Introduction to Quality Management

Systems (QMS, ISO 9001:2015)

Requirements and implementation

Content and Instruction by:

Kampanat Wiriyanupappong
Instructor and Consultant
Email: [email protected]
 Quality Management Systems
(ISO 9001:2015, QMS)

INTRODUCTION TO
QUALITY MANAGEMENT SYSTEMS
(QMS, ISO 9001:2015)
REQUIREMENTS AND IMPLEMENTATION

Instructor PROFILE
Kampanat Wiriyanupappong
Education Bachelor’s degree in Chemical Engineering, Thammasat University

Work  Instructor and consultant (ISO 9001, IATF 16949, ISO 14001, ISO 50001, ISO
experience 45001, PSM, RSPO Supply Chain, IECQ HSPM)
 Certification Body (CB) auditor and instructor
 Process engineer in automotive supply chain company
Knowledge  Management System Standards (ISO 9001, IATF 16949, ISO 14001, ISO
qualification 50001, ISO 45001, RSPO Supply Chain, IECQ HSPM, ISO 14064)
 Related management systems tools (Automotive core tools (APQP, PPAP,
FMEA, SPC, MSA), Risk management, QCC, CA/PA, Improvement,
Customized topics, etc.)

Email [email protected] , [email protected]

contact info

Introduction to Quality Management Systems (QMS, ISO 9001:2015)

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Training course CONTENT

Quality management systems

INTRODUCTION and PRINCIPLES

Terms and DEFINITIONS

REQUIREMENTS and implementation

Q&A

Quality Management Systems DEVELOPMENT

REVIEW
1 2 3 4 5
Every 5 years
KPI
Quality management system (QMS) Requirements
ISO 9001
(version 1987  1994  2000  2008  2015)

ISO 9000:2015 Quality management systems – Fundamentals and vocabulary

ISO 9001:2015 Quality management systems – Requirements Need to do "shall"

Quality management – Quality of an organization - Guidance to achieve sustained

ISO 9004:2018
success

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Management System – PDCA

Process : transfer input to output
ACT Check-Result PLAN Not dept
 Analyze the data and  Determine process(es)
information  Establish procedure(s)
 Correct the nonconforming  Provide resources Man, Mc, Matrial
issues  Prepare action plans and
 Continual improvement objectives KPI
 Plan for next PDCA cycle  Determine risks and
opportunities IRR

CHECK P=D DO follow the plan

 Monitor the process(es)  Proceed the operation of the
 Monitor the achieving of process(es)
objectives  Follow the action plans and
 Monitor risks and objectives
opportunities  Address risks and
 Determine the opportunity opportunities
for improvement

QUALITY management PRINCIPLES (QMPs)

Customer focus Need and Exp

Leadership Top mng level

Engagement of people follow direction of Top Mng

Process approach

Improvement P D C A

Evidence-based decision making data / information

Relationship management suplier - org -buyer

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PROCESS APPROACH

REQUIREMENTS PROCEDURE EFFICIENCY

INPUT PROCESS OUTPUT

RESOURCES MONITORING & MEASUREMENT EFFECTIVENESS

man, mc, met

Understanding “PROCESS APPROACH” – INPUT

REQUIREMENTS INPUT RESOURCES

 Statutory and regulatory  MAN (recruitment, personnel qualification,

 Customer requirements (orders, forecast,  Any information or results received from competence, skill, training, awareness,
specific requirements, etc.) previous process etc.)
 Organization requirements (policy,  Supporting information  MACHINE (availability of machine and
procedure, company notification, etc.) equipment, maintenance, calibration or
 International standard, reference (i.e., ISO, verification, etc.)
ASTM, JIS, etc.) or equivalent  MATERIAL (materials, consumable
 Other requirements (i.e., Head Quarter, materials, specification, source,
Industrial Group, etc.) applicability of materials, requirements,
NOTE: Requirements should be documented etc.) include the utility resources
information  OTHER (i.e., budget, etc.)

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Understanding “PROCESS APPROACH” – PROCESS

MONITORING &
PROCEDURE PROCESS MEASUREMENT

 Reference METHOD small activity  MONITORING (determining the status of a

 Policy  Process ≠ Unit department system, process, product, service, or an
 Procedure  A unit department can have more than one activity)
 Work instruction process  MEASUREMENT (process to determine a
 Standard  A process is the activity to transfer value)
INPUTS into INTENDED RESULT  Process parameter, product parameter,
 Work process
OUTPUTS (i.e., products, services, profit, frequency of inspection and testing,
NOTE: Procedure should be documented
etc.) acceptance criteria, inspection and testing
information
method, etc.)

Understanding “PROCESS APPROACH” – OUTPUT

OUT:INP Out:Plan
EFFICIENCY OUTPUT EFFECTIVENESS

 Relationship between the result achieved  Data compared between the extent to
and the resources used  INTENDED RESULT OUTPUTS which planned activities are realized and
 Resources can be MAN, MATERIAL, (expected results from process i.e., planned results are achieved
MACHINE, etc. products, services, profit, etc.)  “PLANNED” can be procedure(s), action
 For example, finished products 80kg from  To be delivered to NEXT PROCESS plan(s), expected result(s), etc.
material used 100kg (80% efficiency) 80:100  For example, finished products 80kg but
 For example, consider in term of time used planned to produce 90kg from materials
to produce 100kg products spending 4hr supplied 100kg (89% effectiveness)
(standard time is 3hr)  For example, consider in term of time used
compared with standard time to produce
100kg products spending 4hr (standard
time is 3hr)

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QMS MODEL

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IMS Requirements STRUCTURE

1. Scope
GENERIC 2. Normative references
3. Terms and definitions
4. Context of the organization effect to org
CENTER
5. Leadership

PLAN 6. Planning

7. Support
DO
8. Operation

CHECK 9. Performance evaluation

ACT 10. Improvement

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Terms and DEFINITIONS

set of interrelated or interacting elements of an organization to
Management
system establish policies and objectives, and processes to achieve those
objectives

Context of the combination of internal and external issues that can have an effect on
organization an organization’s approach to developing and achieving its objectives

(stakeholder) person or organization that can affect, be affected by, or

Interested party perceive itself to be affected by a decision or activity

effect of uncertainty
Risk
(An effect is a deviation from the expected — positive or negative)

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GUIDE for using this presentation

REQUIREMENT (shall) • Example of information

INPUT required to use as INPUT to
the requirements
MD is “MAINTAIN documented
• Expected OUTPUT
information” (document)
ref. papper,elctronic, any media documented information or
other evidences required from
the requirements
RD is “RETAIN documented • Link to other related
OUTPUT
information” (record) requirements
reult from process/operation
(history of events
Information required to be controlled and maintained by an organization and
Documented information
the medium on which it is contained (“document” and “record”)

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CLAUSE 4 – CONTEXT OF THE ORGANIZATION

Understanding the Understanding the Determining the QMS and their

organization and its needs and scope of the quality processes
context expectations of management
interested parties systems

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CLAUSE 4 – CONTEXT OF THE ORGANIZATION

External (OT)
Issues Consider purpose and
(context) intended results of QMS
4.1 Internal (SW)

Needs
Interested Determine requirements
party (needs and expectations)
4.2
Expectations
Organization
determine Boundary Location, site, area, address
Boundary &
Activity, process, product, service, and
Scope
4.3
Scope justification of exclusion for any QMS
requirements that is not applicable
Refer to REQ. Determine criteria, method and proceed in 8.1
Process &
Identify risks and
Interactions Determine 5M opportunities (6.1)
4.4

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4.1 Understanding the organization and its CONTEXT

Consider  Source of information (vision, mission, policy,
strategic plan, business plan, SWOT analysis,
 Organization’s purpose (vision, mission, policy etc.)
PESTLE, 5M+1E, etc.)

INPUT
and strategic direction (strategic plan, business
plan, etc.)  Intended results expected from organization to
QMS
 Intended results of QMS
 Other information
Determine, monitor, review  List of external issues

OUTPUT
 External issues Know its status  List of internal issues
 Internal issues  Plan for monitoring and reviewing those issues
4.3, 5.1, 5.2, 6.1, 9.3
Look
write Carefully

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4.2 Understanding the needs and expectations of INTERESTED

PARTIES
Consider  QMS requirements
 Interested parties that relevant to QMS  Ability to provide products and services
(capacity, capability, reliability, etc.)
INPUT

 Interested parties that affect the organization’s

ability to provide products and services that meet  Customer requirements
customer requirements, statutory and regulatory  Statutory and regulatory requirements
requirements  Other information
 List of interested parties
Determine, monitor, review
 List of their requirements (needs and
OUTPUT

 Interested parties expectations)

 Their requirements (need and expectations) to  How to implement and monitor their
organization requirements within organization
 Plan to review those requirements
4.3, 6.1, 9.1.2, 9.3

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4.3 Determining the SCOPE of QMS

Consider  Workplace, unit department within organization,
location, site, address, area
 Workplace, unit department within organization,
location, site, address, area  External and internal issues (4.1)

INPUT
 External and internal issues (4.1)  Requirements (4.2) including needs and
expectations from relevant interested parties
 Requirements (4.2) including needs and
expectations from relevant interested parties  Products and services provided including
activities within organization
 Products and services provided including activities
within organization  Documentation that describe the boundary and
scope of QMS (i.e., Quality manual)

OUTPUT
Determine  Description of activities, processes, products,
 BOUNDARYMD (area, location, site, address, etc.) services applicable to QMS requirements
 SCOPEMD (activities, processes, products, services)  Justification of QMS requirements that is not
and the justification of QMS requirements that is not applicable
applicable to organization’s scope
4.4

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4.4 QUALITY MANAGEMENT SYSTEMS and its PROCESSES

Establish, implement, maintain, continually improve  QMS requirements
INPUT

 Quality management systems (refer to all  Activities, products and services

requirements)  Other information

Determine and implement  Processes needed (inputs/outputs), their

sequence and interaction
 Process needed for QMS including their inputs  Procedures and other documented information
required and outputs expected to support operation (method and criteria
OUTPUT

 Processes sequence and interaction including resourced needed)

 Criteria and method (monitoring, measuring,  Organization’s roles, responsibilities and
evaluation, etc.) authorities
 Resources needed  Risks and opportunities
 Roles, responsibilities and authorities  Other documented information (documents and
 Actions to address risks and opportunities records) according to QMS requirements
 Any changes needed to achieve intended results
5.0, 6.0, 7.0, 8.0, 9.0, 10.0
 DOCUMENTED INFORMATIONMD/RD (as supporting
operations and as evidences of operations)

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CLAUSE 5 – LEADERSHIP
Leadership and Quality policy Organizational roles,
commitment responsibilities and
authorities

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CLAUSE 5 – LEADERSHIP
Context Needs
Purposes (vision, mission, strategy) Interested
(4.1) parties (4.2)
Expect.
Commit:
- To satisfy applicable requirements
- To continual improvement of the QMS
POLICY (5.2) Resources (7.1)
3M (+ 1E)

OBJECTIVES & TOP MGT Roles, responsibilities,

PLAN to achieve
authorities (5.3)
(6.2)
Process owner & MR
1. Take accountability for the effectiveness of QMS
2. Integrate the QMS into organization’s business
processes Management
3. Promote the use of process approach and risk- review (9.3)
based thinking
Employee 4. Ensure the QMS achieves to intended results

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5.1.1 Leadership and COMMITMENT

Demonstrate leadership and commitment  Purposes (vision, mission, strategic direction)
 Taking accountability for effectiveness of the QMS  Context of the organization (4.0)

INPUT
and ensuring QMS achieves intended results  Activities, processes, products, services
 Establishing quality policy and quality objectives  QMS requirements
which compatible with the context and strategic  Other information
direction
 Leadership and commitment from top
 Integrating the QMS into business processes management
 Promoting using process approach, risk-based  Quality policy (5.2) and quality objectives (6.2)

OUTPUT
thinking and improvement
 Resources provided (7.0)
 Ensuring resource needed are available
 Appointing or assigning roles, responsibilities
 Communicating the importance of effective QMS and authorities or personnel related to QMS
 Engaging, directing, supporting persons to (5.3)
contribute the effectiveness of QMS
5.0, 6.0, 7.0, 8.0, 9.0, 10.0

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5.1.2 Customer FOCUS

Demonstrate leadership and commitment  Purposes (vision, mission, strategic direction)
 Context of the organization
INPUT

 Customer focus (understanding customers' needs

and expectations)  Activities, processes, products, services
 QMS requirements
 Other information
Determine and address
 Customer requirements, including statutory and  List of customer requirements (needs and
regulatory requirements expectations) and how to implement
 List of statutory and regulatory requirements
OUTPUT

 Risks and opportunities that can affect conformity of

products and services and ability to enhance related to products and services
customer satisfaction  Internal processes that related to customers
 Focus on enhancing customer satisfaction  Risks and opportunities (6.1) that related to
customers (from activities, processes, products
and services)
6.1, 8.0, 9.1.2

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5.2 Establishing and communicating the quality POLICY

Consider framework and commitment  Purposes (vison, mission, strategic direction)
 Purposes, context of the organization and strategic  Applicable requirements (customer
requirements, statutory and regulatory

INPUT
direction
requirements)
 Commitment to satisfy applicable requirements
(customer requirements, statutory and regulatory  Customer needs and expectations
requirements) and continual improvement of QMS  Products and services provided
 Quality policy and relevant quality objectives
Establish, implement, maintain

OUTPUT
(6.2)
 Quality POLICYMD  Communication of quality policy within
 Framework for setting quality objectives organization and to relevant interested parties
 Be communicated, understood and applied within 6.2, 7.4, 9.3
organization
 Be available to relevant interested parties

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5.3 Organizational ROLES, RESPONSIBILITIES and authorities

Assign, communicate and understand  QMS requirements
 Roles, responsibilities and authorities within  Activities, processes, products and services
INPUT

organization  Applicable requirements (customer

requirements, statutory and regulatory
Assign responsibilities and authorities for requirements)
 Ensuring QMS conforms to requirements  Organization chart, unit department, job
 Ensuring processes are delivering intended outputs description and specification
OUTPUT

 Reporting QMS performance and opportunities for  Process procedures (defines specific roles,
improvement to top management responsibilities and authorities)
 Ensuring promotion of customer focus  Appointment or assignment from top
 Ensuring integrity of the QMS when changes are management for personnel or working team
planned and implemented 7.0, 8.0

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CLAUSE 6 – PLANNING

Actions to address risks Objectives and Planning of changes

and opportunities planning to achieve
them

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CLAUSE 6 – PLANNING
External and
internal issues
(4.1) Opportunities 1. Assure QMS to achieve intended
results
Requirements
from interested Determine
2. Enhance desirable effects, prevent
parties (4.2) or reduce undesired effects
3. Achieve improvement
Risks
QMS scope (4.3) CHANGE
!! (6.3)

Risks and Action plan

Policy (5.2)
opportunities (6.1) (6.1)

What to be done,
Consistent with policy, what resources, Monitoring,
Objectives measurable, be Plan to achieve who is responsible, measurement, analysis
(6.2) monitored and objectives (6.2) when to complete
communicated and improvement (9.1.1)
how to evaluate

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6.1 Actions to address RISKS AND OPPORTUNITIES

Consider  External and internal issues (4.1)
 External and internal issues (4.1)  Requirements (needs and expectations) from
relevant interested parties (4.2)

INPUT
 Requirements from interested parties (4.2)
 QMS scope (4.3) and processes
 QMS scope (4.3)
 Criteria and method to evaluate risks and
Determine opportunities
 Risks and opportunities to be addressed  Risks and opportunities

OUTPUT
 Give assurance to QMS to achieve intended  Actions to address risks and opportunities
results  Plan to monitor and evaluate the effectiveness
 Enhance desirable effects, prevent or reduce of actions taken
undesired effects
8.0, 9.1, 9.3
 Achieve improvement

Plan, address, evaluate the effectiveness

 Risks and opportunities

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6.2 Quality OBJECTIVES and planning to achieve them

Establish  Applicable requirements (customer
requirements, statutory and regulatory
 Quality OBJECTIVESMD (at relevant functions,
INPUT

requirements)
levels, processes needed)
 Quality policy
Consider  QMS processes
 Consistent with quality policy
 Quality objectives (at relevant functions, levels,
 Measurable processes needed)
OUTPUT

 Take into account applicable requirements  Plan to achieve quality objectives

 Conform with products and services, enhance of  Communicate quality objectives to relevant
customer satisfaction processes or personnel
 Monitoring, communicating and updating (as
appropriate) 7.4, 9.1.1, 9.3

Determine
 WHAT will be done, WHAT RESOURCES will be
required, WHO will be responsible, WHEN it will be
completed, HOW the results will be evaluated

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6.3 PLANNING OF CHANGES

Determine  QMS requirements
Changes needed

INPUT
 Need for changes to the QMS 
 QMS processes
Consider  Other information
 Purposes of changes and their potential  Actions for potential consequences from

OUTPUT
consequences changes
 The integrity of the QMS  Action plan to implement changes
 The availability of resources
6.1, 6.2, 7.0, 8.0, 9.3
 The allocation and reallocation of responsibilities
and authorities

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CLAUSE 7 – SUPPORT

Resources Competence Awareness

Communication Documented
information

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CLAUSE 7 – SUPPORT
(availability) buildings, utilities, equipment,
Infrastructure (7.1.3) machines, transportation, IT, etc.)
Resources (7.1)
Environment for operation (safe and work environment) human factors
of processes (7.1.4) and physical factors
People (7.1.2)
Monitoring and measuring (validity and reliability) calibrate/verify,
resources (7.1.5) identify, safeguard from adjustment

Organizational knowledge (knowledge sharing) determine knowledge,

Competence (7.2) Awareness (7.3) (7.1.6) update and share knowledge

(skilled, capabilities) (aware to quality) DocumentMD

determine necessary Documented
competence and take information (7.5)
actions to acquire necessary RecordRD
competence
Internal Determine documented information
Communication communication (7.5.1)
(7.4) External Establish, identify, review, approve
Determine what, when, communication (7.5.2)
with whom, how, and who Distribution, storage, control of changes,
to communicate
retention and disposition (7.5.3)

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7.1.1 RESOURCES
Determine and provide  QMS requirements
 Resources needed for establishment,  Activities, processes, products, services
INPUT

implementation, maintenance, and continual  Applicable requirements (customer

improvement of QMS requirements, statutory and regulatory
requirements)
Consider  Other information
 Capabilities of, and constraints on, existing internal  List of resources needed (i.e., man, machine,
OUTPUT

resources material, etc.) for processes and their

 What needs to be obtained from external providers capabilities
 List of external providers (to be obtained)
8.0, 9.3

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7.1.2 PEOPLE
Determine and provide  QMS requirements
 Persons necessary for effective implementation of  Activities, processes, products, services

INPUT
QMS and processes  Applicable requirements (customer
requirements, statutory and regulatory
requirements)
 Other information
 Organization chart

OUTPUT
 Manpower plan for each process or unit
department
 Employee recruitment process
7.2, 7.3, 8.0, 9.3

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7.1.3 INFRASTRUCTURE
Determine, provide, maintain  QMS requirements
 Infrastructure necessary for operation of processes  Activities, processes, products, services
INPUT

and to achieve conformity of products and service  Applicable requirements (customer

 Infrastructure can include: requirements, statutory and regulatory
requirements)
 buildings and associated utilities
 Other information
 equipment, including hardware and software
 transportation resources  List of infrastructure necessary for each
OUTPUT

 information and communication technology process

 Plan for maintenance those infrastructure with
results
8.0, 9.3

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7.1.4 ENVIRONMENT for the operation of processes

Determine, provide, maintain  QMS requirements
 Environment necessary for operation of processes  Activities, processes, products, services

INPUT
and to achieve conformity of products and service  Applicable requirements (customer
 Environment can include: requirements, statutory and regulatory
requirements)
 Human factors (i.e., social, non-discriminatory,
ergonomics, etc.)  Other information
 Physical factors (i.e., temperature, light, airflow,  List of environment necessary for each process

OUTPUT
humidity, etc.)  Plan to maintain and/or monitor those
environment with results
8.0, 9.3

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7.1.5 MONITORING AND MEASURING resources

Determine and provide  QMS requirements
 Resources needed to ensure valid and reliable  Activities, processes, products, services
INPUT

results from monitoring and measuring resources to  Applicable requirements (customer

verify conformity of products and services to requirements, statutory and regulatory
requirements requirements)
Consider  Requirements for measurement traceability

 Suitability for the TYPE OF ACTIVITIESRD  List of monitoring and measurement resources
 Maintainability for FITNESS TO THE PURPOSESRD (type of use and suitability for use)
 Calibration/verification plan and results
OUTPUT

Take action to
 Calibration/verification identification
 CALIBRATE/VERIFYRD at specified intervals, or prior  Measures and results from actions taken to
to use, against measurements standards traceable to measurement results that found to be unfit for
international or national measurements standards its intended purpose
 Identify their status and safeguard from adjustments,
damage or deterioration 8.0
 Previous measurement results that found to be unfit
for its intended purpose
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7.1.6 Organizational KNOWLEDGE

Determine  Activities, processes, products, services

INPUT
 Necessary knowledge for operation of processes to  Sources of knowledge and information
achieve conformity of products and services  Other information
 List of knowledge for relevant processes
Maintain

OUTPUT
 Plan for updating those knowledge
 Knowledge and be made available to the extent  Process to share these knowledge to relevant
necessary
process
 Internal sources (i.e., experience, lesson learned,
etc.) 7.2, 8.0
 External sources (i.e., standards, conference, etc.)
Consider
 Changing needs and trends for
 Current knowledge
 How to acquire or access necessary additional
knowledge and required updates

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7.2 COMPETENCE
Determine  Activities, processes, products, services
 Necessary competence of person(s) doing work that  QMS requirements
INPUT

affects the performance and effectiveness of QMS  Applicable requirements (customer

requirements, statutory and regulatory
Consider requirements)
 Competence (appropriate education, training, or  Necessary competence (training needs)
experience)  Actions for acquiring those competence (i.e.,
training, coaching, on-the-job training,
Take action to
mentoring, hiring competent persons, etc.)
OUTPUT

 Acquire the necessary competence  Training plan (internal and external training)
 Evaluate the effectiveness of actions taken  Method of evaluation of effectiveness of actions
 Retain evidence of COMPETENCERD taken
 Training and evaluation records or other
evidences
8.0

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7.3 AWARENESS
Ensure  Activities, processes, products, services
 Person(s) doing work under control that affects the  QMS requirements

INPUT
performance and effectiveness of QMS are aware of  Applicable requirements (customer
 Quality policy requirements, statutory and regulatory
requirements)
 Relevant quality objectives
 Quality policy and quality objectives
 Contribution to the effectiveness of QMS including
the benefits of improved performance  Awareness of person(s)

OUTPUT
 Implications of not conforming with QMS  Ability of person(s) to work on their
requirements responsibilities
8.0

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7.4 COMMUNICATION
Determine  Activities, processes, products, services
 Internal and external communications that relevant  QMS requirements
INPUT

to QMS  Applicable requirements (customer

requirements, statutory and regulatory
Consider requirements)
 What to be communicated  Communication plan (internal and external) with
OUTPUT

 When to communicate media, channel, and method to communicate

 With whom to communicate  Response to communication with relevant
 How to communicate persons or interested parties
 Who communicates 8.0

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7.5 DOCUMENTED INFORMATION (General, Creating and

Updating, Control)
Determine documented information  QMS requirements
 Required by QMS requirements  Applicable requirements (customer

INPUT
requirements, statutory and regulatory
 Determined by organization as being necessary
requirements)
Consider  Activities, processes, products, services
 Identification and description, format and media  Documented information (documents and
 Review and approval for suitability and adequacy records) for each process within QMS

OUTPUT
 Process to control internal and external
Control documented information documented (identification, reviewing, revising,
 Available and suitable for use with adequacy approving, distributing, retrieving, accessing,
protected storing, using, control of retention and
 Distribution, access, retrieval and use disposition)
 Storage and preservation (legibility) 4.0, 5.0, 6.0, 7.0, 8.0, 9.0, 10.0
 Control of changes
 Retention and disposition
 Control external documented information

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CLAUSE 8 – OPERATION

Operational Requirements for Design and Control of externally

planning and products and development of provided processes,
control services products and products and
services services

Production and Release of Control of

service provision products and nonconforming
services outputs

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CLAUSE 8.1 Operational PLANNING and CONTROL

OUTSOURCE process control (8.4)

1) Standard and requirement of products/services (8.2.2, 8.3) +

Processes and criteria (acceptance criteria)
interaction (4.4)
DO
2) Process criteria
(8.2-8.7)
Planning (6.0)
3) Resources needed (7.1 = 3M (+1E))

Customer Sale & Mkt Planning Production Inspection

Planning and
validation to
process to
validate products
or services R&D Purchasing Warehouse

45

8.1 Operational PLANNING and CONTROL

Plan, implement, control  Actions from risks and opportunities, quality
objectives, etc.
 Processes needed to meet requirements for
INPUT

provision of products and services  Applicable requirements (customer

requirements, statutory and regulatory
 Actions determined in clause 6.0
requirements)
Take action to  Activities, processes, products, services
 Determine requirements for products and services  Products and services requirements
 Establish and implement criteria for processes and  Process criteria and acceptance criteria for
acceptance of products and services products and services
 Determine resource needed  Lost of resources needed to operate processes
OUTPUT

 Maintain and retain documented information to extent  Documented information to support the
necessary above actions operations and as evidence to demonstrate the
Control conformity
 List of outsource processes and how to control
 Planned changes and review consequences of
 Any changes and their actions
unintended changes
 Outsourced processes 8.2-8.7, 9.1, 9.3

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CLAUSE 8.2 – REQUIREMENTS for products and services

channel
Customer Communication Sale & MKT
Statutory and
regulatory (8.2.2)
1) Information for products/services (8.1, 8.2.2, 8.3) Design inputs (8.3.3)
Organization’s
Products/ Statutory/ capability (8.2.2)
customers Organization
services regulatory

2) Enquiries, contracts or orders, including Review the ability for Review and confirm
changes (8.2.3, 8.2.4) requirements (8.2.3) any changes (8.2.4)

3) Customer feedback including customer Customer satisfaction Customer complaint

complaint (9.1.2, 10.2) (9.1.2) (10.2)

4) Handling or controlling of customer property Identify, verify, protect and safeguard, report to customer
(8.5.3) when lost or damage (including intellectual property)
Consider risks และ opportunities related to customers and
5) Contingency actions (if any) (5.1.2, 6.1)
actions such as contingency actions, business continuity
plan (BCP), etc.

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8.2.1 CUSTOMER communication

Communicate with customer to  Applicable requirements (customer
requirements, statutory and regulatory
 Provide information related to products and services
INPUT

requirements)
 Handle enquiries, contracts or orders, including
 Activities, processes, products, services
changes
 Risks and opportunities
 Obtain customer feedback, including customer
complaints  Customer communication plan
 Handle and control customer property  Products/services requirements provided
 Establish specific requirements for contingency  Media describes products and services
actions requirements (i.e., website, brochure, etc.)
OUTPUT

 Customer enquiries, contracts, orders and their

change
 Receiving and responding for customer
feedback
 Any other actions including handle customer
property, contingency actions
8.3, 8.4, 8.5, 9.1.2, 10.2

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8.2.2 DETERMINATION the requirements for products and

services
Consider  Applicable requirements (customer

INPUT
requirements, statutory and regulatory
 Requirements for products and services to be
requirements)
offered to customers
 Activities, processes, products, services
 Applicable statutory and regulatory
requirements  List of statutory and regulatory requirements
 Any requirements determined by organization related to products and services and how to

OUTPUT
 Organization’s ability to claim for products and implement
services  List of products and services
 Implementation in according to products and
services requirements
8.2.3, 8.3, 8.4, 8.5, 8.6

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8.2.3 REVIEW of the requirements for products and services

Conduct  Applicable requirements (customer
requirements, statutory and regulatory
 A review before committing to supply products and
requirements)
INPUT

services to customers
 Activities, processes, products, services
Review requirements from  Products and services information
 Customers including delivery and post-delivery  Customer contracts, orders, including changes
activities
 Results of customer contracts or orders
OUTPUT

 Necessary for specified or intended use reviewing

 Organization  Result for contracts or orders confirmation
 Statutory and regulatory including changes
Confirm 8.2.4, 8.3, 8.4, 8.5
 Contracts or orders requirements differing from
previously defined are resolved
 Confirm before acceptance
 RESULTSRD of review and any new requirements

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8.2.4 CHANGES to the requirements for products and services

Ensure  Applicable requirements (customer
requirements, statutory and regulatory
 Relevant documented information is amended when
requirements)

INPUT
there is any changes to products and services
requirements  Activities, processes, products, services
 Products and services information
Communicate  Customer contracts, orders, including changes
 To relevant persons to aware of the changed  Results of customer contracts or orders
requirements reviewing

OUTPUT
 Result for contracts or orders confirmation
including changes
 Results of communication to relevant persons
8.3, 8.4, 8.5

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CLAUSE 8.3 – DESIGN and DEVELOPMENT of products and

services
Customers inquire for new products and services
Determine
Development team response and feedback to customers plan and
Customers Development how to
TEAM develop
(8.3.2)

Results from design and Design & Development (8.3.4) Collect information (8.3.3)
development (8.3.5) such as such as customer
formula, process requirements, statutory and
parameters and criteria, regulatory requirements,
specification, inspection and 1. REVIEW  (results or outputs = intended use, similar
testing results, process plan or requirements) products or services, etc.
instructions, etc. 2. VERIFY  (output = input)
3. VALIDATE  (output = intended
use)
4. CHANGE control  changes during
Other related processes design and development (8.3.6)
(8.4, 8.5, 8.6) 5. ACTION  determine actions and
implement

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8.3.1 DESIGN and DEVELOPMENT of products and services

Establish, implement, maintain  QMS requirements
 Design and development process that appropriate to  Applicable requirements (customer

INPUT
subsequent provision of products and services requirements, statutory and regulatory
requirements)
 Activities, processes, products, services
 Products and services information
 Design and development process or procedure

OUTPUT
 Determination of roles, responsibilities and
authorities for development team (relevant
processes)
8.3.2-8.3.6

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8.3.2 Design and development PLANNING

Plan and consider (for design and development)  QMS requirements
 Nature, duration and complexity of the activities  Applicable requirements (customer
INPUT

requirements, statutory and regulatory

 Required process stages, including applicable design
requirements)
and development review, verification and validation
activities  Activities, processes, products, services
 Responsibilities and authorities involved  Products and services information
 Internal and external resource needs  Design and development plan (activities,
 Need to control interfaces between persons involved responsible person, planned date, etc.)
OUTPUT

 Need for involvement of customers and users  Interfaces of each process and relevant
 Requirements for subsequent provision of products interested parties including customers in the
and services design and development plan
 Level of control expected by customers and other 8.3.3-8.3.6
relevant interested parties
 Documented information needed to demonstrate that
design and development requirements have been
met

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8.3.3 Design and development INPUTS

Determine  Applicable requirements (customer
requirements, statutory and regulatory
 Requirements essential for the specific types of
requirements) including standards and codes

INPUT
products and services to be designed and
developed  Activities, processes, products, services
 Products and services information and
Consider requirements
 Functional and performance requirements  Information from relevant interested parties,
 Information from previous similar design and customers, other processes
development activities  List of products and services requirements
 Statutory and regulatory requirements including intended use

OUTPUT
 Standards or codes of practice  List of requirements (customers, statutory and
 Potential consequences of failure due to the nature regulatory, standards, codes, etc.)
of the products and services  Information of previous design and development
Inputs cover  List of potential consequences of failure and
plan to actions
 Adequate, complete, unambiguous
8.3.4, 8.3.5, 8.3.6
 Design and development INPUTSRD

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8.3.4 Design and development CONTROLS

Control  Design and development plan
 Design and development process  Results from design and development inputs
INPUT

 Other information
Consider and ensure  List of products and services requirements
 Results to be achieved are defined including intended use
 Reviews and evaluate the ability of the results  Results from review, verification ,validation
OUTPUT

(results/output = plan, requirements) activities

 Verification activities are conducted (outputs =  Action for those results
inputs)  Other supporting information
 Validation activities are conducted (outputs =
8.3.5, 8.3.6
intended use)
 Any necessary actions are taken

Retain
 Documented information of these ACTIVITIESRD

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8.3.5 Design and development OUTPUTS

Consider  Design and development plan
 Design and development outputs  Results from design and development inputs

INPUT
 Other information
Ensure outputs  List of products and services requirements
 Meet the input requirements including intended use
 Adequate for the subsequent processes for the  Results from design and development (formula,
provision of products and services products and services parameters and
 Include or reference monitoring and measuring acceptance criteria, process parameters,

OUTPUT
requirements and acceptance criteria process instructions, inspection and testing
 Specify the characteristics of the products and methods, other results according to design and
services that are essential for their intended purpose development inputs)
 List of materials, machines to be used
Retain
8.3.6, 8.4, 8.5, 8.6
 Design and development OUTPUTSRD

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8.3.6 Design and development CHANGES

Identify, review, control  Design and development plan
 Changes during, or subsequent to, design and  Design and development inputs
development of products and services to ensure no  Design and development review, verification,
INPUT

Adverse impact on conformity to requirements validation

 Design and development outputs
Retain  Other information (from team, processes,
 Design and development CHANGESRD relevant interested parties, etc.)
 Results of REVIEWSRD  Design and development changes information
 AUTHORIZATIONRD for changes and their consequences (from team, customers,
OUTPUT

 ACTIONSRD taken to prevent adverse impact processes, relevant interested parties, etc.)
 Authorized person to change
 Actions for authorized changes
 Other information
8.3.3, 8.3.4, 8.3.5

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CLAUSE 8.4 – Control of EXTERNALLY PROVIDED processes,

products and services
Select, evaluate, Status of external
External
Criteria and method re-evaluate, monitor providers
Providers
performance (8.4.1) (accept/reject)
1. Incorporate with products
and services
2. Provide directly to customers
3. A process, or part of process External Communication
Organization
Providers (8.4.3)

1. Processes, products, services

2. Approval of products and services, methods, processes,
equipment, release of products and services
3. Competence, required qualification
Type and extent to
4. Interaction with organization
control (depend on the
5. Control and monitor performance
results) (8.4.2)
6. Verification and validation activities
Such as incoming inspection,
on-site audit, annual self
assessment, ISO certification,
performance monitoring, etc.

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8.4.1 Control of EXTERNALLY PROVIDED processes, products and

services
Ensure  Applicable requirements (customer
requirements, statutory and regulatory
 Externally provided processes, products, services
requirements)
INPUT

conform to requirements
 Activities, processes, products, services
Control external providers  Products and services information and
 Products and services are intended for incorporation requirements
into the organization’s own products and services  List of external providers (provide processes,
 Products and services are provided directly to the products, services)
customer(s)  Method and criteria to evaluate, select, monitor
OUTPUT

 A process, or part of a process, is provided by an performance and re-evaluate

external provider  Results from evaluation, selection, monitoring
performance and re-evaluation
Determine
 Actions taken from those results
 Criteria for evaluation, selection, monitoring
performance, re-evaluation 8.4.2, 8.4.3, 9.1.3, 9.3
 ACTIVITIESRD and the ACTIONSRD from evaluation

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8.4.2 Type and extent of CONTROL

Ensure  Applicable requirements (customer
requirements, statutory and regulatory
 Externally provided processes, products, services
requirements)
do not adversely affect to ability to intently deliver

INPUT
conforming products and services to customers  Activities, processes, products, services
 Products and services information and
Take action to requirements
 Control external providers under QMS  List of external providers (provide processes,
 Define controls to be taken to external providers and products, services)
resulting outputs  Measures to control those external providers
 Consider potential impact that affect to customers, depending on their importance of their resulting
applicable statutory and regulatory requirements, outputs to customers (i.e., incoming inspection,

OUTPUT
and the effectiveness of the controls on-site audit, self assessment, ISO certification,
 Determine the actions to verify, or other activities, to performance monitoring, etc.)
ensure externally provided processes, products,  Risks and opportunities from external providers
services meet the requirements to customers including the actions
8.4.1, 8.4.3, 8.6

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8.4.3 INFORMATION for external providers

Ensure  Applicable requirements (customer
requirements, statutory and regulatory
 Adequacy requirements prior to communication to
requirements)
the external providers
 Activities, processes, products, services
INPUT

Communicate to external providers  Products and services information and

 Processes, products and services to be provided requirements
 Approval of products and services, methods,  List of external providers (provide processes,
processes and equipment, the release of products products, services)
and services  Information to be communicated to external
 Competence, qualification of persons providers (i.e., service agreement, purchasing
 Interaction of external providers with organization order, etc.)
OUTPUT

 Control and monitoring of performance by  Details of any requirements of processes,

organization products, services to be provided from external
 Verification or validation activities that the providers to organization (i.e., specification,
organization, or its customer, intends to perform at delivery information, inspection method, etc.)
the external providers’ premises 8.4.1, 8.5, 8.6

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CLAUSE 8.5 – PRODUCTION and SERVICE provision

Control provision of products and
Control changes (8.5.6)
services under CONTROLLED Review and approve prior implementation
CONDITIONS (8.5.1)

1) Characteristics of products, services, activities (8.1, Identification and traceability (8.5.2)

8.2.2, 8.3), methods (8.3.5) and results from process
2) Availability and use of suitable monitoring and Control of property belonging to
measuring resources (7.1.5) and implement to control customers and external providers (8.5.3)

3) Use of suitable infrastructure (7.1.3) Product preservation (8.5.4)

4) Use of suitable environment for the operation of

processes (7.1.4) Statutory and regulatory requirements

5) Process validation and re-validation Potential consequences or intended

lifetime from products and services
6) Appointment of competence persons (7.2) and
implement actions to prevent human error Customer requirements

7) Implement release (8.6), delivery and post-delivery Customer feedback

activities (8.5.5)

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8.5.1 CONTROL of production and service provision

Implement  Results from design and development (formula,
products and services parameters and
 Production and service provision under controlled
acceptance criteria, process parameters,
conditions
Control conditions include process instructions, inspection and testing
INPUT

 Availability of documented information for methods, etc.)

characteristics of products, services, activities and  Infrastructure, monitoring and measuring
their results resources, etc.
 Availability and use of monitoring and measuring  Other information
resources and their implementation to verify the  Results from provision of products and services
control criteria including monitoring results
OUTPUT

 Use of suitable infrastructure, environment for  Results of validation and revalidation

operation of processes  Results of release, delivery and post-delivery
 Appointment of competent persons or required activities
qualification, and the actions to prevent human error
 Process validation and revalidation 8.5.2-8.5.6, 8.6
 Implementation of release, delivery and post-
delivery activities

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8.5.2 IDENTIFICATION and traceability

Use suitable means to  Products and services

INPUT
 Identify outputs to ensure the conformity of products  Traceability requirements
and services  Other information

Identify  Tag identification, Status tag for products and

services

INPUT
 A status of outputs with respect to monitoring and  Format and information for traceability of
measurement requirements throughout production products and services
and service provision
8.5.4-8.5.6, 8.6, 8.7
Control
 The unique identification of the outputs when
traceability is a requirements
 Information necessary to enable TRACEABILITYRD

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8.5.3 PROPERTY belonging to customers or external providers

Exercise care  Products and services that belong to customers
and external providers
INPUT

 Property belongs to customers and external

providers while it is under organization's control or  Customer requirements
use  Other information

Consider  List of customer property

 List of external provider property
OUTPUT

 Identification, verification, protection and

 Method to control the property that belong to
safeguarding those properties for use or
customers and external providers
incorporation into products and services
 Results of actions taken to customers and
Report external providers
 When the property is lost, damaged, found to be 8.2.1, 8.4.3, 8.5.4, 8.7
unsuitable for use
 ACTIONSRD to what has occurred

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8.5.4 PRESERVATION
Preserve  Products and services

INPUT
 The outputs during production and service provision  Environment condition to be controlled
to ensure conformity to requirements  Methods for preserving the products and
services
Consider preservation cover
 List of environment for operation and how to
 Identification, handling, contamination control, control and monitor

OUTPUT
packaging, storage, transmission or transportation,  Layout of storage and location
protection
 Tag identification, stock controlling, products
and services handling
8.5.5, 8.6, 8.7

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8.5.5 POST-DELIVERY activities

Meet  Applicable requirements (customer
requirements, statutory and regulatory
 The requirements for post-delivery activities
requirements)
associated with the products and services
INPUT

 Products and services information and

Consider requirements
 Statutory and regulatory requirements  Products and services from processes
 Potential undesired consequences associated with  Other information
the products and services  List of applicable statutory and regulatory
 Nature, use and intended lifetime of products and requirements related to products and services
services for post-delivery activities
OUTPUT

 Customer requirements  List of customer requirements related to post-

 Customer feedback delivery activities
 Measures for post-delivery activities
 Information received from or provided to
customers
8.2.1, 8.6, 8.7, 9.1.2, 9.3

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8.5.6 Control of CHANGES

Review and control  Applicable requirements (customer
requirements, statutory and regulatory
 Changes for production and service provision to
requirements)

INPUT
ensure continuing conformity with requirements
 Products and services information and
Retain requirements
 RESULTSRD of review of changes  Other information
 PERSONRD authorized the change  Request for change for provision of products
 ACTIONSRD arising from the review and services

OUTPUT
 Review results of consequence from changes
and approval
 Actions to be taken to changes and
consequences
6.0, 7.0, 8.1, 8.2, 8.5.1, 8.6, 8.7

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CLAUSE 8.6 – RELEASE of products and services

CLAUSE 8.7 – Control of NONCONFORMING outputs
Control provision of products and
services under CONTROLLED
CONDITIONS (8.5.1)

Requirements for
products and services Release of products and services (8.6)
(8.1) + criteria

Correction (rework, Retain documented

repair, reprocess, etc.)
information describes
Segregation,  Nonconformity
Control of nonconforming outputs (8.7) containment  Actions taken
 Any concession
Informing to customer obtained
Identify nonconforming products and  Authority deciding
services Obtaining
the action
authorization

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8.6 RELEASE of products and services

Implement planned arrangement to  Applicable requirements (customer
requirements, statutory and regulatory

INPUT
 Verify, at appropriate stages, that the product and
requirements)
service requirements have been met
 Products and services information and
Consider requirements including acceptance criteria
 The release of products and services to the  Results of verification of products and services
customer must not proceed until planned against the requirements

OUTPUT
arrangements have been satisfactorily completed,  Results of acceptance
unless otherwise approved by relevant authority and  Results of person reviews and approves the
by customer results
Retain 8.5.1, 8.5.2, 8.5.4, 8.7
 Evidence of CONFORMTYRD with the acceptance
criteria
 TRACEABILITYRD to person authorizing the release

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8.7 Control of NONCONFORMING outputs

Identify and control  Applicable requirements (customer
requirements, statutory and regulatory
INPUT

 Nonconforming outputs to their requirements to

requirements)
prevent their unintended use or delivery
 Products and services information and
Deal with nonconforming outputs requirements including acceptance criteria
 Correction  Tag identification for nonconforming outputs
 Segregation, containment, return or suspension  Results of actions taken to nonconforming
 Informing to customer outputs (appropriate methods and nature of
OUTPUT

 Obtaining the authorization for acceptance under nonconforming outputs)

concession  Results of reviewing and verifying corrected
 Verify corrected nonconforming outputs for nonconforming outputs
conformity to requirements  Other information
Retain documented information 8.2.1, 8.5, 8.6, 9.1.3, 9.3
 DESCRIBERD nonconformity, actions taken, any
concessions obtained, the authority deciding the
actions

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CLAUSE 9 – PERFORMANCE EVALUATION

Monitoring, Internal audit Management review

measurement,
analysis and
evaluation

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CLAUSE 9 – PERFORMANCE EVALUATION

Activities and
Summary results from top
processes (4.4) Review outputs management to management
systems including improvement
1) Monitor processes and
their performance (9.1.1)
Determine monitoring,
measurement, 2) Evaluate the customer Management
analysis and satisfaction (9.1.2) review (9.3)
evaluation (9.1.1)
Determine what needs to
monitored and measure, that 3) Management systems
methods, when and how to
analyze and evaluate the
internal audit (9.2)
results Evaluate compliance against the QMS
requirements, define plan, frequency,
method, responsibilities, reporting and
take corrective action to nonconformity
found Results from activities and
Analysis and Review inputs processes within QMS including
evaluation (9.1.3) any changes

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9.1.1 MONITORING, MEASUREMENT, analysis and evaluation –

General
Determine  QMS requirements and QMS processes

LOOK AT
 What needs to be monitored and measured  Applicable requirements (customer
 The methods for monitoring, measurement, analysis requirements, statutory and regulatory
and evaluation requirements)
 When the monitoring and measurement preforms  Other information
 When results to be analyzed and evaluated  List of activities, processes, products and

LOOK FOR
services to be monitored and measured
Evaluate
 Monitoring and measurement plan
 Performance and effectiveness of QMS  Methods, criteria, and results of monitoring and
measuring activities and processes within QMS
Retain documented information
9.1.3, 9.3
 RESULTSRD of monitoring, measurement, analysis
and evaluation

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9.1.2 Customer SATISFACTION

Monitor  Customer requirements
INPUT

 Customer’s perceptions of the degree to which their  Products and services provided to customers
needs and expectations have been fulfilled  Other information

Determine  Method and criteria to evaluate customer

satisfaction
OUTPUT

 The methods for obtaining, monitoring and  Results of customer satisfaction

reviewing this information, i.e.,
 Information from customer feedback
 Customer surveys  Actions taken from results
 Customer feedback
9.1.3, 9.3
 Meeting with customers
 Market-share analysis
 Etc.

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9.1.3 ANALYSIS and EVALUATION

Analyze and evaluate  Monitoring and measurement plan

INPUT
 Data and information arising from monitoring and  Results from monitoring and measurement
measurement  Other information

Evaluate  Analyzed data and information (i.e., graph,

summarized table, etc.) including evaluation

OUTPUT
 Conformity of products and services  Effectiveness and efficiency of QMS and other
 Degree of customer satisfaction information
 Performance and effectiveness of QMS  Suggestions and opportunities for improvement
 Planning have been implemented effectively
9.3
 Effectiveness of actions taken to address risks and
opportunities
 Performance of external providers
 Needs for improvement of QMS

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9.2 Internal AUDIT

Conduct internal audit  QMS requirements and QMS processes
INPUT

 At planned intervals to provide information whether  Applicable requirements (customer

QMS conforms to requirements, and effectively requirements, statutory and regulatory
implemented and maintained requirements)

Take action to  List of internal auditors and their qualification

 Internal audit program and plan
OUTPUT

 Establish, implement and maintain audit program,

frequency, methods, responsibilities, planning  Internal audit report
requirements and reporting, consider importance of  Results of nonconformity issues raised and
processes, changes, and results from previous audit their corrective actions
 Define criteria and scope 9.3, 10.2
 Select auditors, ensure objectivity and impartiality
 Report the audit results to relevant management
 Take appropriate correction and corrective actions
Retain documented information
 EVIDENCERD of implementation of audit program, audit results

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9.3 Management REVIEW

Review  Analyzed data and information (i.e., graph,
summarized table, etc.) including evaluation
 QMS at planned intervals

INPUT
 Effectiveness and efficiency of QMS and other
Consider information
 Continuing suitability, adequacy and effectiveness  Review inputs information
 Alignment with strategic direction of the organization  Results of management review outputs

OUTPUT
 ***Review inputs  Suggestions and opportunities for improvement
 Comment from top management
Decide and take actions to
4.0, 5.0, 6.0, 7.0, 10.0
 Opportunities for improvement
 Any need for changes to QMS
 Resource needs
 Retain evidence of RESULTSRD of management
reviews

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Management review INPUTS

1) Status of actions from previous reviews (9.3) 4) Adequacy of resources (7.1)
2) Changes in external and internal issues that 5) Effectiveness of actions taken to address risks
relevant to QMS (4.1) and opportunities (6.1)
3) Information on performance and effectiveness 6) Opportunities for improvement (10.1, 10.3)
of QMS, including trends in;
 Customer satisfaction and feedback from
relevant interested parties (9.1.2, 10.2)
 Extent to which quality objectives have been
met (5.2, 6.2, 9.1.1)
 Process performance (9.1.1, 9.3) and
conformity of products and services (8.6)
 Nonconformities and corrective actions
(10.2)
 Monitoring and measurement results (9.1.1)
 Audit results (9.2)
 Performance of external providers (8.4.1)
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CLAUSE 10 – IMPROVEMENT

General Nonconformity and Continual

corrective action improvement

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CLAUSE 10 – IMPROVEMENT

Determine
opportunity for Plan actions
improvement (10.1)

Results from
monitoring and Nonconformities, Identify cause(s), take correction
measurement including and corrective actions, review
(9.0) complaints (10.2) effectiveness of actions

Continual
improvement (10.3)

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10.1 IMPROVEMENT – General

Determine and select  Analyzed data and information (i.e., graph,
summarized table, etc.) including evaluation

INPUT
 Opportunities for improvement
 Suggestions and opportunities for improvement
Implement  Other information
 Any necessary actions to  List of opportunities for improvement

OUTPUT
 Meet customer requirements  Action plan for opportunities for improvement
 Enhance customer satisfaction  Results of action plans

Consider 6.0, 7.0, 8.0

 Improve products and services to meet

requirements and address future needs and
expectations
 Correct, prevent or reduce undesired effects
 Improve the performance and effectiveness of QMS

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10.2 Nonconformity and CORRECTIVE ACTION

Consider  QMS requirements and QMS processes
 Occurred nonconformity, including complaints  Applicable requirements (customer
INPUT

requirements, statutory and regulatory

Take action to requirements)
 React to the nonconformity, i.e., take action to control  Activities, processes, products and services
and correct, deal with consequences
 Nonconformity issues raised from activities,
 Evaluate the needs for action to eliminate the processes, products and services
cause(s) of nonconformity to ensure it does not recur
OUTPUT

 Results of cause(s) analysis, correction,

or occur elsewhere (review and analyze, determine
corrective action
causes, determine similar or potential occur)
 Review results of actions taken including risks
 Implement action needed
and opportunities
 Review effectiveness of corrective action taken
 Update risks and opportunities 6.0, 7.0, 8.0
 Make changes to QMS
Retain documented information
 NATURERD of nonconformities and SUBSEQUENTRD actions taken, RESULTSRD of corrective action

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10.3 Continual IMPROVEMENT

Continually improve  Analyzed data and information (i.e., graph,
summarized table, etc.) including evaluation
 Suitability, adequacy and effectiveness of QMS

INPUT
 Suggestions and opportunities for improvement
 Action plan from activities, processes, products
and services
 Other information
 List of continual improvement within

OUTPUT
organization
 Projects or activities for improvement
6.0, 7.0, 8.0, 9.0

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QUESTION & ANSWER

INTRODUCTION TO QUALITY MANAGEMENT SYSTEMS (QMS, ISO 9001:2015)
REQUIREMENTS AND IMPLEMENTATION

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