IATF 16949:2016 — Reference Resource and Table of Contents

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IATF 16949:2016 — Table of Contents

1 SCOPE

1.1 SCOPE – AUTOMOTIVE SUPPLEMENTAL TO ISO 9001:2015

2 NORMATIVE REFERENCES

2.1 NORMATIVE AND INFORMATIVE REFERENCES

3 TERMS AND DEFINITIONS

3.1 TERMS AND DEFINITIONS FOR THE AUTOMOTIVE INDUSTRY

4 CONTEXT OF THE ORGANIZATION

4.1 UNDERSTANDING THE ORGANIZATION AND ITS CONTEXT

4.2 UNDERSTANDING THE NEEDS AND EXPECTATIONS OF INTERESTED PARTIES

4.3 DETERMINING THE SCOPE OF THE QUALITY MANAGEMENT SYSTEM

4.3.1 Determining the scope of the quality management system – supplemental

4.3.2 Customer-specific requirements

4.4 QUALITY MANAGEMENT SYSTEM AND ITS PROCESSES

4.4.1.1 Conformance of products and processes

4.4.1.2 Product safety

5 LEADERSHIP

5.1 LEADERSHIP AND COMMITMENT

5.1.1 GENERAL

5.1.1.1 Corporate responsibility

5.1.1.2 Process effectiveness and efficiency

5.1.1.3 Process owners

5.1.2 CUSTOMER FOCUS

5.2 POLICY

5.2.1 ESTABLISHING THE QUALITY POLICY

5.2.2 COMMUNICATING THE QUALITY POLICY

5.3 ORGANIZATIONAL ROLES, RESPONSIBILITIES AND AUTHORITIES

5.3.1 Organizational roles, responsibilities, and authorities – supplemental

5.3.2 Responsibility and authority for product requirements and corrective actions

6 PLANNING

6.1 ACTIONS TO ADDRESS RISKS AND OPPORTUNITIES

6.1.1 AND 6.1.2

6.1.2.1 Risk analysis

6.1.2.2 Preventive action

6.1.2.3 Contingency plans

6.2 QUALITY OBJECTIVES AND PLANNING TO ACHIEVE THEM

6.2.1 AND 6.2.2

6.2.2.1 Quality objectives and planning to achieve them – supplemental

6.3 PLANNING OF CHANGES

7 SUPPORT

7.1 RESOURCES

7.1.1 GENERAL

7.1.2 PEOPLE

7.1.3 INFRASTRUCTURE

7.1.3.1 Plant, facility, and equipment planning

7.1.4 ENVIRONMENT FOR THE OPERATION OF PROCESSES

7.1.4.1 Environment for the operation of processes – supplemental

7.1.5 MONITORING AND MEASURING RESOURCES

7.1.5.1 GENERAL

7.1.5.1.1 Measurement systems analysis

7.1.5.2 MEASUREMENT TRACEABILITY

7.1.5.2.1 Calibration/verification records

7.1.5.3 Laboratory requirements

7.1.5.3.1 Internal laboratory

7.1.5.3.2 External laboratory

7.1.6 ORGANIZATIONAL KNOWLEDGE

7.2 COMPETENCE

7.2.1 Competence – supplemental

7.2.2 Competence – on-the-job training

7.2.3 Internal auditor competency

7.2.4 Second-party auditor competency

7.3 AWARENESS

7.3.1 Awareness – supplemental

7.3.2 Employee motivation and empowerment

7.4 COMMUNICATION

7.5 DOCUMENTED INFORMATION

7.5.1 GENERAL

7.5.1.1 Quality management system documentation

7.5.2 CREATING AND UPDATING

7.5.3 CONTROL OF DOCUMENTED INFORMATION

7.5.3.1 AND 7.5.3.2

7.5.3.2.1 Record retention

7.5.3.2.2 Engineering specifications

8 OPERATION

8.1 OPERATIONAL PLANNING AND CONTROL

8.1.1 Operational planning and control - supplemental

8.1.2 Confidentiality

8.2 REQUIREMENTS FOR PRODUCTS AND SERVICES

8.2.1 CUSTOMER COMMUNICATION

8.2.1.1 Customer communication – supplemental

8.2.2 DETERMINING THE REQUIREMENTS FOR PRODUCTS AND SERVICES

8.2.2.1 Determining the requirements for products and services – supplemental

8.2.3 REVIEW OF THE REQUIREMENTS FOR PRODUCTS AND SERVICES

8.2.3.1

8.2.3.1.1 Review of the requirements for products and services – supplemental

8.2.3.1.2 Customer-designated special characteristics

8.2.3.1.3 Organization manufacturing feasibility

8.2.4 CHANGES TO REQUIREMENTS FOR PRODUCTS AND SERVICES

8.3 DESIGN AND DEVELOPMENT OF PRODUCTS AND SERVICES

8.3.1 GENERAL

8.3.1.1 Design and development of products and services – supplemental

8.3.2 DESIGN AND DEVELOPMENT PLANNING

8.3.2.1 Design and development planning – supplemental

8.3.2.2 Product design skills

8.3.2.3 Development of products with embedded software

8.3.3 DESIGN AND DEVELOPMENT INPUTS

8.3.3.1 Product design input

8.3.3.2 Manufacturing process design input

8.3.3.3 Special characteristics

8.3.4 DESIGN AND DEVELOPMENT CONTROLS

8.3.4.1 Monitoring

8.3.4.2 Design and development validation

8.3.4.3 Prototype programme

8.3.4.4 Product approval process

8.3.5 DESIGN AND DEVELOPMENT OUTPUTS

8.3.5.1 Design and development outputs – supplemental

8.3.5.2 Manufacturing process design output

8.3.6 DESIGN AND DEVELOPMENT CHANGES

8.3.6.1 Design and development changes – supplemental

8.4 CONTROL OF EXTERNALLY PROVIDED PROCESSES, PRODUCTS AND SERVICES

8.4.1 GENERAL

8.4.1.1 General – supplemental

8.4.1.2 Supplier selection process

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

8.4.2 TYPE AND EXTENT OF CONTROL

8.4.2.1 Type and extent of control – supplemental

8.4.2.2 Statutory and regulatory requirements

8.4.2.3 Supplier quality management system development

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

8.4.2.4 Supplier monitoring

8.4.2.4.1 Second-party audits

8.4.2.5 Supplier development

8.4.3 INFORMATION FOR EXTERNAL PROVIDERS

8.4.3.1 Information for external providers – supplemental

8.5 PRODUCTION AND SERVICE PROVISION

8.5.1 CONTROL OF PRODUCTION AND SERVICE PROVISION

8.5.1.1 Control plan

8.5.1.2 Standardized work – operator instructions and visual standards

8.5.1.3 Verification of job set-ups

8.5.1.4 Verification after shutdown

8.5.1.5 Total productive maintenance

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

8.5.1.7 Production scheduling

8.5.2 IDENTIFICATION AND TRACEABILITY

8.5.2.1 Identification and traceability – supplemental

8.5.3 PROPERTY BELONGING TO CUSTOMERS OR EXTERNAL PROVIDERS

8.5.4 PRESERVATION

8.5.4.1 Preservation – supplemental

8.5.5 POST-DELIVERY ACTIVITIES

8.5.5.1 Feedback of information from service

8.5.5.2 Service agreement with customer

8.5.6 CONTROL OF CHANGES

8.5.6.1 Control of changes – supplemental

8.5.6.1.1 Temporary change of process controls

8.6 RELEASE OF PRODUCTS AND SERVICES

8.6.1 Release of products and services – supplemental

8.6.2 Layout inspection and functional testing

8.6.3 Appearance items

8.6.4 Verification and acceptance of conformity of externally provided products and services

8.6.5 Statutory and regulatory conformity

8.6.6 Acceptance criteria

8.7 CONTROL OF NONCONFORMING OUTPUTS

8.7.1.1 Customer authorization for concession

8.7.1.2 Control of nonconforming product – customer-specified process

8.7.1.3 Control of suspect product

8.7.1.4 Control of reworked product

8.7.1.5 Control of repaired product

8.7.1.6 Customer notification

8.7.1.7 Nonconforming product disposition

9 PERFORMANCE EVALUATION

9.1 MONITORING, MEASUREMENT, ANALYSIS AND EVALUATION

9.1.1 GENERAL

9.1.1.1 Monitoring and measurement of manufacturing processes

9.1.1.2 Identification of statistical tools

9.1.1.3 Application of statistical concepts

9.1.2 CUSTOMER SATISFACTION

9.1.2.1 Customer satisfaction – supplemental

9.1.3 ANALYSIS AND EVALUATION

9.1.3.1 Prioritization

9.2 INTERNAL AUDIT

9.2.1 AND 9.2.2

9.2.2.1 Internal audit programme

9.2.2.2 Quality management system audit

9.2.2.3 Manufacturing process audit

9.2.2.4 Product audit

9.3 MANAGEMENT REVIEW

9.3.1 GENERAL

9.3.1.1 Management review – supplemental

9.3.2 MANAGEMENT REVIEW INPUTS

9.3.2.1 Management review inputs – supplemental

9.3.3 MANAGEMENT REVIEW OUTPUTS

9.3.3.1 Management review outputs – supplemental

10 IMPROVEMENT

10.1 GENERAL

10.2 NONCONFORMITY AND CORRECTIVE ACTION

10.2.1 AND 10.2.2

10.2.3 Problem solving

10.2.4 Error-proofing

10.2.5 Warranty management systems

10.2.6 Customer complaints and field failure test analysis

10.3 CONTINUAL IMPROVEMENT

10.3.1 Continual improvement – supplemental

ANNEX A: CONTROL PLAN

A. PHASES OF THE CONTROL PLAN

B. ELEMENTS OF THE CONTROL PLAN

ANNEX B: BIBLIOGRAPHY – SUPPLEMENTAL AUTOMOTIVE