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Technical update on ISO 9001:2015 Colin MacNee Duncan MacNee Limited

Technical update on ISO 9001:2015 Colin MacNee Duncan MacNee Limited. Caveat. The views expressed are my own and do not represent BSI CQI IAF IBM IRCA ISO. Content. What is the process for updating ISO standards? What are the stages Who is involved What is the current situation?

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Technical update on ISO 9001:2015 Colin MacNee Duncan MacNee Limited

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  1. Technical update onISO 9001:2015 Colin MacNeeDuncan MacNee Limited

  2. Caveat The views expressed are my own and do not represent BSI CQI IAF IBM IRCA ISO

  3. Content • What is the process for updating ISO standards? • What are the stages • Who is involved • What is the current situation? • Background:1994, 2000 and 2008 revisions, User Surveys and QMPs • The ISO 9001:2015 Project plan, what we have achieved and what we have still to do • Current major revisions of ISO 9001, ISO 14001 and ISO 27001 (Reference to Annex SL) • How IRCA auditors influence the development? • When to contribute • How to contribute • What ISO 9001:2015 could look like? • Annex SL plus possible changes

  4. ISO Development Process 1 of 3 The ISO/IEC Directives Part 1 and Consolidated ISO Supplement1 describes in detail the following stages: • Preliminary - Preliminary work item (PWI) • Proposal - New work item proposal (NP or NWIP) • Preparatory – working draft(s) (WD) • Committee – committee draft(s) (CD) • Enquiry – draft international standard (DIS) • Approval – final draft international standard (FDIS) • Publication – international standard (IS)1 Third edition, 2012 (based on the ninth edition of the ISO/IEC Directives, Part 1)

  5. ISO Development Process 2 of 3 Who will receive the documents? • Member bodies. E.g. JISC(Japanese Industrial Standards Committee) • Participating Countries: 73 • Observing Countries: 16 • Internal liaison to SC 2 (ISO: 8, IEC: 3) • External liaison to SC 2 (21) • ALL of the above are allowed to comment. • ONLY member bodies are allowed to vote.

  6. ISO Development Process 3 of 3 Voting • CD: 2/3 positive of total of member bodies voting • DIS: 2/3 positive AND not more than ¼ negative of total of member bodies voting • FDIS: 2/3 positive AND not more than ¼ negative of total of member bodies voting • Not counted in the total vote: • Abstentions • Negative votes without technical justification

  7. Current Situation • Background • 1994, 2000 and 2008 revisions • User Surveys • Quality Management Principles (QMPs) • The ISO 9001:2015 Project plan • What we have achieved • What we have still to do • 3 major ISO MSSs in development – all using Annex SL • ISO/IEC 27001 (expected later this year) • ISO 14001 (expected early 2015) • ISO 9001 (expected late 2015) • ISO 22301:2012 developed using an early draft

  8. ISO/CD 9001 2013 CD ballot opens: June 2013 CD ballot closes: August 2013 It is standard practice for the CD to be distributed only to member body mirror committees. However, some member bodies may distribute the CD to the public (free or for sale)

  9. ISO/DIS 9001 2014 DIS ballot opens: April 2014 DIS ballot closes: August 2014 It is standard practice for the DIS to be distributed to members of the public (free or for sale). Some member bodies provide electronic tools for viewing and commenting on the DIS.

  10. ISO/FDIS 9001 2015 FDIS ballot opens: July 2015 FDIS ballot closes: August 2015 ISO 9001 published: September 2015

  11. MSS – High Level Structure1 of 3 4. Context of the organization 5. Leadership 6. Planning 7. Support 8. Operation 9. Performance evaluation 10. Improvement Introduction 1. Scope 2. Normative references 3. Terms and definition Appendix Bibliography

  12. MSS – High Level Structure2 of 3 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 XXX management system 4.4 XXX management system 5. Leadership 5.1 Leadership and commitment 5.2 Policy 5.3 Organization roles, responsibilities and authorities 6. Planning 6.1 Actions to address risks and opportunities 6.2 XXX objectives and planning to achieve them

  13. MSS – High Level Structure3 of 3 8. Operation 8.1 Operational planning and control 9. Performance evaluation 9.1 Monitoring, measurement, analysis and evaluation 9.2 Internal audit 9.3 Management review 10. Improvement 10.1 Nonconformity and corrective action 10.2 Continual improvement 7. Support 7.1 Resources 7.2 Competence 7.3 Awareness 7.4 Communication 7.5 Documented information 7.5.1 General 7.5.2 Creating and updating 7.5.3 Control of documented information

  14. MSS – Common Terms and Definitions Organization Interested party (preferred term) Stakeholder (admitted term) Requirement Management system Top management Effectiveness Policy Objective Risk Competence Documented information Process Performance Outsource (verb) Monitoring Measurement Audit Conformity Nonconformity Correction Corrective action Continual improvement

  15. Possible* ISO 9001:2015 1 of 3 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 4.4 Quality management system 5. Leadership 5.1 Leadership and commitment 5.2 Policy 5.3 Organization roles, responsibilities and authorities 6. Planning 6.1 Actions to address risks and opportunities 6.2 Quality objectives and planning to achieve them 6.3 Planning of changes *Note: This structure is based on a early draft of ISO CD 9001:2015

  16. Possible* ISO 9001:2015 2 of 3 8. Operation 8.1 Operational planning and control 9. Performance evaluation 9.1 Monitoring, measurement, analysis and evaluation 9.1.1 General 9.1.2 Customer satisfaction 9.1.3 Analysis and evaluation of data 9.2 Internal audit 9.3 Management review 10. Improvement 10.1 Nonconformity and corrective action 10.2 Continual improvement 7. Support 7.1 Resources 7.1.1 General 7.1.2 Infrastructure 7.1.3 Processenvironment 7.1.4 Monitoring and measuring devices 7.1.5 Knowledge 7.2 Competence 7.3 Awareness 7.4 Communication 7.5 Documented information 7.5.1 General 7.5.2 Creating and updating 7.5.3 Control of documented information *Note: This structure is based on a early draft of ISO CD 9001:2015

  17. Possible* ISO 9001:2015 3 of 3 8.5 Development of goods and services 8.5.1 Development processes 8.5.2 Development controls 8.5.3 Development transfer 8.6 Realization of goods and services 8.6.1 Control of production of goods and provision of services 8.6.2 Identification and traceability 8.6.3 Property belonging to customers or external providers 8.6.4 Preservation of goods or services 8.6.5 Post delivery activities 8.6.6 Control of changes 8.7 Release of goods or services 8.8 Nonconforming goods and services 8. Operation 8.1 Operational planning and control 8.2 Determination of market needs and interactions with customers 8.2.1 General 8.2.2 Determination of requirements related to the goods and services 8.2.3 Review of requirements related to the goods and services 8.2.4 Customer communication 8.3 Operational planning 8.4 Control of external provision of goods and services 8.4.1 General 8.4.2 Type and extent of control of external provision 8.4.3 Documented information for external providers *Note: This structure is based on a early draft of ISO CD 9001:2015

  18. Thank YouAny Questions?

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