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ISO - Planning

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

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ISO - Planning

  1. 1. PLANNING Quality is Culture 1 November 2016
  2. 2. 2 * 
  3. 3. 3 * 
  4. 4. *  Recall: 4.1 Understanding the organization and it context 4.2 Understanding the needs and expectations of interested parties 4.3 Determining the scope of the QMS 4.4 Quality Management System and its processes 4
  5. 5. *  6.1 Actions to address risks and opportunities 6.2 Quality objectives and planning to achieve them 6.3 Planning of Changes 5
  6. 6. *  6.1 Actions to address risks and opportunities Consider the issues and determine the risks and opportunities that need to be addressed to: a. Give assurance that that the QMS can achieve intended results b. Prevent, or reduce undesired effects c. Achieve continual improvement Plan: - Actions to address these risks and opportunities - How to integrate/implement actions into QMS - Evaluation effectiveness of these actions 6
  7. 7. *  * Note: Options to address risks and opportunities can include: avoiding risk, taking risk in order to pursue an opportunity, eliminating the risk source, changing the likelihood or consequences, sharing risk, or retaining risk by informed decision. 7
  8. 8. *  6.2 Quality Objectives - similar to previous revision - relevant and enhancement of customer satisfaction - retain documented information on the quality objectives Determine: - What will be done, what resources, who will be responsible, when completed, how evaluated. 8
  9. 9. *  6.3 Planning of changes: This is new Changes (to QMS) shall be carried out in a planned manner. Consider: a) Purpose of the change and potential consequences b) the integrity of the QMS c) availability of resources d) allocation or reallocation of responsibilities and authorities <Feedback loop Management Review 9.3.2.c.2> 9
  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 Outputs: decisions and actions related to: -  Opportunity for improvement -  Changes to QMS -  Resource needs 10