ISO/CD 9001 2007-02-8 - What are your thoughts?

[SteelMaiden]

So, have you looked through the draft yet? What are your thoughts?

I haven't spent a great deal of time analyzing the changes but I did notice one big change that should have (imho) always been there. Corrective and preventive actions now have the requirement to review the effectiveness of the corrective or preventive action taken.

So, what is your take on the revisions? Anything earth shattering? Something near and dear to your heart taking place? Something you think is a total waste?

[Sidney Vianna]

Originally Posted by SteelMaiden

So, have you looked through the draft yet? What are your thoughts?

I haven't spent a great deal of time analyzing the changes but I did notice one big change that should have (imho) always been there. Corrective and preventive actions now have the requirement to review the effectiveness of the corrective or preventive action taken.

So, what is your take on the revisions? Anything earth shattering? Something near and dear to your heart taking place? Something you think is a total waste?

Just like you, I have not spent a lot of time digesting the MINUSCULE changes, yet. By design, the revision (amendment) is supposed to bring MINOR clarifications to the ISO 9001 document. Concerning specifically the "effectiveness" of CAPA's, that should be tagged in the back to the future category, because the 2nd Edition of ISO 9001, a.k.a., ISO 9001:1994 had that very requirement already.

The ISO TC 176 and TAG's around the World would have a tough time to justify all the meetings and trips vis a vis the (lack of) changes to ISO 9001:2009.

[SteelMaiden]

You are so right, Sidney. I always kind of wondered about taking that step backwards. We never did drop that requirement for reviewing effectiveness from out QMS.

If all goes as documented, I cannot really find anything that will cause any revisions to the way we operate.

[Randy]

I've been looking at it and the 9004 document as well. Some new words, minor changes and stuff like that. I found the recommended changes below a bit interesting.

5.5.2 Management representative
Top management shall appoint a member of the organization’s management who, irrespective of other responsibilities, shall have responsibility and authority that includes.

6.4 Work Environment
NOTE: The term work environment relates to conditions necessary to achieve conformity to product requirements such as clean rooms, anti-static precautions and hygiene controls.

7.5.4 Customer property
NOTE: Customer property can include intellectual property and personal data

[SteelMaiden]

Originally Posted by Randy

I've been looking at it and the 9004 document as well. Some new words, minor changes and stuff like that. I found the recommended changes below a bit interesting.

5.5.2 Management representative
Top management shall appoint a member of the organization’s management who, irrespective of other responsibilities, shall have responsibility and authority that includes.

I guess I just skimmed over that one, cuz I am a member of the org's management....so what does it mean for people who hire a consultant/contractor to act as an MR?

[Randy]

Originally Posted by SteelMaiden

I guess I just skimmed over that one, cuz I am a member of the org's management....so what does it mean for people who hire a consultant/contractor to act as an MR?

Dunno really. I guess that some "real" connection will have to be proven. Actually I've never asked a MR if they are a fulltime, part-time or cntractor. I knda figured there were more important things to be concerned with.

[SteelMaiden]

Originally Posted by Randy

Dunno really. I guess that some "real" connection will have to be proven. Actually I've never asked a MR if they are a fulltime, part-time or cntractor. I knda figured there were more important things to be concerned with.

I am not an auditor (except within my own org) but I never really felt that the contractor scenario was necessarily wrong. I've known some folks from other companies that used a contractor. I don't think you could do that at my plant, but if 1) you have the culture, 2) the contractor/employee relationship is good, and 3) the contractor is dedicated to doing the right things by the org, then I'm with you, there are lots of more important things to worry about.

[Sidney Vianna]

Originally Posted by SteelMaiden

so what does it mean for people who hire a consultant/contractor to act as an MR?

Good question. One of the sources for input in to the 2009 amended 9001 is the bank of interpretations maintained by the TC 176. As discussed several times here, one of the interpretations contained therein is the one that allows for the MR function to be performed by someone that is NOT a full time employee of the organization. If the TC 176 wants to clarify this issue, they better do a better job of reconciling that interpretation with the draft.