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Revised ISO 9001 - in a viewpoint of top management

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Revised ISO 9001 - in a viewpoint of top management by Yoshikazu Kameyama - Japanese Society for Quality Control. The revised ISO 9001 will be issued, considering
issues relevant with these changes of business environment. Strong leadership of the top management is required to cope with these changes, integrating QMS into his/her organization management.

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Revised ISO 9001 - in a viewpoint of top management

  1. 1. Copyright 2015 QuEST Forum. All Rights Reserved. 1 Revised ISO 9001 in a viewpoint of the top management 15 April 2015 The Japanese Society for Quality Control QMS Subcommittee Yoshikazu Kameyama
  2. 2. Contents • Annex SL • Attention for organizations to apply ISO 9001 • Important points in ISO DIS 9001:2014 in a viewpoint of the top management • Conclusion 2
  3. 3. Annex SL • Annex SL document has been discussed and prepared by JTCG (Joint Technical Coordination Group) since 2006 and was issued as one of directives in ISO/IEC Directives, Consolidated ISO Supplement, Annex SL in 2012. • Annex SL mentions common structure, identical core text, common terms and core definitions for management system standards. • Standard writers should, in principle, follow this Annex SL when they establish or modify management system standards. 3
  4. 4. Structure of Annex SL Introduction 1 Scope 2 Normative reference 3 Terms and definitions 4 Context of the organization 4.1 Understanding the organization and its context 4.2 Understanding the needs and expectations of the 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 7 Support 8 Operation 9 Performance evaluation 10 Continual improvement 4
  5. 5. Possible integration of management systems as a consequence of applied Annex SL 5 Customer requirements Customer Satisfaction Business management processes Realization processes of products and services Support processes Common requirements QMS specific requirements EMS specific requirements Other MSs specific requirements
  6. 6. Attention for organizations to apply ISO 9001 a) “The design and implementation of an organization's quality management system is influenced by the context of the organization and the changes in that context,” b) “all the requirements of this International Standard are generic but the ways in which they are applied can differ from one organization to another. Accordingly, it is not the intent of this International Standard to imply the need for uniformity in the structure of different quality management systems, or uniformity of documentation to align to the clause structure of this International Standard, or to impose specific terminology to be used within the organization.” 6
  7. 7. Important points in ISO DIS 9001:2014 in a viewpoint of top management • Determination of external and internal issues • Determination of interested parties and their requirements • Determination of risks and opportunities that need to be addressed • Leadership of the top management (integration of QMS requirements into business processes) 7
  8. 8. Determination of external and internal issues (No.1) 4.1 Understanding the organization and its context The organization shall determine external and internal issues that are relevant to its purpose and its strategic direction and that affect its ability to achieve the intended result(s) of its quality management system. The organization shall monitor and review the information about these external and internal issues. 8
  9. 9. Determination of external and internal issues (No.2) 9 External and internal issues Quality objectives Role of top management Role of middle management Management policy and objectives Quality policy
  10. 10. Determination of interested parties and their requirements 4.2 Understanding the needs and expectations of interested parties The organization shall determine: a) the interested parties that are relevant to the quality management system; b) the requirements of these interested parties that are relevant to the quality management system. The organization shall monitor and review the information about these interested parties and their relevant requirements. 10
  11. 11. Determination of risks and opportunities that need to be addressed (No.1) 6.1 Actions to address risks and opportunities 6.1.1 When planning for the quality management system, the organization shall consider the issues referred to in 4.1 and the requirements referred to in 4.2 and determine the risks and opportunities that need to be addressed to: a) give assurance that the quality management system can achieve its intended result(s); b) prevent, or reduce, undesired effects; c) achieve continual improvement. 11
  12. 12. Determination of risks and opportunities that need to be addressed (No.2) 12 Change of business environment Risks Opportunities Management policy and objectives Planning Medium term Short term Role of top management Role of middle management
  13. 13. Leadership of the top management (integration of QMS requirements into business processes) No.1 5.1 Leadership and commitment 5.1.1 Leadership and commitment for the quality management system Top management shall demonstrate leadership and commitment with respect to the quality management system by: d) ensuring the integration of the quality management system requirements into the organization’s business processes; 13
  14. 14. Leadership of the top management (integration of QMS requirements into business processes) No.2 Some assumed examples of the integration are; 1. Integration of competence evaluation system required by QMS into personnel evaluation program of the organization (JTCG example) 2. Integration of QMS documents into the organization’s electronic document control system 3. Utilization of internal audits for evaluating top management’s concerns 14
  15. 15. Conclusion • The business environment greatly changes. Organizations should cope with these changes to survive in severe competition. • The revised ISO 9001 will be issued, considering issues relevant with these changes of business environment. • Strong leadership of the top management is required to cope with these changes, integrating QMS into his/her organization management. • In order for the top management to be a true leader, he/she should understand the intent of QMS standard. 15
  16. 16. Thank you for your cooperation! 16

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