The Next version of ISO 9001 (2008 version) - Any news?

[aostrom]

Re: The Next version of ISO 9001 - Any news?

Thank you very much for the summary that clears a few questions I have had on the types of changes we were to expect.

 

[Sidney Vianna]

Re: The Next version of ISO 9001 - Any news?

8.5.2f & 8.5.3e The word effectiveness has been removed

Thanks, Colin, for this. I also noticed that some paragraphs are misidentified. For example, in the DIS document, 7.2.3 sub paragraphs are identified as j, k and l, instead of a, b and c. Similar problem in 7.4.2.

Now, the removal (AGAIN) of the word effectiveness in 8.5.2.f) and 8.5.3.e) is baffling to me. I was curious if anyone could attempt to explain it's removal from the DIS document.

 

[Paul Simpson]

Re: The Next version of ISO 9001 - Any news?

Thanks, Colin, for this. I also noticed that some paragraphs are misidentified. For example, in the DIS document, 7.2.3 sub paragraphs are identified as j, k and l, instead of a, b and c. Similar problem in 7.4.2.

I noticed this and passed it to the UK validation process lead. He tells me it has been passed on.

Now, the removal (AGAIN) of the word effectiveness in 8.5.2.f) and 8.5.3.e) is baffling to me. I was curious if anyone could attempt to explain it's removal from the DIS document.

Can't help, Sidney. My only involvement has been from the current to the DIS (not steps in between).

My thanks, too to Colin for the effort put in. I have obviously stripped out the text, rebadged it and will make it available on my web site in the next day or so - only £10 to download!

 

[Colin]

Re: The Next version of ISO 9001 - Any news?

I have obviously stripped out the text, rebadged it and will make it available on my web site in the next day or so - only £10 to download!

Sounds a good idea to me, what was the percentage 'cut' we agreed?

 

[Colin]

Re: The Next version of ISO 9001 - Any news?

Thanks, Colin, for this. I also noticed that some paragraphs are misidentified. For example, in the DIS document, 7.2.3 sub paragraphs are identified as j, k and l, instead of a, b and c. Similar problem in 7.4.2.

Now, the removal (AGAIN) of the word effectiveness in 8.5.2.f) and 8.5.3.e) is baffling to me. I was curious if anyone could attempt to explain it's removal from the DIS document.

Sidney, yes I noticed the mis-numbering, I guess thats the sort of thing that will be swept up in the FDIS,

Can't understand why they took out the word effectiveness, I am sure that is what we should be doing, not just seeing if the action was done.

 

[vanputten]

Re: The Next version of ISO 9001 - Any news?

The price of an item has nothing to do with copyright infringement.

I am going to guees that the changes from DIS to FDIS to IS will be almost zero since the current activity is an amendment of the standard for clarification and no requirements are expected to change. This effort is to clarify current requirements. The 2000 effort was a revision with requirement changes.

 

[Sidney Vianna]

Re: The Next version of ISO 9001 - Any news?

This effort is to clarify current requirements.

Dirk, since you participate in the US TAG, can you provide any information about why in the World the TC 176 does not touch on the most glaring unclear requirement of ISO 9001? I am referring to the preventive action clause. Since the goal of the 2008 amendment is to clarify the requirements of the standard and so far, via the WD, CD and DIS, no change is proposed to 8.5.3, it seems to me that either:

1. The TC 176 is totally removed from the real World and doesn't realize that preventive action is EXTREMELLY ambiguous, or,
2. They realize it, but have no idea of how to re-word the requirements to make it clear (or clearer)

You, as a Cover, know that we have countless and prolonged discussions over the PA aspect of the CAPA process. Knowledgeable and seasoned quality professionals disagree in what true preventive actions should be. The APG paper Auditing Preventive Action, just like many other papers of the series, is inconclusive. One of the underlying expectations for ISO 9001 is that the requirements are clear and auditable. I find hard to believe that the TC 176 does not realize the problem exists.

Any comments?

 

[vanputten]

Re: The Next version of ISO 9001 - Any news?

Hello Sidney:

No, I cannot comment on any of the things you ask. I review documents, provide my input at the US level, review comments from others, and vote on proposed changes. I have no delusions that the TC 176 process is effective.

I would contact the Chairs of the US TAG and ask them.

Yes, for sure a problem exists related to the text of 8.5.3, the western world's understanding and knowledge of Preventive Action, and the western world's emphasis on Preventive Action.

In my opinion, it is impossible to define preventive action and satisfy all users.

Regards,

Dirk

 

[James Gutherson]

Re: The Next version of ISO 9001 - Any news?

...

In my opinion, it is impossible to define preventive action and satisfy all users.

Regards,

Dirk

I agree Dirk - Preventative action requires foresight, while criticism of a lack of PA uses hindsight - a decidedly unfair advantage.

 

[Helmut Jilling]

Re: The Next version of ISO 9001 - Any news?

Dirk, since you participate in the US TAG, can you provide any information about why in the World the TC 176 does not touch on the most glaring unclear requirement of ISO 9001? I am referring to the preventive action clause. Since the goal of the 2008 amendment is to clarify the requirements of the standard and so far, via the WD, CD and DIS, no change is proposed to 8.5.3, it seems to me that either:

1. The TC 176 is totally removed from the real World and doesn't realize that preventive action is EXTREMELLY ambiguous, or,
2. They realize it, but have no idea of how to re-word the requirements to make it clear (or clearer)

You, as a Cover, know that we have countless and prolonged discussions over the PA aspect of the CAPA process. Knowledgeable and seasoned quality professionals disagree in what true preventive actions should be. The APG paper Auditing Preventive Action, just like many other papers of the series, is inconclusive. One of the underlying expectations for ISO 9001 is that the requirements are clear and auditable. I find hard to believe that the TC 176 does not realize the problem exists.

Any comments?

Of course, as a spokesperson for the camp that says it means just what it says, why can't we just accept it as written? A proactive cousin to corrective action, after launch, before failure, following the same steps as corrective action? Alas, perhaps it is just my simple mind... ...but to me it is cyrstal clear.