Table of Contents
TABLE OF CONTENTS
FOREWORD – AUTOMOTIVE QMS STANDARD
HISTORY
GOAL
REMARKS FOR CERTIFICATION
INTRODUCTION
0.1 GENERAL
0.2 QUALITY MANAGEMENT PRINCIPLES
0.3 PROCESS APPROACH
0.3.1 GENERAL
0.3.2 PLAN-DO-CHECK-ACT-CYCLE
0.3.3 RISK-BASED-THINKING
0.4 RELATIONSHIP WITH OTHER MANAGEMENT SYSTEM STANDARDS
QUALITY MANAGEMENT SYSTEMS – REQUIREMENTS
1 SCOPE
1.1 AUTOMOTIVE SUPPLEMENTAL TO ISO 9001 :201 5
2 NORMATIVE REFERENCES
2.1 NORMATIVE AND INFORMATIVE REFERENCES
3 TERMS AND DEFINITIONS
3.1 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
4.4.1.1 Conformance of products and processes
4.4.1.2 Product safety
4.4.2
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 THE 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 plan
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 system 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 Operation 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 Determination of product and service requirements – supplemental
8.2.3 REVIEW OF THE REQUIREMENTS FOR PRODUCTS AND SERVICES
8.2.3.1.1 Review of product and service requirements – supplemental
8.2.3.1.2 Customer-designated special characteristics
8.2.3.1.3 Organization manufacturing feasibility
8.2.3.2
8.2.4 CHANGES TO PRODUCT AND SERVICE REQUIREMENTS
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 OUTPUT
8.3.5.1 Design and development output – 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 setups
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 the 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
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 products
8.7.1.5 Control of repaired product
8.7.1.6 Customer notification
8.7.1.7 Nonconforming product disposition
8.7.2
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 program
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 Quality management system performance
9.3.2 MANAGEMENT REVIEW INPUTS
9.3.2.1 Management review input – supplemental
9.3.3 MANAGEMENT REVIEW OUTPUTS
9.3.3.1 Management review output – supplement
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 complaint and field failure test analysis
10.3 CONTINUAL IMPROVEMENT
10.3.1 Continual improvement – supplemental
ANNEX–A: CONTROL PLAN
a.1 Phases of control plan
a.2 Elements of control plan
ANNEX–B: BIBLIOGRAPHY– SUPPLEMENTAL AUTOMOTIVE