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ISO - Philosophy of New Revision

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ISO 9001:2016 Philosophy and Introduction. Created by RAMP Enterprises LLC - Quality is Culture

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ISO - Philosophy of New Revision

  1. 1. PHILOSOPHY AND INTRODUCTION Quality is Culture 1 10/25/2015
  2. 2. * *Maintain relevance in the marketplace *Integration of management system standards (common structure, text, terminology) –Annex SL *Increase variety of business users (Service industries, office environments) *Address increased complexity of business environment *Less emphasis on documents and instead alignment with ERP systems *Greater emphasis on results to improve customer satisfaction; add value; less prescriptive = performance based Quality is Culture 2 10/25/2015
  3. 3. * *Designed for fully integrated management systems – based on Annex SL – utilize a single management system (Appendix 3 of ISO/IEC Directives, Part 1 Annex SL) *Risk-based thinking throughout all processes *PDCA/Process-based implementation maintained and enhanced Quality is Culture 3 10/25/2015
  4. 4. * Change in numbering structure of the standard Define the Context of the organization Plan the QMS (including Risk), related to the business Leadership emphasis / Leveraging management review process Change Management Knowledge Management “Documented information” and “Retained information” No quality manual or Management Representative required Improved PDCA philosophy Preventive Action removed and implied with Risk-based thinking methodology through-out all processes Quality is Culture 4 10/25/2015
  5. 5. * *Customer-related process *Purchasing process *Design and Development process *Resources *Production and Servicing process *Calibration *Corrective action process *Internal Audit Process *Nonconforming product process *Customer Satisfaction *Analysis and evaluation *Improvement Quality is Culture 5 10/25/2015
  6. 6. * *Product is now Products and Services *Purchased product is now Externally provided product and services *Supplier is now External provider *Outsourcing is now External Provision *Document Control and Record Control is now Documented information and Retained information Quality is Culture 6 10/25/2015
  7. 7. Quality is Culture * *ISO 9000 – Fundamentals and Vocabulary *ISO 9004 – Managing for sustained success of an organization - Guidance document *ISO 31000 – Risk Management Principles and Guidelines 7 10/25/2015
  8. 8. Quality is Culture 8 * *Annex A (ISO 9001) – Clarification of new structure, terminology and concepts - Structure and Terminology - Products and Services - Understanding the needs and expectations of interested parties - Risk-based thinking - Applicability - Documented information - Organizational knowledge *Annex B (ISO 9001) – Other International Standards on QMS 10/25/2015
  9. 9. * *New Plan-Do-Check-Act *Risk-based thinking defined *Intent is harmonization with other ISO management systems. *Appendix 3 of ISO/IEC Directives, Part 1 Annex SL Quality is Culture 9 10/25/2015
  10. 10. Quality is Culture 10 * 10/25/2015
  11. 11. Quality is Culture 11 * 10/25/2015
  12. 12. * *Clause 4 – Context of the organization *Clause 5 – Leadership *Clause 6 – Planning for the quality management system *Clause 7 – Support *Clause 8 – Operation *Clause 9 – Performance Evaluation *Clause 10 – Improvement *See handout Correlation of Clauses previous/new standard. *www.iso.prg/tc176/sc02/public Quality is Culture 12 10/25/2015

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