ISO 9001: 2015 新版發展趨勢 - twap.sgs.com

1 ISO 9001: 2015 Quality Management System ISO 9001: 2015 Committee Draft ( ) 2 SGS SA 2013 ALL RIGHTS RESERVED Agenda of ISO 9001: 2015 CD ISO 9001 ISO Annex SL ISO 9001: 2015 CD ISO ISO 9001 4 SGS SA 2013 ALL RIGHTS RESERVED Vision of ISO 9001 : 2015 25 TC176 /SC2 Nigel H. Croft 5 SGS SA 2013 ALL RIGHTS RESERVED ISO 9001: 2015 Timeline 2013 2014 2015 3rd June 2013 (Committee Draft) Q2 2014 DIS (Draft International Standard) Q1 2015 FDIS (Final Draft International Standard) Q4 2015 PIS ( ) Published International Standard 6 SGS SA 2013 ALL RIGHTS RESERVED ISO9001:2015 Certification Transition Timeline 2015 2016 2017 2018 Q4 2015 Published International Standard Normally after PIS ( ) give 3 years as transition period ( estimated up to Q4 2018 ) ISO ANNEX SL 8 SGS SA 2013 ALL RIGHTS RESERVED ISO Directives Annex SL ISO TMB JTCG 83 ( Draft Guide 83 ) 2012 4 ISO ( ISO Directives) SL(Annex SL ) ISO Directives Annex SL 9 SGS SA 2013 ALL RIGHTS RESERVED Discipline Specific Standard (ISO 9001) Discipline Specific Standard (ISO 14001) Discipline Specific Standard (ISO 22000) Annex SL ISO Directive ANNEX SL ISO Annex SL 10 SGS SA 2013 ALL RIGHTS RESERVED ISO Annex SL 10 1.

2 (Scope) 2. (Normative references) 3. (Terms and Definitions) 4. (Context of Organization) 5. (Leadership) 6. (Planning) 7. (Support) 8. (Operation) 9. (Performance Evaluation) 10. (Improvement) ISO DIRECTIVE ANNEX SL 11 SGS SA 2013 ALL RIGHTS RESERVED Key Value adding activities Information flow Figure 1 - Illustration of a process-based quality management system ISO 9001 : 2008 REQUIREMENTS 12 SGS SA 2013 ALL RIGHTS RESERVED ISO Annex SL (ISO 27001: 2013 ) 4 6 7 5 10 9 Documented Information 8 Context & Interested Parties Context & Interested Parties Information Security Management requirements and expectations Information Security managed 13 SGS SA 2013 ALL RIGHTS RESERVED ISO 14001:2015 CD 14 SGS SA 2013 ALL RIGHTS RESERVED Key Value adding activities Information flow Figure 1 - Illustration of a process-based quality management system ISO 9001.

3 2015 15 SGS SA 2013 ALL RIGHTS RESERVED ( ) ( ) ( ) 15 ISO 27001 ISO 20000 ISO 28001 ISO 9001 ISO 22000 ISO 50001 ISO 14001 ISO 14004 ISO 14040 ISO 14064 ISO 20121 ISO/TS 14067 ISO 39001 ISO 22301 ISO 26000 SA 8000 OHSAS 18001 ISO/TS 16949 IT ( ) ( ) ISO - 16 SGS SA 2013 ALL RIGHTS RESERVED ISO ( SIGNIFICANT IMPACT OF ISO ANNEX SL ) ISO 9001: 2008 => ISO 9001: 2015 ISO 14001:2004 => ISO 14001:2015 ISO/IEC 27001:2005 => ISO/IEC 27001:2013 OHSAS 18001:2007 => ISO 45001:2016 BS 25999 => ISO 22301: 2013 ISO 22000:2005 => ISO 22000:201x TL 9000 AS 9100 ISO 13485 ISO/TS 16949 ISO 55001:2014 (Asset management system) ISO 39001 : 2013 ( In land transportation safety MS ) ISO 20121: 2012 ( Event Sustainability MS ) 18 SGS SA 2013 ALL RIGHTS RESERVED QM Principle Change ISO 9001: 2008 ISO 9001: 2015 focus of people approach approach to management improvement approach to decision making beneficial supplier relationships Focus of People Approach Decision Making Management 19 SGS SA 2013 ALL RIGHTS RESERVED ( clause 5 ) ( h ) ( ) ( , ) ( Clause 10 ) ( ) ( ) ISO 9001: 2015 CD ISO 9001: 2015 CD 21 SGS SA 2013 ALL RIGHTS RESERVED Structure Change ( Annex SL ) ISO9001:2008 ISO9001.

4 2015 references and definitions management system responsibility management realization , analysis and improvement references and definitions of the organization evaluation 10. improvement 22 SGS SA 2013 ALL RIGHTS RESERVED ISO 9001: 2015 CD .. 23 SGS SA 2013 ALL RIGHTS RESERVED CD version Major Changes (1) Top management engagement - 4 - 5 - 6 - 9 Context of Organization - - Process Approach ( ) 24 SGS SA 2013 ALL RIGHTS RESERVED CD version Major Changes (2 ) Leadership & Commitment - - Risks and Opportunities ( ) Document control - Outsource management - - - - 25 SGS SA 2013 ALL RIGHTS RESERVED CD VERSION OTHER CHANGES Exclusion ( ) 8 / (competence) ( awareness ) : ( ) : ( ) 26 SGS SA 2013 ALL RIGHTS RESERVED ISO 9001: 2008 ISO 9001: 2015 CD 0.

5 Introduction 0. Introduction 1. Scope 1. Scope 2. Normative references 2. Normative references 3. Terms and definitions 3. Terms and definitions 4. Quality Management System 4. Context of the organization General Requirements Understanding the organization and its context Documentation Requirements Understanding the needs and expectations of interested parties Determining the scope of the quality management system Quality management system 5. Management Responsibility Management Commitment Leadership and commitment Customer Focus Quality Policy Quality Policy Organizational roles, responsibilities and authorities Planning 6. Planning Responsibility, Authority, and Communication Actions to address risks and opportunities Management Review Quality objectives and planning to achieve them Planning of changes ISO 9001: 2008 2015 CD 27 SGS SA 2013 ALL RIGHTS RESERVED ISO 9001: 2008 ISO 9001: 2015 CD 6.

6 Resource Management 7. Support Provision of Resources Resources Human Resources Competence Infrastructure Awareness Work Environment Communication Documented information Planning of Product Realization 8. Operation Customer-Related Processes Operational planning and control Design and Development Determination of market needs and interactions with customers Purchasing Operational planning process Production and Service Provision Control of external provision of goods and services Control of Monitoring and Measuring Equipment Development of goods and services Production of goods and provision of services Release of goods and services Nonconforming goods and services ISO 9001: 2008 2015 CD 28 SGS SA 2013 ALL RIGHTS RESERVED ISO 9001: 2008 ISO 9001: 2015 CD 8. Measurement, Analysis, and Improvement 9. Performance evaluation General Monitoring, measurement, analysis and evaluation Monitoring and Measurement Internal Audit Control of Nonconforming Product Management review Analysis of Data 10.

7 Improvement Improvement Nonconformity and corrective action Improvement ISO 9001: 2008 2015 CD ISO 30 SGS SA 2013 ALL RIGHTS RESERVED ISO 9001 : 2015 ISO 9001: 2015 CD 25 TC176 /SC2 Nigel H. Croft 31 SGS SA 2013 ALL RIGHTS RESERVED ISO 9001 : 2015 Manager & staff 32 SGS SA 2013 ALL RIGHTS RESERVED ISO SGS : SGS , : ISO 9004 good practice : 33 SGS SA 2013 ALL RIGHTS RESERVED ISO 9001: 2015 Risk approach audit ( Performance Approach audit ( Integration audit ( Auditor awareness and competence : 34 SGS SA 2013 ALL RIGHTS RESERVED Further Excellence)))