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What should be changed in the ISO 9001:2015 Standard?

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Sidney Vianna

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Staff member
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Hope that CD for ISO9001:2015 will be opened and circulated when it is drafted by TC176 ISO/WG SC2.
It is possible that the CD is openly and freely circulated for feedback. When the document reaches DIS stage, though, and very likely, ISO will start making the draft available for purchase.

On another note, IRCA has a briefing note concerning the new structure of ISO MSS. The document is available for free download (once you provide minimum information) or online viewing from this link.
 

LUV-d-4UM

Quite Involved in Discussions
There has never been a nonconformance issued against Preventive Action although the standard requires it. This is a very important clause that links into programs such as LEAN and 6 Sigma.
 

Randy

Super Moderator
There has never been a nonconformance issued against Preventive Action although the standard requires it. This is a very important clause that links into programs such as LEAN and 6 Sigma.
You're incorrect there pard...I did it one time because a PA failed due to poor cause analysis, faulty planning and poor implementation...creating a "Major" problem (And I've done it more than once)
 

LUV-d-4UM

Quite Involved in Discussions
Should it not be in the 8.5.2 instread of 8.5.3? I had an NC on RCA but it was a nonconformance on the CAR. 8.5.3 is more on Preventing problems before they happen. No auditor has ever given an NC on 8.5.3... maybe just an opportunity for improvement.

Thanks for your response Randy.
 

John Broomfield

Staff member
Super Moderator
There has never been a nonconformance issued against Preventive Action although the standard requires it. This is a very important clause that links into programs such as LEAN and 6 Sigma.
LUV-d-4UM,

Yes, nonconformity statements that highlight the failure to change to system to be assured of meeting new KPIs, objectives and other requirements beyond the scope of product quality planning are probably rare from internal auditors too.

Auditors should sell the value of their well-crafted nonconformity statements including the really valuable ones that cause corrective action so the system invokes timely preventive action.

Dropping the preventive action requirement from ISO 9001 should make auditors more creative in addressing system weaknesses before they cause the organization to fail.

Perhaps CBs will continue issuing OFIs thereby deepening the system's dependency on CB auditors instead. Internal auditors should not imitate this behavior.

John
 

LUV-d-4UM

Quite Involved in Discussions
With the exception of 8.5.2 and perhaps 8.2.2, the section 8 of the standard- which I call remedial clauses are never addressed seriously by the CB. I think to make the ISO9001 move business oriented, section 8 should be called the DMAIC standard and needs a written procedure. Thank you.
 
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