical,
and economic relationship between design alternatives.
4. Context of the Organization

4.1 Understanding the Organization and Its Context
The organization shall determine external and internal issues that are relevant to its purpose and its strategic direction
and that affect its ability to achieve the intended result(s) of its quality management system.
The organization shall monitor and review information about these external and internal issues
NOTE 1: Issues can include positive and negative factors or conditions for consideration.
NOTE 2: Understanding the external context can be facilitated by considering issues arising from legal, technological,
competitive, market, cultural, social and economic environments, whether international, national, regional or local.
NOTE 3: Understanding the internal context can be facilitated by considering issues related to values, culture, knowledge
and performance of the organization.
4.2 Understanding the Needs and Expectations of Interested Parties

Due to their effect or potential effect on the organization’s ability to consistently provide products and services that meet
customer and applicable statutory and regulatory requirements, the organization shall determine:
a) the interested parties that are relevant to the quality management system;
b) the requirements of these interested parties that are relevant to the quality management system.
The organization shall monitor and review information about these interested parties and their relevant requirements.
4.3 Determining the Scope of the Quality Management System

The organization shall determine the boundaries and applicability of the quality management system to establish its
scope.
When determining this scope, the organization shall consider:
a) the external and internal issues referred to in 4.1;
b) the requirements of relevant interested parties referred to in 4.2;
c) the products and services of the organization.
The organization shall apply all the requirements of this International Standard if they are applicable within the
determined scope of its quality management system.
The scope of the organization’s quality management system shall be available and be maintained as documented
information. The scope shall state the types of products and services covered, and provide justification for any
requirement of this International Standard that the organization determines is not applicable to the scope of its quality
management system.
Conformity to this International Standard may only be claimed if the requirements determined as not being applicable do
not affect the organization’s ability or responsibility to ensure the conformity of its products and services and the
enhancement of customer satisfaction.
4.3.1 Determining the scope of the quality management system — supplemental

Supporting functions, whether on‐site or remote (such as design centres, corporate headquarters, and distribution
centres), shall be included in the scope of the Quality Management System (QMS).
The only permitted exclusion for this Automotive QMS Standard relates to the product design and development
requirements within ISO 9001, Section 8.3. The exclusion shall be justified and maintained as documented information (see
ISO 9001, Section 7.5).
Permitted exclusions do not include manufacturing process design.
4.3.2 Customer‐specific requirements

Customer‐specific requirements shall be evaluated and included in the scope of the organization’s quality management
system.
4.4 Quality management system and its processes
4.4.1 The organization shall establish, implement, maintain and continually improve a quality
management system, including the processes needed and their interactions, in accordance with the
requirements of this International Standard.
The organization shall determine the processes needed for the quality management system and their application
throughout the organization, and shall:
a) determine the inputs required and the outputs expected from these processes;
e) determine the sequence and interaction of these processes;
b) determine and apply the criteria and methods (including monitoring, measurements and related performance
indicators) needed to ensure the effective operation and control of these processes;
c) determine the resources needed for these processes and ensure their availability;
d) assign the responsibilities and authorities for these processes;
e) address the risks and opportunities as determined in accordance with the requirements of 6.1;
f) evaluate these processes and implement any changes needed to ensure that these processes achieve their
intended results;
g) improve the processes and the quality management system.
4.4.1.1 Conformance of products and processes

The organization shall ensure conformance of all products and processes, including service parts and those that are
outsourced, to all applicable customer, statutory, and regulatory requirements (see Section 8.4.2.2).
4.4.1.2 Product safety

The organization shall have documented processes for the management of product‐safety related products and
manufacturing processes, which shall include but not be limited to the following, where applicable:
a) identification by the organization of statutory and regulatory product‐safety requirements;
b) customer notification of requirements in item a);
c) special approvals for design FMEA;
d) identification of product safety‐related characteristics;
e) identification and controls of safety‐related characteristics of product and at the point of manufacture;
f) special approval of control plans and process FMEAs;
reaction plans (see Section 9.1.1.1);
g) defined responsibilities, definition of escalation process and flow of information, including top management, and
customer notification;
h) training identified by the organization or customer for personnel involved in product‐safety related products and
associated manufacturing processes;
i) changes of product or process shall be approved prior to implementation, including evaluation of potential effects
on product safety from process and product changes (see ISO 9001, Section 8.3.6);
j) transfer of requirements with regard to product safety throughout the supply chain, including customer‐
designated sources (see Section 8.4.3.1);
k) product traceability by manufactured lot (at a minimum) throughout the supply chain (see Section 8.5.2.1);
l) lessons learned for new product introduction.
NOTE: Special approval is an additional approval by the function (typically the customer) that is responsible to approve
such documents with safety‐related content.
4.4.2 To the extent necessary, the organization shall:

a) maintain documented information to support the operation of its processes;
b) retain documented information to have confidence that the processes are being carried out as planned.
5. Leadership
5.1 Leadership and commitment
5.1.1 General
Top management shall demonstrate leadership and commitment with respect to the quality management system by:
a) taking accountability for the effectiveness of the quality management system;
b) ensuring that the quality policy and quality objectives are established for the quality management system and
are compatible with the context and strategic direction of the organization;
c) ensuring the integration of the quality management system requirements into the organization’s business
processes;
d) promoting the use of the process approach and risk‐based thinking;
e) ensuring that the resources needed for the quality management system are available;
f) communicating the importance of effective quality management and of conforming to the quality management
system requirements;
g) ensuring that the quality management system achieves its intended results;
h) engaging, directing and supporting persons to contribute to the effectiveness of the quality management
system;
i) promoting improvement;
j) supporting other relevant management roles to demonstrate their leadership as it applies to their areas of
responsibility.
NOTE: Reference to “business” in this International Standard can be interpreted broadly to mean those activities that are
core to the purposes of the organization’s existence, whether the organization is public, private, for profit or not for
profit.
5.1.1.1 Corporate responsibility

The organization shall define and implement corporate responsibility policies, including at a minimum an anti‐bribery
policy, an employee code of conduct, and an ethics escalation policy (“whistle‐blowing policy”).
5.1.1.2 Process effectiveness and efficiency

Top management shall review the product realization processes and support processes to evaluate and improve their
effectiveness and efficiency. The results of the process review activities shall be included as input to the management
review (see Section 9.3.2.1.).
5.1.1.3 Process owners

Top management shall identify process owners who are responsible for managing the organization’s processes and
related outputs. Process owners shall understand their roles and be competent to perform those roles (see ISO 9001,
Section 7.2).
5.1.2 Customer focus

Top management shall demonstrate leadership and commitment with respect to customer focus by ensuring that:
a) Customer and applicable statutory and regulatory requirements are determined, understood and consistently
met;
b) The risks and opportunities that can affect conformity of products and services and the ability to enhance
customer satisfaction are determined and addressed;
c) The focus on enhancing customer satisfaction is maintained.
5.2 Policy
5.2.1 Establishing the quality policy

Top management shall establish, implement and maintain a quality policy that:
a) is appropriate to the purpose and context of the organization and supports its strategic direction;
b) provides a framework for setting quality objectives;
c) includes a commitment to satisfy applicable requirements;
d) includes a commitment to continual improvement of the quality management system.
5.2.2 Communicating the quality policy

The quality policy shall:
a) be available and be maintained as documented information;
b) be communicated, understood and applied within the organization;
c) be available to relevant interested parties, as appropriate.
5.3 Organizational roles, responsibilities and authorities

Top management shall ensure that the responsibilities and authorities for relevant roles are assigned, communicated and
understood within the organization.
Top management shall assign the responsibility and authority for:
a) ensuring that the quality management system conforms to the requirements of this International Standard;
b) ensuring that the processes are delivering their intended outputs;
c) reporting on the performance of the quality management system and on opportunities for improvement (see
10.1), in particular to top management;
d) ensuring the promotion of customer focus throughout the organization;
e) ensuring that the integrity of the quality management system is maintained when changes to the quality
management system are planned and implemented.
5.3.1 Organizational roles, responsibilities, and authorities — supplemental

Top management shall assign personnel with the responsibility and authority to ensure that customer requirements are
met. These assignments shall be documented. This includes but is not limited to the selection of special characteristics,
setting quality objectives and related training, corrective and preventive actions, product design and development,
capacity analysis, logistics information, customer scorecards, and customer portals.
5.3.2 Responsibility and authority for product requirements and corrective actions
Top management shall ensure that:
a) personnel responsible for conformity to product requirements have the authority to stop shipment and stop
production to correct quality problems;
NOTE: Due to the process design in some industries, it might not always be possible to stop production
immediately. In this case, the affected batch must be contained and shipment to the customer prevented.
b) personnel with authority and responsibility for corrective action are promptly informed of products or processes
that do not conform to requirements to ensure that nonconforming product is not shipped to the customer and
that all potential nonconforming product is identified and contained;
c) production operations across all shifts are staffed with personnel in charge of, or delegated responsibility for,
ensuring conformity to product requirements.
6. Planning
6.1 Actions to address risks and opportunities
6.1.1 When planning for the quality management system, the organization shall consider the issues
referred to in 4.1 and the requirements referred to in 4.2 and determine the risks and opportunities
that need to be addressed to:
a) give assurance that the quality management system can achieve its intended result(s);
b) enhance desirable effects;
c) prevent, or reduce, undesired effects;
d) achieve improvement.
6.1.2 The organization shall plan:

a) actions to address these risks and opportunities;
b) how to:
1. integrate and implement the actions into its quality management system processes (see 4.4);
2. evaluate the effectiveness of these actions.
c) Actions taken to address risks and opportunities shall be proportionate to the potential impact on the
conformity of products and services.
NOTE 1: Options to address risks can include avoiding risk, taking risk in order to pursue an opportunity, eliminating the
risk source, changing the likelihood or consequences, sharing the risk, or retaining risk by informed decision.
NOTE 2: Opportunities can lead to the adoption of new practices, launching new products, opening new markets,
addressing new customers, building partnerships, using new technology and other desirable and viable possibilities to
address the organization’s or its customers’ needs.
6.1.2.1 Risk analysis

The organization shall include in its risk analysis, at a minimum, lessons learned from product recalls, product audits, field
returns and repairs, complaints, scrap, and rework.
The organization shall retain documented information as evidence of the results of risk analysis.
6.1.2.2 Preventive action

The organization shall determine and implement action(s) to eliminate the causes of potential nonconformities in order to
prevent their occurrence. Preventive actions shall be appropriate to the severity of the potential issues.
The organization shall establish a process to lessen the impact of negative effects of risk including the following:
a) determining potential nonconformities and their causes;
b) evaluating the need for action to prevent occurrence of nonconformities;
c) determining and implementing action needed;
d) documented information of action taken;
e) reviewing the effectiveness of the preventive action taken;
f) utilizing lessons learned to prevent recurrence in similar processes (see ISO 9001, Section 7.1.6).
6.1.2.3 Contingency plans

The organization shall:
a) identify and evaluate internal and external risks to all manufacturing processes and infrastructure equipment
essential to maintain production output and to ensure that customer requirements are met;
b) define contingency plans according to risk and impact to the customer;
c) prepare contingency plans for continuity of supply in the event of any of the following: key equipment failures
(also see Section 8.5.6.1.1); interruption from externally provided products, processes, and services; recurring
natural disasters; fire; utility interruptions; labour shortages; or infrastructure disruptions;
d) include, as a supplement to the contingency plans, a notification process to the customer and other interested
parties for the extent and duration of any situation impacting customer operations;
e) periodically test the contingency plans for effectiveness (e.g., simulations, as appropriate);
f) conduct contingency plan reviews (at a minimum annually) using a multidisciplinary team including top
management, and update as required;
g) document the contingency plans and retain documented information describing any revision(s), including the
person(s) who authorized the change(s).
The contingency plans shall include provisions to validate that the manufactured product continues to meet customer
specifications after the re‐start of production following an emergency in which production was stopped and if the regular
shutdown processes were not followed.
6.2 Quality objectives and planning to achieve them
6.2.1 The organization shall establish quality objectives at relevant functions, levels and processes
needed for the quality management system.
The quality objectives shall:
a) be consistent with the quality policy;
b) be measurable;
c) take into account applicable requirements;
d) be relevant to conformity of products and services and to enhancement of customer satisfaction;
e) be monitored;
f) be communicated;
g) be updated as appropriate.
The organization shall maintain documented information on the quality objectives.
6.2.2 When planning how to achieve its quality objectives, the organization shall determine:
a) what will be done;
b) what resources will be required;
c) who will be responsible;
d) when it will be completed;
e) how the results will be evaluated.
6.2.2.1 Quality objectives and planning to achieve them — supplemental

Top management shall ensure that quality objectives to meet customer requirements are defined, established, and
maintained for relevant functions, processes, and levels throughout the organization.
The results of the organization’s review regarding interested parties and their relevant requirements shall be considered
when the organization establishes its annual (at a minimum) quality objectives and related performance targets (internal
and external).
6.3 Planning of changes

When the organization determines the need for changes to the quality management system, the changes shall be carried
out in a planned manner (see 4.4).
The organization shall consider:
a) the purpose of the changes and their potential consequences;
b) the integrity of the quality management system;
c) the availability of resources;
d) the allocation or reallocation of responsibilities and authorities.
7. Support
7.1 Resources
7.1.1 General
The organization shall determine and provide the resources needed for the establishment, implementation, maintenance
and continual improvement of the quality management system.
The organization shall consider:
a) the capabilities of, and constraints on, existing internal resources;
b) what needs to be obtained from external providers.
7.1.2 People
The organization shall determine and provide the persons necessary for the effective implementation of its quality
management system and for the operation and control of its processes.
7.1.3 Infrastructure
The organization shall determine, provide and maintain the infrastructure necessary for the operation of its processes
and to achieve conformity of products and services.
NOTE: Infrastructure can include:
a) buildings and associated utilities;
b) equipment, including hardware and software;
c) transportation resources;
d) information and communication technology.
7.1.3.1 Plant, facility, and equipment planning

The organization shall use a multidisciplinary approach including risk identification and risk mitigation methods for
developing and improving plant, facility, and equipment plans. In designing plant layouts, the organization shall:
a) optimize material flow, material handling, and value‐added use of floor space including control of nonconforming
product, and
b) facilitate synchronous material flow, as applicable.
Methods shall be developed and implemented to evaluate manufacturing feasibility for new product or new operations.
Manufacturing feasibility assessments shall include capacity planning. These methods shall also be applicable for
evaluating proposed changes to existing operations.
The organization shall maintain process effectiveness, including periodic re‐evaluation relative to risk, to incorporate any
changes made during process approval, control plan maintenance (see Section 8.5.1.1), and verification of job set‐ups (see
Section 8.5.1.3).
Assessments of manufacturing feasibility and evaluation of capacity planning shall be inputs to management reviews (see
ISO 9001, Section 9.3).
NOTE 1: These requirements should include the application of lean manufacturing principles.
NOTE 2: These requirements should apply to on‐site supplier activities, as applicable.
7.1.4 Environment for the operation of processes

The organization shall determine, provide and maintain the environment necessary for the operation of its processes and
to achieve conformity of products and services.
NOTE: A suitable environment can be a combination of human and physical factors, such as:
a) social (e.g., non‐discriminatory, calm, non‐confrontational);
b) psychological (e.g., stress‐reducing, burnout prevention, emotionally protective);
c) physical (e.g., temperature, heat, humidity, light, airflow, hygiene, noise).
These factors can differ substantially depending on the products and services provided.
NOTE: Where third‐party certification to ISO 45001 (or equivalent) is recognized, it may be used to demonstrate the
organization's conformity to the personnel safety aspects of this requirement.
7.1.4.1 Environment for the operation of processes — supplemental

The organization shall maintain its premises in a state of order, cleanliness, and repair that is consistent with the product
and manufacturing process needs.
7.1.5 Monitoring and measuring resources
7.1.5.1 General
The organization shall determine and provide the resources needed to ensure valid and reliable results when monitoring
or measuring is used to verify the conformity of products and services to requirements.
The organization shall ensure that the resources provided:
a) are suitable for the specific type of monitoring and measurement activities being undertaken;
b) are maintained to ensure their continuing fitness for their purpose.
The organization shall retain appropriate documented information as evidence of fitness for purpose of the monitoring
and measurement resources.
7.1.5.1.1 Measurement systems analysis

Statistical studies shall be conducted to analyse the variation present in the results of each type of inspection,
measurement, and test equipment system identified in the control plan. The analytical methods and acceptance criteria
used shall conform to those in reference manuals on measurement systems analysis. Other analytical methods and
acceptance criteria may be used if approved by the customer.
Records of customer acceptance of alternative methods shall be retained along with results from alternative measurement
systems analysis (see Section 9.1.1.1).
NOTE: Prioritization of MSA studies should focus on critical or special product or process characteristics.
7.1.5.2 Measurement traceability

When measurement traceability is a requirement, or is considered by the organization to be an essential part of providing
confidence in the validity of measurement results, measuring equipment shall be:
a) calibrated or verified, or both, at specified intervals, or prior to use, against measurement standards traceable to
international or national measurement standards; when no such standards exist, the basis used for calibration or
verification shall be retained as documented information;
b) identified in order to determine their status;
c) safeguarded from adjustments, damage or deterioration that would invalidate the calibration status and
subsequent measurement results.
The organization shall determine if the validity of previous measurement results has been adversely affected when
measuring equipment is found to be unfit for its intended purpose, and shall take appropriate action as necessary.
NOTE: A number or another identifier traceable to the device calibration record meets the intent of the requirements in
ISO 9001:2015.
7.1.5.2.1 Calibration/verification records

The organization shall have a documented process for managing calibration/verification records. Records of the
calibration/verification activity for all gauges and measuring and test equipment (including employee‐owned equipment
relevant for measuring, customer‐owned equipment, or on‐site supplier‐owned equipment) needed to provide evidence of
conformity to internal requirements, legislative and regulatory requirements, and customer‐defined requirements shall be
retained.
The organization shall ensure that calibration/verification activities and records shall include the following details:
a) revisions following engineering changes that impact measurement systems;
b) any out‐of‐specification readings as received for calibration/verification;
c) an assessment of the risk of the intended use of the product caused by the out‐of‐specification condition;
d) when a piece of inspection measurement and test equipment is found to be out of calibration or defective during
its planned verification or calibration or during its use, documented information on the validity of previous
measurement results obtained with this piece of inspection measurement and test equipment shall be retained,
including the associated standard's last calibration date and the next due date on the calibration report;
e) notification to the customer if suspect product or material has been shipped;
f) statements of conformity to specification after calibration/verification;
g) verification that the software version used for product and process control is as specified;
h) records of the calibration and maintenance activities for all gauging (including employee‐owned equipment,
customer‐owned equipment, or on‐site supplier‐owned equipment);
i) production‐related software verification used for product and process control (including software installed on
employee‐owned equipment, customer‐owned equipment, or on‐site supplier‐owned equipment).
7.1.5.3 Laboratory requirements
7.1.5.3.1 Internal laboratory

An organization's internal laboratory facility shall have a defined scope that includes its capability to perform the required
inspection, test, or calibration services. This laboratory scope shall be included in the quality management system
documentation. The laboratory shall specify and implement, as a minimum, requirements for:
a) adequacy of the laboratory technical procedures;
b) competency of the laboratory personnel;
c) testing of the product;
d) capability to perform these services correctly, traceable to the relevant process standard (such as ASTM, EN, etc.);
when no national or international standard(s) is available, the organization shall define and implement a
methodology to verify measurement system capability;
e) customer requirements, if any;
f) review of the related records.
NOTE: Third‐party accreditation to ISO/IEC 17025 (or equivalent) may be used to demonstrate the organization's in‐house
laboratory conformity to this requirement.
7.1.5.3.2 External laboratory

External/commercial/independent laboratory facilities used for inspection, test, or calibration services by the organization
shall have a defined laboratory scope that includes the capability to perform the required inspection, test, or calibration,
and either:
• the laboratory shall be accredited to ISO/IEC 17025 or national equivalent and include the relevant inspection,
test, or calibration service in the scope of the accreditation (certificate); the certificate of calibration or test report
shall include the mark of a national accreditation body; or
• there shall be evidence that the external laboratory is acceptable to the customer.
NOTE: Such evidence may be demonstrated by customer assessment, for example, or by customer‐approved second‐party
assessment that the laboratory meets the intent of ISO/IEC 17025 or national equivalent. The second‐party assessment
may be performed by the organization assessing the laboratory using a customer‐approved method of assessment.
Calibration services may be performed by the equipment manufacturer when a qualified laboratory is not available for a
given piece of equipment. In such cases, the organization shall ensure that the requirements listed in Section 7.1.5.3.1
have been met.
Use of calibration services, other than by qualified (or customer accepted) laboratories, may be subject to government
regulatory confirmation, if required.
7.1.6 Organizational knowledge

The organization shall determine the knowledge necessary for the operation of its processes and to achieve conformity of
products and services.
This knowledge shall be maintained and be made available to the extent necessary.
When addressing changing needs and trends, the organization shall consider its current knowledge and determine how to
acquire or access any necessary additional knowledge and required updates.
NOTE 1: Organizational knowledge is knowledge specific to the organization; it is generally gained by experience. It is
information that is used and shared to achieve the organization’s objectives.
NOTE 2 Organizational knowledge can be based on:
a) internal sources (e.g., intellectual property; knowledge gained from experience; lessons learned from failures
and successful projects; capturing and sharing undocumented knowledge and experience; the results of
improvements in processes, products and services);
b) external sources (e.g., standards; academia; conferences; gathering knowledge from customers or external
providers).
7.2 Competence
a) determine the necessary competence of person(s) doing work under its control that affects the performance and
effectiveness of the quality management system;
b) ensure that these persons are competent on the basis of appropriate education, training, or experience;
c) where applicable, take actions to acquire the necessary competence, and evaluate the effectiveness of the
actions taken;
d) retain appropriate documented information as evidence of competence.
NOTE” Applicable actions can include, for example, the provision of training to, the mentoring of, or the re‐ assignment of
currently employed persons; or the hiring or contracting of competent persons.
7.2.1 Competence — supplemental

The organization shall establish and maintain a documented process(es) for identifying training needs including awareness
(see Section 7.3.1) and achieving competence of all personnel performing activities affecting conformity to product and
process requirements. Personnel performing specific assigned tasks shall be qualified, as required, with particular
attention to the satisfaction of customer requirements.
7.2.2 Competence — on‐the‐job training

The organization shall provide on‐the‐job training (which shall include customer requirements training) for personnel in
any new or modified responsibilities affecting conformity to quality requirements, internal requirements, regulatory or
legislative requirements; this shall include contract or agency personnel. The level of detail required for on‐the‐job training
shall be commensurate with the level of education the personnel possess and the complexity of the task(s) they are
required to perform for their daily work. Persons whose work can affect quality shall be informed about the consequences
of nonconformity to customer requirements.
7.2.3 Internal auditor competency

The organization shall have a documented process(es) to verify that internal auditors are competent, taking into account
any customer‐specific requirements. For additional guidance on auditor competencies, refer to ISO 19011. The
organization shall maintain a list of qualified internal auditors.
Quality management system auditors, manufacturing process auditors, and product auditors shall all be able to
demonstrate the following minimum competencies:
a) understanding of the automotive process approach for auditing, including risk‐based thinking;
b) understanding of applicable customer‐specific requirements;
c) understanding of applicable ISO 9001 and IATF 16949 requirements related to the scope of the audit;
d) understanding of applicable core tool requirements related to the scope of the audit;
e) understanding how to plan, conduct, report, and close out audit findings.
Additionally, manufacturing process auditors shall demonstrate technical understanding of the relevant manufacturing
process(es) to be audited, including process risk analysis (such as PFMEA) and control plan. Product auditors shall
demonstrate competence in understanding product requirements and use of relevant measuring and test equipment to
verify product conformity.
Where training is provided to achieve competency, documented information shall be retained to demonstrate the trainer’s
competency with the above requirements.
Maintenance of and improvement in internal auditor competence shall be demonstrated through:
f) executing a minimum number of audits per year, as defined by the organization; and
g) maintaining knowledge of relevant requirements based on internal changes (e.g., process technology, product
technology) and external changes (e.g., ISO 9001, IATF 16949, core tools, and customer specific requirements).
7.2.4 Second‐party auditor competency

The organization shall demonstrate the competence of the auditors undertaking the second‐party audits. Second‐party
auditors shall meet customer specific requirements for auditor qualification and demonstrate the minimum following core
competencies, including understanding of:
a) the automotive process approach to auditing, including risk based thinking;
b) applicable customer and organization specific requirements;
c) applicable ISO 9001 and IATF 16949 requirements related to the scope of the audit;
d) applicable manufacturing process(es) to be audited, including PFMEA and control plan;
e) applicable core tool requirements related to the scope of the audit;
f) how to plan, conduct, prepare audit reports, and close out audit findings.
7.3 Awareness
The organization shall ensure that persons doing work under the organization’s control are aware of:
a) the quality policy;
b) relevant quality objectives;
c) their contribution to the effectiveness of the quality management system, including the benefits of improved
performance;
d) the implications of not conforming with the quality management system requirements.
7.3.1 Awareness — supplemental

The organization shall maintain documented information that demonstrates that all employees are aware of their impact
on product quality and the importance of their activities in achieving, maintaining, and improving quality, including
customer requirements and the risks involved for the customer with non‐conforming product.
7.3.2 Employee motivation and empowerment

The organization shall maintain a documented process(es) to motivate employees to achieve quality objectives, to make
continual improvements, and to create an environment that promotes innovation. The process shall include the promotion
of quality and technological awareness throughout the whole organization.
7.4 Communication
The organization shall determine the internal and external communications relevant to the quality management system,
including:
a) on what it will communicate;
b) when to communicate;
c) with whom to communicate;
d) how to communicate;
e) who communicates.
7.5 Documented information
7.5.1 General
The organization’s quality management system shall include:
a) documented information required by this International Standard;
b) documented information determined by the organization as being necessary for the effectiveness of the quality
management system.
NOTE: The extent of documented information for a quality management system can differ from one organization to
another due to:
• the size of organization and its type of activities, processes, products and services;
• the complexity of processes and their interactions;
• the competence of persons.
7.5.1.1 Quality management system documentation

The organization’s quality management system shall be documented and include a quality manual, which can be a series
of documents (electronic or hard copy).
The format and structure of the quality manual is at the discretion of the organization and will depend on the
organization’s size, culture, and complexity. If a series of documents is used, then a list shall be retained of the documents
that comprise the quality manual for the organization.
The quality manual shall include, at a minimum, the following:
a) the scope of the quality management system, including details of and justification for any exclusions;
b) documented processes established for the quality management system, or reference to them;
c) the organization’s processes and their sequence and interactions (inputs and outputs), including type and extent
of control of any outsourced processes;
d) a document (i.e., matrix) indicating where within the organization’s quality management system their customer‐
specific requirements are addressed.
NOTE: A matrix of how the requirements of this Automotive QMS standard are addressed by the organization’s processes
may be used to assist with linkages of the organization’s processes and this Automotive QMS.
7.5.2 Creating and updating

When creating and updating documented information, the organization shall ensure appropriate:
a) identification and description (e.g., a title, date, author, or reference number);
b) format (e.g., language, software version, graphics) and media (e.g., paper, electronic);
c) review and approval for suitability and adequacy.
7.5.3 Control of documented information
7.5.3.1 Documented information required by the quality management system and by this
International Standard shall be controlled to ensure:
a) it is available and suitable for use, where and when it is needed;
b) it is adequately protected (e.g., from loss of confidentiality, improper use, or loss of integrity).
7.5.3.2 For the control of documented information, the organization shall address the following
activities, as applicable:
a) distribution, access, retrieval and use;
b) storage and preservation, including preservation of legibility;
c) control of changes (e.g., version control);
d) retention and disposition.
Documented information of external origin determined by the organization to be necessary for the planning and
operation of the quality management system shall be identified as appropriate, and be controlled.
Documented information retained as evidence of conformity shall be protected from unintended alterations.
NOTE: Access can imply a decision regarding the permission to view the documented information only, or the permission
and authority to view and change the documented information.
7.5.3.2.1 Record retention

The organization shall define, document, and implement a record retention policy. The control of records shall satisfy
statutory, regulatory, organizational, and customer requirements.
Production part approvals, tooling records (including maintenance and ownership), product and process design records,
purchase orders (if applicable), or contracts and amendments shall be retained for the length of time that the product is
active for production and service requirements, plus one calendar year, unless otherwise specified by the customer or
regulatory agency.
NOTE: Production part approval documented information may include approved product, applicable test equipment
records, or approved test data.
7.5.3.2.2 Engineering specifications

The organization shall have a documented process describing the review, distribution, and implementation of all customer
engineering standards/specifications and related revisions based on customer schedules, as required.
When an engineering standard/specification change results in a product design change, refer to the requirements in ISO
9001, Section 8.3.6. When an engineering standard/specification change results in a product realization process change,
refer to the requirements in Section 8.5.6.1. The organization shall retain a record of the date on which each change is
implemented in production. Implementation shall include updated documents.
Review should be completed within 10 working days of receipt of notification of engineering standards/specifications
changes.
NOTE: A change in these standards/specifications may require an updated record of customer production part approval
when these specifications are referenced on the design record or if they affect documents of the production part approval
process, such as control plan, risk analysis (such as FMEAs), etc.
8. Operation
8.1 Operational planning and control
The organization shall plan, implement and control the processes (see 4.4) needed to meet the requirements for the
provision of products and services, and to implement the actions determined in Clause 6, by:
a) determining the requirements for the products and services;
b) establishing criteria for:
c) the processes;
d) the acceptance of products and services;
e) determining the resources needed to achieve conformity to the product and service requirements;
f) implementing control of the processes in accordance with the criteria;
g) determining, maintaining and retaining documented information to the extent necessary:
1. to have confidence that the processes have been carried out as planned;
2. to demonstrate the conformity of products and services to their requirements. The output of this planning
shall be suitable for the organization’s operations.
The organization shall control planned changes and review the consequences of unintended changes, taking action to
mitigate any adverse effects, as necessary.
The organization shall ensure that outsourced processes are controlled (see 8.4).
8.1.1 Operational planning and control — supplemental

When planning for product realization, the following topics shall be included:
a) customer product requirements and technical specifications;
b) logistics requirements;
c) manufacturing feasibility;
d) project planning (refer to ISO 9001, Section 8.3.2);
e) acceptance criteria.
The resources identified in ISO 9001, Section 8.1 c), refer to the required verification, validation, monitoring, measurement,
inspection, and test activities specific to the product and the criteria for product acceptance.
8.1.2 Confidentiality
The organization shall ensure the confidentiality of customer‐contracted products and projects under development,
including related product information.
8.2 Requirements for products and services
8.2.1 Customer communication

Communication with customers shall include:
a) providing information relating to products and services;
b) handling enquiries, contracts or orders, including changes;
c) obtaining customer feedback relating to products and services, including customer complaints;
d) handling or controlling customer property;
e) establishing specific requirements for contingency actions, when relevant.
8.2.1.1 Customer communication — supplemental

Written or verbal communication shall be in the language agreed with the customer. The organization shall have the
ability to communicate necessary information, including data in a customer‐specified computer language and format (e.g.,
computer‐aided design data, electronic data interchange).
8.2.2 Determining the requirements for products and services

When determining the requirements for the products and services to be offered to customers, the organization shall
ensure that:
a) the requirements for the products and services are defined, including:
any applicable statutory and regulatory requirements;
those considered necessary by the organization;
b) the organization can meet the claims for the products and services it offers.
8.2.2.1 Determining the requirements for products and services — supplemental

These requirements shall include recycling, environmental impact, and characteristics identified as a result of the
organization's knowledge of the product and manufacturing processes.
Compliance to ISO 9001, Section 8.2.2 item a) 1), shall include but not be limited to the following: all applicable
government, safety, and environmental regulations related to acquisition, storage, handling, recycling, elimination, or
disposal of material.
8.2.3 Review of the requirements for products and services
8.2.3.1 The organization shall ensure that it has the ability to meet the requirements for products
and services to be offered to customers. The organization shall conduct a review before committing
to supply products and services to a customer, to include:
a) requirements specified by the customer, including the requirements for delivery and post‐ delivery activities;
b) requirements not stated by the customer, but necessary for the specified or intended use, when known;
c) requirements specified by the organization;
d) statutory and regulatory requirements applicable to the products and services;
e) contract or order requirements differing from those previously expressed.
The organization shall ensure that contract or order requirements differing from those previously defined are resolved.
The customer’s requirements shall be confirmed by the organization before acceptance, when the customer does not
provide a documented statement of their requirements.
NOTE: In some situations, such as internet sales, a formal review is impractical for each order. Instead, the review can
cover relevant product information, such as catalogues.
8.2.3.1.1 Review of the requirements for products and services — supplemental

The organization shall retain documented evidence of a customer‐authorized waiver for the requirements stated in ISO
9001, Section 8.2.3.1, for a formal review.
8.2.3.1.2 Customer‐designated special characteristics

The organization shall conform to customer requirements for designation, approval documentation, and control of special
characteristics.
8.2.3.1.3 Organization manufacturing feasibility

The organization shall utilize a multidisciplinary approach to conduct an analysis to determine if it is feasible that the
organization’s manufacturing processes are capable of consistently producing product that meets all of the engineering
and capacity requirements specified by the customer. The organization shall conduct this feasibility analysis for any
manufacturing or product technology new to the organization and for any changed manufacturing process or product
design.
Additionally, the organization should validate through production runs, benchmarking studies, or other appropriate
methods, their ability to make product to specifications at the required rate.
8.2.3.2 The organization shall retain documented information, as applicable:

a) on the results of the review;
b) on any new requirements for the products and services.
8.2.4 Changes to requirements for products and services

The organization shall ensure that relevant documented information is amended, and that relevant persons are made
aware of the changed requirements, when the requirements for products and services are changed.
8.3 Design and Development of Products and Services
8.3.1 General
The organization shall establish, implement and maintain a design and development process that is appropriate to ensure
the subsequent provision of products and services.
8.3.1.1 Design and development of products and services — supplemental

The requirements of ISO 9001, Section 8.3.1, shall apply to product and manufacturing process design and development
and shall focus on error prevention rather than detection.
The organization shall document the design and development process.
8.3.2 Design and development planning

In determining the stages and controls for design and development, the organization shall consider:
a) the nature, duration and complexity of the design and development activities;
b) the required process stages, including applicable design and development reviews;
c) the required design and development verification and validation activities;
d) the responsibilities and authorities involved in the design and development process;
e) the internal and external resource needs for the design and development of products and services; f) the need to
control interfaces between persons involved in the design and development process;
f) the need for involvement of customers and users in the design and development process;
g) the requirements for subsequent provision of products and services;
h) the level of control expected for the design and development process by customers and other relevant
interested parties;
i) the documented information needed to demonstrate that design and development requirements have been
met.
8.3.2.1 Design and development planning — supplemental

The organization shall ensure that design and development planning includes all affected stakeholders within the
organization and, as appropriate, its supply chain. Examples of areas for using such a multidisciplinary approach include
but are not limited to the following:
a) project management (for example, APQP or VDA‐RGA);
b) product and manufacturing process design activities (for example, DFM and DFA), such as consideration of the
use of alternative designs and manufacturing processes;
c) development and review of product design risk analysis (FMEAs), including actions to reduce potential risks;
d) development and review of manufacturing process risk analysis (for example, FMEAs, process flows, control
plans, and standard work instructions).
NOTE: A multidisciplinary approach typically includes the organization’s design, manufacturing, engineering, quality,
production, purchasing, supplier, maintenance, and other appropriate functions.
8.3.2.2 Product design skills

The organization shall ensure that personnel with product design responsibility are competent to achieve design
requirements and are skilled in applicable product design tools and techniques. Applicable tools and techniques shall be
identified by the organization.
NOTE: An example of product design skills is the application of digitized mathematically based data.
8.3.2.3 Development of products with embedded software

The organization shall use a process for quality assurance for their products with internally developed embedded software.
A software development assessment methodology shall be utilized to assess the organization’s software development
process. Using prioritization based on risk and potential impact to the customer, the organization shall retain documented
information of a software development capability self‐assessment.
The organization shall include software development within the scope of their internal audit programme (see Section
9.2.2.1).
8.3.3 Design and development inputs

The organization shall determine the requirements essential for the specific types of products and services to be designed
and developed. The organization shall consider:
a) functional and performance requirements;
b) information derived from previous similar design and development activities;
c) statutory and regulatory requirements;
d) standards or codes of practice that the organization has committed to implement;
e) potential consequences of failure due to the nature of the products and services.
Inputs shall be adequate for design and development purposes, complete and unambiguous. Conflicting design and
development inputs shall be resolved.
The organization shall retain documented information on design and development inputs.
8.3.3.1 Product design input

The organization shall identify, document, and review product design input requirements as a result of contract review.
Product design input requirements include but are not limited to the following:
a) product specifications including but not limited to special characteristics (see Section 8.3.3.3);
b) boundary and interface requirements;
c) identification, traceability, and packaging;
d) consideration of design alternatives;
e) assessment of risks with the input requirements and the organization’s ability to mitigate/manage the risks,
including from the feasibility analysis;
f) targets for conformity to product requirements including preservation, reliability, durability, serviceability, health,
safety, environmental, development timing, and cost;
g) applicable statutory and regulatory requirements of the customer‐identified country of destination, if provided;
h) embedded software requirements.
The organization shall have a process to deploy information gained from previous design projects, competitive product
analysis (benchmarking), supplier feedback, internal input, field data, and other relevant sources for current and future
projects of a similar nature.
NOTE: One approach for considering design alternatives is the use of trade‐off curves.
8.3.3.2 Manufacturing process design input

The organization shall identify, document, and review manufacturing process design input requirements including but not
limited to the following:
a) product design output data including special characteristics;
b) targets for productivity, process capability, timing, and cost;
c) manufacturing technology alternatives;

d) customer requirements, if any;
e) experience from previous developments;
f) new materials;
g) product handling and ergonomic requirements; and
h) design for manufacturing and design for assembly.
The manufacturing process design shall include the use of error‐proofing methods to a degree appropriate to the
magnitude of the problem(s) and commensurate with the risks encountered.
8.3.3.3 Special characteristics

The organization shall use a multidisciplinary approach to establish, document, and implement its process(es) to identify
special characteristics, including those determined by the customer and the risk analysis performed by the organization,
and shall include the following:
a) documentation of all special characteristics in the drawings (as required), risk analysis (such as FMEA), control
plans, and standard work/operator instructions; special characteristics are identified with specific markings and
are cascaded through each of these documents;
b) development of control and monitoring strategies for special characteristics of products and production
processes;
c) customer‐specified approvals, when required;
d) compliance with customer‐specified definitions and symbols or the organization’s equivalent symbols or
notations, as defined in a symbol conversion table. The symbol conversion table shall be submitted to the
customer, if required.
8.3.4 Design and development controls

The organization shall apply controls to the design and development process to ensure that:
a) the results to be achieved are defined;
b) reviews are conducted to evaluate the ability of the results of design and development to meet requirements;
c) verification activities are conducted to ensure that the design and development outputs meet the input
requirements;
d) validation activities are conducted to ensure that the resulting products and services meet the requirements for
the specified application or intended use;
e) any necessary actions are taken on problems determined during the reviews, or verification and validation
activities;
f) documented information of these activities is retained.
NOTE: Design and development reviews, verification and validation have distinct purposes. They can be conducted
separately or in any combination, as is suitable for the products and services of the organization.
8.3.4.1 Monitoring
Measurements at specified stages during the design and development of products and processes shall be defined,
analysed, and reported with summary results as an input to management review (see Section 9.3.2.1).
When required by the customer, measurements of the product and process development activity shall be reported to the
customer at stages specified, or agreed to, by the customer.
NOTE: When appropriate, these measurements may include quality risks, costs, lead times, critical paths, and other
measurements.
8.3.4.2 Design and development validation

Design and development validation shall be performed in accordance with customer requirements, including any
applicable industry and governmental agency‐issued regulatory standards. The timing of design and development
validation shall be planned in alignment with customer‐specified timing, as applicable.
Where contractually agreed with the customer, this shall include evaluation of the interaction of the organization’s
product, including embedded software, within the system of the final customer’s product.
8.3.4.3 Prototype programme

When required by the customer, the organization shall have a prototype programme and control plan. The organization
shall use, whenever possible, the same suppliers, tooling, and manufacturing processes as will be used in production.
All performance‐testing activities shall be monitored for timely completion and conformity to requirements. When services
are outsourced, the organization shall include the type and extent of control in the scope of its quality management
system to ensure that outsourced services conform to requirements (see ISO 9001, Section 8.4).
8.3.4.4 Product approval process

The organization shall establish, implement, and maintain a product and manufacturing approval process conforming to
requirements defined by the customer(s).
The organization shall approve externally provided products and services per ISO 9001, Section 8.4.3, prior to submission
of their part approval to the customer.
The organization shall obtain documented product approval prior to shipment, if required by the customer. Records of
such approval shall be retained.
NOTE: Product approval should be subsequent to the verification of the manufacturing process.
8.3.5 Design and development outputs

The organization shall ensure that design and development outputs:
a) meet the input requirements;
b) are adequate for the subsequent processes for the provision of products and services;
c) include or reference monitoring and measuring requirements, as appropriate, and acceptance criteria;
d) specify the characteristics of the products and services that are essential for their intended purpose and their
safe and proper provision.
The organization shall retain documented information on design and development outputs.
8.3.5.1 Design and development outputs — supplemental

The product design output shall be expressed in terms that can be verified and validated against product design input
requirements. The product design output shall include but is not limited to the following, as applicable:
a) design risk analysis (FMEA);
b) reliability study results;
c) product special characteristics;
d) results of product design error‐proofing, such as DFSS, DFMA, and FTA;
e) product definition including 3D models, technical data packages, product manufacturing information, and
geometric dimensioning & tolerancing (GD&T);
f) 2D drawings, product manufacturing information, and geometric dimensioning & tolerancing (GD&T);
g) product design review results;
h) service diagnostic guidelines and repair and serviceability instructions;

i) service part requirements;
j) packaging and labeling requirements for shipping.
NOTE: Interim design outputs should include any engineering problems being resolved through a trade‐off process.
8.3.5.2 Manufacturing process design output

The organization shall document the manufacturing process design output in a manner that enables verification against
the manufacturing process design inputs. The organization shall verify the outputs against manufacturing process design
input requirements. The manufacturing process design output shall include but is not limited to the following:
a) specifications and drawings;
b) special characteristics for product and manufacturing process;
c) identification of process input variables that impact characteristics;
d) tooling and equipment for production and control, including capability studies of equipment and process(es);
e) manufacturing process flow charts/layout, including linkage of product, process, and tooling;
f) capacity analysis;
g) manufacturing process FMEA;
h) maintenance plans and instructions;
i) control plan (see Annex A);
j) standard work and work instructions;
k) process approval acceptance criteria;
l) data for quality, reliability, maintainability, and measurability;
m) results of error‐proofing identification and verification, as appropriate;
n) methods of rapid feedback, and correction of product/manufacturing process nonconformities.
8.3.6 Design and development changes

The organization shall identify, review and control changes made during, or subsequent to, the design and development
of products and services, to the extent necessary to ensure that there is no adverse impact on conformity to
requirements.
The organization shall retain documented information on:
a) design and development changes;
b) the results of reviews;
c) the authorization of the changes;
d) the actions taken to prevent adverse impacts.
8.3.6.1 Design and development changes — supplemental

The organization shall evaluate all design changes after initial product approval, including those proposed by the
organization or its suppliers, for potential impact on fit, form, function, performance, and/or durability. These changes
shall be validated against customer requirements and approved internally, prior to production implementation.
If required by the customer, the organization shall obtain documented approval, or a documented waiver, from the
customer prior to production implementation.
For products with embedded software, the organization shall document the revision level of software and hardware as
part of the change record.
8.4 Control of externally provided processes, products and services
8.4.1 General
The organization shall ensure that externally provided processes, products and services conform to requirements.
The organization shall determine the controls to be applied to externally provided processes, products and services when:
a) products and services from external providers are intended for incorporation into the organization’s own
products and services;
b) products and services are provided directly to the customer(s) by external providers on behalf of the organization;
c) a process, or part of a process, is provided by an external provider as a result of a decision by the organization.
The organization shall determine and apply criteria for the evaluation, selection, monitoring of performance, and re‐
evaluation of external providers, based on their ability to provide processes or products and services in accordance with
requirements.
The organization shall retain documented information of these activities and any necessary actions arising from the
evaluations.
8.4.1.1 General — supplemental

The organization shall include all products and services that affect customer requirements such as sub‐assembly,
sequencing, sorting, rework, and calibration services in the scope of their definition of externally provided products,
processes, and services.
8.4.1.2 Supplier selection process

The organization shall have a documented supplier selection process. The selection process shall include:
a) an assessment of the selected supplier’s risk to product conformity and uninterrupted supply of the organization’s
product to their customers;
b) relevant quality and delivery performance;
c) an evaluation of the supplier’s quality management system;
d) multidisciplinary decision making; and
e) an assessment of software development capabilities, if applicable.
Other supplier selection criteria that should be considered include the following:
• volume of automotive business (absolute and as a percentage of total business);

• financial stability;
• purchased product, material, or service complexity;
• required technology (product or process);
• adequacy of available resources (e.g., people, infrastructure);
• design and development capabilities (including project management);
• manufacturing capability;
• change management process;
• business continuity planning (e.g., disaster preparedness, contingency planning);
• logistics process;
• customer service.
8.4.1.3 Customer‐directed sources (also known as “Directed–Buy”)

When specified by the customer, the organization shall purchase products, materials, or services from customer‐directed
sources.
All requirements of Section 8.4 (except the requirements in IATF 16949, Section 8.4.1.2) are applicable to the
organization’s control of customer‐directed sources unless specific agreements are otherwise defined by the contract
between the organization and the customer.
8.4.2 Type and extent of control

The organization shall ensure that externally provided processes, products and services do not adversely affect the
organization’s ability to consistently deliver conforming products and services to its customers.
a) ensure that externally provided processes remain within the control of its quality management system;
b) define both the controls that it intends to apply to an external provider and those it intends to apply to the
resulting output;
c) take into consideration:
1. the potential impact of the externally provided processes, products and services on the organization’s ability
to consistently meet customer and applicable statutory and regulatory requirements;
2. the effectiveness of the controls applied by the external provider;
d) determine the verification, or other activities, necessary to ensure that the externally provided processes,
products and services meet requirements.
8.4.2.1 Type and extent of control — supplemental

The organization shall have a documented process to identify outsourced processes and to select the types and extent of
controls used to verify conformity of externally provided products, processes, and services to internal (organizational) and
external customer requirements.
The process shall include the criteria and actions to escalate or reduce the types and extent of controls and development
activities based on supplier performance and assessment of product, material, or service risks.
8.4.2.2 Statutory and regulatory requirements

The organization shall document their process to ensure that purchased products, processes, and services conform to the
current applicable statutory and regulatory requirements in the country of receipt, the country of shipment, and the
customer‐identified country of destination, if provided.
If the customer defines special controls for certain products with statutory and regulatory requirements, the organization
shall ensure they are implemented and maintained as defined, including at suppliers.
8.4.2.3 Supplier quality management system development

The organization shall require their suppliers of automotive products and services to develop, implement, and improve a
quality management system certified to ISO 9001, unless otherwise authorized by the customer [e.g., item a) below], with
the ultimate objective of becoming certified to this Automotive QMS Standard. Unless otherwise specified by the
customer, the following sequence should be applied to achieve this requirement:
a) compliance to ISO 9001 through second‐party audits;
b) certification to ISO 9001 through third‐party audits; unless otherwise specified by the customer, suppliers to the
organization shall demonstrate conformity to ISO 9001 by maintaining a third‐party certification issued by a
certification body bearing the accreditation mark of a recognized IAF MLA (International Accreditation Forum
Multilateral Recognition Arrangement) member and where the accreditation body’s main scope includes
management system certification to ISO/IEC 17021;
c) certification to ISO 9001 with compliance to other customer‐defined QMS requirements (such as Minimum
Automotive Quality Management System Requirements for Sub‐Tier Suppliers [MAQMSR] or equivalent) through
second‐party audits;
d) certification to ISO9001 with compliance to IATF 16949 through second‐party audits;
e) certification to 16949 through third‐party audits (valid third‐party certification of the supplier to IATF 16949 by an
IATF‐recognized certification body).
8.4.2.3.1 Automotive product‐related software or automotive products with embedded software

The organization shall require their suppliers of automotive product‐related software, or automotive products with
embedded software, to implement and maintain a process for software quality assurance for their products.
A software development assessment methodology shall be utilized to assess the supplier’s software development process.
Using prioritization based on risk and potential impact to the customer, the organization shall require the supplier to
retain documented information of a software development capability self‐assessment.
8.4.2.4 Supplier monitoring

The organization shall have a documented process and criteria to evaluate supplier performance in order to ensure
conformity of externally provided products, processes, and services to internal and external customer requirements.
At a minimum, the following supplier performance indicators shall be monitored:
a) delivered product conformity to requirements;
b) customer disruptions at the receiving plant, including yard holds and stop ships;
c) delivery schedule performance;
d) number of occurrences of premium freight.
If provided by the customer, the organization shall also include the following, as appropriate, in their supplier performance
monitoring:
a) special status customer notifications related to quality or delivery issues;
b) dealer returns, warranty, field actions, and recalls.
8.4.2.4.1 Second‐party audits

The organization shall include a second‐party audit process in their supplier management approach. Second‐party audits
may be used for the following:
a) supplier risk assessment;
b) supplier monitoring;
c) supplier QMS development;
d) product audits;
e) process audits.
Based on a risk analysis, including product safety/regulatory requirements, performance of the supplier, and QMS
certification level, at a minimum, the organization shall document the criteria for determining the need, type, frequency,
and scope of second‐party audits.
The organization shall retain records of the second‐party audit reports.
If the scope of the second‐party audit is to assess the supplier’s quality management system, then the approach shall be
consistent with the automotive process approach.
NOTE: Guidance may be found in the IATF Auditor Guide and ISO 19011.
8.4.2.5 Supplier development

The organization shall determine the priority, type, extent, and timing of required supplier development actions for its
active suppliers. Determination inputs shall include but are not limited to the following:
a) performance issues identified through supplier monitoring (see Section 8.4.2.4);
b) second‐party audit findings (see Section 8.4.2.4.1);
c) third‐party quality management system certification status;
d) risk analysis.
The organization shall implement actions necessary to resolve open (unsatisfactory) performance issues and pursue
opportunities for continual improvement.
8.4.3 Information for external providers

The organization shall ensure the adequacy of requirements prior to their communication to the external provider.
The organization shall communicate to external providers its requirements for:
a) the processes, products and services to be provided;
b) the approval of:
1. products and services;
2. methods, processes and equipment;
3. the release of products and services;
c) competence, including any required qualification of persons;
d) the external providers’ interactions with the organization;
e) control and monitoring of the external providers’ performance to be applied by the organization;
f) verification or validation activities that the organization, or its customer, intends to perform at the external
providers’ premises.
8.4.3.1 Information for external providers — supplemental

The organization shall pass down all applicable statutory and regulatory requirements and special product and process
characteristics to their suppliers and require the suppliers to cascade all applicable requirements down the supply chain to
the point of manufacture.
8.5 Production and Service Provision
8.5.1 Control of Production and Service Provision

The organization shall implement production and service provision under controlled conditions. Controlled conditions
shall include, as applicable:
a) the availability of documented information that defines:
1. the characteristics of the products to be produced, the services to be provided, or the activities to be
performed;
2. the results to be achieved;
b) the availability and use of suitable monitoring and measuring resources;
c) the implementation of monitoring and measurement activities at appropriate stages to verify that criteria for
control of processes or outputs, and acceptance criteria for products and services, have been met;
d) the use of suitable infrastructure and environment for the operation of processes;
e) the appointment of competent persons, including any required qualification;
f) the validation, and periodic revalidation, of the ability to achieve planned results of the processes for production
and service provision, where the resulting output cannot be verified by subsequent monitoring or measurement;
g) the implementation of actions to prevent human error;
h) the implementation of release, delivery and post‐delivery activities.
NOTE: Suitable infrastructure includes appropriate manufacturing equipment required to ensure product compliance.
Monitoring and measuring resources include appropriate monitoring and measuring equipment required to ensure
effective control of manufacturing processes.
8.5.1.1 Control plan

The organization shall develop control plans (in accordance with Annex A) at the system, subsystem, component, and/or
material level for the relevant manufacturing site and all product supplied, including those for processes producing bulk
materials as well as parts. Family control plans are acceptable for bulk material and similar parts using a common
manufacturing process.
The organization shall have a control plan for pre‐launch and production that shows linkage and incorporates information
from the design risk analysis (if provided by the customer), process flow diagram, and manufacturing process risk analysis
outputs (such as FMEA).
The organization shall, if required by the customer, provide measurement and conformity data collected during execution
of either the pre‐launch or production control plans. The organization shall include in the control plan:
a) controls used for the manufacturing process control, including verification of job set‐ups;
b) first‐off/last‐off part validation, as applicable;
c) methods for monitoring of control exercised over special characteristics (see Annex A) defined by both the
customer and the organization;
d) the customer‐required information, if any;
e) specified reaction plan (see Annex A); when nonconforming product is detected, the process becomes statistically
unstable or not statistically capable.
The organization shall review control plans, and update as required, for any of the following:
a) the organization determines it has shipped nonconforming product to the customer;
b) when any change occurs affecting product, manufacturing process, measurement, logistics, supply sources,
production volume changes, or risk analysis (FMEA) (see Annex A);
c) after a customer complaint and implementation of the associated corrective action, when applicable;
d) at a set frequency based on a risk analysis.
If required by the customer, the organization shall obtain customer approval after review or revision of the control
plan.
8.5.1.2 Standardised work — operator instructions and visual standards

The organization shall ensure that standardised work documents are:
a) communicated to and understood by the employees who are responsible for performing the work;
b) legible;
c) presented in the language(s) understood by the personnel responsible to follow them;
d) accessible for use at the designated work area(s).
The standardised work documents shall also include rules for operator safety.
8.5.1.3 Verification of job set‐ups

a) verify job set‐ups when performed, such as an initial run of a job, material changeover, or job change that
requires a new set‐up;
b) maintain documented information for set‐up personnel;
c) use statistical methods of verification, where applicable;
d) perform first‐off/last‐off part validation, as applicable; where appropriate, first‐off parts should be retained for
comparison with the last‐off parts; where appropriate, last‐off‐parts should be retained for comparison with first‐
off parts in subsequent runs;
e) retain records of process and product approval following set‐up and first‐off/last‐off part validations.
8.5.1.4 Verification after shutdown

The organization shall define and implement the necessary actions to ensure product compliance with requirements after
a planned or unplanned production shutdown period.
8.5.1.5 Total productive maintenance

The organization shall develop, implement, and maintain a documented total productive maintenance system.
At a minimum, the system shall include the following:
a) identification of process equipment necessary to produce conforming product at the required volume;
b) availability of replacement parts for the equipment identified in item a);
c) provision of resource for machine, equipment, and facility maintenance;
d) packaging and preservation of equipment, tooling, and gauging;
e) applicable customer‐specific requirements;
f) documented maintenance objectives, for example: OEE (Overall Equipment Effectiveness), MTBF (Mean Time
Between Failure), and MTTR (Mean Time To Repair), and Preventive Maintenance compliance metrics.
Performance to the maintenance objectives shall form an input into management review (see ISO 9001, Section
9.3);
g) regular review of maintenance plan and objectives and a documented action plan to address corrective actions
where objectives are not achieved;
h) use of preventive maintenance methods;
i) use of predictive maintenance methods, as applicable;
j) periodic overhaul.
8.5.1.6 Management of production tooling and manufacturing, test, inspection tooling and
equipment
The organization shall provide resources for tool and gauge design, fabrication, and verification activities for production
and service materials and for bulk materials, as applicable.
The organization shall establish and implement a system for production tooling management, whether owned by the
organization or the customer, including:
a) maintenance and repair facilities and personnel;
b) storage and recovery;
c) set‐up;
d) tool‐change programmes for perishable tools;
e) tool design modification documentation, including engineering change level of the product;
f) tool modification and revision to documentation;

g) tool identification, such as serial or asset number; the status, such as production, repair or disposal; ownership;
and location.
The organization shall verify that customer‐owned tools, manufacturing equipment, and test/inspection equipment are
permanently marked in a visible location so that the ownership and application of each item can be determined.
The organization shall implement a system to monitor these activities if any work is outsourced.
8.5.1.7 Production scheduling

The organization shall ensure that production is scheduled in order to meet customer orders/demands such as Just‐In‐Time
(JIT) and is supported by an information system that permits access to production information at key stages of the process
and is order driven.
The organization shall include relevant planning information during production scheduling, e.g., customer orders, supplier
on‐time delivery performance, capacity, shared loading (multi‐part station), lead time, inventory level, preventive
maintenance, and calibration.
8.5.2 Identification and traceability

The organization shall use suitable means to identify outputs when it is necessary to ensure the conformity of products
and services.
The organization shall identify the status of outputs with respect to monitoring and measurement requirements
throughout production and service provision.
The organization shall control the unique identification of the outputs when traceability is a requirement, and shall retain
the documented information necessary to enable traceability.
NOTE: Inspection and test status is not indicated by the location of product in the production flow unless inherently
obvious, such as material in an automated production transfer process. Alternatives are permitted if the status is clearly
identified, documented, and achieves the designated purpose.
8.5.2.1 Identification and traceability — supplemental

The purpose of traceability is to support identification of clear start and stop points for product received by the customer
or in the field that may contain quality and/or safety‐related nonconformities. Therefore, the organization shall implement
identification and traceability processes as described below.
The organization shall conduct an analysis of internal, customer, and regulatory traceability requirements for all
automotive products, including developing and documenting traceability plans, based on the levels of risk or failure
severity for employees, customers, and consumers. These plans shall define the appropriate traceability systems,
processes, and methods by product, process, and manufacturing location that:
a) enable the organization to identify nonconforming and/or suspect product;
b) enable the organization to segregate nonconforming and/or suspect product;
c) ensure the ability to meet the customer and/or regulatory response time requirements;
d) ensure documented information is retained in the format (electronic, hardcopy, archive) that enables the
organization to meet the response time requirements;
e) ensure serialized identification of individual products, if specified by the customer or regulatory standards;
f) ensure the identification and traceability requirements are extended to externally provided products with
safety/regulatory characteristics.
8.5.3 Property belonging to customers or external providers

The organization shall exercise care with property belonging to customers or external providers while it is under the
organization’s control or being used by the organization.
The organization shall identify, verify, protect and safeguard customers’ or external providers’ property provided for use
or incorporation into the products and services.
When the property of a customer or external provider is lost, damaged or otherwise found to be unsuitable for use, the
organization shall report this to the customer or external provider and retain documented information on what has
occurred.
NOTE: A customer’s or external provider’s property can include materials, components, tools and equipment, premises,
intellectual property and personal data.
8.5.4 Preservation
The organization shall preserve the outputs during production and service provision, to the extent necessary to ensure
conformity to requirements.
NOTE: Preservation can include identification, handling, contamination control, packaging, storage, transmission or
transportation, and protection.
8.5.4.1 Preservation — supplemental

Preservation shall include identification, handling, contamination control, packaging, storage, transmission or
transportation, and protection.
Preservation shall apply to materials and components from external and/or internal providers from receipt through
processing, including shipment and until delivery to/acceptance by the customer.
In order to detect deterioration, the organization shall assess at appropriate planned intervals the condition of product in
stock, the place/type of storage container, and the storage environment.
The organization shall use an inventory management system to optimize inventory turns over time and ensure stock
rotation, such as “first‐in‐first‐out” (FIFO).
The organization shall ensure that obsolete product is controlled in a manner similar to that of nonconforming product.
Organizations shall comply with preservation, packaging, shipping, and labeling requirements as provided by their
customers.
8.5.5 Post‐delivery activities

The organization shall meet requirements for post‐delivery activities associated with the products and services.
In determining the extent of post‐delivery activities that are required, the organization shall consider:
a) statutory and regulatory requirements;
b) the potential undesired consequences associated with its products and services;
c) the nature, use and intended lifetime of its products and services;
d) customer requirements;
e) customer feedback.
NOTE: Post‐delivery activities can include actions under warranty provisions, contractual obligations such as maintenance
services, and supplementary services such as recycling or final disposal.
8.5.5.1 Feedback of information from service

The organization shall ensure that a process for communication of information on service concerns to manufacturing,
material handling, logistics, engineering, and design activities is established, implemented, and maintained.
NOTE 1: The intent of the addition of “service concerns” to this sub‐clause is to ensure that the organization is aware of
nonconforming product(s) and material(s) that may be identified at the customer location or in the field.
NOTE 2: “Service concerns” should include the results of field failure test analysis (see Section 10.2.6) where applicable.
8.5.5.2 Service agreement with customer

When there is a service agreement with the customer, the organization shall:
a) verify that the relevant service centres comply with applicable requirements;
b) verify the effectiveness of any special purpose tools or measurement equipment;
c) ensure that all service personnel are trained in applicable requirements.
8.5.6 Control of changes

The organization shall review and control changes for production or service provision, to the extent necessary to ensure
continuing conformity with requirements.
The organization shall retain documented information describing the results of the review of changes, the person(s)
authorizing the change, and any necessary actions arising from the review.
8.5.6.1 Control of changes — supplemental

The organization shall have a documented process to control and react to changes that impact product realization. The
effects of any change, including those changes caused by the organization, the customer, or any supplier, shall be
assessed.
a) define verification and validation activities to ensure compliance with customer requirements;
b) validate changes before implementation;
c) document the evidence of related risk analysis;
d) retain records of verification and validation.
Changes, including those made at suppliers, should require a production trial run for verification of changes (such as
changes to part design, manufacturing location, or manufacturing process) to validate the impact of any changes on the
manufacturing process.
When required by the customer, the organization shall:
a) notify the customer of any planned product realization changes after the most recent product approval;
b) obtain documented approval, prior to implementation of the change;
c) complete additional verification or identification requirements, such as production trial run and new product
validation.
8.5.6.1.1 Temporary change of process controls

The organization shall identify, document, and maintain a list of the process controls, including inspection, measuring,
test, and error‐proofing devices, that includes the primary process control and the approved back‐up or alternate
methods.
The organization shall document the process that manages the use of alternate control methods. The organization shall
include in this process, based on risk analysis (such as FMEA), severity, and the internal approvals to be obtained prior to
production implementation of the alternate control method.
Before shipping product that was inspected or tested using the alternate method, if required, the organization shall obtain
approval from the customer(s). The organization shall maintain and periodically review a list of approved alternate
process control methods that are referenced in the control plan.
Standard work instructions shall be available for each alternate process control method. The organization shall review the
operation of alternate process controls on a daily basis, at a minimum, to verify implementation of standard work with the
goal to return to the standard process as defined by the control plan as soon as possible. Example methods include but are
not limited to the following:
a) daily quality focused audits (e.g., layered process audits, as applicable);
b) daily leadership meetings.
Restart verification is documented for a defined period based on severity and confirmation that all features of the error‐
proofing device or process are effectively reinstated.
The organization shall implement traceability of all product produced while any alternate process control devices or
processes are being used (e.g., verification and retention of first piece and last piece from every shift).
8.6 Release of products and services

The organization shall implement planned arrangements, at appropriate stages, to verify that the product and service
requirements have been met.
The release of products and services to the customer shall not proceed until the planned arrangements have been
satisfactorily completed, unless otherwise approved by a relevant authority and, as applicable, by the customer.
The organization shall retain documented information on the release of products and services. The documented
information shall include:
a) evidence of conformity with the acceptance criteria;
b) traceability to the person(s) authorizing the release.
8.6.1 Release of products and services — supplemental

The organization shall ensure that the planned arrangements to verify that the product and service requirements have
been met encompass the control plan and are documented as specified in the control plan (see Annex A).
The organization shall ensure that the planned arrangements for initial release of products and services encompass
product or service approval.
The organization shall ensure that product or service approval is accomplished after changes following initial release,
according to ISO 9001, Section 8.5.6.
8.6.2 Layout inspection and functional testing

A layout inspection and a functional verification to applicable customer engineering material and performance standards
shall be performed for each product as specified in the control plans. Results shall be available for customer review.
NOTE 1: Layout inspection is the complete measurement of all product dimensions shown on the design record(s).
NOTE 2: The frequency of layout inspection is determined by the customer.
8.6.3 Appearance items

For organizations manufacturing parts designated by the customer as “appearance items,” the organization shall provide
the following:
a) appropriate resources, including lighting, for evaluation;
b) masters for colour, grain, gloss, metallic brilliance, texture, distinctness of image (DOI), and haptic technology, as
appropriate;
c) maintenance and control of appearance masters and evaluation equipment;
d) verification that personnel making appearance evaluations are competent and qualified to do so.
8.6.4 Verification and acceptance of conformity of externally provided products and services
The organization shall have a process to ensure the quality of externally provided processes, products, and services
utilizing one or more of the following methods:
a) receipt and evaluation of statistical data provided by the supplier to the organization;
b) receiving inspection and/or testing, such as sampling based on performance;
c) second‐party or third‐party assessments or audits of supplier sites when coupled with records of acceptable
delivered product conformance to requirements;
d) part evaluation by a designated laboratory;
e) another method agreed with the customer.
8.6.5 Statutory and regulatory conformity

Prior to release of externally provided products into its production flow, the organization shall confirm and be able to
provide evidence that externally provided processes, products, and services conform to the latest applicable statutory,
regulatory, and other requirements in the countries where they are manufactured and in the customer‐identified countries
of destination, if provided.
8.6.6 Acceptance criteria

Acceptance criteria shall be defined by the organization and, where appropriate or required, approved by the customer.
For attribute data sampling, the acceptance level shall be zero defects (see Section 9.1.1.1).
8.7 Control of nonconforming outputs
8.7.1 The organization shall ensure that outputs that do not conform to their requirements are
identified and controlled to prevent their unintended use or delivery.
The organization shall take appropriate action based on the nature of the nonconformity and its effect on the conformity
of products and services. This shall also apply to nonconforming products and services detected after delivery of
products, during or after the provision of services.
The organization shall deal with nonconforming outputs in one or more of the following ways:
a) correction;
b) segregation, containment, return or suspension of provision of products and services;
c) informing the customer;
d) obtaining authorization for acceptance under concession.
Conformity to the requirements shall be verified when nonconforming outputs are corrected.
8.7.1.1 Customer authorization for concession

The organization shall obtain a customer concession or deviation permit prior to further processing whenever the product
or manufacturing process is different from that which is currently approved.
The organization shall obtain customer authorization prior to further processing for “use as is” and rework dispositions of
nonconforming product. If sub‐components are reused in the manufacturing process, that sub‐component reuse shall be
clearly communicated to the customer in the concession or deviation permit.
The organization shall maintain a record of the expiration date or quantity authorized under concession. The organization
shall also ensure compliance with the original or superseding specifications and requirements when the authorization
expires. Material shipped under concession shall be properly identified on each shipping container (this applies equally to
purchased product). The organization shall approve any requests from suppliers before submission to the customer.
8.7.1.2 Control of nonconforming product — customer‐specified process

The organization shall comply with applicable customer‐specified controls for nonconforming product(s).
8.7.1.3 Control of suspect product

The organization shall ensure that product with unidentified or suspect status is classified and controlled as
nonconforming product. The organization shall ensure that all appropriate manufacturing personnel receive training for
containment of suspect and nonconforming product.
8.7.1.4 Control of reworked product

The organization shall utilize risk analysis (such as FMEA) methodology to assess risks in the rework process prior to a
decision to rework the product. If required by the customer, the organization shall obtain approval from the customer
prior to commencing rework of the product.
The organization shall have a documented process for rework confirmation in accordance with the control plan or other
relevant documented information to verify compliance to original specifications.
Instructions for disassembly or rework, including re‐inspection and traceability requirements, shall be accessible to and
utilized by the appropriate personnel.
The organization shall retain documented information on the disposition of reworked product including quantity,
disposition, disposition date, and applicable traceability information.
8.7.1.5 Control of repaired product

The organization shall utilize risk analysis (such as FMEA) methodology to assess risks in the repair process prior to a
decision to repair the product. The organization shall obtain approval from the customer before commencing repair of the
product.
The organization shall have a documented process for repair confirmation in accordance with the control plan or other
relevant documented information.
Instructions for disassembly or repair, including re‐inspection and traceability requirements, shall be accessible to and
utilized by the appropriate personnel.
The organization shall obtain a documented customer authorization for concession for the product to be repaired.
The organization shall retain documented information on the disposition of repaired product including quantity,
disposition, disposition date, and applicable traceability information.
8.7.1.6 Customer notification

The organization shall immediately notify the customer(s) in the event that nonconforming product has been shipped.
Initial communication shall be followed with detailed documentation of the event.
8.7.1.7 Nonconforming product disposition

The organization shall have a documented process for disposition of nonconforming product not subject to rework or
repair. For product not meeting requirements, the organization shall verify that the product to be scrapped is rendered
unusable prior to disposal.
The organization shall not divert nonconforming product to service or other use without prior customer approval.
8.7.2 The organization shall retain documented information that:

a) describes the nonconformity;
b) describes the actions taken;
c) describes any concessions obtained;
d) identifies the authority deciding the action in respect of the nonconformity.
9. Performance Evaluation
9.1 Monitoring, measurement, analysis and evaluation
9.1.1 General
The organization shall determine:
a) what needs to be monitored and measured;
b) the methods for monitoring, measurement, analysis and evaluation needed to ensure valid results;
c) when the monitoring and measuring shall be performed;
d) when the results from monitoring and measurement shall be analysed and evaluated.
The organization shall evaluate the performance and the effectiveness of the quality management system. The
organization shall retain appropriate documented information as evidence of the results.
9.1.1.1 Monitoring and measurement of manufacturing processes

The organization shall perform process studies on all new manufacturing (including assembly or sequencing) processes to
verify process capability and to provide additional input for process control, including those for special characteristics.
NOTE: For some manufacturing processes, it may not be possible to demonstrate product compliance through process
capability. For those processes, alternate methods such as batch conformance to specification may be used.
The organization shall maintain manufacturing process capability or performance results as specified by the customer’s
part approval process requirements. The organization shall verify that the process flow diagram, PFMEA, and control plan
are implemented, including adherence to the following:
a) measurement techniques;
b) sampling plans;
c) acceptance criteria;
d) records of actual measurement values and/or test results for variable data;
e) reaction plans and escalation process when acceptance criteria are not met.
Significant process events, such as tool change or machine repair, shall be recorded and retained as documented
information.
The organization shall initiate a reaction plan indicated on the control plan and evaluated for impact on compliance to
specifications for characteristics that are either not statistically capable or are unstable. These reaction plans shall include
containment of product and 100 percent inspection, as appropriate. A corrective action plan shall be developed and
implemented by the organization indicating specific actions, timing, and assigned responsibilities to ensure that the
process becomes stable and statistically capable. The plans shall be reviewed with and approved by the customer, when
required.
The organization shall maintain records of effective dates of process changes.
9.1.1.2 Identification of statistical tools

The organization shall determine the appropriate use of statistical tools. The organization shall verify that appropriate
statistical tools are included as part of the advanced product quality planning (or equivalent) process and included in the
design risk analysis (such as DFMEA) (where applicable), the process risk analysis (such as PFMEA), and the control plan.
9.1.1.3 Application of statistical concepts

Statistical concepts, such as variation, control (stability), process capability, and the consequences of over‐adjustment,
shall be understood and used by employees involved in the collection, analysis, and management of statistical data.
9.1.2 Customer satisfaction

The organization shall monitor customers’ perceptions of the degree to which their needs and expectations have been
fulfilled. The organization shall determine the methods for obtaining, monitoring and reviewing this information.
NOTE: Examples of monitoring customer perceptions can include customer surveys, customer feedback on delivered
products and services, meetings with customers, market‐share analysis, compliments, warranty claims and dealer reports.
9.1.2.1 Customer satisfaction — supplemental

Customer satisfaction with the organization shall be monitored through continual evaluation of internal and external
performance indicators to ensure compliance to the product and process specifications and other customer requirements.
Performance indicators shall be based on objective evidence and include but not be limited to the following:
a) delivered part quality performance;
b) customer disruptions;
c) field returns, recalls, and warranty (where applicable);
d) delivery schedule performance (including incidents of premium freight);
e) customer notifications related to quality or delivery issues, including special status.
The organization shall monitor the performance of manufacturing processes to demonstrate compliance with customer
requirements for product quality and process efficiency. The monitoring shall include the review of customer performance
data including online customer portals and customer scorecards, where provided.
9.1.3 Analysis and evaluation

The organization shall analyse and evaluate appropriate data and information arising from monitoring and measurement.
The results of analysis shall be used to evaluate:
a) conformity of products and services;
b) the degree of customer satisfaction;
c) the performance and effectiveness of the quality management system;

d) if planning has been implemented effectively;
e) the effectiveness of actions taken to address risks and opportunities;
f) the performance of external providers;
g) the need for improvements to the quality management system.
NOTE: Methods to analyse data can include statistical techniques.
9.1.3.1 Prioritization
Trends in quality and operational performance shall be compared with progress toward objectives and lead to action to
support prioritization of actions for improving customer satisfaction.
9.2 Internal audit
9.2.1 The organization shall conduct internal audits at planned intervals to provide information
on whether the quality management system:
a) conforms to:
1. the organization’s own requirements for its quality management system;
2. the requirements of this International Standard;
b) is effectively implemented and maintained.
9.2.2 The organization shall:

a) plan, establish, implement and maintain an audit programme(s) including the frequency, methods,
responsibilities, planning requirements and reporting, which shall take into consideration the importance of the
processes concerned, changes affecting the organization, and the results of previous audits;
b) define the audit criteria and scope for each audit;
c) select auditors and conduct audits to ensure objectivity and the impartiality of the audit process;
d) ensure that the results of the audits are reported to relevant management;
e) take appropriate correction and corrective actions without undue delay;
f) retain documented information as evidence of the implementation of the audit programme and the audit
results.
NOTE: See ISO 19011 for guidance.
9.2.2.1 Internal audit programme

The organization shall have a documented internal audit process. The process shall include the development and
implementation of an internal audit programme that covers the entire quality management system including quality
management system audits, manufacturing process audits, and product audits.
The audit programme shall be prioritized based upon risk, internal and external performance trends, and criticality of the
process(es).
Where the organization is responsible for software development, the organization shall include software development
capability assessments in their internal audit programme.
The frequency of audits shall be reviewed and, where appropriate, adjusted based on occurrence of process changes,
internal and external nonconformities, and/or customer complaints. The effectiveness of the audit programme shall be
reviewed as a part of management review.
9.2.2.2 Quality management system audit

The organization shall audit all quality management system processes over each three‐year calendar period, according to
an annual programme, using the process approach to verify compliance with this Automotive QMS Standard. Integrated
with these audits, the organization shall sample customer‐specific quality management system requirements for effective
implementation.
9.2.2.3 Manufacturing process audit

The organization shall audit all manufacturing processes over each three‐year calendar period to determine their
effectiveness and efficiency using customer‐specific required approaches for process audits. Where not defined by the
customer, the organization shall determine the approach to be used.
Within each individual audit plan, each manufacturing process shall be audited on all shifts where it occurs, including the
appropriate sampling of the shift handover.
The manufacturing process audit shall include an audit of the effective implementation of the process risk analysis (such as
PFMEA), control plan, and associated documents.
9.2.2.4 Product audit

The organization shall audit products using customer‐specific required approaches at appropriate stages of production
and delivery to verify conformity to specified requirements. Where not defined by the customer, the organization shall
define the approach to be used.
9.3 Management review
9.3.1 General
Top management shall review the organization’s quality management system, at planned intervals, to ensure its
continuing suitability, adequacy, effectiveness and alignment with the strategic direction of the organization.
9.3.1.1 Management review — supplemental

Management review shall be conducted at least annually. The frequency of management review(s) shall be increased
based on risk to compliance with customer requirements resulting from internal or external changes impacting the quality
management system and performance‐related issues.
9.3.2 Management review inputs

The management review shall be planned and carried out taking into consideration:
a) the status of actions from previous management reviews;
b) changes in external and internal issues that are relevant to the quality management system;
c) information on the performance and effectiveness of the quality management system, including trends in:
customer satisfaction and feedback from relevant interested parties;
the extent to which quality objectives have been met;
process performance and conformity of products and services;
nonconformities and corrective actions;
monitoring and measurement results;
audit results;
the performance of external providers;
d) the adequacy of resources;
e) the effectiveness of actions taken to address risks and opportunities (see 6.1); f) opportunities for improvement.
9.3.2.1 Management review inputs — supplemental

Input to management review shall include:
a) cost of poor quality (cost of internal and external nonconformance);
b) measures of process effectiveness;
c) measures of process efficiency;
d) product conformance;
e) assessments of manufacturing feasibility made for changes to existing operations and for new facilities or new
product (see Section 7.1.3.1);
f) customer satisfaction (see ISO 9001, Section 9.1.2);
g) review of performance against maintenance objectives;
h) warranty performance (where applicable);
i) review of customer scorecards (where applicable);
j) identification of potential field failures identified through risk analysis (such as FMEA);
k) actual field failures and their impact on safety or the environment.
9.3.3 Management review outputs

The outputs of the management review shall include decisions and actions related to:
a) opportunities for improvement;
b) any need for changes to the quality management system;
c) resource needs.
The organization shall retain documented information as evidence of the results of management reviews.
9.3.3.1 Management review outputs — supplemental

Top management shall document and implement an action plan when customer performance targets are not met.
10. Improvement
10.1 General
The organization shall determine and select opportunities for improvement and implement any necessary actions to meet
customer requirements and enhance customer satisfaction.
These shall include:
a) improving products and services to meet requirements as well as to address future needs and expectations;
b) correcting, preventing or reducing undesired effects;
c) improving the performance and effectiveness of the quality management system.
NOTE: Examples of improvement can include correction, corrective action, continual improvement, breakthrough change,
innovation and re‐organization.
10.2 Nonconformity and corrective action
10.2.1 When a nonconformity occurs, including any arising from complaints, the organization shall:
a) react to the nonconformity and, as applicable:
1. take action to control and correct it;
2. deal with the consequences;
b) evaluate the need for action to eliminate the cause(s) of the nonconformity, in order that it does not recur or
occur elsewhere, by:
1. reviewing and analysing the nonconformity;
2. determining the causes of the nonconformity;
3. determining if similar nonconformities exist, or could potentially occur;
c) implement any action needed;
d) review the effectiveness of any corrective action taken;
e) update risks and opportunities determined during planning, if necessary; f) make changes to the quality
management system, if necessary.
Corrective actions shall be appropriate to the effects of the nonconformities encountered.
10.2.2 The organization shall retain documented information as evidence of:

a) the nature of the nonconformities and any subsequent actions taken;
b) the results of any corrective action.
10.2.3 Problem solving

The organization shall have a documented process(es) for problem solving including:
a) defined approaches for various types and scale of problems (e.g., new product development, current
manufacturing issues, field failures, audit findings);
b) containment, interim actions, and related activities necessary for control of nonconforming outputs (see ISO
9001, Section 8.7);
c) root cause analysis, methodology used, analysis, and results;
d) implementation of systemic corrective actions, including consideration of the impact on similar processes and
products;
e) verification of the effectiveness of implemented corrective actions;
f) reviewing and, where necessary, updating the appropriate documented information (e.g., PFMEA, control plan).
Where the customer has specific prescribed processes, tools, or systems for problem solving, the organization shall use
those processes, tools, or systems unless otherwise approved by the customer.
10.2.4 Error‐proofing
The organization shall have a documented process to determine the use of appropriate error‐proofing methodologies.
Details of the method used shall be documented in the process risk analysis (such as PFMEA) and test frequencies shall be
documented in the control plan.
The process shall include the testing of error‐proofing devices for failure or simulated failure. Records shall be maintained.
Challenge parts, when used, shall be identified, controlled, verified, and calibrated where feasible. Error‐proofing device
failures shall have a reaction plan.
10.2.5 Warranty management systems

When the organization is required to provide warranty for their product(s), the organization shall implement a warranty
management process. The organization shall include in the process a method for warranty part analysis, including NTF (no
trouble found). When specified by the customer, the organization shall implement the required warranty management
process.
10.2.6 Customer complaints and field failure test analysis

The organization shall perform analysis on customer complaints and field failures, including any returned parts, and shall
initiate problem solving and corrective action to prevent recurrence.
Where requested by the customer, this shall include analysis of the interaction of embedded software of the organization’s
product within the system of the final customer’s product.
The organization shall communicate the results of testing/analysis to the customer and also within the organization.
10.3 Continual improvement

The organization shall continually improve the suitability, adequacy and effectiveness of the quality management system.
The organization shall consider the results of analysis and evaluation, and the outputs from management review, to
determine if there are needs or opportunities that shall be addressed as part of continual improvement.
10.3.1 Continual improvement — supplemental

The organization shall have a documented process for continual improvement. The organization shall include in this
process the following:
a) identification of the methodology used, objectives, measurement, effectiveness, and documented information;
b) a manufacturing process improvement action plan with emphasis on the reduction of process variation and
waste;
c) risk analysis (such as FMEA).
NOTE: Continual improvement is implemented once manufacturing processes are statistically capable and stable or when
product characteristics are predictable and meet customer requirements.
Annex A: Control Plan – supplemental automotive

A.1 Phases of the control plan
A control plan covers three distinct phases, as appropriate:
a) Prototype: a description of the dimensional measurements, material, and performance tests that will occur
during building of the prototype. The organization shall have a prototype control plan, if required by the
customer.
b) Pre‐launch: a description of the dimensional measurements, material, and performance tests that occur
after prototype and before full production. Pre‐launch is defined as a production phase in the process of
product realization that may be required after prototype build.
c) Production: documentation of product/process characteristics, process controls, tests, and measurement
systems that occur during mass production.
Control plans are established at a part number level; but in many cases, family control plans may cover a number of
similar parts produced using a common process. Control plans are an output of the quality plan.
NOTE 1: It is recommended that the organization require its suppliers to meet the requirements of this Annex.
NOTE 2: For some bulk materials, the control plans do not list most of the production information. This information
can be found in the corresponding batch formulation/recipe details.
A.2 Elements of the control plan

A control plan includes, as a minimum, the following contents:
General data
a) control plan number;
b) issue date and revision date, if any;
c) customer information (see customer requirements);
d) organization's name/site designation;
e) part number(s);
f) part name/description;
g) engineering change level;
h) phase covered (prototype, pre‐launch, production);
i) key contact;
j) part/process step number;
k) process name/operation description;
l) functional group/area responsible.
Product control
a) product‐related special characteristics;
b) other characteristics for control (number, product or process);
c) specification/tolerance;
Process control
a) process parameters (including process settings and tolerances);
b) process‐related special characteristics;
c) machines, jigs, fixtures, tools for manufacturing (including identifiers, as appropriate);
Methods
a) evaluation measurement technique;
b) error‐proofing;
c) sample size and frequency;
d) control method;
Reaction plan
a) reaction plan (include or reference);
Annex B: Bibliography – supplemental automotive

Internal audit
AIAG
CQI‐8 Layered Process Audit
CQI‐9 Special Process: Heat Treatment System Assessment
CQI‐11 Special Process: Plating System Assessment
CQI‐12 Special Process: Coating System Assessment CQI‐15 Special
Process: Welding System Assessment CQI‐17 Special Process: Soldering
System Assessment CQI‐23 Special Process: Molding System
Assessment CQI‐27 Special Process: Casting System Assessment
ANFIA
AQ 008 Process Audit
FIEVA
V2.0 Production Process Audit Manual
IATF
Auditor Guide for IATF 16949
VDA
Volume 6 part 3 Process Audit
Volume 6 part 5 Product Audit
Nonconformity and corrective action

AIAG
CQI‐14 Automotive Warranty Management Guideline
CQI‐20 Effective Problem Solving Practitioner Guide
VDA
Volume “Audit standard field failure analysis”
Volume “Field failures analysis”
Measurement systems analysis

AIAG
Measurement Systems Analysis (MSA)
ANFIA
AQ 024 MSA Measurement Systems Analysis
VDA
Volume 5 “Capability of Measuring Systems”
Product approval
AIAG
Production Part Approval Process (PPAP)
VDA
Volume 2 Production process and product approval (PPA)
Volume 19 Part 1 (“Inspection of Technical Cleanliness ‐ Particulate Contamination of Functionally Relevant
Automotive Components”)
Volume 19 Part 2 (“Technical cleanliness in assembly ‐ Environment, Logistics, Personnel and Assembly Equipment”)
Product design
AIAG
APQP and Control Plan
CQI‐24 Design Review Based on Failure Modes (DRBFM Reference Guide) Potential Failure Mode & Effects Analysis
(FMEA)
ANFIA
AQ 009 FMEA
AQ 014 Manual of Experimental Design AQ 025 Reliability Guide
VDA
Volume 4 Chapter Product and Process FMEA
Volume VDA‐RGA “Maturity Level Assurance for New Parts” Volume “Robust Production Process”
Volume Special Characteristics (SC)
Production control
AIAG
MMOG/LE Materials Management Operational Guidelines / Logistics Evaluation
SMMT
Implementing Standardised Work
Quality management system administration

ANFIA
AQ 026 Managing and improving the process
IATF
Rules for achieving and maintaining IATF recognition
Risk analysis
VDA
Volume 4 “Ring‐binder” (elementary aids, risk analyses, methods, and process models)
Software Process Assessment

Capability Maturity Model Integration (CMMI)
VDA
Automotive SPICE® (Software Process Improvement and Capability Determination)
Statistical tools
AIAG
Statistical Process Control (SPC)
ANFIA
AQ 011 SPC
Supplier quality management

AIAG
CQI‐19 Sub‐Tier Supplier Management Process Guideline
IATF
Minimum Automotive Quality Management System Requirements for Sub‐Tier Suppliers (MAQMSR)
Health and safety

ISO
ISO 45001 Occupational health and safety management systems

ISO9001 and IATF 16949 Combined - Reference

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ISO 9001:2015 and

Quality Management Systems — Requirements ............................................................................ 5

3. Terms and Definitions .............................................................................................................. 6

4. Context of the Organization ..................................................................................................... 9

9. Performance Evaluation ......................................................................................................... 43

Annex A: Control Plan .........................................................................................................................................50

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• uniformity in the structure of different quality management systems;

• “shall” indicates a requirement;

0.2 Quality Management Principles

0.3 Process Approach

0.3.2 Plan‐Do‐Check‐Act Cycle

NOTE: Numbers in brackets refer to the clauses in this International Standard.

0.3.3 Risk‐based thinking

0.4 Relationship with other Management System Standards

Quality Management Systems — Requirements

1.1 Scope – automotive supplemental to ISO 9001:2015

2.1 Normative and informative references

3. Terms and Definitions

performance within the customer's specified application.

4. Context of the Organization

4.2 Understanding the Needs and Expectations of Interested Parties

4.3 Determining the Scope of the Quality Management System

4.3.1 Determining the scope of the quality management system — supplemental

4.3.2 Customer‐specific requirements

4.4 Quality management system and its processes

4.4.1.1 Conformance of products and processes

4.4.1.2 Product safety

4.4.2 To the extent necessary, the organization shall:

5.1.1.1 Corporate responsibility

5.1.1.2 Process effectiveness and efficiency

5.1.1.3 Process owners

5.1.2 Customer focus

5.2.1 Establishing the quality policy

5.2.2 Communicating the quality policy

5.3 Organizational roles, responsibilities and authorities

5.3.1 Organizational roles, responsibilities, and authorities — supplemental

6.1.2 The organization shall plan:

6.1.2.1 Risk analysis

6.1.2.2 Preventive action

6.1.2.3 Contingency plans

6.2 Quality objectives and planning to achieve them

The organization shall maintain documented information on the quality objectives.

6.2.2.1 Quality objectives and planning to achieve them — supplemental

6.3 Planning of changes

7.1.3.1 Plant, facility, and equipment planning

7.1.4 Environment for the operation of processes

7.1.4.1 Environment for the operation of processes — supplemental

7.1.5 Monitoring and measuring resources

7.1.5.1.1 Measurement systems analysis

7.1.5.2 Measurement traceability

7.1.5.2.1 Calibration/verification records

7.1.5.3 Laboratory requirements

7.1.5.3.1 Internal laboratory

7.1.5.3.2 External laboratory

7.1.6 Organizational knowledge

7.2.1 Competence — supplemental

7.2.2 Competence — on‐the‐job training