ISO9K:2015 Revision – From the Source

In October, Sustaining Edge Solutions was a proud Sponsor and Exhibitor at the American Society for Quality (ASQ) 22nd Annual Audit Division and Quality Management Division Conference.  This conference was well received by all, and we made some great connections with many of our booth visitors.

One of the breakout sessions that caught our interest was titled “ISO 9001:2015 -A Sneak Peak at the Draft Standard.”   The following is information we collected during the presentation from the presenter, a member of the United States TAG (Technical Advisory Group).  Keep in mind that this information is derived from the current Committee Draft.

  • The PDCA Model will not be identified in the ISO 9001:2015 and no formal requirement for risk management.
  • A defined Management Representative has been removed; however actions are still applicable.
  • Top Management shall be “Accountable” for QMS Effectiveness. +
  • Quality objectives will include: What, who, where, and when – results will be evaluated. +
  • Competencies requirements will remain, but knowledge is new.
  • Many of the current Calibration Requirements have been removed to apply to service organizations
  • Replaced the word product with goods and services.
  • Evaluate performance and effectiveness of QMS – KPIs +
  • Internal audit reference  “status and importance of processes” is replaced with “consideration of quality processes and the importance of processes concerned.”
  • The organization shall “improve the QMS.”  Note: This is not continual improvement.

This journey to the new ISO 9001 revision should be quite a ride; with more changes we are sure to hear about. Stay tuned, we will keep you informed.

 

 

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