Checklist ISO TS

Table for planing and review of process oriented application of ISO/TS 16949:200
Auditor: Audit-Reference No.:
applicable
Section is
Audited Site: Processname: Audited supporting
Function/Activity
Audited activities:
4 Quality management system

4.1 General requirements
4.1.1 General requirements - Supplemental
4.2 Documentation requirements
4.2.1 General
4.2.2 Quality manual
4.2.3 Control of documents
4.2.3.1 Engineering specifications
4.2.4 Control of records
4.2.4.1 Records retention
5 Management responsability
5.1 Management commitment
5.1.1 Process efficiency
5.2 Customer focus
5.3 Quality Policy
5.4 Planning
5.4.1 Quality Objetives
5.4.1.1 Quality Objetives - Supplemental
5.4.2 Quality management system planning
5.5 Responsability, authority and communication
5.5.1 Responsability and authority
5.5.1.1 Responsability for quality
5.5.2 Management representative
5.5.2.1 Customer Representative
5.5.3 Internal communication
5.6 Management review
5.6.1 General
5.6.1.1 Quality managemente system performance
5.6.2 Review imput
5.6.2.1 Review input - Supplemetal
5.6.3 Review output
6 Resource management
6.1 Provision of resources
6.2 Human resources
6.2.1 General
6.2.2 Competence, awareness and training
6.2.2.1 Product desing skill
6.2.2.2 Training
6.2.2.3 Training on the job
6.2.2.4 Employee motivation and empowerment
6.3 Infraestructure
6.3.1 Plant, facility and equipment planning
6.3.2 Contingency plans
6.4 Work environment
6.4.1 Personnel safety to achieve product quality
6.4.2 Cleanliness of premises
7 Product realization
7.1 Planning of product realization
7.1.1 Planning of product realization - Supplemental
7.1.2 Acceptance criteria
7.1.3 Confidentiality
7.1.4 Change control
7.2 Customer-related processes
7.2.1 Determination of requeriments related to the product
7.2.1.1 Customer-designated special characteristics
7.2.2 Review of requeriments related to the product
7.2.2.1 Review of requeriments related to the product - Suppl.
7.2.2.2 Organization manufacturing feasibility
7.2.3 Customer communication
7.2.3.1 Customer communication - Suplemental
7.3 Design and development
7.3.1 Design and developent planning
7.3.1.1 Multidisciplinary approach
7.3.2 Design and development inputs
7.3.2.1 Product design input
7.3.2.2 Manufacturing process design input
7.3.2.3 Special characteristics
7.3.3 Design and development outputs
7.3.3.1 Product design outputs - Supplemental
7.3.3.2 Manufacturing process design output
7.3.4 Design and development review
7.3.4.1 Monitoring
7.3.5 Desing and development verification
7.3.6 Design and development validation
7.3.6.1 Design and development validation - Supplemental
7.3.6.2 Prototype programme
7.3.6.3 Product approval process
7.3.7 Control of design and development changes
7.4 Purchasing
7.4.1 Purchasing process
7.4.1.1 Regulatory conformity
7.4.1.2 Supplier quality management system development
7.4.1.3 Customer-approved sources
7.4.2 Purchasing information
7.4.3 Verification of purchased product
7.4.3.1 Incoming product quality
7.4.3.2 Supplier monitoring
7.5 Production and service provision
7.5.1 Control of production and service provision
7.5.1.1 Control Plan
7.5.1.2 Work instructions
7.5.1.3 Verification of job set-ups
7.5.1.4 Preventive and predictive maintenance
7.5.1.5 Management of production tooling
7.5.1.6 Production scheduling
7.5.1.7 Feedback of information from service
7.5.1.8 Service agreement with customer
7.5.2 Validation of processes for production and service provision
7.5.2.1 Validation of processes for product. And service prov. - Suppl.
7.5.3 Identification and traceability
7.5.3.1 Identification and traceability - Supplemental
7.5.4 Customer property
7.5.4.1 Customer-owned prouction tooling
7.5.5 Preservation of product
7.5.5.1 Storage and inventory
7.6 Control of monitoring and measuring devices
7.6.1 Measurement system analysis
7.6.2 Calibration/verification records
7.6.3 Laboratory requeriments
7.6.3.1 Internal laboratory
7.6.3.2 External laboratory
8 Measurement, analysis and improvement
8.1 General
8.1.1 Identification of statiscal tools
8.1.2 Knowledge of basic statistical concepts
8.2 Monitoring and measurement
8.2.1 Customer satisfaction
8.2.1.1 Customer satisfaction - Supplemental
8.2.2 Internal audit
8.2.2.1 Quality management system audit
8.2.2.2 Manufacturing process audit
8.2.2.3 Product audit
8.2.2.4 Internal audits plans
8.2.2.5 Internal auditor qualification
8.2.3 Monitoring and measurement
8.2.3.1 Monitoring and measurement of manufacturing processes
8.2.4 Monitoring and measurement of product
8.2.4.1 Layout inspection and functional testing
8.2.4.2 Appearance items
8.3 Control of nonconforming product
8.3.1 Control of nonconforming product - Supplemental
8.3.2 Control of reworked product
8.3.3 Customer information
8.3.4 Customer waiver
8.4 Analysis of data
8.4.1 Analysis and use of data
8.5 Improvement
8.5.1 Continual improvement
8.5.1.1 Continual improvement of the organization
8.5.1.2 Manufacturing process improvement
8.5.2 Corrective action
8.5.2.1 Problem solving
8.5.2.2 Error proofing
8.5.2.3 Corrective action impact
8.5.2.4 Reject product test/analysis
8.5.3 Preventive action
Annex A (normative) Control plan
A.1 Phases of the control plan
A.2 Elements of the control plan
Customer Requirements
Customer Requirements 1:
Customer Requirements ….
ISO/TS 16949:2009 checklist
(NR) Needs Further

Research
Audited interface to -
Checklist Question (OI) Opportunities for
( I ) Input
(s)-No. Improvement
- ( O ) Output
(NC) Non-
Conformance
Checklist ISO/TS 16949:2009
Requirements What to look for Asessor notes / Objetives evidence

ELEMENT 4 - Quality management system
4.1 General Requirements
Has the organization established and * Quality manual according to ISO/TS
documented a quality management system in 16949:2002 or one with a conversion matrix.
4.1.1
accordance with the requirements of ISO/TS
16949:2002? (4.1)
* Key personnel interview.
Has the organization implemented and
* Examples of effective implementation.
maintained its established quality
4.1.2
management system in accordance with the
requirements of ISO/TS 16949:2002 (4.1)
* Examples and status of quality management

Is the organization continually improving the
system continuos improvement projects, not
effectiveness of its quality management
4.1.3 corrective actions. *
system in accordance with the requirements
Management review results
of ISO/TS 16949:2002? (4.1.1.1)
* Quality manual according to ISO/TS

Does the organization's quality management 16949:2002 or one with a conversion matrix.
system:
a) identify the processes needed for the
quality management system and their
application throughout the organization?
4.1.4
b) determine the sequence and interaction of
these processes?
c) determine criteria and methods needed to
ensure that both the operation and control of
these processes are effective? (4.1. a,b,c)
Does the organization's quality management * Review of all the elements of quality
system: a) management system to insure its continuing
ensure the availability of resources and suitability and effectivenesss. *
information necessary to support the Review of quality cost indicators.
operation and monitoring of the processes * Management review meeting minutes,
needed for its quality management system? attendance and adequate frequency. *
4.1.5 b) monitor, measure and Action plans and follow-up
analyze the processes needed for its quality
management system?
c) implement actions necessary
to achieve planned results and continual
improvement of the processes needed for its
quality management system? (4.1.d, e, f)
Does the organization manage the processes

needed for its quality management system is
4.1.6
accordance with the requirement of ISO/TS
16949:2002? (4.1)
Does the organization ensure control over

4.1.7 outsource processes that affects product
conformity with requirements? (4.1)
Is the control organization's outsourced * Quality manual according to ISO/TS
processes that effects product conformity with 16949:2002 or one with a conversion matrix.
4.1.8
requirements identified within the quality
management system? (4.1)
ELEMENT 4.2 Documentation requirements
4.2.1 General
Does the quality management system * Quality manual according to ISO/TS
documentation include the following: a) 16949:2002 or one with a conversion matrix. *
documented statements of a quality policy Adequacy of the procedures to the complexity of
and quality objectives? the organziaton. *
b) a quality manual? Quality management system procedures. *
c) documented procedures required by Quality records.
4.2.1
ISO/TS 16949:2002?
d) documents needed by the organization
to ensure the effective planning, operation
and control of it processes?
e) records required by ISO/TS
16949:2002 (see element 4.2.4)? (4.2.1)
4.2.2 Quality Manual
maintained a quality manual that includes: a) 16949:2002 or one with a conversion matrix.
the scope of the quality management system,
including details of and justification for any
exclusions (see section 1.2 of ISO/TS
16949:2002)?
4.2.2
b) the documented procedures
established for the quality management
system, or reference to them?
c) a description of the interaction
between the processes of the quality
management system? (4.2.2)
4.2.3 Control of documents
Does the organization control the documents * Quality manual according to ISO/TS
4.2.3 required by the quality management system? 16949:2002 or one with a conversion matrix. *
(4.2.3) Document control master list or equivalent.
Has the organization established a * Document approval authority
documented procedure to define controls * Document approval records.
needed: * Availability of documents in various
a) to approve documents for adequacy prior locations. * Knowledge of document location.
to issue? b) * Document accessibilit. * Storage and
to review and update as neccesary and re- disponsal of obsolete documents. *
approve documents? Process for notification/distribution of
c) to ensure that changes and the current documents from internal and external origins.
revision status of documents are identified? * Review and approval of revised documents.
d) to ensure that relevante versions of
4.2.4
applicable documents are available at points
of use?
e) to ensure that documents remain legible
and readily identifiable. f)
to ensure documents of external origin are
identified and their distribution controlled?
g) to prevent the unintended use of obsolete
documents, and to apply suitable
identification to them if they are retained for
any purpose? (4.2.3)
4.2.3.1 Enginnering specifications

Does the organization have a process to * Process for notification/distribution of
assure the timely review, distribution and customer engineering standards changes.
implementation of all customer engineering * Process for implementation of customer
4.2.5 standards/specifications and changes initiated changes. *
(including the updating of appropriate Document changes triggered by engineering
documents) based on customer required changes.
schedule? (4.2.3.1)
Does the organization maintain a record of * Records of engineering changes implemented.
4.2.6 the date on wich each change is implemented
in production? (4.2.3.1)
4.2.4 Control of records
Has the organization established and * Quality management system records. *
maintained records to provide evidence of Records maintenance system, including disposal
4.2.7 conformity to requirements and of the of records.
effective operation of the quality management
system? (4.2.4)
Are records legible, readily identifiable and * Quality management system records legibility.
retrievable? (4.2.4 *
Identification of quality management system
4.2.8 records.
* Environment and storage conditions must be
compatible with the file storage medium (ex;
hard, copy, floppy, disk, etc).
Has the organization established a * Quality manual according to ISO/TS
documented procedure to define controls 16949:2002. *
needed for the identification, storage, Defined record retention time compared to
protection, retrieval, retention time and customer/regulatory requirements.
4.2.9 disposition of records? ( 4.2.4) * Records disposal after retention period
expires.
* Including identification of obsolescence
documents.
* Identification of invalid/obsolete documents.
Does the organization treat quality records as * Evidence of quality records records being
a special type of document and control them maintained and controlled per quality manual.
4.2.10
according to the requirements given in
questions 4.2.7 and 4.2.8? ( 4.2.4)
5 - Management responsability
5.1 Management commitment
Does top management have evidence of * Documented policy statement with clearly
rpoviding commitment to the development defined and measurable quality objetives
5.1.1
and implementation of its quality approved by CEO.
*Customer defined objetives (Customer
Does the organization's top management specifications) adn company goals stated in the
have evidence of providing commitment to business plan and their alignment quith the
continually improving its quality management quality policy statement. *
system effectiveness by Quality manual according to ISO/TS
a) communicating to the organization the 16949:2002.
importance of meeting customer as well as * Management reviews meeting minutes,
5.1.2
statutory and regulatory requirements? attendance and adequate frecuency.
b) establishing the quality policy? * Action plans and follow-up.
c) essuring that quality objetives are
established?
d) conducting management reviews?
e) ensuring the availability of resources? (5.1)
5.1.1 Process Efficiency

Does organization's top management monitor * Review o product realization and support
the product realization processes and the processes by top management.
5.1.3
support processes to assure their * Indicators and records.
effectiveness and efficiency? (5.1.1) * Reporting process.
Customer performance reviews
Does top management ensure that customer * Description of an objetive process.
requirements are determined and fulfilled * Methodology use for surveys.
5.2.1 with the aim of enchancing customer * Original Customer data and scope such as
satisfaction? (5.2) customer satisfaction feedback (surveys,
scorecards, awards, etc.).
5.3 Quality Policy
Does top management ensure that the quality * Documented policy statement with clearly
policy: a) is defined and measurable quality objetives
appropriate to the purpose of the approved by CEO. *
organization? Records of improvement. *
b) includes a commitment to comply with Quality objetives included/linked to the business
requirements and continually improve the plan. * Scope
effectiveness of the quality management of the Quality objetives. * Direct
5.3.1 system? iterviews with randomly selected people of the
c) provides a framework for establishing and organization. * Evidence of
reviewing quality objetives? periodic review of the quality policy.
d) is communicated and understood within * Review of all the
the organization? e) is reviewed for elements of the quality system to insure its
continuing suitability? (5.3) continuing suitability and effectiveness.
5.4 Quality objectives

Does the organization's top management
ensure that quality objectives, including those
needed to meet requirements for product
5.4.1 (see section of the ISO/TS 16949:2002
technical specification) are established at
relevant functions and levels within the
organization? (5.4.1)
Are the organization's quality objectives *Quality cost indicators and quality indices. *
5.4.2 measurable and consistent with the quality Quality objectives included/linked to the
policy? (5.4.1) business plan.
Did top management define any quality * Quality objectives included/linked to the
5.4.3 objectives and measurements? (5.4.1.1) business plan. *
Scope of the Quality objectives.
Are the organization's quality objectives and * Quality objectives included/linked to the
measurements included in the business plan business plan. *
5.4.4 and used by top management to deploy the Management review meeting minutes,
oorganization's quality policy? (5.4.1.1) attendance and adequate frecuency..
5.4.2 Quality management system planning

Does top management of the organization * Internal audits results.
ensure that
a) the planning of the quality management
system is carried out in order to meet the
general quality management system
requirements stated in section 4.1 of ISO/TS
5.4.5
16949:2002, as well as the quality
objectives? b)
the integrity of the quality management
system is maintained when changes to the
quality management system are planned and
implemented (5.4.2)
Job descritions and
5.5.1 Responsability and authority
Does the organization's top management * Responsabilities and authority as defined in
ensure that the responsabilities and job descriptions, responsibilities matrices,
5.5.1
authorities are difined and communicated procedures and accntabilities documents.
within the organization? (5.5.1)
5.5.1.1 Quality responsability
Is management with responsability and * Select examples of non-compliance from
authority for corrective action promptly suitable sources sush as internal or external
5.5.2
informed of products or processes that do not concerns/complaints, etc. *
conform to requirements? (5.5.1.1) Communication channels and timeliness.
Does the organization's personnel responsible * Who is responsible for quality in the
for quality have the authority to stop production process? *
5.5.3
production to correct qualit problems? How the authority is defined. *
(5.5.1.1) Recent examples.
* Quality assurance responsible personnel in all
Are the organization's production operations
shifts.
5.5.4 staffed with pesonnel that ensure product
quality across all shifts? (5.5.1.1)
Q
Did the organization's stop management * Who is the person in charge of this
appoint a member of management who, responsability?
irrespective of other responsabilities, shall * Evidence of activities performed including
have responsability and authority that empowerment for all applicable system
includes elements including design, sales, manufacturing,
a) ensuring that processes needed for the delivery, etc. * Management
quality management system are established, review minutes.
5.5.5
implemented and maintained?
b) reporting to top management on the
performace of the quality management
system and any need for improvement?
c) ensuring the promotion of awareness of
customer requirements throughout the
5.5.2.1 Customer representative
* Quality function representative in project
Did the organization's stop management
teams. *
design individual(s) to represent the needs of
Quality function participation in milestones
the customer to address quality requirements,
decision points (production realese, engineering,
5.5.6 such as selection of special characteristics,
release,…). *
setting quality objectives and related training,
Responsabilities and job description of the
corrective and preventive actions, product
customer representative (ex Quality function).
design and development? (5.5.2.1)
5.5.3 Internal communication

Does top management ensure that * Communication channels and timeliness
5.5.7 appropriate communication processes are
established within the organization? (5.5.3)
Does top management ensure that * Communication channels and timeliness
communication takes place within the
5.5.8
organization regarding the effectiveness of
the quality management system? (5.5.3)
Does the organization's top management * Review of all the elements of quality system to
review its quality management system, at insure its continuing suitability and
planned intervals, to ensure its continuing effectivenesss. *
5.6.1 suitability, adequacy and effectiveness? Review of quality cost indicators.
(5.6.1) * Management review meeting minutes,
attendance and adequate frecuency. *
Action plans management reviews.
* Evidence of continuos improvement projects
Do the organization's management reviews
iniated from management reviews.
include assessing opportunities for
5.6.2
improvement and the need for changes to the
quality policy and quality objectives? (5.6.1)
Are the organization's records from * Retention of management reviews meeting

5.6.3
management reviews maintained? (5.6.1) minutes.
5.6.1.1 Quality management system performance
Do the management reviews include all * Review of all the elements of the quality
elements of the quality management system system to insure its continuing suitability and
and its performance trends as an essential effectiveness. *
5.6.4
part of the continual improvement process? Trend in metrics (business and customer
(5.6.1.1) satisfaction). *
Basis for continuos improvement projects.
Do the management reviews include * Policy, business plan and customer satisfaction
monitoring of quality objectives, and the metrics reports. * Product
5.6.5 regular reporting and evaluation of the cost of results (quality, cost, time) againnst quality
poor quality (see elements 8.4.1 and 8.5.1 of policy goals and customer specified tagets.
ISO/TS 16949:2002))? (5.6.1.1)
Are the results of the management reviews * Trend in metrics (business and customer
recorded to provide, as minimum, evidence of satisfaction). *
the achievement of: Basis for continuos improvement projects. *
5.6.6 a) objectives specified in the quality policy? Management review meeting minute. *
b) objectivesspecified Actions plans ad follow-up
in the business plan? c) customer satisfaction
with product supplied? (5.6.1.1)
5.6.2 Review input
* Reports prepared for management reviews. *
Does the organization's input to its Management review meeting minutes. *
management review include information on: Action plans and follow-up. *
a) results of audits? Content of management review meeting
b) customer feedback? agenda.
c) process performance and product
conformity? d)
5.6.7 status of preventive and corrective actions?
e) follow-up
actions from previous management reviews?
f) planned changes that
could affect the quality management system?
g) recommendations for
improvement? (5.6.2)
5.6.2.1 Review input - Supplemental

Do management reviews include an analysis * Content of management review meeting
of actual and potential field-failures and their agenda.
5.6.8
impact on quality, safety, or the environment?
(5.6.2.1)
5.6.3 Review output
Does the output from the organization's * Examples of continuos improvement projects
management review include any decisions intiated from management reviews. *
and actions related to: Examples of product improvements intiated from
a) improvement of the effectiveness of the management reviews.
5.6.9 quality management system and its
processes?
b) improvement of product related to
customer requirements? c)
resource needs? (5.6.3)
6 Resource management
6.1 Provision of resources
Does the organization determine and provide * job descriptions.
the resources needed * Training record. *
a) to implement and maintain the quality Quality Plans. *
6.1.1 management system and continually improve Shift staffing/supervision *
is effectiveness? Personnel workload.
b) to enhance customer satisfaction by
meeting customer requirements? (6.1
6.2 Human resources
6.2.1 General
Are the personnel performing work affecting * Training records complementing the type of
product quality competent on the basis of work that personnel perform on the product.
6.2.2
appropriate education, training, skils and * Personnel records. *
experience? (6.2.1) Interviews with design personnel.
6.2.2 Competence, awareness and training
Does the organization a) * job descriptions.
determine the necessary competence for * Qualification for each position.
personnel performing work affecing product * Training Plans.
quality? b) * Training records.
provide training or take other actions to
satisfy these needs?
c) evaluate the effectiveness of the actions
6.2.3 taken?
d) ensure that its personnel are aware of the
relevance and importance of their activities
and how they contribute to the achievement
of the quality objectives?
e) maintain appropiate records of
education, training, skills and experience?
(6.2.2)
6.2.2.1 Products design skills

Does the organization ensure that personnel * Training records complementing the type of
with product design responsibility are design activity. *
6.2.4 qualified to achieve design requirements and Personnel records. *
are skilled in applicable tools and techiques? Interviews with design personnel.
(6.2.2.1)
Has the organization identified applicable * Listing of tools needed for product design.
tools and techniques needed for product * Personnel tarining on product design
6.2.5
design? (6.2.2.1) techniques needed.
* PO(s) n tools needed.
6.2.2.2 Training
maintained document procedures for 16949:2002
6.2.6 identifying trainning needs and achieving
competence of all personnel performing
activities affecting product quality. (6.2.2.2)
Are the personnel performing specific * Training records complementing the type of
assigned tasks qualified on the basis of tasks assigned to personnel.
6.2.7
education, training, skills and/or experience, * Personnel records. *
as required? (6.2.2.2) Interviews with personnel.
Has the organization given attention to * Evidence of personnel training that satisfies
6.2.8 training taht satisfies customer specific customer specific requirements.
requirements? (6.2.2.2)
6.2.2.2 Training
* Training records for personnel in new
Does the organization provide on the job
assignments.
training for personnel in any new or modified
6.2.9 * Training records for contract personnel.
job affecting product quality including
contract or agency personnel? (6.2.2.3)
Are the personnel affecting quality, informed * Training contents.

about the consequences to the customer of
6.2.10
nonconformity to quality requirements?
(6.2.2.3)
6.2.2.2 Training
Does the organization have a process for * Incentive systems used.
motivation of employees to achieve quality
6.2.11 objectives, to make continual improvements,
and create an environment to promote
innovation? (6.2.2.4)
Does the organization's employee motivation * Scope of employee motivation
process include promotion of quality and
6.2.12
technological awareness through the whole
organization? (6.2.2.4)
Does the organizaton have a process for * Measurement of employee satisfaction.
measurement to ensure that its personnel are
aware of the relevance and importance of
6.2.13
their activities and how they contribute to the
achievement of the quality objectives?
(6.2.2.4)
6.3 Infraestructure
Does the organization determine, provide and
16949:2002.
6.3.1 mantain the infrastructure needed to achieve
* Products results - internal and external
conformity to product requirements? (6.3)
product failure rate.
6.3.1 Plant, facility and equipment planning
Does the organization use a multidisciplinary * Team composition has to be cross-functional.
6.3.2 approach for developing plant, facility and
equipment plans? (6.3.1)
Is the organization's plant layouts optimized * Process flow analysis. *
for material travel, handling and value-added Plant layout (current and planned).
6.3.3
use of floor space and shall facilitate
synchronous material flow? (6.3.1
Has the organization developed and * Metrics for ergonomics, automation, line
implemented methods to evaluate and balance, inventory levels.
6.3.4
monitor the effectiveness of existing
operations? (6.3.1)
6.3.2 Contingency plans
* Contingency plans.
Has the organziation prepare contingency
* Identification of Key Equipment.
plans to satisfy the customer requirements in
6.3.5 the event of an emergency sush as utility
interruptions, labour shortages, key
equipment failure, and field returns? (6.3.2)
6.4 Work environment

Does the organization determine and manage
16949:2002.
6.4.1 the work environment needed to achieve
conformity to product requirements? (6.4)
6.4.1 Personnel safety

Does the organization's quality policy and * Preventice activities in design and process
practices address product safety and means control.
to minimize potential risks to employees, * Knowledge and application of legislation.
especially in design and development process * Risk analysis sush as FMEA.
6.4.2 and in the manufacturing process activities? * Results of internal/external audits including:
(6.4.1) a) System certifications,
b) Corrective actions.
* Records of accidents.
* Safety related customer complaints.
6.4.2 Cleanliness of premises
Does the organization maintain its premises in * Tour of plan
6.4.3 a state of order cleanliness and repai
consistent with the product? (6.4.2)
7 Product realization
7.1 Planning of product realization
Has the organization planned and developed * Quality planning process. *
7.1.1 the processes needed for product realization? Project planning process. *
(7.1) Quality plans for new products.
Is the organization's planning of product * Development of Quality plan(s).
realiization consistent with the requirements
7.1.2
of the other processes of the qualit
* Quality plan and design record, control plan,
In planning product realization, does the operator instructions, product approval records,
organization determine the following, as resources/facilities and any plans to enhance
appropriate: them. *
a) quality objectives and requirements for Design validation at the various stages of the
the product? b) design. *
the need to establish processes, documents, Link between process changes and updates in
and provide resources specific to the product? the quality plan(s).
7.1.3
c) required
verification, validation, monitoring, inspection
and test avtivities specific to the product and
the criteria for product acceptance?
d) records needed to provide
evidence that the realization processes and
resulting product meet requirements? (7.1)
Is the organization's planning of product * Product realization output format & content.
7.1.4 realiization output in a from suitable for the
organzation's method of operations? (7.1)
7.1.1 Planning of product realization - supplemental
Are the customer requirements and * Quality plans.
references to its technical specifications * Customer specifications. *
7.1.5
included in the planning of product realization Technical specifications.
as a quality plan? (7.1.1)
7.1.2 Acceptance criteria
Did the organization define acceptance * Test specification. *
criteria for the product beig developed and Product validation test plan with defined
7.1.6
where required, approved by the customer? acceptance criteria.
(7.1.2)
* Acceptance criteria in test plan ans test
Is the organization's acceptance criteria for
7.1.7 specifications.
atribute data sampling zero defects? (7.1.2)
7.1.3 Confidentiality
Does the organization ensure the * Information acces security.
confidentiality of customer contracted * Security for product development.
7.1.8
products and projects under development,
and related product information? (7.1.3)
7.1.4 Change Control
Does the organization have a process to * Engineering change request process.
control and react to changes that impact * Change records.
7.1.9
product realization including those initiated by
the supplier? (7.14)
Does organization assess the effects of * Impact study including proprietary design. *
7.1.10
changes? (7.1.4) Change management process.
Has the organization defined the verification * Test specification. *
and validation activities for changes, to Product validation test plan with defined
7.1.11
ensure compliance with customer acceptance criteria.
requirements? (7.1.4)
Does the organization validate changes before * Evidence of design and production validation
7.1.12 tests conducted for products changes.
implementation? (7.1.4)
Does the organizaton review proprietary * Impact study including proprietary design. *
designs, impact on form, fit, function, Change management process.
7.1.13 (inclunding performace, and/or durability)
with the customer so that all effects can be
properly evaluated (7.1.4)
* Design and production validation rest report.
Does the organization meet additional
verification/identification requirements such
7.1.14
as those required for new product itroduction
when required by the customer? (7.1.4)
7.2 Customer-related processes

7.2.1 Determination of requirements related to the product
Does the organization determine: * Process for government, safety an
a) requirements specified by the customer, environmental regulations compliance. *
including the requirements for delivery and Organization's internal product specification.
post-delivery activities?
b) requirements not stated by the customer
7.2.1 but necessary for specified or intended use,
where known? c)
statutory and regulatory requirements related
to the product? d) any
additional requirements determined by the
7.2.1.1 Customer designated special characteristics
Can the organization demostrate conformity * Designation and control of special
to customer requirements for designation, characteristics. * Quality documents: control
7.2.2
documentation and control of special plan, specifications, drawings, etc shall report
characteristics? (7.2.1.1 special characteristics designation.
7.2.2 Review of requirements related to the product
Does the organizations review the * Feasibility studies.
requirements related to a product prior to the
7.2.3
organization's commitment supply to the
customer? (7.2.2)
Does the organization ensure that a) product * Customer contract review. *
requirements are defined? B) contract or Product specification review. *
order requirements differing from those Resolution of differences. *
7.2.4
previously expressed are resolved? C) the Feasibility assessments.
organization has the ability to meet the
defined requirements? (7.2.2)
Does the organization maintain records of the * Records of contract review.
7.2.5 results of the review and actions arising from
the review? (7.2.2)
Where the customer provides no documented * Sign off design validation and production
statement of requirement, does the validation test plan with acceptance criteria.
7.2.6
organization confirm the customer
requirements before acceptance? (7.2.2)
7.2.2.1 Organization manufacturing feasibility
* Feasibility studies. *
Does the organization investigate, confirm
Risk analysis.
and document the manufacturing feasibility of
7.2.7
the proposed products in the contract review
process including risk analysis? (7.2.2.1)
7.2.3 Customer communication

Has the organization determined and * Common language at the interface level.
implemented effective arrangements for
communicating with customers in relation to:
a) product information?
7.2.8
b) enquires, contracts or order handling,
including amendments?
c) customer feedback, including customer
complaints? (7.2.3
7.2.3.1 Customer communication - supplemental
Does the organization have the ability to * Common language at the interface level.
communicate necessary information including * Common language for technical
7.2.9 data in a customes specified language and specifications and important documents.
format? (7.2.3.1) * Customer/supplier EDI system
requirements and supplier capabilities.
7.3 Design and development
7.3.1 Design and development planning
Does the organization plan and control the *The organization taking lead in product design
design and development of product? (7.3.1) and development activities. *
The organization managing the product design
7.3.1 and development processes. * Project
records sush as milestones decision points are
controlled and approved by the organization.
During the design and development planning, * Product design and development process. *
does the organization determine: a) the Product design review; verification and
design and development stages? B) the validation process. *
review, verification and validation that is Job description for product design and
7.3.2
appropriate to each design and development development personnel.
stage? C) the responsabilities and authorities
for design and development? (7.3.1)
Does the organization manage the interfaces * Internal audits results.

between different groups involved in design * Review of organizational interfaces with roles
7.3.3 and development to ensure effective and communication processe.
communication and clear assignment of
responsibility? (7.3.1)
Is the organization's product design and * Evidence of product design and development
development planning output updated, as planning output updated as design and
7.3.4
appropriate, as the design and development development progresses.
progresses? (7.3.1)
7.3.1.1Multidisciplinary approach
Does the organziation use a multidisciplinary * Functions represented in product decelopment
approach to prepare for product realization, teams. * Personnel involved in definition of
including: special characteristics, FMEA, and Control Plan.
- development/finalization and monitoring of
7.3.5 special characteristics?
- development, and review of FMEAs including
actions to reduce potential risks? -
development, and review of contol plans?
(7.3.1.1)
7.3.2 Design an development inputs
Does the organization determine inputs * Design input records & documents
7.3.6 relating to product requirements and maintain
the related records? (7.3.2)
Does the organization's input relating to * Customer contract review. *
product requirements include: Statutory and regulatory requirements. *
a) functional and performance requirements? Previous / existing product design information.
b) aplicable * Product
statutory and regulatory requirements? benchmarking
7.3.7
c) where applicable,
information derived from previous similar
designs? d) other
requirements essential for design and
development? (7.3.2)
* Customer specification analysis *
Does organization review its inputs reting to
7.3.8 Feasibility contract review.
product requirements for adequacy? (7.3.2)
Are the inputs relating to product * Customer specification analysis *

7.3.9 requirements complete, unambiguos and not Feasibility contract review minutes.
in conflict with each other? (7.3.2)
7.3.2.1 Product design input
Does the organization identify, document and *Customer specification analysis. *
review the product design inputs requiriments Feasibility contract review minutes
including: - customer
requirements (contract review)? - use of
information (the organziation shall have a
7.3.10
process to deploy infomation gained)?
-
targets for product quality, life, reliability,
durability, maintainability, timing, and cost?
(7.3.2.1)
7.3.2.2 Manufacturing process design input
Does the organization identify, document and * Design FMEA
review the manufacturing process design * Productivity, process capability, costs targets.
input requirements, including: * Regulations.
- product design output data? * Customer requirements, if any. *
7.3.11 - targets for prouctivity, process capability Experience from previous development.
and cost?
- customer requirements if any?
- experience from previous
developments? (7.3.2.2)
7.3.2.3 Special characteristics
Does the organization identify special * Process to establish specia characteristics. *
characteristics and: Design Record.
- include all special characteristics in the * Review customer requirements for special
control plan? characteristics, difinitions and symbol
- comply with customer specified definitions identification.
ans symbols? * Control plans.
7.3.12 * Product drawings.
- identify processes control document
including drawings, FMEAs, control plans, and * Operator instructions.
operator instructions with the customer's
special characteristics symbol or notation to
include those process steps that affect special
characteristics? (7.3.2.3)
7.3.3 Design and development outputs
Does the organization provide outputs of * Design output records matching criteria
design and development in a form that established in design input requirements.
7.3.13 enables verification against the design and
development input and approved prior to
realease? (7.3.3)
Do the organization's design and development * DV test reports that show test results;
output a) meet acceptance criteria. *
the input requirements for design and Engineering drawings.
decelopment? b)
provide appropriate information for
purchasing, production and for service
7.3.14
provision?
c) contain or reference product acceptance
criteria?
d) specify the characteristics of the product
that are essential for its safe and proper use?
(7.3.3)
7.3.3.1 Product design outputs - Supplemental
Is the organization's product design output * Design putput records matching criteria
expressed in terms that can be verified and established in design input requirements.
7.3.15
validated against product design input
Does the organization's product design output * Availability of all applicable product design
include: output documents.
- design FMEA, reliabilty results?
- product special characteristics,
specifications?
7.3.16
- product error-proofing, as appropriate?
- product definition including drawings? -
product design reviews results?
- diagnostic guidelines where applicable?
(7.3.3.1)
7.3.3.2 Manufacturing process design output
Is the organization's manufacturing process * Process specifications and drawings.
design output expressed in terms that can be * Process FMEA's
verified against manufacturing process design * Job instructions. *
input requirements and validated? (7.3.3.2) Process approval acceptance criteria.
7.3.17
* Quality, reliability, maintainability data.
* Mistake-proofingactivities results.
* Nonconformity detection methods.
* Product/Processverification plans.
Does the organization's manufacturing * Availability of all applicable product design
process design output include: output documents.
- specifications and drawings?
- manufacturing process flow chart / layout? -
manufacturing process FMEA's?
- control plan? -
work instructions? -
7.3.18 process approval acceptance criteria? -
data for quality, reliability, maintainability and
measurability? -
results of error-proofing activities, as
appropriate? -
methods or rapid detection and feedback of
product/manufacturing process non-
conformities? (7.3.3.2)
7.3.4 Design and development review
Does the organization perform systematic * Design review planning and records.
reviews of design and developent at suitable * Design review extended to all functions
stages in accordance with planned affected by it
arrangements: a) * Product design and development status
7.3.19 to evaluate the ability of the results of design reviews.
and development to fulfill requirements? * Links of corrective action to status reviews
b) to identif any
problems and propose necessary actions?
(7.3.4)
Do the participants in the systematic reviews * Link of corrective action to status/ design
of design and development identify any reviews.
7.3.20
problems and propose necessary actions?
(7.3.4
Are the records of the results of the reviews * Design review planning and records
7.3.21 and any necessary actions maintained by the maintained.
7.3.4.1 Monitoring
Does the organization define and analyze * Project reviews at different phases of product
measurements at specified stages of design realization process for all active projects.
7.3.22 and development and reported with summary * Policy
results as an input to management review? deployment summary results.
( 7.3.4.1)
7.3.5 Design and develoment verification
Does the organization perform design and * Design verification done in according to he
development verification in accordance with planning. *
planned arrangements to ensure that the Comparison between outputs an design
7.3.23
design and development outputs have requirements.
satisfied the design and development input * Corrective actions based on results.
Does te organziation maintain records of te * Design verification reports.
7.3.24 results of the verification and any necessary
actions? (7.3.5)
7.3.6 Design and development validation
Does the organization perform design and * Design validation against user requirements /
development validation, accordance with needs.
planned arrangements (see element 7.3.1 of * Comparison between customer plan and
7.3.25 ISO/TS 16949:2002) to ensure that the internal development plans.
resulting product is capable of meeting the * Design validation records.
requirements for the specified application or * Documented failure.
intended use, where known? (7.3.6)
Whereber practicable, does the organization * Completion of product validation testing prior
complete design and development validation to star of production.
7.3.26
prior to the delivery or implementation of the
product? (7.3.6)
* Product validation test report.
Does the organization maintain records of the
* Corrective action process for the design
7.3.27 results of validation an any necessary actions?
activity. *
(7.3.6
Corrective Action Records.
7.3.6.1 Design and development validation - supplemental
* Design validation against user requirements /
Does the organization perform design an needs.
development validation in accordance with * Comparison between customer plan and
7.3.28
customer requirements including program internal development plans.
timing? (7.3.6.1) * Design validation records.
* Documented failure
7.3.6.2 Prototype program
When required by the customer, does th * Prototype facilities.
7.3.29 organization have a prototype program and * Prototype records.
control plan? (7.3.6.2) * Prototype control plan.
Werever possible, does the organization use * Design / pototype / production tooling.
the same suppliers, tooling and * Prototype realization and test coditions
7.3.30
manufacturing processes as will be used in must be known and controlled.
production? (7.3.6.2)
Does the organziation monitor all * Test records.
performance testing activities for timely
7.3.31
completion and conformance to
Is the organization responsible for the * Sub-contractor management as appropriate.
7.3.32 subcontracted services, including tchnical
leadership? (7.3.6.2)
7.3.6.3 Product approval process
Does the organization conform to a product * Compliance with customer requirements
7.3.33 and process approval procedure recognized regarding product approval process.
by the customer? (7.3.6.3)
Does the organization apply a product and * Product approval process documentation and
7.3.34 process approval procedure recognized by the records for suppliers.
customer to its suppliers? (7.3.6.3)
7.3.7 control of design and develompment changes
Does the organization identify design and * Changes records.
7.3.35 development changes and maintain records
relevant to those changes? ( 7.3.7)
* Design change approval process
Does the organization's review of design and
7.3.36 development changes, as appropriate, and
approved before implementation? (7.3.7)
* Impact study including proprietary design. *

Does the organization's review of design and
Change management process.
development changes include evaluation of
7.3.37
the effect of the changes on constituent parts
and already delivered product? (7.3.7)
Does the organization maintain records of the * Changes records.

results for the review od design and
7.3.38
development changes and any necessary
actions? (7.3.7)
7.4 Purchasing
7.4.1 Purchasing process
Does the organization ensure that purchased * Organziation's incoming inspection
7.4.1 product conforms to specified puchase * Source inspection.
requirements? (7.4.1) * Process audit at supplier's site.
Does the organization's type and estenr of * Control methods determined by effect of the
control applied to the supplier and the purchased product on subsequent product
7.4.2
purchased product on subsequent product realization or final product.
realization or the final product? (7.4.1)
Does the organization evaluate and select * Selection system.
suppliers based on their ability to supply * Performance rating system.
7.4.3
products in accordance qith the organziation's * Organzation's supplier manual.
Has the organization established criteria for * Selection system.
7.4.4 selection, evaluation, a re-evaluation of its * Performance rating system.
supplier? (7.4.1)
Does the organization maintain records of the * Suppliers'2nd party audit results conducted by
results of supplier evaluations and any the organization.
7.4.5
necessary actions arising from the supplier * Approved supplier records.
evaluation? (7.4.1
7.4.1.1 Regulatory compliance
Do all purchase products or material used in * Audit results drom goverment and
the organization's product satisfy applicable environment organizations.
7.4.6 regulatory requeriments? (7.4.1.1) * Supplier Internal Audits.
* Warrants or certificates of compliance.
* Audits of suppliers.
7.4.1.2 Supplier quality management system development
Are the organization's suppliers registered to * Copies of supplier's ISO 9001:2000
7.4.7
ISO 9001:2000 by a third party (7.4.1.2) certificates.
Does the organization perform quality * Copies of supplier's ISO 9001:2000
management system development with the certificates.
7.4.8
goal of supplier compliance to ISO/TS
16949:2002 (E) ? (7.4.1.2)
7.4.1.3 Customer-approved sources
Where specified by the contract, does the * Approved suppliers list if applicable. *
7.4.9 organization purchase products, materials or How are these lists used?
service from approve sources? (7.4.1.3)
Is the organization responsible for ensuring * Scope of organization's incoming inspection
the quality of purchased products supplied by includes purchased products supplier by
7.4.10
customer-designated sources, including customer-designated sources.
tool/gage suppliers? (7.4.1.3)
7.4.2 Purchasing infotmation
Does the organization's purchasing * Purchase order / release. *
information descibe the product to be Commercial contract.
purchased, including where appropriate:
a) requirements for approval of product,
7.4.11 procedures, processes and equipment?
b) requirements for qualification of
personnel?
c) quality management system
Does the organization ensure the adequacy of * Review of contract/purchase order extends to
specified purchase requirements prior to their suppliers.
7.4.12
communication to the supplier? (7.4.2)
7.4.3 verification of purchased product

Does the organization establis and implement * Incoming inspection plans.
the inspection or other activities necessary for
7.4.13 ensuring that purchased product meets
specified purchase requirements? (7.4.3)
Where the organization or its customer * Supplier and subcontractors.

intends to perform verification at the * Purchase order and contract.
supplier's premises, does the organization
7.4.14 state the intended verification arrangements
and method of product release in the
purchasing information? (7.4.3)
7.4.3.1 Incoming product quality

Does the organization have a process to *Incoming inspection.
ensure the quality of purchased product * Source inspection
utilizing one or more of the following * 2nd or 3rd party audits of supplier sites.
methods: * Independent evaluation of acceptabilty of
-receipt of, and evaluation of, statiscal data product by a designated 3 rd party.
by the organization?
- receiving inspection and/or testing such as
7.4.15 sampling based on performance?
- second or third party assements or
audits of supplier sites, when coupled with
records of accpetable quality performance?
- part evaluation by a designated
laboratory? - another method agreed with the
customer? (7.4.3.1)
7.4.3.2 Supplier monitoring

Does the organization monitor supplier * Subcontractor performance records.
performance through the following indicators: * Subcontractor corrective action.
- Delivered
part quality performance? -
7.4.16
Customer disruptions including field returns?
-
Delivery schedule performance (including
incidents of premium freight)? (7.4.3.2)
Does the organization promote supplier * Evidence of continuos improvements
monitoring of their manufacturing processes' implement by the suppliers through review of
7.4.17
perfomance? (7.4.3.2) their own monitoring of manufactring processes'
performance.
7.5 Production and service provision
7.5.1 Control of production and service provision
Does the organization plan and carry out * Tour of plant and facilities.
production and service provision under the * Master part or correct level assembly
following controlled conditions, as applicable: drawings. *
a) the Work instructions at work stations.
availability of information that describes the
characteristics of the product? b) the
availability of work instructions, as necessary?
7.5.1 c) the use
of suitable equipment? d) the
availability ans use of monitoring and
measurement?
e) the implementation of monitoring and
measurement? f)
the implementation of release, delivery and
post-delivery activities? (7.5.1)
7.5.1.1 Control plan

Does the organization: *Control plans for different product levels.
- develop control plans at the system, * DFMEA and PFMEA were used as inputs to the
subsystem, component and/or material level, control plans.
for the product supplied, including those for
7.5.2 bulk materials?
- have a control plan for pre-launch and
production that take into account the design
FMEA and manufacturing process FMEA
outputs? (7.5.1.1)
Does the organization's control plan: * Review of controls plans.
- list the controls used for the manufacturing * Control Plans for applicable stages.
process control? * Control Plan framework with data.
- includes methods for monitoring and
recording resuls of control exercised over
special characteristics (see 7.3.2.3 of
ISO/ISO/TS 16949:2002:2002 (E) defined by
7.5.3 both the customer and the organization?
- include the customer required information if
any?
- initiate the specified reaction plan (see
8.2.3.1 of ISO/ISO/TS 16949:2002:2002 (E))
when the process becomes unstable or non
capable? (7.5.1.1)
Does the organization review and update * Matching between product/rocess changes,
control plans when any change occurs instability/ non-capability process results, and
affecting product, manufacturing process, control plans updating.
7.5.4
measurement, logistics, supply sources or
FMEA (see 7.1.4 of ISO/TS 16949:2002 (E))?
(7.5.1.1)
7.5.1.2 Work instructions
Has the organization prepare documented * Availability of job instructions at the
work instructions for all employees having workstation.
7.5.5
resposibilities for the operation of processes?
(7.5.1.2)
Are the organization's work instructions * Availability of job instructions at the
7.5.6 accesible for use at the workstation? (7.5.1.2) workstation.
Are the organization's work instructions * Link between job instructions and source
derived from sources susch as the quality documents, e.g Control Plan, Design record,
7.5.7
plan and the product realization process? FMEA.
(7.5.1.2)
7.5.1.3 Verification of job set-ups
7.5.8 Does the organization verify job set-ups * Job set-up records and approval.
whenever performed? (7.5.1.3)
7.5.9 Are the organization's work instructions * Set-up instructions.
available for set-ups personnel? (7.5.1.3)
Does the organization use stastical methods * Job set-up records.
7.5.10 of verification of job set-ups where
applicable? (7.5.1.3)
7.5.1.4 Preventive and predictive maintenance
Does the organization identify key process * Existence of preventive maintenance.
equpment and provide resources for
7.5.11 machine/equipment maintenance and develop
an effective planned total preventive
maintenance system? (7.5.1.4)
Does the organization's preventive * System effectiveness demostrated by specifics
maintenance system minimally include the measurement indicator. *
following: Key equipment list.
- planned maintenance activities? * Maintenance record
- packaging and preservation of * Predictive maintenance examples.
7.5.12 equipment, tooling and gauging? * Plant tour.
- availability of replacement
parts for jey manufacturing equipment?
- documenting, evaluating and
improving maintenance objectives? (7.5.1.4)
Does the organization utilize predictive * Predictive maintenance examples.
maintenance methods to continually improve
7.5.13
the effectiveness of its preventive system?
(7.5.1.4)
7.5.1.5 Tooling management
Does the organization provide resources for * Tool/gage design staffing and qualification.
7.5.14 tool and gauge design, fabrication and
verification activities? (7.5.1.5)
Does the organization establish and * Tool management process.
implement a system for tooling management
including:
- maintenance and repair facilities and
personnel?
- storage and recovery?
- set-up?
7.5.15 - tool-change programmes for perishable
tools?
- tool design modification documentation,
including engineering change level?
- tool modification and revision to
documentation?
- tooling identification defining the
status? (7.5.1.5)
Has the organization implemented a system * Sub-contractor management system (choice,

7.5.16 to monitor its tooling management activities if evaluation and control).
any work is outsourced? (7.5.1.5)
7.5.1.6 Production scheduling
Is the organization's production scheduled in * Process for production scheduling. *
7.5.17 order to meet customer requirementes? The scheduling system should be based on a
(7.5.1.6) "pull" and not on a "push" system.
7.5.1.7 Feedback of information from service
Has the organization established and * Meeting reports, follow up and corrective
maintained a process for communication of actions/responsibility/dates.
7.5.18 information on service concerns to * Product service data.
manufacturing, engineeting and design
activities? (7.5.1.7)
7.5.1.8 Servicing agreemet with customer
When there is a servicing agreement with the * Planning of periodical audits.
customer, does the organization verify the * Reports and follow up.
effectiveness of:
7.5.19 - any organization service centers?
- special purpose tools or measurement
equipment?
- training of servicing personnel? (7.5.1.8)
7.5.2 Validation of processes for production and service provision
Does the organization validate any processes * Process validation/capability studies results. *
for all its production and service provision Process parameters monitoring and control
7.5.20 where the resulting output cannot be verified evidence.
by subsequent monitoring or measurement?
(7.5.2)
Does the organization's validation of * Process validation/capability studies results.
processes for all its production and service
7.5.21 provision demonstrate the ability of these
processes to achieve planned results? (7.5.2)
Has the organization establish arrangements * Requirement specification for operations,

for all its production and service provision equipment and personnel.
including, as applicable: * Related records of qualification.
a) defined criteria for review and approval of * Frecuency and conditions of revalidation.
the processes?
7.5.22 b) approval of equipment and qualification of
personnel?
c) use of specific methods and procedures? d)
requirements for reords?
e ) revalidation? ( 7.5.2)
7.5.3 Identification and traceability
Does the organization idetify the products by * Check for positive recall.
suitable means throughout product * Suitable product identification thoughout
7.5.23 realization? (7.5.3) the facility.
* Traceability from raww materials to
delivered product.
Does the organization identify the product * Clear identification of work in-process; finished
status with respect to monitoring and goods and reject goods and/or components.
7.5.24
measurement requirements? (7.5.3) * Inspection
records.
Where traceability is a requirement, does the * Traceability system.
organization control and record the unique
7.5.25 identification of the product (see element
4.2.4 of ISO/TS 16949:2002? (7.5.3)
7.5.4 Customer property

Does the organization exercise care with * Handling procedure of customer property.
customer property while it is under the
7.5.26
organization's control or being used by the
Does the organization identify, verify, protect * Product identification.
and safeguard customer property provided for * Storage environment.
7.5.27
use or incorporation into the product? (7.5.4)
Does the organization report to the customer * Damage to customer supplier products
an maintain records for customer property reports. *
7.5.28 that is lost, damaged or otherwise foud to be What happend to customer owned returnable
unsuitable for use? (7.5.4) packging? Hos wat is accounted for?
7.5.4.1 Customer owned tooling

Are the customer-owner tools, manufacturing, * Permanent identification of tooling and
test, inspection tooling and equipment equipment ownership.
7.5.29 permanently marked so that the ownerhip of
each item is visible, and can determined?
(7.5.4.1)
7.5.5 Preservation of product
Does the organization presenve the * Procedure development and documentation. *
conformity of product during internal Plant our.
7.5.30
processing and delivery to the intended
destination? (7.5.5)
Does the organization's preservation of * Product preservation procedures. *
7.5.31 product include identification, handling, Plant our.
packaging, storage and protection? (7.5.5)
Does the organization's preservation of * Scope product preservation procedures.
7.5.32 production apply to the constituent parts of a * Plant our.
product? (7.5.5)
7.5.5.1 Storage and inventory
Does the organization asses the condition of * Storage product specifications.
7.5.33 product in stock at appropriate planned * Inspection records.
intervals to detect deterioration? (7.5.5.1) * Plant tour
Does the organization use an inventory * Inventory management system.
management system to optimize inventory * Evidence of FIFO.
7.5.34
turns over time and assure stock rotation? * Control of obsolete product.
(7.5.5.1)
Does the organization control obsolete * Obsolete products stored in quarantine area.
7.5.35 product in a similar manner to nonconforming
product? (7.5.5.1)
7.6 Control of monitoring and measuring devices
Has the organization determined the * Test equipment accuracy and precision
monitoring and measurement to be capability related to the required measurement.
undertaken and the monitoring and
7.6.1
measuring device needed to provide evidence
of conformity of product to determined
requirements? (7.6)
Has the organization established processes to * Monitoring adn measurement trials during
ensure that monitoring and measurement can prtotype builds. * Procedure address in
be carried out and are carried out in a organization's quality manual in accordance to
7.6.2
manner that is consistent with the monitoring ISO/TS 16949:2002(E).
and measurement requirements? (7.6)
Where neccessary to ensure valid results, are * Test equipment inventory.
the organization's measuring equipment: a) * Certifications for calibration masters and their
calibrated or verified at specified intervals, or traceability to international national recognizad
prior to use, against measurement standars standard.
traceable to international or national * Calibration results records.
measurement standards? * Method of control of calibration settings.
b) adjusted or re- * Calibration status identification.
7.6.3 adjusted as necessary? c) identified to
enable the calibration status to be
determined? d)
safeguared from adjustments that would
invalidate the measurement result?
e) protect from damage and
deterioration during handling, maintenance
and storage? (7.6)
Does the organization asses and record the * Records of re-inspected product.
validity of the previous measuring results
7.6.4
when te equipment is found not to conform to
requirements? (7.6)
Does the organization take appropriate action * Actions taken on the equipment that are found
on the equipment that is found not not conforming to requirements and any
7.6.5
conforming to requirements and any product products that was affected by it.
affected it?(7.6)
Does the organization maintain records of the * Gage stdies records.
results of calibration and verification (see
7.6.6
element 4.2.4 of ISO/TS 16949:2002)? (7.6)
When the equipment is used in the * Product labeling system.

monitoring ad measurement of specified * Customer requirements.
7.6.7 requirements, has the organization confirm * Labeling audit.
the ability of computer software satisfy the
intended application? (7.6)
Has the organization undertaken the * Test software / comparative references
confirmationof computer software satisfying verification.
7.6.8 an intended application prior to initial use and
reconfirmed as necessary? (7.6)
7.6.1 Measurement system analysis

Does organization conduct statiscal studies to * Measurement system analysis studies
analyze the variation present in the results of including gage repeatability & reproducability.
7.6.9
each type of measuring and test equipment
system? (7.6.1)
Does the organization conduct measurement * Measurement system analysis results.
system analysis for measurement systems
7.6.10
referenced in the control plan? ( 7.6.1)
Does the organization's records of the * Measurement equipment records.

calibration activity for all gauges, measuring * Original specification of measurement
and test equipment, including employee-and equipment.
customer-owned gauges, include:
a) equipment identification including the
measuremente estándar against which the
equipment is calibrated?
b) revisions folloeing engineering changes?
c) any out specification readings as received
7.6.11 for calibration/verification?
d) as assessment of the impact of out of
specification condition?
e) statements of conformance to
specification after calibration/verification?
f) notification to the customer if suspect
product or material has been shipped? (7.6.2)
7.6.3 Laboratory requirements

7.6.3.1 Internal laboratory
Does the organization's internal laboratory * Laboratory Scope.
facility have a defined scope that include
7.6.13 capability to perform the required inspection,
test or calibration services? (7.6.3.1)
Is the organization's lab scope included in the * Organization's quality manua ISO/TS
quality management system and comply with 16949:2002 (E).
technical requirements including:
- adequiacy of the laboratory
procesdures? - qualifications of the
laboratory personnel cnsucting tests?
7.6.14 - testing of the
commodity? - performing
these tests correctly, traceable to the relevan
process standard? - review of the
related quality records? (7.6.3.1)
7.6.3.2 External laboratory

Do the external / commercial/ independent * Commercial Laboratory Accreditation records.
laboratory facilities used for inspection, test or
calibration services by the organization have a
defined laboratory scope that includes
capability to perform the required inspection,
7.6.15 test or calibration, and: -
be accredited to ISO/IEC 17025 or national
equivalent?
- have evidence that the external laboratory
is acceptable to the customer? (7.6.3.2)
8 Measurement, analysis and improvement
8.1 General
Has the organization planned and * Internal audit results.
implemented the monitoring, measurement, * Product conformance data.
analysis and improvement processes needed
a) to demonstrate conformity of the product?
8.1.1 b) to ensure conformity of the quality
management system?
c) to continually improve the effectiveness
of the quality management system? (8.1)
Has the organization determined * Methods used for organization's monitoring,

theapplicable methods and the estent of their measurement, analysis and improvement
8.1.2
use for its monitoring, measurement, analysis processes.
and improvement processes? (8.1)
8.1.1 Identification of statistical tools
Does the organization determine the * Review of control plan.
appropriate statistical tools for each process * Review of quality plan.
8.1.3
during advance quality planning and included * Plan tour.
in the control plan? (8.1.1)
8.1.2 Knowledge of basic statistical concepts
Does the organization understand basic *Interview with personnel including
statistical concepts, such as variation, control management demonstrating the knowledge of
(stability), process capability and over- major statistical concepts like variation and
8.1.4
adjustment? (8.1.2) distribution, process control, cause and effect
relationship, common and special causes.
* Statistical techniques training records.
Does the organization utilize basic statistical * Basic statistical study reports.
8.1.5 concepts throughout its establishment?
(8.1.2)
8.2 Monitoring and measurement
8.2.1 Customer satisfaction
Does the organization monitor information * Review of information relating to customer
relating to customer perception as to whether satisfaction routinely/set interval.
8.2.1 the organization has met customer * Customer satisfaction performance
requirements as one of the performance of indicators.
the quality management system? (8.2.1)
Has the organization determine the methods * Methods for obtaining information relating to
for obtaining information relating to customer customer perception as to whether the
8.2.2 perception as to whether the organizaton has organization has met customer requirements.
met customer requirements? (8.2.1)
8.2.1.1 Customer satisfaction - Supplmental

Does the organization monitor customer * Continual evaluation of performance of
stisfaction through continual evaluation of realization processes.
8.2.3
performance of the realization processes?
(8.2.11)
Are the organization's performance indicators * Review of performance indicators for customer
for customer satisfaction based on objective satisfaction-
data and include, but not be limited to:
-
delivered part quality performance?
8.2.4 - customer disruptions including field
returns?
- delivery schedule performance (including
incidents of premium reight)?
- customer notifications related to
quality or delivery issues? (8.2.1.1)
Does the organization monitor manufacturing * Measuremment of manufacturing proceses
processes performance to demonstrate against compliance to customer requirements.
8.2.5 compliance with customer requirements for
product quality and efficiency of the process?
(8.2.1.1)
8.2.2 Internal audit
Does the organization conduct internal audits * Audit schedule.
at planned intervals to determine whether the * Records of performed audits.
quality management system:
a) conforms to the planned arrangements
(see 7.1), to the requirements ISO/TS
8.2.6 16949:2002 and to the quality management
systems requirements established by the
organization?
b) is effectively implemented and
maintained? (8.2.2)
Has the organization planned for an audit * Appropriate prioritization.
program tha takes into consideration the
8.2.7 status and importance of the processes and
areas to be audited, as well as the results of
previous audits)? (8.2.2)
Has the organization define the internal audit * Audit schedule.
8.2.8 criteria, cope, frecuency and methods? (8.2.2) * Internal audit procedure stated in quality
manual.
Does the organization ensure objectivity and * Organization charts. * Auditors only conduct
impartiality of the audit process in the audits in areas that are independent of the job
8.2.9
selection of auditors and conduct of internal functions.
audits? (8.2.2)
Has the organziation define the * Deparment or individual responsible for
responsabilities and requirements for planning internal audit activities and also the reporting of
8.2.10 and conducting audits, and for reporting audit results upper management.
results and maintaining records in a
document procedure? (8.2.2)
Does the management responsible for the * Closure time for audits findings.
area being audited ensure that actions are
8.2.11 taken without undue delay to eliminate
detected non-conformities and their causes?
(8.2.2)
Does the organization's internal audit follow- * Records of verification.
up activities inlude the verification of the
8.2.12 actions taken and the reporting of verification
results (see element 8.5.2 of ISO/TS
16949:2002)? (8.2.2)
8.2.2.1 Quality management system audit
Does the organization audit its quality * Audit plans and schedule.
management system to verify compliance * Interview with the different area managers.
8.2.13 with ISO/TS 16949:2002 and any additional * Audits reports.
quality management system requirements?
(8.2.2.1)
8.2.2.2 Manufacturing process audit
Does the organization audit each * Audit plans.
8.2.14 manufacturing process to determine its * Audit reports.
effectiveness? (8.2.2.2)
8.2.2.3 Product audit
Does the organization audit products at * Audit plan, process flow chart and schedule. *
appropriate stages of production and delivery Product audit procedure and reports.
8.2.15 conformance to all specified requirements at
a defined frecuency? (8.2.2.3)
8.2.2.4 Internal audit plans

Does the organization's internal audits cover * Audit plan.
all quality management related processes, * Audit schedule.
8.2.16 activities and shifts, and schenduled
according to an annual plan? ( 8.2.2.4)
Does the organization increase its audit * Audit schedule.

frecuency appropriately when interna/external * Appropriate prioritization.
8.2.17
non-conformities or customer complaints
occur? (8.2.2.4)
8.2.2.5 Internal auditor qualification
Are the organization's internal auditors * Compliance to customer requirements.
qualified to audit the requirements of ISO/TS
8.2.18
16949:2002 (see element 6.2.2.2)? (8.2.2.5)
8.2.3 Monitoring and measurement of processes

Does the organization apply suitable methods * Methods of monitoring/measuring quality
for monitoring and, where applicable, management system processes.
8.2.19
measurement of the quality management
system processes? (8.2.3)
Does the organization's methods for * Monitoring and measurement results.
monitoring and measurement of processes
8.2.20
demonstrate the ability of the processes to
achieve planned results? (8.2.3)
When planned results are not achieved by the * Planned/executed corrective actions.
organization's processes, does the
8.2.21 organization take correction and corrective
action to ensure conformity of the product?
(8.2.3)
8.2.3.1 Monitoring and measurement of manufacturing processes
Does the organization perform process * Preliminary process capability results.
studies on all new manufacturing processes to * Production control plan.
8.2.22 verify process capability and to provide
additional input for process control? (8.2.3.1)
Does the organization document the results of *Process study reports.

process studies with specifications where * Plan/executed actions from process study
8.2.23 applicable for means of production, results.
measurement and test, and maintenance
instructions? (8.2.3.1)
Does the organization's documents for * Monitoring & measurement of manufacturing
monitoring and measurement of processes douments.
manufacturing processes include objectives
8.2.24
for manufacturing process capability,
reliability, maintainability and availability, as
well as acceptance criteria? (8.2.3.1)
Does the organization maintain manufacturing * Current Cpk/Ppk verus customer approver
process capability or performance as specified Cpk/Ppk.
8.2.25 by the customer part approval process * Existing reaction plan.
requirements? (8.2.3.1) * Verifying the accuaracy of Cpk/Ppk
calculations.
Does the organization ensure that the control * Review of production line to process flow
plan and process flow diagram are diagram and control plan.
implemented, including adherence to the
specified:
8.2.26 - measurement techniques?
- sampling plans.
- acceptance criteria?
- reaction plans when
acceptance criteria are not met? (8.2.3.1)
Does the organization note significant process * Review of control charts.
8.2.27 events on the control charts? (8.2.3.1)
Does the organization initiate the appropriate * Records of reaction taken.

reaction plan from the control plan for
8.2.28
characterisctics that are either unstable or
non-capable? (8.2.3.1)
Does the organizaton's reacion plans fro * Contents of reaction plan for unstable and
characteristics tha are either unstable or non- non-capable processes.
8.2.29 capable include containment of product and * Records.
100% inspetction as appropriate? (8.2.3.1)
Does the organization establish a corrective * Corrective action reports.

action following the initiation or reaction
plans, indicating specific timing and assigned
8.2.30
responsabilities to assure that the process
becomes stable adn capable? (8.2.3.1)
Are the organization's corrective action plans * Corrective action approval process.
8.2.31 reviewed with and approved by the customer * Corrective action reports.
when so required? (8.2.3.1)
Does the organization maintain records of * Records of process change dates.
8.2.32 effective dates of process changes? (8.2.3.1)
8.2.4 Monitoring and measurement of product

Does the organization monitor and measure * Control plans.
the characteristics of the product to verify * Inspection instructions.
8.2.33
that product requirements have been met? * Records.
(8.2.4)
Does the organization monitor and measure * Control plans.
the characteristics of the product at * Inspection instructions.
appropriate stages of the product realization * Records.
8.2.34
process in accordance with the planned
arrangements (see element 7.1 of ISO/TS
16949:2002)? (8.2.4)
Does the organization maintain evidence of * Inspection records that include acceptance
8.2.35 product conformity with the acceptance criteria, inspector performing the test, test
criteria? (8.2.4) status and, testing date.
Does the organization's records on monitoring * Inspection records that include the person (s)
and measurement of product indicate the authorizing release of product.
8.2.36 person(S) authorizing release of product (see
element 4.2.4 of ISO/ISO/TS
16949:2002:2002 (E))? (8.2.4)
Are the organization's product release and * Release of product and service delivery after
service delivery proceed only after all the all planned arrangement is satisfactorily
planned arrangements (see element 7.1 of completed.
8.2.37 ISO/TS 16949:2002) have been satisfactorily
complement, unless otherwise approved by a
relevant authority, and where applicable by
the customer? (8.2.4)
8.2.4.1 Layout inspection and functional testing
Does the organization perform a layout * Layout inspection reports.
inspection and a functional verification to * Control Plan.
applicable customer engineering material an
8.2.38
performance standards for all products at a
sufficient frecuency as specified in the control
plan? (8.2.4.1)
Does the organization have layout inspection * Inspection records that include acceptance
8.2.39 and functional testing results available for criteria, inspector performing the test, test
customer review? (8.2.4.1) status and, testing date.
8.2.4.2 Appearance items
For organizations manufacturing parts * Maintenance/Control and storage conditions of
desginated by the customer as "appearance masters.
items", does the organization provide. * Visual aids.
- appropriate resources including lighting for * Personnel qualification / training records.
evaluation? * Tour of facility.
- masters for color, grain, gloss, metallic
8.2.40 brilliance, texture, destinctness of image
(DOI) as appropriate?
- maintenance and control of appearance
masters and evaluation equipment?
- verificaton that personnel making
appearance evaluations are qualified to do
so? (8.2.4.2)
8.3 Control of nonconforming product

Does the organization ensure that product * Follow one or more nonconforming case and
which does not conform to product verify the flow (identification, segregation, etc).
8.3.1 requirements is identified and controlled to * Obsolete products.
prevent its unintended use or delivery? (8.3)
Does the organization define the controls and * Procedure address in quality manual.
related responsibilities and authorities for
8.3.2
dealing with conoconforming product a
documented procesdure? (8.3)
Does the organization deal with * Follow one or more non-conforming case and
nonconforming product by one or more of the verify the visual indentification and segregation
followinf ways: area.
a) by taking action to eliminate the detected * Records of concession.
nonconforming?
8.3.3 b) by authorizing its use, release or
acceptance under concession by a relevant
authority and, where applicable, by the
customer?
c) by taking action to preclude its original
intended use or application? (8.2.3)
Does the organization maintain records of the * Records.
nature of nonconformities and any
8.3.4 subsequent actions taken, including
concessions obtained (see element 4.2.4 of
ISO/ISO/TS 16949:2002:2002 (E))? (8.2.3)
When nonconforming product is corrected, * Intruction for re-qualifying coreected
does the organization re-verify to demostrate nonconforming product.
8.3.5
conformity to the requirements? (8.2.3)
When nonconforming product is detected * Follow one or more nonconforming case and
after delivery or use has started, does verify the flow (identification, segregation, etc).
8.3.6 organization take action appropriate to the
effects, or potential effects, of the
noncoformity? (8.2.3)
8.3.1 Control of nonconforming product -supplemental
Does the organization classify unidentifie or * Follow one or more nonconforming case and
suspect status produc as nonconforming verify the flow (identification, segregation, etc).
8.3.7
product (see element 7.5.3 of ISO/ISO/TS
16949:2002:2002)? (8.3.1)
8.3.2 Control of reworked product
Are the organization's instructions for rework, * Rework instructions.
including re-inspection requirements
8.3.8
accessible and utilized by the appropriate
personnel? (8.3.2)
8.3.3 Customer information
Does the organization inform the customers * Follow one or more nonconforming case and
promptly in the event that nonconforming verify the flow (identification, segregation, etc).
8.3.9
product has been shipped? (8.3.3) *
Procedure stated in quality manual.
8.3.4 Customer waiver
Does the organization obtain customer * Follow one or more nonconforming case and
concession or deviation permit prior to further verify the flow (identification, segregation, etc).
8.3.10 processing whenever the product or
manufacturing process is different from that
which is currently approved? (8.3.4)
Does the organization maintain a record of * Record of concession with expiration date.
the expiration date or quantity authorized by
8.3.11
customer concession or deviation permit?
(8.3.4)
Does the organization ensure compliance with * Inspection results.
the original or superseding specifications and
8.3.12
requirements when the authorization for
deviation expires? ( 8.3.4)
Does the organization propely identify on * Proper label/identification for material shipped
8.3.13 each shipping container material shipped on on authorization.
an authorization? (8.3.4)
Does the organization apply the customer *Process define in quality manual.
waiver requirements dor production product
8.3.14
to purchased product as well? (8.3.4)
Does the organization agree with any product * Process define in quality manual.
8.3.15 concession equests fromo suppliers before
submission to the customer? (8.3.4)
8.4 Analysis of data
Does the organization determine, collect and * Internal performance data such as:
analyze appropriate data to demonstrate the -Poor quality cost indicators,
suitability and effectiveness of the quality - Effectiveness and efficiency of
management system and to evaluate where production processes,
continual improvement of the effectivenes of - Test results,
the quality management system can be - Process capability data,
8.4.1 made? (8.4) - Quality audits,
- Results of product
inspections, - Internal and
external quality data, -
Subcontractor rating, -
Customer reports, -
Employee's information.
Does the organization's data analysis include * Data analysis report.
data generated as a result of monitoring and
8.4.2
measurement and from other relevant
sources? (8.4)
Does the organization's analysis of data * Data analysis report.
provide information relating to: a) customer
satisfaction (see element 8.2.1 of ISO/ISO/TS
16949:2002:2002)? b)
conformance to product requirements (see
8.4.3 element 7.2.1 of ISO/ISO/TS
16949:2002:2002)?
c) characteristics and trends of processes and
products including opportunities for
preventive action?
d) Suppliers?
8.4.1 Analysis and use of data
Does the organization compare trends in * Customer problem resolution.
quality and operationa performance compared * Comparison of trends to objectives (goals). *
with progress toward objectives and lead to Specific actions to trend analysis.
action to support the following: * Prioritization of action.
- development of priorities
dor prompt solutions to customer-related
8.4.4 problems? - determination of key
customer related trends and correlation to
support status review, decision makin and
longer term planning?
- an information system or
the timely reporting of product information
arising from usage?(8.4.1)
8.5 Improvement
8.5.1 Continual improvement
Does the organization continually improve the * Examples of continuos projects intiated from
effectiveness of the quality management quality policy, quality objectives, audit results,
system through the use of the quality policy, analysis of data, corrective and preventive
8.5.1 quality objectives, audit results, analysis of actions and management review.
data, corrective and preventive actions and
management review? (8.5.1)
8.5.1.1 Organization continual improvement

8.5.2 Has the organization define a process for * Procedure as stated in quality manual.
continual improvement? (8.5.1.1)
8.5.1.2 Manufacturing process improvement
8.5.3 Does the organization's continual * Records showing improvement in special
improvement focus upon control and characteristics.
reduction of variation in products of * Reduction in process parameter variation.
characteristics and manufacturing process
parameters? (8.5.1.2)
8.5.2 Corrective action
8.5.4 Does the organization take action to eliminate * Examples
the cause of non-conformities in order to
prevente recurrence? (8.5.2)
8.5.5 Are the organization's corrective actions * Review examples.
appropriate to the effects of the non-
conformities encountered? (8.5.2)
8.5.6 Has the organization established procedure to * List of customer complaints. *
define requirements for: a) Root Cause Analysis and records. *
reviewing non-conformities (including Determination of corrective action needed. *
customer complaints)? Corrective action taken. *
b) evaluating the need for action to ensure Corrective action effectiveness.
that non-conformities do not recur?
c) determining and implmenting action
needed?
d) records of the results of action taken (see
element 4.2.4 of ISO/TS 16949:2002)?
e) reviewing corrective action taken? (8.5.2)
8.5.2.1 Problem solving

Does the organization have a defined process * Problem solving process used by organization.
for problem solving leading to root cause
8.5.7
identification and elimination? (8.5.2.1)
If a customer-prescribed problem solving *Responses to customer complaints.

8.5.8 format exists, does the organization use the * Customer formats
prescribed format? (8.5.2.1)
8.5.2.2 Error-proofing
Does the organization use error-proofing * Examples.
8.5.9 methods in their corrective action process?
(8.5.2.2)
8.5.2.3 Corrective action impact
Does the organization apply the corrective * Review od documents related to similar
action, and controls implmented, to eliminate products and processes.
8.5.10 the cause of a nonconformity to other similar
processes and products? (8.5.2.3)
8.5.2.4 Rejected product test/analysis

Does the organization analyze parts rejected * List of returned parts.
by the customer's manufacturing plants, * Records of analysis.
8.5.11
engineering facilities, and dealerhips? * Minimalization of cycle time.
(8.5.2.4)
Does the organization minimize the cycle time * Review product test/analysis process.
8.5.12 of its rejected product test/analysis process?
(8.5.2.4)
Does the organization keep records of its * Records.
8.5.13 rejected product test/analyses and make
available upon request? (8.5.2.4)
Does the organization perfom analysis and, * Examples.
8.5.14 intiate corrective action to prevent
recurrence? (8.5.2.4)
8.5.3 Preventive action
Does the organization determine action to * Examples.
elimita the causes of potentia non-
8.5.15
conformities in order to prevent their
ocurrence? (8.5.3)
Are the organization's preventive actions * Examples.
8.5.16 appropriate to the effects of the potential
problems? (8.5.3)
Has the organization establish a documented * Sources of information used for preventice
procedure to define requirements for: action.
a) determining potential non-conformities * Root cause determination (FMEA, FTA, etc).
and their causes? * Records and result analysis.
b) evaluating the need for action to prevent
ocurrence of non-conformities?
c) determining and implementing action
8.5.17 needed?
d) records of results of action taken (see
element 4.2.4 of ISO/ISO/TS
16949:2002:2002)?
e) reviewing preventive action taken?
(8.5.3)
Non conform issue
No. Requierement
6.22
Corrective Accio
Root cause Preventive Actions

Corrective Accions
Initial Due Close

Corrective actions Date Date Date %
Comments
O.K./ No O.K. And evidences

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Table for planing and review of process oriented application of ISO/TS 16949:200

Auditor: Audit-Reference No.:

4 Quality management system

(NR) Needs Further

Requirements What to look for Asessor notes / Objetives evidence

* Examples and status of quality management

* Quality manual according to ISO/TS

Does the organization manage the processes

Does the organization ensure control over

4.2.3.1 Enginnering specifications

5.1.1 Process Efficiency

5.4 Quality objectives

5.4.2 Quality management system planning

5.5.3 Internal communication

Are the organization's records from * Retention of management reviews meeting

5.6.2.1 Review input - Supplemental

6.2.2.1 Products design skills

Are the personnel affecting quality, informed * Training contents.

6.4 Work environment

6.4.1 Personnel safety

7.2 Customer-related processes

7.2.3 Customer communication

Does the organization manage the interfaces * Internal audits results.

Are the inputs relating to product * Customer specification analysis *

* Impact study including proprietary design. *

Does the organization maintain records of the * Changes records.

7.4.3 verification of purchased product

Where the organization or its customer * Supplier and subcontractors.

7.4.3.1 Incoming product quality

7.4.3.2 Supplier monitoring

7.5.1.1 Control plan

Has the organization implemented a system * Sub-contractor management system (choice,

Has the organization establish arrangements * Requirement specification for operations,

7.5.4 Customer property

7.5.4.1 Customer owned tooling

When the equipment is used in the * Product labeling system.

7.6.1 Measurement system analysis

Does the organization's records of the * Measurement equipment records.

7.6.3 Laboratory requirements

7.6.3.2 External laboratory

Has the organization determined * Methods used for organization's monitoring,

8.2.1.1 Customer satisfaction - Supplmental

8.2.2.4 Internal audit plans

Does the organization increase its audit * Audit schedule.

8.2.3 Monitoring and measurement of processes

Does the organization document the results of *Process study reports.

Does the organization initiate the appropriate * Records of reaction taken.

Does the organization establish a corrective * Corrective action reports.

8.2.4 Monitoring and measurement of product

8.3 Control of nonconforming product

8.5.1.1 Organization continual improvement

8.5.2.1 Problem solving

If a customer-prescribed problem solving *Responses to customer complaints.

8.5.2.4 Rejected product test/analysis

Root cause Preventive Actions

Initial Due Close

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