AUTOMOTIVE

QUALITY MANAGEMENT IATF 16949

SYSTEM STANDARD

Quality management system requirements for automotive production

and relevant service parts organizations

International
Automotive
Task Force

1st Edition

1 October 2016

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IATF Copyright Notice

This Automotive Quality Management System Standard, known as IATF 16949, is copyright
protected by the members of the International Automotive Task Force (IATF). The title for
this Automotive QMS Standard “IATF 16949” is a registered trademark of the IATF.

Except as permitted under the applicable laws of the user’s country, neither this Automotive
Quality Management System Standard nor any extract from it may be reproduced, stored in
a retrieval system or transmitted in any form or by any means, electronic, photocopying,
recording or otherwise, without prior written permission being secured from the IATF.

Reproduction may be subject to royalty payments of a licensing agreement and violators are
subject to legal prosecution.

Requests for permission to reproduce and / or translate any part of this Automotiive QMS
Standard should be addressed to one of the following national automotive trade associations
below:

Associazione Nazionale Fra Industrie Automobilistiche (ANFIA / ltaly)

Automotive Industry Action Group (AIAG / USA)

Federation des Industries des Equipements pour vehicules (FIEV / France)

Society of Motor Manufacturers and Traders Ltd. (SMMT / UK)

Verband der Automobilindustrie e.V. (VDA / Germany)

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 Table of Contents

TABLE OF CONTENTS 3

FOREWORD – AUTOMOTIVE QMS STANDARD 9

HISTORY 9

GOAL 9

REMARKS FOR CERTIFICATION 10

INTRODUCTION 11
0.1 GENERAL 11

0.2 QUALITY MANAGEMENT SYSTEM 11

0.3 PROCESS APPROACH 11

0.3.1 GENERAL 11

0.3.2 PLAN-DO-CHECK-ACT 11

0.3.3 RISK-BASED THINKING 11

0.4 RELATIONSHIP WITH OTHER MANAGEMENT SYSTEM STANDARDS 11

QUALITY MANAGEMENT SYSTEMS – REQUIREMENTS 11

1 SCOPE 11

1.1 Scope – Automotive Supplemental to ISO 9001:2015 11

2 NORMATIVE REFERENCE 11

2.1 Normative and Informative References 11

3 TERMS AND DEFINITIONS 12

3.1 Terms and definitions for the automotive industry 12

4 CONTEXT OF THE ORGANIZATION 16

4.1 UNDERSTANDING THE ORGANIZATION AND ITS CONTEXT 16

4.2 UNDERSTANDING THE NEEDS AND EXPECTATIONS OF INTERESTED PARTIES 16

4.3 DETERMINING THE SCOPE OF THE QUALITY MANAGEMENT SYSTEM 16

4.3.1 Determining the scope of Quality Management system - supplemental 17

4.3.2 Customer-specific requirements 17

4.4 QUALITY MANAGEMENT SYSTEM AND ITS PROCESSES 17

4.4.1 17

4.4.1.1 Conformance of products and processes 17

4.4.1.2 Product safety 17

4.4.2 18

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5 LEADERSHIP 18

5.1.1 GENERAL 18

5.1.1.1 Corporate responsibility 18

5.1.1.2 Process effectiveness and efficiency 18

5.1.1.3 Process owners 18

5.1.2 CUSTOMER FOCUS 18

5.2 POLICY 18

5.2.1 ESTABLISHING THE QUALITY POLICY 18

5.2.2 COMMUNICATING THE QUALITY POLICY 18

5.3 ORGANIZATIONAL ROLES, RESPONSIBILITIES AND AUTHORITIES 18

5.3.1 Organizational roles, responsibilities, and authorities – supplemental 18

5.3.2 Responsibility and authority for product requirements and corrective actions 19

6 PLANNING 19

6.1 ACTIONS TO ADDRESS RISK AND OPPORTUNITIES 19

6.1.1 AND 6.1.2 19

6.1.2.1 Risk analysis 19

6.1.2.2 Preventive action 19

6.1.2.3 Contingency plans 19

6.2 QUALITY OBJECTIVES AND PLANNING TO ACHIEVE THEM 20

6.2.1 AND 6.2.2 20

6.2.2.1 Quality objectives and planning to achieve them – supplemental 20

6.3 PLANNING OF CHANGES 20

7 SUPPORT 20

7.1 RESOURCES 20

7.1.1 GENERAL 20

7.1.2 PEOPLE 20

7.1.3 INFRASTRUCTURE 21

7.1.3.1 Plant, facility and equipment planning 21

7.1.4 ENVIRONMENT FOR THE OPERATION OF PROCESSES 21

7.1.4.1 Environment for the operation of processes – supplemental 21

7.1.5 MONITORING AND MEASURING RESOURCES 21

7.1.5.1.1 Measurement system analysis 21

7.1.5.2 MEASUREMENT TRACEABILITY 22

7.1.5.2.1 Calibration / verification records 22

7.1.5.3 Laboratory requirements 22

7.1.5.3.1 Internal laboratory 22

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7.1.5.3.2 External laboratory 23

7.1.6 ORGANIZATIONAL KNOWLEDGE 23

7.2 COMPETENCE 23

7.2.1 Competence – supplemental 23

7.2.2 Competence – on-the-job training 23

7.2.3 Internal auditor competency 24

7.2.4 Second-party auditor competency 24

7.3 AWARENESS 25

7.3.1 Awareness – supplemental 25

7.3.2 Employee motivation and empowerment 25

7.4 COMMUNICATION 25

7.5 DOCUMENTED INFORMATION 25

7.5.1 GENERAL 25

7.5.1.1 Quality management system documentation 25

7.5.2 CREATING AND UPDATING 26

7.5.3 CONTROL OF DOCUMENTED INFORMATION 26

7.5.3.1 AND 7.5.3.2 26

7.5.3.2.1 Record retention 26

7.5.3.2.2 Engineering specifications 26

8 OPERATION 26

8.1 OPERATIONAL PLANNING AND CONTROL 26

8.1.1 Operational planning and control – supplemental 26

8.1.2 Confidentiality 27

8.2 REQUIREMENTS FOR PRODUCTS AND SERVICES 27

8.2.1 CUSTOMER COMMUNICATION 27

8.2.1.1 Customer communication – supplemental 27

8.2.2 DETERMINING THE REQUIREMENTS FOR PRODUCTS AND SERVICES 27

8.2.2.1 Determining the requirements for products and services – supplemental 27

8.2.3 REVIEW OF THE REQUIREMENTS FOR PRODUCTS AND SERVICES 27

8.2.3.1 27

8.2.3.1.1 Review of the requirements for products and services – supplemental 27

8.2.3.1.2 Customer-designated special characteristics 27

8.2.3.1.3 Organization manufacturing feasibility 28

8.2.3.2 28

8.2.4 CHANGES TO REQUIREMENTS FOR PRODUCTS AND SERVICES 26

8.3 DESIGN AND DEVELOPMENT OF PRODUCTS AND SERVICES 26

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8.3.1 GENERAL 28

8.3.1.1 Design and development of products and services – supplemental 28

8.3.2 DESIGN AND DEVELOPMENT PLANNING 28

8.3.2.1 Design and development planning – supplemental 28

8.3.2.2 Product design skills 29

8.3.3.3 Special characteristics 29

8.3.3 DESIGN AND DEVELOPMENT INPUTS 29

8.3.3.1 Product design input 29

8.3.3.2 Manufacturing process design input 29

8.3.3.3 Special characteristics 29

8.3.4 DESIGN AND DEVELOPMENT CONTROLS 29

8.3.4.1 Monitoring 29

8.3.4.2 Design and development validation 29

8.3.4.3 Prototype programme 31

8.3.4.4 Product approval process 31

8.3.5 DESIGN AND DEVELOPMENT OUTPUTS 31

8.3.5.1 Design and development outputs – supplemental 31

8.3.5.2 Manufacturing process design output 31

8.3.6 DESIGN AND DEVELOPMENT CHANGES 32

8.3.6.1 Design and development changes – supplemental 32

8.4 CONTROL OF EXTERNALLY PROVIDED PROCESS, PRODUCTS AND SERVICES 32

8.4.1 GENERAL 32

8.4.1.1 General – Supplemental 32

8.4.1.2 Supplier selection process 32

8.4.1.3 Customer-directed sources (also known as “Directed-Buy”) 33

8.4.2 TYPE AND EXTENT OF CONTROL 33

8.4.2.1 Type and extent of control – supplemental 33

8.4.2.2 Statutory and regulatory requirements 31

8.4.2.3 Supplier quality management system development 34

8.4.2.3.1 Automotive product-related software or automotive products with embedded software 34

8.4.2.4 Supplier monitoring 34

8.4.2.4.1 Second-party audits 35

8.4.2.5 Supplier development 35

8.4.3 INFORMATION FOR EXTERNAL PROVIDERS 35

8.4.3.1 Information for external providers – supplemental 35

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8.5 PRODUCTION AND SERVICE PROVISION
35

8.5.1 CONTROL OF PRODUCTION AND SERVICE PROVISION 35

8.5.1.1 Control plan 36

8.5.1.2 Standardized work – operator instructions and visual standards 36

8.5.1.3 Verification of job set-ups 36

8.5.1.4 Verification after shutdown 37

8.5.1.5 Total productive maintenance 37

8.5.1.6 Management of production tooling & manufacturing, inspection tooling & equipment 37

8.5.1.7 Production scheduling 38

8.5.2 IDENTIFICATION AND TRACEABILITY 38

8.5.2.1 Identification and traceability – supplemental 38

8.5.3 PROPERTY BELONGING TO CUSTOMERS OR EXTERNAL PROVIDERS 38

8.5.4 PRESERVATION 39

8.5.4.1 Preservation – supplemental 39

8.5.5 POST-DELIVERY ACTIVITIES 39

8.5.5.1 Feedback of information from service 39

8.5.5.2 Service agreement with customer 39

8.5.6 CONTROL OF CHANGES 39

8.5.6.1 Control of changes – supplemental 40

8.5.6.1.1 Temporary change of process controls 40

8.6 RELEASE OF PRODUCTS AND SERVICES 41

8.6.1 Release of products and services – supplemental 41

8.6.2 Layout inspection and functional testing 41

8.6.3 Appearance items 41

8.6.4 Verification & acceptance of conformity of externally provided products & services 41

8.6.5 Statutory and regulatory conformity 42

8.6.6 Acceptance criteria 42

8.7 CONTROL OF NONCONFORMING OUTPUTS 42

8.7.1 42

8.7.1.1 Customer authorization for concession 42

8.7.1.2 Control of nonconforming product – customer-specified process 42

8.7.1.3 Control of suspect product 42

8.7.1.4 Control of reworked product 42

8.7.1.5 Control of repaired product 43

8.7.1.6 Customer notification 43

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8.7.1.7 Nonconforming product disposition 43

8.7.2 43

9 PEROFORMANCE EVALUATION 43

9.1 MONITORING, MEASUREMENT, ANALYSIS AND EVALUATION 43

9.1.1 GENERAL 43

9.1.1.1 Monitoring and measurement of manufacturing processes 44

9.1.1.2 Identification of statistical tools 44
9.1.1.3 Application of statistical concepts 44
9.1.2 CUSTOMER SATISFACTION 44

9.1.2.1 Customer satisfaction – supplemental 42

9.1.3 ANALYSIS AND EVALUATION 45

9.1.3.1 Prioritization 45

9.2 INTERNAL AUDIT 45

9.2.1 AND 9.2.2 45

9.2.2.1 Internal audit programme 45

9.2.2.2 Quality management system audit 45

9.2.2.3 Manufacturing process audit 46

9.2.2.4 Product audit 46

9.3 MANAGEMENT REVIEW 46

9.3.1 GENERAL 46

9.3.1.1 Management review – supplemental 46

9.3.2 MANAGEMENT REVIEW INPUTS 46

9.3.2.1 Management review inputs - supplemental 46

9.3.3 MANAGEMENT REVIEW OUTPUTS 47

9.3.3.1 Management review outputs – supplemental 47

10 IMPROVEMENT 47

10.1 GENERAL 47

10.2 NONCONFORMITY AND CORRECTIVE ACTION 47

10.2.1 AND 10.2.2 47

10.2.3 Problem solving 47

10.2.4 Error-proofing 47

10.2.5 Warranty management systems 47

10.2.6 Customer complaints and field failure test analysis 48

10.3 CONTINUAL IMPROVEMENT 48

10.3.1 Continual improvement – supplemental 48

ANNEX A: CONTROL PLAN 49

A.1 Phases of the Control Plan 49

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A.2 Elements of the Control Plan 49

ANNEX B: BIBLIOGRAPHY – Supplemental Automotive 51

Foreword — Automotive QMS Standard

This Automotive Quality Management System Standard, herein referred to as "Automotive
QMS Standard" or "IATF 16949," along with applicable automotive customer-specific
requirements, ISÖ 9001:2015 requirements and ISO 9000:2015 defines the fundamental
quality management system requirements for automotive production and relevant service
parts organizations. As such, this Automotive QMS Standard cannot be considered a stand-
alone QMS Standard but has to be comprehended as a supplement to and used in
conjunction with ISO 9001:2015. ISO 9001:2015 is published as a separate ISO Standard.

IATF 16949:2016 (1st edition) represents an innovative document, given the strong
orientation to the customer, with inclusion of a number of consolidated previous customer
specific requirements.

Annex B is provided for guidance to implement the IATF 16949 requirements unless
otherwise specified by customer specific requirements.

History
ISO/TS 16949 (1st edition) was originally created in 1999 by the International Automotive
Task Force (IATF) with the aim of harmonizing the different assessment and certification
systems worldwide in the supply chain for the automotive sector. Other revisions were
created (2nd edition in 2002, and 3rd edition in 2009) as necessary for either automotive
sector enhancements or ISO 9001 revisions. ISO/TS 16949 (along with supporting technical
publications developed by original equipment manufacturers [herein referred to as OEMs]
and the national automotive trade associations) introduced a common set of techniques and
methods for common product and process development for automotive manufacturing
worldwide.

In preparation for migrating from ISO/TS 16949:2009 (3rd edition) to this Automotive QMS
Standard, IATF 16949, feedback was solicited from certification bodies, auditors, suppliers,
and OEMs to Create IATF 16949:2016 (1st edition), which cancels and replaces ISO/TS
16949:2009 (3rd edition).

The IATF maintains strong cooperation with ISO by continuing liaison committee status
ensuring continued alignment with ISO 9001.

Goal
The goal of this Automotive QMS standard is the development of a quality management
system that provides for continual improvement, emphasizing defect prevention and the
reduction of variation and waste in the supply chain.

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Remarks for certification
Requirements for certification to this Automotive QMS Standard are defined in the Rules for
achieving and maintaining IATF recognition.

Details can be obtained from the local Oversight offices of the IATF cited below:

Associazione Nazionale Filiera Industrie Automobilistiche (ANFIA)

Web site: www.anfia.it
E-mail: [email protected]

International Automotive Oversight Bureau (IAOB)

Web site: www.iaob.org
email:[email protected]

IATF France
Web site: www.iatf-france.com
E-mail: [email protected]

Society of Motor Manufacturers and Traders Ltd. (SMMT Ltd.)

Web site: www.smmtoversight.co.uk
E-mail: [email protected]

Verband der Automobilindustrie — Qualitäts Management Center (VDA QMC)

Web site: www.vda-qmc.de
E-mail: [email protected]

All public information about the IATF can be found at the IATF website: www.iatfglobaloversight.org

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Introduction

0.1 General

See ISO 9001:2015 requirements.

0.2 Quality management principles

See ISO 9001:2015 requirements.

0.3 Process approach

0.3.1 General

See ISO 9001:2015 requirements.

0.3.2 Plan-Do-Check-Act cycle

See 9001:2015 requirements.

0.3.3 Risk-based thinking

See ISO 9001:2015 requirements.

0.4 Relationship with other management system standards

See ISO 9001:2015 requirements.

Quality management systems — Requirements

1 Scope

See ISO 9001:2015 requirements.

1.1 Scope — automotive supplemental to ISO 9001:2015

This Automotive QMS Standard defines the quality management system requirements for the
design and development, production and, when relevant, assembly, installation, and services
of automotive-related products, including products with embedded software.

This Automotive QMS Standard is applicable to sites of the organization where

manufacturing of customer-specified production parts, service parts, and / or accessory parts
occur.

This Automotive QMS Standard should be applied throughout the automotive supply chain.

2 Normative references

See ISO 9001:2015 requirements.

2.1 Normative and informative references

Annex A (Control Plan) is a normative part of this Automotive QMS standard.

Annex B (Bibliography — automotive supplemental) is informative, which provides additional

information intended to assist the understanding or use of this Automotive QMS standard.
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3 Terms and definitions

See ISO 9001:2015 requirements.

3.1 Terms and definitions for the automotive industry

accessory part

customer-specified additional component(s) that are either mechanically or electronically

connected to the vehicle or powertrain before (or after) delivery to the final customer (e.g.,
custom floor mats, truck bed liners, wheel covers, sound system enhancements, sunroofs,
spoilers, super-chargers, etc.)

advanced product quality planning (APQP)

product quality planning process that supports development of a product or service that will
satisfy customer requirements; APQP serves as a guide in the development process and
also a standard way to share results between organizations and their customers; APQP
covers design robustness, design testing and specification compliance, production process
design, quality inspection standards, process capability, production capacity, product
packaging, product testing and operator training plan, among other items

aftermarket part

replacement part(s) not procured or released by an OEM for service part applications, which
may or may not be produced to original equipment specifications

authorization

documented permission for a person(s) specifying rights and responsibilities related to giving
or denying permissions or sanctions within an organization

challenge (master) part

part(s) of known specification, calibrated and traceable to standards, with expected results
(pass or fail) that are used to validate the functionality of an error-proofing device or check
fixtures (e.g., go / no-go gauging)

control plan

documented description of the systems and processes required for controlling the
manufacturing of product (see Annex A)

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customer requirements

all requirements specified by the customer (e.g., technical, commercial, product and
manufacturing process-related requirements, general terms and conditions, customer-
specific requirements, etc.)

customer-specific requirements (CSRs)

interpretations of or supplemental requirements linked to a specific clause(s) of this

Automotive QMS Standard

design for assembly (DFA)

process by which products are designed with ease of assembly considerations. (e.g., if a
product contains fewer parts it will take less time to assemble, thereby reducing assembly
costs)

design for manufacturing (DFM)

integration of product design and process planning to design a product that is easily and
economically manufactured

design for manufacturing and assembly (DFMA)

combination of two methodologies: Design for Manufacture (DFMA), which is the process of
optimizing the design to be easier to produce, have higher throughput, and improved quality;
and Design for Assembly (DFA), which is the optimization of the design to reduce risk of
error, lowering Costs, and making it easier to assemble

design for six sigma (DFSS)

systematic methodology, tools, and techniques with the aim of being a robust design of
products or processes that meets customer expectations and can be produced at a six sigma
quality level

design-responsible organization

organization with authority to establish a new, or change an existing, product specification

NOTE This responsibility includes testing and verification of design performance within the
customer's specified application.

error proofing

product and manufacturing process design and development to prevent manufacture of

nonconforming products

escalation process

process used to highlight or flag certain issues within an organization so that the appropriate
personnel can respond to these situations and monitor the resolutions

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fault tree analysis (FTA)

deductive failure analysis methodology in which an undesired state of a system is analysed;

fault tree analysis maps the relationship between faults, subsystems, and redundant design
elements by creating a logic diagram of the overall system

laboratory

facility for inspection, test, or calibration that may include but is not limited to the following:
chemical, metallurgical, dimensional, physical, electrical, or reliability testing

laboratory scope

controlled document containing

specific tests, evaluations, and calibrations that a laboratory is qualified to perform;

a list of the equipment that the laboratory uses to perform the above; and
a list of methods and standards to which the laboratory performs the above

manufacturing

process of making or fabricating

production materials;
production parts or service parts;
assemblies; or
heat treating, welding, painting, plating, or other finishing services

manufacturing feasibility

an analysis and evaluation of a proposed project to determine if it is technically feasible to

manufacture the product to meet customer requirements. This includes but is not limited to
the following (as applicable): within the estimated costs, and if the necessary resources,
facilities, tooling, capacity, software, and personnel with required skills, including support &
functions, are or are planned to be available

manufacturing services

companies that test, manufacture, distribute, and provide repair services for components and
assemblies

multi-disciplinary approach

method to capture input from all interested parties who may influence how a process is
administered by a team whose, members include personnel from the organization and may
include customer and supplier representatives; team members may be internal or external to
the Organization; either existing teams or ad hoc teams may be used as circumstances
warrant; input to the team may include both organization and customer inputs

no trouble found (NTF)

designation applied to a part replaced during a service event that,. when analysed by the
vehicle or parts manufacturer, meets all the requirements of a "good part" (also referred to as
"No Fault Found" or "Trouble Not Found")

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outsourced process

portion of an organization's function (or processes) that is performed by an external

Organization

periodic overhaul

maintenance methodology to prevent a major unplanned breakdown where, based on fault or

interruption history, a piece of equipment, or subsystem of the equipment, is proactively
taken out of service and disassembled, repaired, parts replaced, reassembled, and then
returned to service

predictive maintenance

an approach and set of techniques to evaluate the condition of in-service equipment by

performing periodic or continuous monitoring of equipment conditions, in order to predict
when maintenance should be performed

premium freight

extra costs or charges incurred in addition to contracted delivery

NOTE This can be caused by method, quantity, unscheduled or late deliveries, etc.

preventive maintenance

planned activities at regular intervals (time-based, periodic inspection, and overhaul) to

eliminate causes of equipment failure and unscheduled interruptions to production, as an
output of the manufacturing process design

product

applies to any intended output resulting from the product realization process

product safety

standards relating to the design and manufacturing of products to ensure they do not
represent harm or hazards to customers

production shutdown

condition where manufacturing processes are idle; time span may be a few hours to a few
months

reaction plan

action or series of steps prescribed in a control plan in the event abnormal or nonconforming
events are detected

remote location

location that supports manufacturing sites and at which non-production processes occur

service part

replacement part(s) manufactured to OEM specifications that are procured or released by the
OEM for service part applications, including remanufactured parts

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site

location at which value-added manufacturing processes occur

special characteristic

classification of a product characteristic or manufacturing process parameter that can affect

safety or compliance with regulations, fit, function, performance, requirements, or
subsequent processing of product

special status

notification of a customer-identified classification assigned to an organization where one Or

more customer requirements are not being satisfied due to a significant quality or delivery
issue

support function

non-production activity (conducted on site or at a remote location) that supports one (or
more) manufacturing sites of the same organization

total productive maintenance

a system of maintaining and improving the integrity of production and quality systems
through machines, equipment, processes, and employees that add value to the organization

trade-off curves

tool to understand and communicate the relationship of various design characteristics of a

product to each Other; a product's performance on one characteristic is mapped on the Y-
axis and another on the x-axis, then a curve is plotted to illustrate product performance
relative to the two characteristics

trade-off process

methodology of developing and using trade-off curves for products and their performance
characteristics that establish the customer, technical, and economic relationship between
design alternatives

4 Context of the organization

4.1 Understanding the organization and its context

See ISO 9001:2015 requirements.

4.2 Understanding the needs and expectations of interested parties

See ISO 9001:2015 requirements.

4.3 Determining the scope of the quality management system

See ISO 9001:2015 requirements.

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4.3.1 Determining the scope of the quality management system — supplemental

Supporting functions, whether on-site or remote (such as design centres, corporate

headquarters, and distribution centres), shall be included in the scope of the Quality
Management System (QMS).

The only permitted exclusion for this Automotive QMS Standard relates to the product design
and development requirements within ISO 9001, Section 8.3. The exclusion shall be justified
and maintained as documented information (see ISO 9001 , Section 7.5).

Permitted exclusions do not include manufacturing process design.

4.3.2 Customer-specific requirements

Customer-specific requirements shall be evaluated and included in the scope of the

organization's quality management system.

4.4 Quality management system and its processes

4.4.1

See ISO 9001:2015 requirements

4.4.1.1 Conformance of products and processes

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

4.4.1.2 Product safety

The organization shall have documented processes for the management of product-safety
related products and manufacturing processes, which shall include but not be limited to the
following, where applicable:

a) identification by the organization of statutory and regulatory product-safety

requirements;
b) customer notification of requirements in item a);
c) special approvals for design FMEA;
d) identification of product safety-related characteristics;
e) identification and controls of safety-related characteristics of product and at the
point of manufacture;
f) special approval of control plans and process FMEAs;
g) reaction plans (see Section 9.1.1.1);
h) defined responsibilities, definition of escalation process and flow of information,
including top management, and customer notification;
i) training identified by the organization or customer for personnel involved in
Product-safety related products and associated manufacturing processes;
j) changes of product or process shall be approved prior to implementation,
including evaluation of potential effects on product safety from process and
product changes (see ISO 9001, Section 8.3.6);
k) transfer of requirements with regard to product safety throughout the supply
chain, including customer-designated sources (see Section 8.4.3.1);
l) product traceability by manufactured lot (at a minimum) throughout the supply
Chain (see Section 8.5.2.1);
m) lessons learned for new product introduction.

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NOTE Special approval is an additional approval by the function (typically the customer) that
is responsible to approve such documents with safety-related content.

4.4.2

See ISO 9001:2015 requirements.

5 Leadership

5.1 Leadership and commitment

5.1.1 General

See ISO 9001:2015 requirements.

5.1.1.1 Corporate responsibility

The organization shall define and implement corporate responsibility policies, including at a
minimum an anti-bribery policy, an employee code of conduct, and an ethics escalation
policy ("whistle-blowing policy").

5.1.1.2 Process effectiveness and efficiency

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

5.1.1.3 Process owners

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

5.1.2 Customer focus

See ISO 9001:2015 requirements.

5.2 Policy

5.2.1 Establishing the quality policy

See ISO 9001:2015 requirements.

5.2.2 Communicating the quality policy

See ISO 9001:2015 requirements.

5.3 Organizational roles, responsibilities and authorities

See ISO 9001:2015 requirements.

5.3.1 Organizational roles, responsibilities, and authorities — supplemental

Top management shall assign personnel with the responsibility and authority to ensure that
customer requirements are met. These assignments shall be documented. This includes but
is not limited to the selection of special characteristics, setting quality objectives and related

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training, corrective and preventive actions, product design and development, capacity
analysis, logistics information, customer scorecards, and customer portals.

5.3.2 Responsibility and authority for product requirements and corrective actions

Top management shall ensure that:

a) personnel responsible for conformity to product requirements have the

authority to stop shipment and stop production to correct quality problems;

NOTE Due to the process design in some industries, it might not always be
possible to stop production immediately. In this case, the affected batch must
be contained and shipment to the customer prevented.

b) personnel with authority and responsibility for corrective action are

promptly informed of products or processes that do not conform to
requirements to ensure that nonconforming product is not shipped to the
customer and that all potential nonconforming product is identified and
contained;
c) production operations across all shifts are staffed with personnel in charge of, or
delegated responsibility for, ensuring conformity to product requirements.

6 Planning

6.1 Actions to address risks and opportunities

6.1.1 and 6.1.2

See ISO 9001:2015 requirements.

6.1.2.1 Risk analysis

The organization shall include in its risk analysis, at a minimum, lessons learned from
product recalls, product audits, field returns and repairs, complaints, scrap, and rework.

The organization shall retain documented information as evidence of the results of risk
analysis.

6.1.2.2 Preventive action

The organization shall determine and implement action(s) to eliminate the causes of potential
nonconformities in order to prevent their occurrence. Preventive actions shall be appropriate
to the severity of the potential issues.

The organization shall establish a process to lessen the impact of negative effects of risk
including the following:

a) determining potential nonconformities and their causes;

b) evaluating the need for action to prevent occurrence of nonconformities;
c) determining and implementing action needed;
d) documented information of action taken;
e) reviewing the effectiveness of the preventive action taken;
f) utilizing lessons learned to prevent recurrence in similar processes (see ISO
9001, Section 7.1.6).

6.1.2.3 Contingency plans

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The organization shall:

a) identify and evaluate internal and external risks to all manufacturing processes
and infrastructure equipment essential to maintain production output and to
ensure that customer requirements are met;
b) define contingency plans according to risk and impact to the customer;
c) prepare contingency plans for continuity of supply in the event of any of the
following: key equipment failures (also see Section 8.5.6.1.1); interruption from
externally provided products, processes, and services; recurring natural
disasters; fire; utility interruptions; labour shortages; or infrastructure
disruptions;
d) include, as a supplement to the contingency plans, a notification process to
the customer and Other interested parties for the extent and duration of any
situation impacting customer operations;
e) periodically test the contingency plans for effectiveness (e.g., simulations,
as appropriate);
f) conduct contingency plan reviews (at a minimum annually) using a
multidisciplinary team including top management, and update as required;
g) document the contingency plans and retain documented information
describing any revision(s), including the person(s) who authorized the
change(s).

The contingency plans shall include provisions to validate that the manufactured
product continues to meet customer specifications after the re-start of production
following an emergency in which production was stopped and if the regular shutdown
processes were not followed.

6.2 Quality objectives and planning to achieve them

6.2.1 and 6.2.2

See ISO 9001:2015 requirements.

6.2.2.1 Quality objectives and planning to achieve them — supplemental

Top management shall ensure that quality objectives to meet customer requirements are
defined, established, and maintained for relevant functions, processes, and levels
throughout the organization.

The results of the organization's review regarding interested parties and their relevant
requirements shall be considered when the organization establishes its annual (at a
minimum) quality objectives and related performance targets (internal and external).

6.3 Planning of changes

See ISO 9001:2015 requirements.

7 Support

7.1 Resources

7.1.1 General

See ISO 9001:2015 requirements.

7.1.2 People

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See ISÖ 9001:2015 requirements.

7.1.3 Infrastructure

See ISO 9001:2015 requirements.

7.1.3.1 Plant, facility, and equipment planning

The organization shall use a multidisciplinary approach including risk identification and risk
mitigation methods for developing and improving plant, facility, and equipment plans. In
designing plant layouts, the organization shall:

a) optimize material flow, material handling, and value-added use of floor space
including control of nonconforming product, and
b) facilitate synchronous material flow, as applicable.

Methods shall be developed and implemented to evaluate manufacturing feasibility for new
product or new operations. Manufacturing feasibility assessments shall include capacity
planning. These methods shall also be applicable for evaluating proposed changes to
existing operations.

The organization shall maintain process effectiveness, including periodic re-evaluation

relative to risk, to incorporate any changes made during process approval, control plan
maintenance (see Section 8.5.1.1), and verification of job set-ups (see Section 8.5.1.3).

Assessments of manufacturing feasibility and evaluation of capacity planning shall be inputs

to management reviews (see ISO 9001, Section 9.3).

NOTE 1 These requirements should include the application of lean manufacturing principles.

NOTE 2 These requirements should apply to on-site supplier activities, as applicable.

7.1.4 Environment for the operation of processes

See ISO 9001:2015 requirements.

NOTE Where third-party certification to ISO 45001 (or equivalent) is recognized, it may be
used to demonstrate the organization's conformity to the personnel safety aspects of this
requirement.

7.1.4.1 Environment for the operation of processes — supplemental

The organization shall maintain its premises in a state of order, cleanliness, and repair that is
consistent with the product and manufacturing process needs.

7.1.5 Monitoring and measuring resources

7.1.5.1 General

See ISO 9001:2015 requirements.

7.1.5.1.1 Measurement systems analysis

Statistical studies shall be conducted to analyse the variation present in the results of each
type of inspection, measurement, and test equipment system identified in the control plan.
The analytical methods and acceptance criteria used shall conform to those in reference

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manuals on measurement systems analysis. Other analytical methods and acceptance
criteria may be used if approved by the customer.

Records of customer acceptance of alternative methods shall be retained along with

results from alternative measurement systems analysis (see Section 9.1.1.1).

NOTE Prioritization of MSA studies should focus on critical or special product or

process characteristics.

7.1.5.2 Measurement traceability

See ISO 9001:2015 requirements.

NOTE A number or another identifier traceable to the device calibration record meets the
intent of the requirements in ISO 9001:2015.

7.1.5.2.1 Calibration / verification records

The organization shall have a documented process for managing calibration/verification

records.

Records of the calibration / verification activity for all gauges and measuring and test
equipment (including employee-owned equipment relevant for measuring, customer-owned
equipment, or on-site supplier Owned equipment) needed to provide evidence of conformity
to internal requirements, legislative and regulatory requirements, and customer-defined
requirements shall be retained.

The organization shall ensure that calibration / verification activities and records shall
include the following details:

a) revisions following engineering changes that impact measurement systems;

b) any out-of-specification readings as received for calibration/verification;
c) an assessment of the risk of the intended use of the product caused by the
out-of-specification condition;
d) when a piece of inspection measurement and test equipment is found to be
out of calibration or defective during its planned verification or calibration
or during its use, documented information on the validity of previous
measurement results obtained with this piece of inspection measurement
and test equipment shall be retained, including the associated standard’s
last calibration date and the next due date on the calibration report;
e) notification to the customer if suspect product or material has been shipped;
f) statements of conformity to specification after calibration/verification;
g) verification that the software version used for product and process control
is as specified;
h) records of the calibration and maintenance activities for all gauging
(including employee-owned equipment, customer-owned equipment, or on-site
supplier-owned equipment);
i) production-related software verification used for product and process
control (including software installed on employee-owned equipment,
customer-owned equipment, or on-site supplier-owned equipment).

7.1.5.3 Laboratory requirements

7.1.5.3.1 Internal laboratory

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

NOTE Third-party accreditation to ISÖ/IEC 17025 (or equivalent) may be used to

demonstrate the organization's in-house laboratory conformity. to this requirement.

7.1.5.3.2 External laboratory

External/commercial/independent laboratory facilities used for inspection, test, or calibration

services by the organization shall have a defined laboratory scope that includes the
capability to perform the required inspection, test, or calibration, and either:

— the laboratory shall be accredited to ISO/IEC 17025 or national equivalent and

include the relevant inspection, test, or calibration service in the scope of the
accreditation (certificate); the certificate of calibration or test report shall
include the mark of a national accreditation body; or
there shall be evidence that the external laboratory is acceptable to the customer.

NOTE Such evidence may be demonstrated by customer assessment, for example, or by

customer approved second-party assessment that the laboratory meets the intent of ISO/IEC
17025 or national equivalent. The second-party assessment may be performed by the
organization assessing the laboratory using a customer-approved method of assessment.

Calibration services may be performed by the equipment manufacturer when a qualified

laboratory is not available for a given piece of equipment. In such cases, the organization
shall ensure that the requirements listed in Section 7.1.5.3.1 have been met.

Use of calibration services, other than by qualified (or customer accepted)

laboratories, may be subject to government regulatory confirmation, if required.

7.1.6 Organizational knowledge

See ISO 9001:2015 requirements.

7.2 Competence

See ISO 9001:2015 requirements.

7.2.1 Competence — supplemental

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

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7.2.2 Competence — on-the-job training

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

7.2.3 Internal auditor competency

The organization shall have a documented process(es) to verify that internal auditors are
competent, taking into account any customer-specific requirements. For additional guidance
on auditor competencies, refer to ISO 19011. The organization shall maintain a list of
qualified internal auditors.

Quality management system auditors, manufacturing process auditors, and product auditors
shall all be able to demonstrate the following minimum competencies:

a) understanding of the automotive process approach for auditing, including risk-

based thinking;
b) understanding of applicable customer-specific requirements;
c) understanding of applicable ISO 9001 and IATF 16949 requirements related
to the scope of the audit;
d) understanding of applicable core tool requirements related to the scope of the
audit;
e) understanding how to plan, conduct, report, and close out audit findings.

Additionally, manufacturing process auditors shall demonstrate technical understanding of

the relevant manufacturing process(es) to be audited, including process risk analysis (such
as PFMEA) and control plan. Product auditors shall demonstrate competence in
understanding product requirements and use of relevant measuring and test equipment to
verify product conformity.

Where training is provided to achieve competency, documented information shall be retained

to demonstrate the trainer's competency with the above requirements.

Maintenance of and improvement in internal auditor competence shall be demonstrated

through:

f) executing a minimum number of audits per year, as defined by the organization;

and
g) maintaining knowledge of relevant requirements based on internal changes (e.g.,
process technology, product technology) and external changes (e.g., ISO 9001,
IATF 16949, core tools, and customer specific requirements).

7.2.4 Second-party auditor competency

The organization shall demonstrate the competence of the auditors undertaking the second-
party audits. Second-party auditors shall meet customer specific requirements for auditor
qualification and demonstrate the minimum following core Competencies, including
understanding of:

a) the automotive process approach to auditing, including risk based thinking;

b) applicable customer and organization Specific requirements;

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 c) applicable ISO 9001 and IATF 16949 requirements related to the scope of the
audit;
d) applicable manufacturing process(es) to be audited, including PFMEA and
control Plan;
e) applicable core tool requirements related to the scope of the audit;
f) how to plan, conduct, prepare audit reports, and close out audit findings.

7.3 Awareness

See ISO 9001:2015 requirements.

7.3.1 Awareness — supplemental

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

7.3.2 Employee motivation and empowerment

The organization shall maintain a documented process(es) to motivate employees to achieve

quality objectives, to make continual improvements, and to create an environment that
promotes innovation. The process shall include the promotion of quality and technological
awareness throughout the whole organization.

7.4 Communication

See ISO 9001:2015 requirements.

7.5 Documented information

7.5.1 General

See ISO 9001:2015 requirements.

7.5.1.1 Quality management system documentation

The organization's quality management system shall be documented and include a quality
manual, which can be a series of documents (electronic or hard copy).

The format and structure of the quality manual is at the discretion of the organization and will
depend on the organization's size, culture, and complexity. If a series of documents is used,
then a list shall be retained of the documents that comprise the quality manual for the
organization.

The quality manual shall include, at a minimum, the following:

a) the scope of the quality management system, including details of and

justification for any exclusions;
b) documented processes established for the quality management system, or
reference to them;
c) the organization's processes and their sequence and interactions (inputs and
outputs), including type and extent of control of any outsourced processes;
d) a document (i.e., matrix) indicating where within the organization's quality
management system their customer-specific requirements are addressed.

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NOTE A matrix of how the requirements of this Automotive QMS standard are addressed by
the organization's processes may be used to assist with linkages of the organization's
processes and this Automotive QMS.

7.5.2 Creating and updating

See ISO 9001:2015 requirements.

7.5.3 Control of documented information

7.5.3.1 and 7.5.3.2

See ISO 9001 :2015 requirements.

7.5.3.2.1 Record retention

The organization shall define, document, and implement a record retention policy. The
control of records shall satisfy statutory, regulatory, organizational, and customer
requirements.

Production part approvals, tooling records (including maintenance and ownership), product
and process design records, purchase orders (if applicable), or contracts and amendments
shall be retained for the length of time that the product is active for production and service
requirements, plus one calendar year, unless Otherwise specified by the customer or
regulatory agency.

NOTE Production part approval documented information may include approved product,
applicable test equipment records, or approved test data.

7.5.3.2.2 Engineering specifications

The organization shall have a documented process describing the review, distribution,
and implementation of all customer engineering standards / specifications and related
revisions based on customer schedules, as required.

When an engineering standard/specification change results in a product design change, refer

to the requirements in ISO 9001, Section 8.3.6. When an engineering standard/specification
change results in ä product realization process change, refer to the requirements in Section
8.5.6.1. The organization shall retain a record of the date on which each change is
implemented in production. Implementation shall include updated documents.

Review should be completed within 10 working days of receipt of notification of

engineering standards/specifications changes.

NOTE A change in these standards / specifications may require an updated record of

customer production part approval when these specifications are-referenced on the design
record or if they affect documents of the production part approval process, such as control
plan, risk analysis (such as FMEAs), etc.

8 Operation

8.1 Operational planning and control

See ISO 9001:2015 requirements.

8.1.1 Operational planning and control — supplemental

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When planning for product realization, the following topics shall be included:

a) customer product requirements and technical specifications;

b) logistics requirements;
c) manufacturing feasibility;
d) project planning (refer to ISO 9001, Section 8.3.2);
e) acceptance criteria.

The resources identified in ISO 9001, Section 8.1 c), refer to the required verification,
validation, monitoring, measurement, inspection, and test activities specific to the
product and the criteria for product acceptance.

8.1.2 Confidentiality

The organization shall ensure the confidentiality of customer-contracted products and

projects under development, including related product information.

8.2 Requirements for products and services

8.2.1 Customer communication

See ISO 9001:2015 requirements.

8.2.1.1 Customer communication — supplemental

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

8.2.2 Determining the requirements for products and services

See ISO 9001:2015 requirements,

8.2.2.1 Determining the requirements for products and services — supplemental

These requirements shall include recycling, environmental impact, and characteristics

identified as ä result of the organization's knowledge of the product and manufacturing
processes.

Compliance to ISO 9001, Section 8.2.2 item a) 1), shall include but not be limited to the
following:
all applicable government, safety, and environmental regulations related to acquisition,
storage, handling, recycling, elimination, or disposal of material.

8.2.3 Review of the requirements for products and services

8.2.3.1

See ISO 9001:2015 requirements.

8.2.3.1.1 Review of the requirements for products and services — supplemental

The organization shall retain documented evidence of a customer-authorized waiver for the
requirements stated in ISO 9001, Section 8.2.3.1, for a formal review.

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8.2.3.1.2 Customer-designated special characteristics

The organization shall conform to customer requirements for designation, approval

documentation, and control of special characteristics.

8.2.3.1.3 Organization manufacturing feasibility

The Organization shall utilize a multidisciplinary approach to conduct an analysis to

determine if it is feasible that the organization's manufacturing processes are capable of
consistently producing product that meets all of the engineering and capacity requirements
specified by the customer. The Organization shall conduct this feasibility analysis for any
manufacturing or product technology new to the organization and for any changed
manufacturing process or product design.

Additionally, the organization should validate through production runs, benchmarking studies,
or other appropriate methods, their ability to make product to specifications at the required
rate.

8.2.3.2

See ISO 9001:2015 requirements.

8.2.4 Changes to requirements for products and services

See ISO 9001:2015 requirements.

8.3 Design and development of products and services

8.3.1 General

See ISO 9001:2015 requirements.

8.3.1.1 Design and development of products and services — supplemental

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

The organization shall document the design and development process.

8.3.2 Design and development planning

See ISO 9001:2015 requirements.

8.3.2.1 Design and development planning — supplemental

The organization shall ensure that design and development planning includes all affected
stakeholders within the organization and, as appropriate; its supply chain. Examples of areas
for using such a multidisciplinary approach include but are not limited to the following:

a) project management (for example, APQP or VDA-RGA);

b) product and manufacturing process design activities (for example, DFM and
DFA), such as consideration of the use of alternative designs and manufacturing
processes;
c) development and review of product design risk analysis (FMEAs), including
actions to reduce potential risks;
d) development and review of manufacturing process risk analysis (for example,
FMEAs, process flows, control plans, and standard work instructions).

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NOTE A multidisciplinary approach typically includes the organization's design,
manufacturing, engineering, quality, production, purchasing, supplier, maintenance, and
other appropriate functions.

8.3.2.2 Product design skills

The organization shall ensure that personnel with product design responsibility are
competent to achieve design requirements and are skilled in applicable product design tools
and techniques. Applicable tools and techniques shall be identified by the organization.

NOTE An example of product design skills is the application of digitized mathematically

based data.

8.3.2.3 Development of products with embedded software

The organization shall use a process for quality assurance for their products with internally
developed embedded software. A software development assessment methodology shall be
utilized to assess the organization's software development process. Using prioritization
based on risk and potential impact to the customer, the organization shall retain documented
information of a software development capability self-assessment.

The organization shall include software development within the scope of their internal audit
programme (see Section 9.2.2.1).

8.3.3 Design and development inputs

See ISO 9001:2015 requirements.

8.3.3.1 Product design input

The organization shall identify, document, and review product design input requirements as a
result of contract review. Product design input requirements include but are not limited to the
following:

a) product specifications including but not limited to special characteristics (see

Section 8.3.3.3);
b) boundary and interface requirements;
c) identification, traceability, and packaging;
d) consideration of design alternatives;
e) assessment of risks with the input requirements and the organization's ability to
mitigate/manage the risks, including from the feasibility analysis;
f) f) targets for conformity to product requirements including preservation, reliability,
durability, serviceability, health, safety, environmental, development timing, and
cost;
g) applicable statutory and regulatory requirements of the customer-identified
country of destination, if provided;
h) embedded software requirements.

The organization shall have a process to deploy information gained from previous design
projects, competitive product analysis (benchmarking), supplier feedback, internal input, field
data, and other relevant sources for current and future projects of a similar nature.

NOTE One approach for considering design alternatives is the use of trade-off curves.

8.3.3.2 Manufacturing process design input

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The organization shall identify, document, and review manufacturing process design input
requirements including but not limited to the following:

a) product design output data including special characteristics;

b) targets for productivity, process capability, timing, and cost;
c) manufacturing technology alternatives;
d) customer requirements, if any;
e) experience from previous developments;
f) new materials;
g) product handling and ergonomic requirements; and
h) design for manufacturing and design for assembly.

The manufacturing process design shall include the use of error-proofing methods to a
degree appropriate to the magnitude of the problem(s) and commensurate with the risks
encountered.

8.3.3.3 Special characteristics

The organization shall use a multidisciplinary approach to establish, document, and

implement its process(es) to identify special characteristics, including those determined by
the customer and the risk analysis performed by the organization, and shall include the
following:

a) documentation of all special characteristics in the drawings (as required), risk

analysis (such as FMEA), control plans, and standard work/operator instructions;
special characteristics are identified with specific markings and are cascaded
through each of these documents;
b) development of control and monitoring strategies for special characteristics of
products and production processes;
c) customer-specified approvals, when required;
d) compliance with customer-specified definitions and symbols or the organization's
equivalent symbols or notations, as defined in a symbol conversion table. The
symbol conversion table shall be submitted to the customer, if required.

8.3.4 Design and development controls

See ISO 9001:2015 requirements.

8.3.4.1 Monitoring

Measurements at specified stages during the design and development of products and
processes shall be defined, analysed, and reported with summary results as an input to
management review (see Section 9.3.2.1).

When required by the customer, measurements of the product and process development
activity shall be reported to the customer at stages specified, or agreed to, by the customer.

NOTE When appropriate, these measurements may include quality risks, costs, lead times,
critical paths, and other measurements.

8.3.4.2 Design and development validation

Design and development validation shall be performed in accordance with customer

requirements, including any applicable industry and governmental agency-issued regulatory
standards. The timing of design and development validation shall be planned in alignment
with customer-specified timing, as applicable.

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Where contractually agreed with the customer, this shall include evaluation of the interaction
of the organization's product, including embedded software, within the system of the final
customer's product.

8.3.4.3 Prototype programme

When required by the customer, the organization shall have a prototype programme and
control plan. The organization shall use, whenever possible, the same suppliers, tooling, and
manufacturing processes as will be used in production.

All performance-testing activities shall be monitored for timely completion and conformity to
requirements.

When services are outsourced, the organization shall include the type and extent of control in
the scope of its quality management system to ensure that outsourced services conform to
requirements (see ISÖ 9001, Section 8.4).

8.3.4.4 Product approval process

The organization shall establish, implement, and maintain a product and manufacturing
approval process conforming to requirements defined by the customer(s).

The organization shall approve externally provided products and services per ISO 9001,
Section 8.4.3, prior to submission of their part approval to the customer.

The organization shall obtain documented product approval prior to shipment, if required by
the customer. Records of such approval shall be retained.

NOTE Product approval should be subsequent to the verification of the manufacturing

process.

8.3.5 Design and development outputs

See ISO 9001:2015 requirements.

8.3.5.1 Design and development outputs — supplemental

The product design output shall be expressed in terms that can be verified and validated
against product design input requirements. The product design output shall include but is not
limited to the following, as applicable:

a) design risk analysis (FMEA);

b) reliability study results;
c) product special characteristics;
d) results of product design error-proofing, such as DFSS, DFMA, and FTA;
e) product definition including 3D models, technical data packages, product
manufacturing information, and geometric dimensioning & tolerancing (GD&T);
f) 2D drawings, product manufacturing information, and geometric dimensioning
& tolerancing (GD&T);
g) product design review results;
h) service diagnostic guidelines and repair and serviceability instructions;
i) service part requirements;
j) packaging and labeling requirements for shipping.

NOTE Interim design outputs should include any engineering problems being resolved
through a trade-off process.
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8.3.5.2 Manufacturing process design output

The organization shall document the manufacturing process design output in a manner that
enables verification against the manufacturing process design inputs. The organization shall
verify the outputs against manufacturing process design input requirements. The
manufacturing process design output shall include but is not limited to the following:

a) specifications and drawings;

b) special characteristics for product and manufacturing process;
c) identification of process input variables that impact characteristics;
d) tooling and equipment for production and control, including capability studies of
equipment and process(es);
e) manufacturing process flow charts/layout, including linkage of product, process,
and tooling;
f) capacity analysis;
g) manufacturing process FMEA;
h) maintenance plans and instructions;
i) control plan (see Annex A);
j) standard work and work instructions;
k) process approval acceptance criteria;
l) data for quality, reliability, maintainability, and measurability;
m) results of error-proofing identification and verification, as appropriate;
n) methods of rapid detection, feedback, and correction of product / manufacturing
process nonconformities.

8.3.6 Design and development changes

See ISO 9001:2015 requirements.

8.3.6.1 Design and development changes — supplemental

The organization shall evaluate all design changes after initial product approval, including
those proposed by the organization or its suppliers, for potential impact on fit, form, function,
performance, and/or durability. These changes shall be validated against customer
requirements and approved internally, prior to production implementation.

If required by the customer, the organization shall obtain documented approval, or a

documented waiver, from the customer prior to production implementation.

For products with embedded software, the organization shall document the revision level of
software and hardware as part of the change record.

8.4 Control of externally provided processes, products and services

8.4.1 General

See ISO 9001:2015 requirements.

8.4.1.1 General— supplemental

The organization shall include all products and services that affect customer requirements
such as subassembly, sequencing, sorting, rework, and calibration services in the scope of
their definition of externally provided products, processes, and services.

8.4.1.2 Supplier selection process

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The organization shall have a documented supplier selection process. The selection process
shall include:

a) an assessment of the selected supplier's risk to product conformity and

uninterrupted supply of the organization's product to their customers;
b) relevant quality and delivery performance;
c) an evaluation of the supplier's quality management system;
d) multidisciplinary decision making; and
e) an assessment of software development capabilities, if applicable.

Other supplier selection criteria that should be considered include the following:

⎯ volume of automotive business (absolute and as a percentage of total business);

⎯ financial stability;
⎯ purchased product, material, or service complexity;
⎯ required technology (product or process);
⎯ adequacy of available resources (e.g., people, infrastructure);
⎯ design and development capabilities (including project management);
⎯ manufacturing capability;
⎯ change management process;
⎯ business continuity planning (e.g., disaster preparedness, Contingency planning);
⎯ logistics process;
⎯ customer service.

8.4.1.3 Customer-directed sources (also known as "Directed—Buy")

When specified by the customer, the organization shall purchase products, materials, or
services from customer-directed sources.

All requirements of Section 8.4 (except the requirements in IATF 16949, Section 8.4.1.2) are
applicable to the organization's control of customer-directed sources unless specific
agreements are otherwise defined by the contract between the Organization and the
customer.

8.4.2 Type and extent of control

See ISO 9001:2015 requirements.

8.4.2.1 Type and extent of control — supplemental

The organization shall have a documented process to identify outsourced processes and to
select the types and extent of controls used to verify conformity of externally provided
products, processes, and services to internal (organizational) and external customer
requirements.

The process shall include the criteria and actions to escalate or reduce the types and extent
of controls and development activities based on supplier performance and assessment of
product, material, or service risks.

8.4.2.2 Statutory and regulatory requirements

The organization shall document their process to ensure that purchased products,
processes, and services conform to the current applicable statutory and regulatory
requirements in the country of receipt, the country of shipment, and the customer-identified
country of destination, if provided.

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If the customer defines special controls for certain products with statutory and regulatory
requirements, the organization shall ensure they are implemented and maintained as
defined, including at suppliers.

8.4.2.3 Supplier quality management system development

The organization shall require their suppliers of automotive products and services to develop,
implement, and improve a quality management system certified to ISO 9001, unless
otherwise authorized by the customer [e.g., item a) below], with the ultimate objective of
becoming certified to this Automotive QMS Standard. Unless otherwise specified by the
customer, the following sequence should be applied to achieve this requirement:

a) compliance to ISO 9001 through second-party audits;

b) certification to ISO 9001 through third-party audits; unless otherwise specified by
the customer, suppliers to the organization shall demonstrate conformity to ISO
9001 by maintaining a third party certification issued •by a certification body
bearing the accreditation mark of a recognized IAF MLA (International
Accreditation Forum Multilateral Recognition Arrangement) member and where
the accreditation body's main scope includes management system certification to
ISO/IEC 17021;
c) certification to ISO 9001 with compliance to other customer-defined QMS
requirements (such as Minimum Automotive Quality Management System
Requirements for Sub-Tier Suppliers [MAQMSRI or equivalent) through second-
party audits;
d) certification to ISO 9001 with compliance to IATF 16949 through second-party
audits;
e) certification to 16949 through third-party audits (valid third-party certification of the
supplier to IATF 16949 by an IATF-recognized certification body).

8.4.2.3.1 Automotive product-related software or automotive products with embedded

software

The organization shall require their suppliers of automotive product-related software, or

automotive products with embedded software, to implement and maintain a process for
software quality assurance for their products.

A software development assessment methodology shall be utilized to assess the supplier's

software development process. Using prioritization based on risk and potential impact to the
customer, the organization shall require the supplier to retain documented information of a
software development capability self-assessment.

8.4.2.4 Supplier monitoring

The organization shall have a documented process and criteria to evaluate supplier
performance in order to ensure conformity of externally provided products, processes, and
services to internal and external customer requirements.

At a minimum, the following supplier performance indicators shall be monitored:

a) delivered product conformity to requirements;

b) customer disruptions at the receiving plant, including yard holds and stop ship
c) delivery schedule performance;
d) number of occurrences of premium freight.

If provided by the customer, the organization shall also include the following, as appropriate,
in their supplier performance monitoring:

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 e) special status customer notifications related to quality or delivery issues;
f) dealer returns, warranty, field actions, and recalls.

8.4.2.4.1 Second-party audits

The organization shall include a second-party audit process in their supplier management
approach. Second-party audits may be used for the following:

a) supplier risk assessment;

b) supplier monitoring;
c) supplier QMS development;
d) product audits;
e) process audits.

Based on a risk analysis, including product safety / regulatory requirements, performance of

the supplier, and QMS certification level, at a minimum, the organization shall document the
criteria for determining the need, type, frequency, and scope of second-party audits.

The organization shall retain records of the second-party audit reports.

If the scope of the second-party audit is to assess the supplier's quality management system,
then the approach shall be consistent with the automotive process approach.

NOTE Guidance may be found in the IATF Auditor Guide and ISO 19011.

8.4.2.5 Supplier development

The organization shall determine the priority, type, extent, and timing of required supplier
development actions for its active suppliers. Determination inputs shall include but are not
limited to the following:

a) performance issues identified through supplier monitoring (see Section 8.4.2.4);

b) second-party audit findings (see Section 8.4.2.4.1);
c) third-party quality management system certification status;
d) risk analysis.

The organization shall implement actions necessary to resolve open (unsatisfactory)

performance issues and pursue opportunities for continual improvement.

8.4.3 Information for external providers

See ISO 9001:2015 requirements.

8.4.3.1 Information for external providers — supplemental

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

8.5 Production and service provision

8.5.1 Control of production and service provision

See ISO 9001:2015 requirements.

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NOTE Suitable infrastructure includes appropriate manufacturing equipment required to
ensure product compliance. Monitoring and measuring resources include appropriate
monitoring and measuring equipment required to ensure effective control of manufacturing
processes.

8.5.1.1 Control plan

The organization shall develop control plans (in accordance with Annex A) at the system,
subsystem, component, and/or material level for the relevant manufacturing site and all
product supplied, including those for processes producing bulk materials as well as parts.
Family control plans are acceptable for bulk material and similar parts using a common
manufacturing process.

The organization shall have a control plan for pre-launch and production that shows linkage
and incorporates information from the design risk analysis (if provided by the customer),
process flow diagram, and manufacturing process risk analysis outputs (such as FMEA).

The organization shall, if required by the customer, provide measurement and conformity
data collected during execution of either the pre-launch or production control plans. The
organization shall include in the control plan:

a) controls used for the manufacturing process control, including verification of job
set-ups;
b) first-off/last-off part validation, as applicable;
c) methods for monitoring of control exercised over special characteristics (see
Annex A) defined by both the customer and the organization;
d) the customer-required information, if any;
e) specified reaction plan (see Annex A); when nonconforming product is detected,
the process becomes statistically unstable or not statistically capable.

The Organization shall review control plans, and update as required, for any of the following:

f) the organization determines it has shipped nonconforming product to the

customer;
g) when any change occurs affecting product, manufacturing process,
measurement, logistics, supply sources, production volume changes, or risk
analysis (FMEA(see Annex A);
h) after a customer complaint and implementation of the associated corrective
action, when applicable;
i) at a set frequency based on a risk analysis.

If required by the customer, the organization shall obtain customer approval after review or
revision of the control plan.

8.5.1.2 Standardised work —— operator instructions and visual standards

The organization shall ensure that standardised work documents are:

a) communicated to and understood by the employees who are responsible for

performing the work;
b) legible;
c) presented in the language(s) understood by the personnel responsible to
follow them;
d) accessible for use at the designated work area(s).

The standardised work documents shall also include rules for operator safety.

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8.5.1.3 Verification of job set-ups

The organization shall:

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

8.5.1.4 Verification after shutdown (New Requirements)

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

8.5.1.5 Total productive maintenance

The organization shall develop, implement, and maintain a documented total productive
maintenance system.

At a minimum, the system shall include the following:

a) identification of process equipment necessary to produce conforming product at

the required volume;
b) availability of replacement parts for the equipment identified in item a);
c) provision of resource for machine, equipment, and facility maintenance;
d) packaging and preservation of equipment, tooling, and gauging;
e) applicable customer-specific requirements;
f) documented maintenance objectives, for example: OEE (Overall Equipment
Effectiveness), MTBF (Mean Time Between Failure), and MTTR (Mean Time
To Repair), and Preventive Maintenance compliance metrics. Performance
to the maintenance objectives shall form an input into management review
(see ISO 9001 , Section 9.3);
g) regular review of maintenance plan and objectives and a documented action
plan to address corrective actions where objectives are not achieved;
h) use of preventive maintenance methods;
i) use of predictive maintenance methods, as applicable;
j) periodic overhaul.

8.5.1.6 Management of production tooling and manufacturing, test, inspection tooling

and equipment

The organization shall provide resources for tool and gauge design, fabrication, and
verification activities for production and service materials and for bulk materials, as
applicable.

The organization shall establish and implement a system for production tooling management,
whether owned by the organization or the customer, including:

a) maintenance and repair facilities and personnel;

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 b) storage and recovery;
c) set-up;
d) tool-change programmes for perishable tools;
e) tool design modification documentation, including engineering change level of the
product;
f) tool modification and revision to documentation;
g) tool identification, such as serial or asset number; the status, such as production,
repair or disposal; ownership; and location.

The Organization shall verify that customer-owned tools, manufacturing equipment, and test /
inspection equipment are permanently marked in a visible location so that the ownership and
application of each item can be determined.

The organization shall implement a system to monitor these activities if any work is
Outsourced.

8.5.1.7 Production scheduling

The organization shall ensure that production is scheduled in order to meet customer
orders/demands such as Just-ln-Time (JIT) and is supported by an information system that
permits access to production information at key stages of the process and is order driven.

The organization shall include relevant planning information during production

scheduling, e.g., customer orders, supplier on-time delivery performance, capacity,
shared loading (multi-part station), lead time, inventory level, preventive maintenance,
and calibration.

8.5.2 Identification and traceability

See ISO 9001:2015 requirements.

NOTE Inspection and test status is not indicated by the location of product in the production
flow unless inherently obvious, such as material in an automated production transfer
process. Alternatives are permitted if the status is clearly identified, documented, arid
achieves the designated purpose.

8.5.2.1 Identification and traceability — supplemental

The purpose of traceability is to support identification of Clear start and stop points for
product received by the customer or in the field that may contain quality and/or safety-related
nonconformities. Therefore, the organization shall implement identification and traceability
processes as described below.

The organization shall conduct an analysis of internal, customer, and regulatory traceability
requirements for all automotive products, including developing and documenting traceability
plans, based on the levels of risk or failure severity for employees, Customers, and
consumers. These plans shall define the appropriate traceability systems, processes, and
methods by product, process, and manufacturing location that:

a) enable the organization to identify nonconforming and/or suspect product;

b) enable the organization to segregate nonconforming and/or suspect product;
c) ensure the ability to meet the customer and/or regulatory response time
requirements;
d) ensure documented information is retained in the format (electronic, hardcopy,
archive) that enables the organization to meet the response time requirements;
e) ensure serialized identification of individual products, if specified by the customer
or regulatory standards;

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 f) ensure the identification and traceability requirements are extended to externally
provided products with safety/regulatory characteristics.

8.5.3 Property belonging to customers or external providers

See ISO 9001:2015 requirements.

8.5.4 Preservation

See ISO 9001:2015 requirements.

8.5.4.1 Preservation — supplemental

Preservation shall include identification, handling, contamination control, packaging, storage,

transmission or transportation, and protection.

Preservation shall apply to materials and components from external and/or internal providers
from receipt through processing, including shipment and until delivery to/acceptance by the
customer.

In order to detect deterioration, the organization shall assess at appropriate planned intervals
the condition of product in stock, the place/type of storage container, and the storage
environment.

The organization shall use an inventory management system to optimize inventory turns over
time and ensure stock rotation, such as "first-in-first-out" (FIFO).

The organization shall ensure that obsolete product is controlled in a manner similar to that
of nonconforming product.

Organizations shall comply with preservation, packaging, shipping, and labeling

requirements as provided by their customers.

8.5.5 Post-delivery activities

See ISO 9001:2015 requirements.

8.5.5.1 Feedback of information from service

The organization shall ensure that a process for communication of information on service
concerns to manufacturing, material handling, logistics, engineering, and design activities is
established, implemented, and maintained.

NOTE 1 The intent of the addition of "service concerns" to this sub-clause is to ensure that
the organization is aware of nonconforming product(s) and material(s) that may be identified
at the customer location or in the field.

NOTE 2 "Service concerns" should include the results of field failure test analysis (see
Section 10.2.6) where applicable.

8.5.5.2 Service agreement with customer

When there is a service agreement with the customer, the organization shall:

a) verify that the relevant service centres comply with applicable requirements;
b) verify the effectiveness of any special purpose-tools or measurement
equipment;

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 c) ensure that all service personnel are trained in applicable requirements.

8.5.6 Control of changes

See 9001:2015 requirements.

8.5.6.1 Control of changes — supplemental

The organization shall have a documented process to control and react to changes that
impact product realization. The effects of any change, including those changes caused by
the organization, the customer, or any supplier, shall be assessed.

The Organization shall:

a) define verification and validation activities to ensure compliance with customer

requirements;
b) validate changes before implementation;
c) document the evidence of related risk analysis;
d) retain records of verification and validation.

Changes, including those made at suppliers, should require a production trial run for
verification of changes (such as changes to part design, manufacturing location, or
manufacturing process) to validate the impact of any changes on the manufacturing process.

When required by the customer, the organization shall:

a) notify the customer of any planned product realization changes after the most
recent product approval;
b) obtain documented approval, prior to implementation of the change;
c) complete additional verification or identification requirements, such as
production trial run and new product validation.

8.5.6.1.1 Temporary change of process controls

The organization shall identify, document, and maintain a list of the process controls,
including inspection, measuring, test, and error-proofing devices, that includes the
primary process control and the approved back-up or alternate methods.

The organization shall document the process that manages the use of alternate
control methods. The organization shall include in this process, based on risk
analysis (such as FMEA), severity, and the internal approvals to be obtained prior to
production implementation of the alternate control method.

Before shipping product that was inspected or tested using the alternate method, if
required, the organization shall obtain approval from the customer(s). The
organization shall maintain and periodically review a list of approved alternate
process control methods that are referenced in the control plan.

Standard work instructions shall be available for each alternate process control
method. The organization shall review the operation of alternate process controls on a
daily basis, at a minimum, to verify implementation of standard work with the goal to
return to the standard process as defined by the control plan as soon as possible.
Example methods include but are not limited to the following:

a) daily quality focused audits (e.g., layered process audits, as applicable);

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 b) daily leadership meetings.

Restart verification is documented for a defined period based on severity and

confirmation that all features of the error-proofing device or process are effectively
reinstated.

The organization shall implement traceability of all product produced while any
alternate process control devices or processes are being used (e.g., verification and
retention of first piece and last piece from every shift).

8.6 Release of products and services

See ISO 9001:2015 requirements.

8.6.1 Release of products and services — supplemental

The organization shall ensure that the planned arrangements to verify that the product and
service requirement has been met encompass the control plan and are documented as
specified in the control plan (see Annex A)

The organization shall ensure that the planned arrangements for initial release of products
and services encompass product or service approval.

The organization shall ensure that product or service approval is accomplished after changes
following initial release, according to ISO 9001, Section 8.5.6.

8.6.2 Layout inspection and functional testing

A layout inspection and a functional verification to applicable customer engineering material

and performance standards shall be performed for each product as specified in the control
plans. Results shall be available for customer review.

NOTE I Layout inspection is the complete measurement of all product dimensions shown on
the design record(s).

NOTE 2 The frequency of layout inspection is determined by the customer.

8.6.3 Appearance items

For organizations manufacturing parts designated by the customer as "appearance items,"

the organization shall provide the following:

a) appropriate resources, including lighting, for evaluation;

b) masters for colour, grain, gloss, metallic brilliance, texture, distinctness of
image (DOI), and haptic technology, as appropriate;
c) maintenance and control of appearance masters and evaluation equipment;
d) verification that personnel making appearance evaluations are competent and
qualified to do so.

8.6.4 Verification and acceptance of conformity of externally provided products and

services

The organization shall have a process to ensure the quality of externally provided processes,
products, and services utilizing one or more of the following methods:

a) receipt and evaluation of statistical data provided by the supplier to the

organization;

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 b) receiving inspection and/or testing, such as sampling based on performance;
c) second-party or third-party assessments or audits of supplier sites when coupled
with records of acceptable delivered product conformance to requirements;
d) part evaluation by a designated laboratory;
e) another method agreed with the customer.

8.6.5 Statutory and regulatory conformity

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

8.6.6 Acceptance criteria

Acceptance criteria shall be defined by the Organization and, where appropriate or required,
approved by the customer. For attribute data sampling, the acceptance level shall be zero
defects (see Section 9.1.1.1).

8.7 Control of nonconforming outputs

8.7.1

See ISO 9001:2015 requirements.

8.7.1.1 Customer authorization for concession

The organization shall obtain a customer concession or deviation permit prior to further
processing whenever the product or manufacturing process is different from that which is
currently approved.

The organization shall obtain customer authorization prior to further processing for "use as is"
and rework dispositions of nonconforming product. If sub-components are reused in the
manufacturing process, that sub-component reuse shall be clearly communicated to the
customer in the concession or deviation permit.

The organization shall maintain a record of the expiration date or quantity authorized under
concession. The organization shall also ensure compliance with the original or superseding
specifications and requirements when the authorization expires. Material shipped under
concession shall be properly identified on each shipping container (this applies equally to
purchased product). The organization shall approve any requests from suppliers before
submission to the customer.

8.7.1.2 Control of nonconforming product — customer-specified process

The organization shall comply with applicable customer-specified contrc& for nonconforming
product(s).

8.7.1.3 Control of suspect product

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

8.7.1.4 Control of reworked product

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The organization shall utilize risk analysis (such as FMEA) methodology to assess risks in
the rework process prior to a decision to rework the product. If required by the customer, the
organization shall obtain approval from the customer prior to commencing rework of the
product.

The organization shall have a documented process for rework confirmation in accordance
with the control plan or other relevant documented information to verify compliance to original
specifications.

Instructions for disassembly or rework, including re-inspection and traceability requirements,

shall be accessible to and utilized by the appropriate personnel.

The organization shall retain documented information on the disposition of reworked product
including quantity, disposition, disposition date, and applicable traceability information.

8.7.1.5 Control of repaired product

The organization shall utilize risk analysis (such as FMEA) methodology to assess risks in
the repair process prior to a decision to repair the product. The organization shall obtain
approval from the customer before commencing repair of the product.

The organization shall have a documented process for repair confirmation in accordance with
the control plan or other relevant documented information.

Instructions for disassembly or repair, including re-inspection and traceability requirements,

shall be accessible to and utilized by the appropriate personnel.

The organization shall obtain a documented customer authorization for concession for the
product to be repaired.

The organization shall retain documented information on the disposition of repaired product
including quantity, disposition, disposition date, and applicable traceability information.

8.7.1.6 Customer notification

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

8.7.1.7 Nonconforming product disposition

The organization shall have a documented process for disposition of nonconforming product
not subject to rework or repair. For product not meeting requirements, the organization shall
verify that the product to be scrapped is rendered unusable prior to disposal.

The organization shall not divert nonconforming product to service or other use without prior
customer approval.

8.7.2

See ISO 9001:2015 requirements.

9 Performance evaluation

9.1 Monitoring, measurement, analysis and evaluation

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9.1.1 General

See ISO 9001:2015 requirements.

9.1.1.1 Monitoring and measurement of manufacturing processes

The organization shall perform process studies on all new manufacturing (including assembly
or sequencing) processes to verify process capability and to provide additional input for
process control, including those for special characteristics.

NOTE For some manufacturing processes, it may not be possible to demonstrate product
compliance through process capability. For those processes, alternate methods such as
batch conformance to specification may be used.

The organization shall maintain manufacturing process capability or performance results as

specified by the customer's part approval process requirements. The organization shall verify
that the process flow diagram, PFMEA, and control plan are implemented, including
adherence to the following:

a) measurement techniques;
b) sampling plans;
c) acceptance criteria;
d) records of actual measurement values and/or test results for variable data;
e) reaction plans and escalation process when acceptance criteria are not met.

Significant process events, such as tool change or machine repair, shall be recorded and
retained as documented information.

The organization shall initiate a reaction plan indicated on the control plan and evaluated for
impact on compliance to specifications for characteristics that are either not statistically
capable or are unstable. These reaction plans shall include containment of product and 100
percent inspection, as appropriate. A corrective action plan shall be developed and
implemented by the organization indicating specific actions, timing, and assigned
responsibilities to ensure that the process becomes stable and statistically capable. The
plans shall be reviewed with and approved by the customer, when required.

The organization shall maintain records of effective dates of process changes.

9.1.1.2 Identification of statistical tools

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

9.1.1.3 Application of statistical concepts

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

9.1.2 Customer satisfaction

See ISO 9001:2015 requirements.

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9.1.2.1 Customer satisfaction — supplemental

Customer satisfaction with the organization shall be monitored through continual evaluation
of internal and external performance indicators to ensure compliance to the product and
process specifications and other customer requirements.

Performance indicators shall be based on objective evidence and include but not be limited
to the following:

a) delivered part quality performance;

b) customer disruptions;
c) field returns, recalls, and warranty (where applicable);
d) delivery schedule performance (including incidents of premium freight);
e) customer notifications related to quality or delivery issues, including special
status.

The organization shall monitor the performance of manufacturing processes to

demonstrate compliance with customer requirements for product quality and process
efficiency. The monitoring shall include the review of customer performance data
including online customer portals and customer scorecards, where provided.

9.1.3 Analysis and evaluation

See ISO 9001:2015 requirements.

9.1.3.1 Prioritization

Trends in quality and operational performance shall be compared with progress toward
objectives and lead to action to support prioritization of actions for improving customer
satisfaction.

9.2 Internal audit

9.2.1 AND 9.2.2

See ISO 9001:2015 requirements.

9.2.2.1 Internal audit programme

The organization shall have a documented internal audit process. The process shall include
the development and implementation of an internal audit programme that covers the entire
quality management system including quality management system audits, manufacturing
process audits, and product audits.

The audit programme shall be prioritized based upon risk, internal and external performance
trends, and criticality of the process(es).

Where the organization is responsible for software development, the organization shall
include software development capability assessments in their internal audit programme.

The frequency of audits shall be reviewed and, where appropriate, adjusted based on
occurrence of process changes, internal and external nonconformities, and/or customer
complaints. The effectiveness of the audit programme shall be reviewed as a part of
management review.

9.2.2.2 Quality management system audit

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

9.2.2.3 Manufacturing process audit

The organization shall audit all manufacturing processes over each three-year calendar
period to determine their effectiveness and efficiency using customer-specific required
approaches for process audits. Where not defined by the customer, the organization shall
determine the approach to be used.

Within each individual audit plan, each manufacturing process shall be audited on all shifts
where it occurs, including the appropriate sampling of the shift handover.

The manufacturing process audit shall include an audit of the effective implementation of the
process risk analysis (such as PFMEA), control plan, and associated documents.

9.2.2.4 Product audit

The organization shall audit products using customer-specific required approaches at

appropriate stages pf production and delivery to verify conformity to specified requirements.
Where not defined by the customer, the organization shall define the approach to be used.

9.3 Management review

9.3.1 General

See 9001:2015 requirements.

9.3.1.1 Management review— supplemental

Management review shall be conducted at least annually. The frequency of management

review(s) shall be increased based on risk to compliance with customer requirements
resulting from internal or external changes impacting the quality management system and
performance-related issues.

9.3.2 Management review inputs

See ISO 9001:2015 requirements.

9.3.2.1 Management review inputs — supplemental

Input to management review shall include:

a) cost of poor quality (cost of internal and external non-conformance);

b) measures of process effectiveness;
c) measures of process efficiency;
d) product conformance;
e) assessments of manufacturing feasibility made for changes to existing operations
and for new facilities or new product (see Section 7.1.3.1);
f) customer satisfaction (see ISO 9001 , Section 9.1.2);
g) review of performance against maintenance objectives;
h) warranty performance (where applicable);
i) review of customer scorecards (where applicable);

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 j) identification of potential field failures identified through risk analysis (such as
FMEA);
k) actual field failures and their impact on safety or the environment.

9.3.3 Management review outputs

See ISO 9001:2015 requirements.

9.3.3.1 Management review outputs — supplemental

Top management shall document and implement an action plan when customer performance
targets are not met.

10 Improvement

10.1 General

See ISO 9001:2015 requirements.

10.2 Nonconformity and corrective action

10.2.1 and 10.2.2

See ISO 9001:2015 requirements.

10.2.3 Problem solving

The organization shall have a documented process(es) for problem solving including:

a) defined approaches for various types and scale of problems (e.g., new product
development, current manufacturing issues, field failures, audit findings);
b) containment, interim actions, and related activities necessary for control of
nonconforming outputs (see ISO 9001, Section 8.7);
c) root cause analysis, methodology used, analysis, and results;
d) implementation of systemic corrective actions, including consideration of the
impact on similar processes and products;
e) verification of the effectiveness of implemented corrective actions;
f) reviewing and, where necessary, updating the appropriate documented
information (e.g., PFMEA, control plan).

Where the customer has specific prescribed processes, tools, or for problem solving, the
organization shall use those processes, tools, or systems unless otherwise approved by the
customer.

10.2.4 Error-proofing

The organization shall have a documented process to determine the use of appropriate error-
proofing methodologies. Details of the method used shall be documented in the process risk
analysis (such as PFMEA) and test frequencies shall be documented in the control plan.

The process shall include the testing of error-proofing devices for failure or simulated failure.
Records shall be maintained. Challenge parts, when used, shall be identified, controlled,
verified, and calibrated where feasible. Error-proofing device failures shall have a reaction
plan.

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10.2.5 Warranty management systems

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

10.2.6 Customer complaints and field failure test analysis

The organization shall perform analysis on customer complaints and field failures,
including any returned parts, and shall initiate problem solving and corrective action
to prevent recurrence.

Where requested by the customer, this shall include analysis of the interaction of embedded
software of the organization's product within the system of the final customer's product.
The organization shall communicate the results of testing/analysis to the customer
and also within the organization.

10.3 Continual improvement

See ISO 9001:2015 requirements.

10.3.1 Continual improvement— supplemental

The organization shall have a documented process for continual improvement. The
organization shall include in this process the following:

a) identification of the methodology used, objectives, measurement,

effectiveness, and documented information;
b) a manufacturing process improvement action plan with emphasis on the
reduction of process variation and waste;
c) risk analysis (such as FMEA).

NOTE Continual improvement is implemented once manufacturing processes„ are

statistically capable and stable or when product characteristics are predictable and meet
customer requirements.

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Annex A: Control Plan

A.1 Phases of the control plan

A control plan covers three distinct phases, as appropriate:

a) Prototype: a description of the dimensional measurements, material, and

performance tests that will occur during building of the prototype. The
organization shall have a prototype control plan, if required by the customer.
b) Pre-launch: a description of the dimensional measurements, material, and
performance tests that occur after prototype and before full production. Pre-
launch is defined as a production phase in the process of product realization that
may be required after prototype build,
c) Production: documentation of product / process characteristics, process
controls, tests, and measurement systems that occur during mass production.

Control plans are established at a part number level; but in many cases, family control plans
may cover a number of similar parts produced using a common process. Control plans are
an output of the quality plan.

NOTE 1 It is recommended that the organization require its suppliers to meet the
requirements of this Annex.

NOTE 2 For some bulk materials, the control plans do not list most of the production
information. This information can be found in the corresponding batch formulation/recipe
details.

A.2 Elements of the control plan

A control plan includes, as a minimum, the following contents:

General data

a) control plan number;

b) issue date and revision date, if any;
c) customer information (see customer requirements);
d) organization's name/site designation;
e) part number(s);
f) part name/description;
g) engineering change level;
h) phase covered (prototype, pre-launch, production);
i) key contact;
j) part/process step number;
k) process name/operation description;
l) functional group/area responsible.

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Product control

a) product-related special characteristics;

b) other characteristics for control (number, product or process);
c) specification/tolerance.
Process control

a) process parameters (including process settings and tolerances);

b) process-related special characteristics;
c) machines, jigs, fixtures, tools for manufacturing (including identifiers, as
appropriate).

Methods

a) evaluation measurement technique;

b) error-proofing;
c) sample size and frequency;
d) control method.

Reaction plan

a) reaction plan (include or reference).

- -

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ANNEX B: Bibliography- supplemental automotive
Internal audit

CQl-8 Layered Process Audit

CQl-9 Special Process: Heat Treatment System Assessment
CQI-II Special Process: Plating System Assessment
CQl-12 Special Process: Coating System Assessment
CQl-15 Special Process: Welding System Assessment
CQl-17 Special Process: Soldering System Assessment
QQl-23 Special Process: Molding System Assessment
CQl-27 Special Process: Casting System Assessment

ANF-IA

AQ 008 Process Audit

FIEV
V2.O Production Process Audit Manual

IATF

Auditor Guide for IATF 16949

VOA

Volume 6 part 3 Process Audit

Volume 6 part 5 Product Audit

Nonconformity and corrective action

AIAG
CQl-14 Automotive Warranty Management Guideline
CQl-20 Effective Problem Solving Practitioner Guide

VDA

Volume "Audit standard field failure analysis" Volume "Field failures analysis"
Measurement systems analysis

Measurement Systems Analysis (MSA)

AIAG

Measurement Systems Analysis (MSA)

ANF-IA

AQ 024 MSA Measurement Systems Analysis

VDA

Volume 5 "Capability of Measuring Systems"

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Product approval

AIAG

Production Part Approval Process (PPAP)

VDA

Volume 2 Production process and product approval (PPA)

Volume 19 Part 1 ("Inspection of Technical Cleanliness - Particulate Contamination of
Functionally Relevant Automotive Components")
Volume 19 Part 2 ("Technical cleanliness in assembly - Environment, Logistics,
Personnel and Assembly Equipment")

Product design

AIAG

APQP and Control Plan

CQl-24 Design Review Based on Failure Modes (DRBFM Reference Guide)
Potential Failure Mode & Effects Analysis (FMEA)

ANFIA

AQ 009 FMEA
AQ 014 Manual of Experimental Design
AQ 025 Reliability Guide

VDA

Volume 4 Chapter Product and Process FMEA

Volume VDA-RGA "Maturity Level Assurance for New Parts"
Volume "Robust Production Process"
Volume Special Characteristics (SC)

Production control

AIAG

MMOG/LE Materials Management Operational Guidelines / Logistics Evaluation

SMMT

Implementing Standardised Work

Quality management system administration

ANF-IA

AQ 020 Managing and improving the process

IATF

Rules for achieving and maintaining IATF recognition

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Risk analysis

VOA

Volume 4 "Ring-binder" (elementary aids, risk analyses, methods, and process

models)

Software Process Assessment

Capability Maturity Model Integration (CMMI)

VDA

Automotive SPICEe (Software Process Improvement and Capability Determination)

Statistical tools

AIAG

Statistical Process Control (SPC)

ANFIA

AQ 011 SPC

Supplier quality management

AIAG

CQl-19 Sub-Tier Supplier Management Process Guideline

IATF

Minimum Automotive Quality Management System Requirements for

Sub-Tier Suppliers (MAQMSR)

Health and safety

ISO
ISO 45001 Occupational health and safety management systems

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