ISO/TS 16949
This second edition of ISO/TS 16949 cancels and replaces the second edition (ISO/TS 16949:2002), which has been technically revised. Boxed text is original ISO 9001:2008 text. The sector-specific supplemental requirements are outside the boxes. In this Technical Specification, the word “shall” indicates a requirement. The word “should” indicates a recommendation. Paragraphs marked “NOTE” are for guidance in understanding or clarifying the associated requirement. Where the term “such as” is used, any suggestions given are for guidance only.
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Certification IS/TS 16949
ISO/TS 16949 is technical specification for supply chain in automotive industry based on the ISO 9001. The certification to this Technical Specification, including customer-specific requirements if any, is recognized by the customer members of IATF when achieved according to the IATF certification scheme (see the “Rules for achieving IATF recognition”).
Contents ISO/TS 16949
Foreword
Remarks for certification
Introduction
0.1 General
0.2 Process approach
0.3 Relationship with ISO 9004
0.3.1 IATF Guidance to ISO/TS 16949:2002
0.4 Compatibility with other management systems
0.5 Goal of this Technical Specification
1 Scope
1.1 General
1.2 Application
2 Normative reference
3 Terms and definitions
3.1 Terms and definitions for the automotive industry
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 - Suplemental
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 Management 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 - Suplemental
5.6.3 Review output
6 Resource management
6.1 Provision of resources
6.2 Human resources
6.2.1 General
6.2.1 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 to achieve product quality
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
Content ISO/TS 16949
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 - Suplemental
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 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 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 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 devices
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
Annex A (normative) Control plan
A.1 Phases of the control plan
A.2 Elements of the control plan
Bibliography
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