IATF 16949:2016 Elements

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 QMS
4.3.1
4.4 QMS & its processes
4.4.1

4.4.1.1 Conformance of Products and Processes

4.4.1.2 Product Safety
4.4.2 Documentation Requirements

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 Quality 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
5.3.2 Responsibity & Authority for Products requirements and Correcive
actions
6 Planning
6.1 Action to Address Risks and Opportunities
6.1.1
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
6.2.2
6.2.2.1
6.3 Planing of Change

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
7.1.5 Monitoring and Measuring Resources
7.1.5.1 General
7.1.5.1.1 MSA
7.1.5.2 Measurement System Traceability
7.1.5.2.1 Calibration/Vertification 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
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
7.3.2 Employee Motivation and Empowerment
7.4 Communication
7.5 Documented Information
7.5.1 General
7.5.1.1 QMS Documentations
7.5.2 Creating & Updating
7.5.3 Control f documented Information
7.5.3.1
7.5.3.2
7.5.3.2.1 Record Retention
7.5.3.2.2 Engineering Specifications
 TS 16949:2009 Elements

4
4.1
4.1.1

4.2
4.2.1
4.2.2
4.2.3
4.2.3.1
4.2.4
4.2.4.1
5
5.1

5.1.1

5.2
5.3

5.5
5.5.1
5.5.1.1

5.4
5.4.1
5.4.1.1
5.4.2

5.5.2
 5.5.2.1
5.5.3
5.6
5.6.1
5.6.1.1
5.6.2
5.6.2.1
5.6.3

6.2.1

6.2.2.1

6.3.2

6.4.1

6.1

6.2
6.3
6.3.1
6.4
6.4.2

6.2.2

6.2.2.3

6.2.2.2
6.2.2.4
 TS 16949:2009 Elements

Quality management system

General requirements
General requirements — Supplemental

Documentation requirements
General.
Quality manual
ontrol of documents
Engineering specifications
Control of records
Records retention
Management responsibility
Management commitment

Process efficiency

Customer focus
Quality policy

Responsibility, authority and communication

Responsibility and authority
Responsibility for quality

Planning
Quality objectives
Quality objectives — Supplemental
Quality management system planning

Management representative
Customer representative
Internal communication
Management review
General.
Quality management system performance
Review input
Review input — Supplemental
Review output.

Resource management

General

Product design skills

Contingency plans

Personnel safety to achieve conformity to product requirements.

Provision of resources

Human resources
Infrastructure
Plant, facility and equipment planning
Work environment
Cleanliness of premises

Competence, training and awareness

Training on the job

Training
Employee motivation and empowerment
4 Quality management system
4.1 General requirements
4.1.1 General requirements — Supplemental
4.2 Documentation requirements
4.2.1 General
4.2.2 Quality manual.
4.2.3 Control of documents
4.2.3.1 Engineering specifications
4.2.4 Control of records
4.2.4.1 Records retention
5 Management responsibility
5.1 Management commitment
5.1.1 Process efficiency
5.2 Customer focus
5.3 Quality policy
5.4 Planning
5.4.1 Quality objectives
5.4.1.1 Quality objectives — Supplemental.
5.4.2 Quality management system planning
5.5 Responsibility, authority and communication.
5.5.1 Responsibility and authority
5.5.1.1 Responsibility for quality
5.5.2 Management representative
5.5.2.1 Customer representative
5.5.3 Internal communication
5.6 Management review
5.6.1 General.
5.6.1.1 Quality management system performance
5.6.2 Review input
5.6.2.1 Review input — Supplemental
5.6.3 Review output
6 Resource management
6.1 Provision of resources
6.2 Human resources
6.2.1 General
6.2.2 Competence, training and awareness
6.2.2.1 Product design skills
6.2.2.2 Training
6.2.2.3 Training on the job
6.2.2.4 Employee motivation and empowerment
6.3 Infrastructure
6.3.1 Plant, facility and equipment planning
6.3.2 Contingency plans
6.4 Work environment
6.4.1 Personnel safety to achieve conformity to product requirements
6.4.2 Cleanliness of premises
7 Product realization
7.1 Planning of product realization
7.1.1 Planning of product realization — Supplemental
7.1.2 Acceptance criteria
7.1.3 Confidentiality
7.1.4 Change control
7.2 Customer-related processes.
7.2.1 Determination of requirements related to the product
7.2.1.1 Customer-designated special characteristics
7.2.2 Review of requirements related to the product
7.2.2.1 Review of requirements related to the product — Supplemental
7.2.2.2 Organization manufacturing feasibility
7.2.3 Customer communication
7.2.3.1 Customer communication — Supplemental
7.3 Design and development
7.3.1 Design and development planning
7.3.1.1 Multidisciplinary approach
7.3.2 Design and development inputs
7.3.2.1 Product design input
7.3.2.2 Manufacturing process design input
7.3.2.3 Special characteristics
7.3.3 Design and development outputs
7.3.3.1 Product design outputs — Supplemental
7.3.3.2 Manufacturing process design output.
7.3.4 Design and development review
7.3.4.1 Monitoring
7.3.5 Design and development verification
7.3.6 Design and development validation.
7.3.6.1 Design and development validation — Supplemental
7.3.6.2 Prototype programme
7.3.6.3 Product approval process
7.3.7 Control of design and development changes
7.4 Purchasing
7.4.1 Purchasing process
7.4.1.1 Statutory and regulatory conformity
7.4.1.2 Supplier quality management system development
7.4.1.3 Customer-approved sources
7.4.2 Purchasing information.
7.4.3 Verification of purchased product
7.4.3.1 Incoming product conformity to requirements
7.4.3.2 Supplier monitoring.
7.5 Production and service provision
7.5.1 Control of production and service provision
7.5.1.1 Control plan
7.5.1.2 Work instructions
7.5.1.3 Verification of job set-ups
7.5.1.4 Preventive and predictive maintenance
7.5.1.5 Management of production tooling
7.5.1.6 Production scheduling
7.5.1.7 Feedback of information from service
7.5.1.8 Service agreement with customer
7.5.2 Validation of processes for production and service provision
7.5.2.1 Validation of processes for production and service provision — Supplemental
7.5.3 Identification and traceability
7.5.3.1 Identification and traceability — Supplemental
7.5.4 Customer property
7.5.4.1 Customer-owned production tooling
7.5.5 Preservation of product
7.5.5.1 Storage and inventory
7.6 Control of monitoring and measuring equipment
7.6.1 Measurement system analysis .
7.6.2 Calibration/verification records
7.6.3 Laboratory requirements
7.6.3.1 Internal laboratory
7.6.3.2 External laboratory
8 Measurement, analysis and improvement
8.1 General.
8.1.1 Identification of statistical tools
8.1.2 Knowledge of basic statistical concepts
8.2 Monitoring and measurement.
8.2.1 Customer satisfaction.
8.2.1.1 Customer satisfaction — Supplemental ..
8.2.2 Internal audit..
8.2.2.1 Quality management system audit .
8.2.2.2 Manufacturing process audit
8.2.2.3 Product audit
8.2.2.4 Internal audit plans
8.2.2.5 Internal auditor qualification.
8.2.3 Monitoring and measurement of processes .
8.2.3.1 Monitoring and measurement of manufacturing processes
8.2.4 Monitoring and measurement of product.
8.2.4.1 Layout inspection and functional testing
8.2.4.2 Appearance items
8.3 Control of nonconforming product
8.3.1 Control of nonconforming product — Supplemental.
8.3.2 Control of reworked product
8.3.3 Customer information
8.3.4 Customer waiver.
8.4 Analysis of data.
8.4.1 Analysis and use of data.
8.5 Improvement.
8.5.1 Continual improvement.
8.5.1.1 Continual improvement of the organization
8.5.1.2 Manufacturing process improvement.
8.5.2 Corrective action.
8.5.2.1 Problem solving
8.5.2.2 Error-proofing.
8.5.2.3 Corrective action impact
8.5.2.4 Rejected product test/analysis.
8.5.3 Preventive action
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 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 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 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
8.2.3.2
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 Standardised 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
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 .
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 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
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 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 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 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
8.2.3.2
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 Standardised 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
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 .
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 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
4 Quality management system

Scope

4.1 General requirements

4.1.1 General requirements — Supplemental

5 Management responsibility
5.1 Management commitment

5.1.1 Process efficiency

5.2 Customer focus

5.3 Quality policy

5.5 Responsibility, authority and communication.

5.5.1 Responsibility and authority
5.5.1.1 Responsibility for quality
5.5.2 Management representative
5.5.2.1 Customer representative

5.4 Planning

8.5.3 Preventive action

6.3.2 Contingency plans
5.4.1 Quality objectives

5.4.1.1 Quality objectives — Supplemental.

7.1.4 Change control
5.4.2 Quality management system planning
6 Resource management
6.2.1 General
6.1 Provision of resources
6.2 Human resources
6.3 Infrastructure
6.3.1 Plant, facility and equipment planning
6.4 Work environment
6.2.2 Competence, training and awareness

6.2.2.3 Training on the job

6.4.1 Personnel safety to achieve conformity to product requirements

6.4.2 Cleanliness of premises
6.2.2.2 Training
6.2.2.4 Employee motivation and empowerment
5.5.3 Internal communication

4.2 Documentation requirements

4.2.1 General
4.2.2 Quality manual.

4.2.3 Control of documents

4.2.4 Control of records
4.2.4.1 Records retention
4.2.3.1 Engineering specifications

7 Product realization
7.1 Planning of product realization
7.1.1 Planning of product realization — Supplemental
7.1.3 Confidentiality
7.1.2 Acceptance criteria
7.2.3 Customer communication
7.2 Customer-related processes.
7.2.1 Determination of requirements related to the product

7.2.2 Review of requirements related to the product

7.2.2.1 Review of requirements related to the product — Supplemental

7.2.1.1 Customer-designated special characteristics

7.2.2.2 Organization manufacturing feasibility

7.2.3.1 Customer communication — Supplemental

7.3 Design and development
7.3.1 Design and development planning
7.3.1.1 Multidisciplinary approach
7.3.2 Design and development inputs
7.3.2.1 Product design input
6.2.2.1 Product design skills
7.3.2.2 Manufacturing process design input
7.3.2.3 Special characteristics
7.3.3 Design and development outputs
7.3.3.1 Product design outputs — Supplemental
7.3.3.2 Manufacturing process design output.
7.3.4 Design and development review
7.3.4.1 Monitoring
7.3.5 Design and development verification
7.3.6 Design and development validation.
7.3.6.1 Design and development validation — Supplemental
7.3.6.2 Prototype programme
7.3.6.3 Product approval process
7.3.7 Control of design and development changes
7.4 Purchasing
7.4.1 Purchasing process
7.4.1.1 Statutory and regulatory conformity
7.4.1.2 Supplier quality management system development
7.4.1.3 Customer-approved sources
7.4.2 Purchasing information.
7.4.3 Verification of purchased product
7.4.3.1 Incoming product conformity to requirements
7.4.3.2 Supplier monitoring.
7.5 Production and service provision
7.5.1 Control of production and service provision
7.5.1.1 Control plan
7.5.1.2 Work instructions
7.5.1.3 Verification of job set-ups
7.5.1.4 Preventive and predictive maintenance
7.5.1.5 Management of production tooling
7.5.1.6 Production scheduling
7.5.1.7 Feedback of information from service
7.5.1.8 Service agreement with customer
7.5.2 Validation of processes for production and service provision
7.5.2.1 Validation of processes for production and service provision — Supplemental
7.5.3 Identification and traceability
7.5.3.1 Identification and traceability — Supplemental
7.5.4 Customer property
7.5.4.1 Customer-owned production tooling
7.5.5 Preservation of product
7.5.5.1 Storage and inventory
7.6 Control of monitoring and measuring equipment
7.6.1 Measurement system analysis .
7.6.2 Calibration/verification records
7.6.3 Laboratory requirements
7.6.3.1 Internal laboratory
7.6.3.2 External laboratory

8 Measurement, analysis and improvement

8.1 General.

8.2 Monitoring and measurement.

8.2.4 Monitoring and measurement of product.

8.2.4.1 Layout inspection and functional testing

8.2.4.2 Appearance items
8.3 Control of nonconforming product
8.3.1 Control of nonconforming product — Supplemental.
8.3.4 Customer waiver.

8.3.2 Control of reworked product

8.3.3 Customer information

5.6.1.1 Quality management system performance

8.2.3 Monitoring and measurement of processes .

8.2.3.1 Monitoring and measurement of manufacturing processes
8.1.1 Identification of statistical tools
8.1.2 Knowledge of basic statistical concepts
8.2.1 Customer satisfaction.
8.2.1.1 Customer satisfaction — Supplemental ..
8.4 Analysis of data.
8.4.1 Analysis and use of data.
8.2.2 Internal audit..

8.2.2.4 Internal audit plans

8.2.2.1 Quality management system audit .
8.2.2.2 Manufacturing process audit
8.2.2.3 Product audit
8.2.2.5 Internal auditor qualification.
5.6 Management review
5.6.1 General.

5.6.2 Review input

5.6.2.1 Review input — Supplemental
5.6.3 Review output

8.5 Improvement.

8.5.2 Corrective action.

8.5.1.2 Manufacturing process improvement.
8.5.2.3 Corrective action impact
8.5.2.1 Problem solving
8.5.2.2 Error-proofing.

8.5.1 Continual improvement.

8.5.1.1 Continual improvement of the organization
8.5.2.4 Rejected product test/analysis.