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Ant坦nio Ferreira
Ant坦nio Ferreira

This document outlines additions and changes to ISO 9001:2008 quality management system standards for the automotive industry as specified in ISO/TS 16949:2009. Key changes include additional terms and definitions relevant to the automotive industry, expanded requirements for design and development processes, additional controls for purchasing and production processes, enhanced monitoring and measurement of processes and products, and expanded requirements for continual improvement.

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Red Text represents additions to ISO 9001:2008 ISO 9001:2008 ISO/TS 16949:2009 Introduction 0.1 General 0.2 Process approach 0.3 Relationship with ISO 9004 0.4 Compatibility with other management systems 0.5 Goal of this Technical Specification 1. SCOPE 1 Scope1 1.1 General 1.1 General1 1.2 Application 1.2 Application 2 Normative references 2 Normative references ISO 9000:2005 ISO 9000:2005 3 Terms and definitions 3 Terms and definitions 3.1 Terms and definitions for the automotive industry 3.1.1 Control Plan 3.1.2 Design Responsible Organization 3.1.3 Error Proofing 3.1.4 Laboratory 3.1.5 Laboratory Scope 3.1.6 Manufacturing 3.1.7 Predictive Maintenance 3.1.8 Preventive Maintenance 3.1.9 Premium Freight 3.1.10 Remote Location 3.1.11 Site 3.1.12 Special Characteristic 4 Quality management system 4 Quality management system 4.1 General requirements 4.1 General requirements 4.1.1 General requirements Supplemental 4.2 Documentation requirements 4.2 Documentation requirements 4.2.1 General 4.2.1 General 4.2.2 Quality Manual 4.2.2 Quality manual 4.2.3 Control of Documents 4.2.3 Control of documents 4.2.3.1 Engineering specifications 4.2.4 Control of Records 4.2.4 Control of records 4.2.4.1 Records retention 5 MANAGEMENT RESPONSIBILITY 5 Management responsibility 5.1 Management commitment 5.1 Management commitment 5.1.1 Process efficiency 5.2 Customer focus 5.2 Customer focus 5.3 Quality policy 5.3 Quality policy 5.4 Planning 5.4 Planning 5.4.1 Quality Objectives 5.4.1 Quality objectives 5.4.1.1 Quality objectives Supplemental 5.4.2 Quality Management System Planning 5.4.2 Quality management system planning 5.5 Responsibility, authority and communication 5.5 Responsibility, authority and communication 5.5.1 Responsibility and Authority 5.5.1 Responsibility and authority 5.5.1.1 Responsibility for quality 5.5.2 Management Representative 5.5.2 Management representative 5.5.2.1 Customer representative 5.5.3 Internal Communication 5.5.3 Internal communication 5.6 Management Review 5.6 Management review 5.6.1 General 5.6.1 General 5.6.1.1 Quality management system performance 5.6.2 Review Input 5.6.2 Review input 5.6.2.1 Review input Supplemental 5.6.3 Review Output 5.6.3 Review output 6 Resource management 6 Resource management 6.1 Provision of resources 6.1 Provision of resources 6.2 Human resources 6.2 Human resources 6.2.1 General 6.2.1 General 6.2.2 Competence, Training and Awareness 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 Infrastructure 6.3.1 Plant, facility and equipment planning 6.3.2 Contingency plans 6.4 Work environment 6.4 Work environment 6.4.1 Personnel safety to achieve conformity to product requirements 6.4.2 Cleanliness of premises
Red Text represents additions to ISO 9001:2008 ISO 9001:2008 ISO/TS 16949:2009 7 Product realization 7 Product realization 7.1 Planning of 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 Customer-related processes 7.2.1 Determination of requirements related to the product 7.2.1 Determination of requirements related to the product 7.2.2 Review 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 Customer communication 7.2.3.1 Customer communication Supplemental 7.3 Design and development 7.3 Design and development 7.3.1 Design and Development Planning 7.3.1 Design and development planning 7.3.1.1 Multidisciplinary approach 7.3.2 Design and Development Inputs 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 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 Design and development review 7.3.4.1 Monitoring 7.3.5 Design and Development Verification 7.3.5 Design and development verification 7.3.6 Design and Development Validation 7.3.6 Design and development validation 7.3.6.1 Design and development validation Supplemental 7.3.6.2 Prototype program 7.3.6.3 Product approval process 7.3.7 Control of Design and Development Changes 7.3.7 Control of design and development changes 7.4 Purchasing 7.4 Purchasing 7.4.1 Purchasing Process 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 7.4.2 Purchasing information 7.4.3 Verification of Purchased Product 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 Production and service provision 7.5.1 Control of 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 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 Identification and traceability 7.5.3.1 Identification and traceability Supplemental 7.5.4 Customer Property 7.5.4 Customer property 7.5.4.1 Customer-owned production tooling 7.5.5 Preservation of Product 7.5.5 Preservation of product 7.5.5.1 Storage and inventory 7.6 Control of monitoring and measuring Equipment 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
Red Text represents additions to ISO 9001:2008 ISO 9001:2008 ISO/TS 16949:2009 8 Measurement, analysis and improvement 8 Measurement, analysis and improvement 8.1 General 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 Monitoring and measurement 8.2.1 Customer Satisfaction 8.2.1 Customer satisfaction 8.2.1.1 Customer satisfaction Supplemental 8.2.2 Internal Audit 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 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 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 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 Analysis of data 8.4.1 Analysis and use of data 8.5 Improvement 8.5 Improvement 8.5.1 Continual 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 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 8.5.3 Preventive action Annex A (normative) Control plan A.1 Phases of the control plan A.2 Elements of the control plan

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Compare 9001-16949

  • 1. Red Text represents additions to ISO 9001:2008 ISO 9001:2008 ISO/TS 16949:2009 Introduction 0.1 General 0.2 Process approach 0.3 Relationship with ISO 9004 0.4 Compatibility with other management systems 0.5 Goal of this Technical Specification 1. SCOPE 1 Scope1 1.1 General 1.1 General1 1.2 Application 1.2 Application 2 Normative references 2 Normative references ISO 9000:2005 ISO 9000:2005 3 Terms and definitions 3 Terms and definitions 3.1 Terms and definitions for the automotive industry 3.1.1 Control Plan 3.1.2 Design Responsible Organization 3.1.3 Error Proofing 3.1.4 Laboratory 3.1.5 Laboratory Scope 3.1.6 Manufacturing 3.1.7 Predictive Maintenance 3.1.8 Preventive Maintenance 3.1.9 Premium Freight 3.1.10 Remote Location 3.1.11 Site 3.1.12 Special Characteristic 4 Quality management system 4 Quality management system 4.1 General requirements 4.1 General requirements 4.1.1 General requirements Supplemental 4.2 Documentation requirements 4.2 Documentation requirements 4.2.1 General 4.2.1 General 4.2.2 Quality Manual 4.2.2 Quality manual 4.2.3 Control of Documents 4.2.3 Control of documents 4.2.3.1 Engineering specifications 4.2.4 Control of Records 4.2.4 Control of records 4.2.4.1 Records retention 5 MANAGEMENT RESPONSIBILITY 5 Management responsibility 5.1 Management commitment 5.1 Management commitment 5.1.1 Process efficiency 5.2 Customer focus 5.2 Customer focus 5.3 Quality policy 5.3 Quality policy 5.4 Planning 5.4 Planning 5.4.1 Quality Objectives 5.4.1 Quality objectives 5.4.1.1 Quality objectives Supplemental 5.4.2 Quality Management System Planning 5.4.2 Quality management system planning 5.5 Responsibility, authority and communication 5.5 Responsibility, authority and communication 5.5.1 Responsibility and Authority 5.5.1 Responsibility and authority 5.5.1.1 Responsibility for quality 5.5.2 Management Representative 5.5.2 Management representative 5.5.2.1 Customer representative 5.5.3 Internal Communication 5.5.3 Internal communication 5.6 Management Review 5.6 Management review 5.6.1 General 5.6.1 General 5.6.1.1 Quality management system performance 5.6.2 Review Input 5.6.2 Review input 5.6.2.1 Review input Supplemental 5.6.3 Review Output 5.6.3 Review output 6 Resource management 6 Resource management 6.1 Provision of resources 6.1 Provision of resources 6.2 Human resources 6.2 Human resources 6.2.1 General 6.2.1 General 6.2.2 Competence, Training and Awareness 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 Infrastructure 6.3.1 Plant, facility and equipment planning 6.3.2 Contingency plans 6.4 Work environment 6.4 Work environment 6.4.1 Personnel safety to achieve conformity to product requirements 6.4.2 Cleanliness of premises
  • 2. Red Text represents additions to ISO 9001:2008 ISO 9001:2008 ISO/TS 16949:2009 7 Product realization 7 Product realization 7.1 Planning of 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 Customer-related processes 7.2.1 Determination of requirements related to the product 7.2.1 Determination of requirements related to the product 7.2.2 Review 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 Customer communication 7.2.3.1 Customer communication Supplemental 7.3 Design and development 7.3 Design and development 7.3.1 Design and Development Planning 7.3.1 Design and development planning 7.3.1.1 Multidisciplinary approach 7.3.2 Design and Development Inputs 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 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 Design and development review 7.3.4.1 Monitoring 7.3.5 Design and Development Verification 7.3.5 Design and development verification 7.3.6 Design and Development Validation 7.3.6 Design and development validation 7.3.6.1 Design and development validation Supplemental 7.3.6.2 Prototype program 7.3.6.3 Product approval process 7.3.7 Control of Design and Development Changes 7.3.7 Control of design and development changes 7.4 Purchasing 7.4 Purchasing 7.4.1 Purchasing Process 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 7.4.2 Purchasing information 7.4.3 Verification of Purchased Product 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 Production and service provision 7.5.1 Control of 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 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 Identification and traceability 7.5.3.1 Identification and traceability Supplemental 7.5.4 Customer Property 7.5.4 Customer property 7.5.4.1 Customer-owned production tooling 7.5.5 Preservation of Product 7.5.5 Preservation of product 7.5.5.1 Storage and inventory 7.6 Control of monitoring and measuring Equipment 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
  • 3. Red Text represents additions to ISO 9001:2008 ISO 9001:2008 ISO/TS 16949:2009 8 Measurement, analysis and improvement 8 Measurement, analysis and improvement 8.1 General 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 Monitoring and measurement 8.2.1 Customer Satisfaction 8.2.1 Customer satisfaction 8.2.1.1 Customer satisfaction Supplemental 8.2.2 Internal Audit 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 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 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 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 Analysis of data 8.4.1 Analysis and use of data 8.5 Improvement 8.5 Improvement 8.5.1 Continual 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 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 8.5.3 Preventive action Annex A (normative) Control plan A.1 Phases of the control plan A.2 Elements of the control plan