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ISO - Leadership


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ISO 9001:2016 Leadership. Created by RAMP Enterprises LLC - Quality is Culture

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ISO - Leadership

  1. 1. LEADERSHIP and Management Review Quality is Culture 1 10/21/15
  2. 2. Quality is Culture 2 * 10/21/15
  3. 3. * 5.1 Leadership and Commitment 5.1.2 Customer Focus 5.2 Quality Policy 5.3 Organizational roles, responsibilities and authorities Quality is Culture 3 10/21/15
  4. 4. * 5.1 Leadership and commitment a) accountability for effectiveness of QMS b) Policy and objectives are compatible with the context and strategic direction c) Integration of QMS into business processes d) Promoting the use of the process approach and risk-based thinking e) Ensuring resources for QMS are available f) Ensuring the importance of effective QMS and of conformance to the QMS requirements (cont.) Quality is Culture 4 10/21/15
  5. 5. * g) Ensuring the QMS achieves its intended results h) Engaging, directing, and supporting persons to contribute to the effectiveness of the QMS i) Promoting improvement j) Support relevant managers to demonstrate their leadership Quality is Culture 5 10/21/15
  6. 6. * 5.1.2 Customer Focus – Top Management demonstrate leadership and commitment: a. customer requirements and applicable statutory and regulatory requirements are met b. the risks and opportunities that can affect conformity of products and services and the ability to enhance customer satisfaction are determined and addressed c. the focus on consistently providing products and services that meet customer and applicable statutory and regulatory requirements is maintained; d. the focus on enhancing customer satisfaction is maintained. Quality is Culture 6 10/21/15
  7. 7. * 5.2 Quality Policy a. Appropriate to the purpose and context of the organization b. Framework for quality objectives c. Commitment to satisfy requirements d. Commitment to Continuous Improvement of QMS *- shall be available as documented information *- be communicated, understood, applied. *- be available to relevant parties, as appropriate Quality is Culture 7 10/21/15
  8. 8. * 5.3 Organizational roles, responsibilities and authorities Top management shall ensure that the responsibilities and authorities for relevant roles are assigned, communicated and understood within the organization. a. Ensure the QMS confirms to ISO 9001 b. Ensure the processes are delivering their intended outputs c. Reporting on the performance of the QMS and on opportunities for improvement d. Ensuring the promotion of customer focus throughout the organization e. Ensuring that the integrity of the QMS is maintained when changes to the QMS are planned and implemented. No requirement for a management representative Quality is Culture 8 10/21/15
  9. 9. Quality is Culture 9 * Management Review process updates 10/21/15
  10. 10. * 9.3 Management Review a) Status of actions b) Changes in external and internal issues that are relevant to the QMS c) Information on the performance and effectiveness of the QMS, including trends in: - Customer satisfaction and feedback from relevant interested parties; - The extent to which quality objectives have been met; - Process performance and conformity of products and services; - Nonconformities and corrective actions; - Monitoring and measuring results; - Audit results; - The performance of external providers; d) The adequacy of resources e) The effectiveness of action taken to address risks and opportunities (see 6.1) f) Opportunities for improvement Quality is Culture 10 10/21/15
  11. 11. Quality is Culture 11 * Outputs: decisions and actions related to: -Opportunity for improvement -Changes to QMS -Resource needs 10/21/15