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Statistics on the Changes in ISO 9001:2015

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By: Scott Dawson

President and Owner of Core Business Solutions, www.thecoresolution.com

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[title] I spent the day studying the released ISO 9001:2015 standard (great way to spend a Saturday, I know). Here’s what I found: [/title]

Of the 48 clauses in the ISO 9001:2015 standard:

40 have new requirements (83%)[progress type=”info” percent=”83″] 10 have changes of requirements from ISO 9001:2008 (21%)[progress type=”warning” percent=”21″] Of the 5727 words in the ISO 9001:2015 requirements 1809 words refer to new or changed requirements (32%).[progress type=”danger” percent=”32″] (not including introductory or Appendix sections)

 

 

The 5 requirements that have been removed:

  1. 1) “Exclusions” (now called Application) are not limited to Product Realization (now called Operations). However, it appears the justifying a clause as “not applicable” will be potentially more problematic (IMHO).
  2. 2) No requirement to specify a member of management as a “management representative”, but the same responsibilities must be assigned to someone.
  3. 3) No requirement to include a “quality manual” or “documented procedures” in your documented information, but similar requirements must still still be documented.
  4. 4) In the internal audit requirements, the statements “Auditors shall not audit their own work” and “Follow-up activities shall include the verification of the actions taken and the reporting of verification results” (8.2.2, ISO 9001:2008) have been removed. However, you still have to have impartiality in your internal auditors and closure of corrective actions still provides verification of closure for internal audit findings.
  5. 5) The requirement for “preventive action” has been removed, but is dealt with through risk-based thinking and a new phrase in the corrective action requirements includes the need to determine if similar nonconformities could “potentially occur”.

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