01/402930 DC : DRAFT OCT 2001

Foreword
Introduction
1 Scope
  1.1 General
  1.2 Application
2 Normative references
3 Terms and definitions
  3.1 Terms and definitions for the automotive industry
4 Quality management system
  4.1 General requirements
  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, awareness and training
            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
      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 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 Regulatory compliance
            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 quality
            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 Servicing 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 devices
      7.6.1 Measurement system analysis
      7.6.2 Calibration 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
Annex A
      A.1 Phases of the control plan
      A.2 Elements of the control plan

ISO/TS 16949