By: Scott Dawson
President and Owner of Core Business Solutions, www.thecoresolution.com
[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:
The 5 requirements that have been removed:
- 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) No requirement to specify a member of management as a “management representative”, but the same responsibilities must be assigned to someone.
- 3) No requirement to include a “quality manual” or “documented procedures” in your documented information, but similar requirements must still still be documented.
- 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) 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”.