ISO 9001:2008 - Implementation in practice

[Asherlee]

Hi Sydney,

Thanks for your input.
My understanding of ISO 9001:2008 is that if a SOP or the QM refers to, let us say, "regulatory requirements", then you need to revise this term to "statutory and regulatory requirements", in line with the new wording of ISO 9001:2008. The issue is not whether you comply in practice with all the legal requirements affecting your product; rather, the NB auditor will want to see that the text in your SOP correctly reflects the changed terminology in ISO 9001:2008. I am sure that we have all been through audits in which the auditor commented that the text in our SOP's did not fully comply with the requirements of ISO.

Regards,

Asherlee.

 

[somerqc]

I have been building and maintaining ISO systems for over 10 years now and NOT ONCE has an auditor said that the terminology in my procedure not match the standard (let alone write a nonconformance against it).

IF I had ever experienced that, the CB would have been notified of my displeasure. (side note: I have had ineffective auditors removed from the potential auditor list in the past)

Too many people forget that the intent of this standard to help you run your business more efficiently not to make auditors happy. I have dealt with 3 different CB's as well over the year's as well as government auditors.


John

 

[AndyN]

Hi Rickray,

I included the reference to CAPA under both the SOP for "Internal Audit" and the SOP for CAPA, as some people refer to CAPA's in both these procedures -take your pick. One of the results of an internal audit may be to initiate a CAPA.

Regards,

Asherlee

I really appreciate the effort put into your document. Thanks for that. I do, however have a concern, based on this post. My understanding is that yur document is an analysis of the changes from ISO9K2K to the 2008 version. This includes any notes or clarifications etc.

Your comment, above, would tend to indicate that you have 'interpreted' the requirements for action in the internal audit requirement and have, therefore (based on your experience) added the requirements from the Corrective Action section....

Am I understanding correctly?

 

[MsHeeler]

I only changed the Quality Manual and two procedures. Since our Quality Manual is a regurgitation of the standard, I made all the changes. I had to rename Competence, Awareness and Training to Competence, Training, and Awareness, and changed Monitoring and Measuring Devices to Monitoring and Measuring Equipment (also all of the statements of “devices”). No big deal!

I got with the registrar and stated that it would not be a problem to update the QMS to state ISO 9001:2008 even though our certificate is for 9001:2000. They said that we would just be ahead of the game.

MsHeeler

 

[JaneB]

I have been building and maintaining ISO systems for over 10 years now and NOT ONCE has an auditor said that the terminology in my procedure not match the standard (let alone write a nonconformance against it).

IF I had ever experienced that, the CB would have been notified of my displeasure. (side note: I have had ineffective auditors removed from the potential auditor list in the past)

Too many people forget that the intent of this standard to help you run your business more efficiently not to make auditors happy. I have dealt with 3 different CB's as well over the year's as well as government auditors.
John

Couldn't agree with you more, John.

Writing a policy or a procedure which simply regurgitates the words of the 9001 Standard is an activity whose value is highly questionable. (And IMO, one reason why 'quality' can acquire a bad name or leave a sour taste.)

Let's keep the focus on the intent of the Standard and keep striving to achieve that. Faithfully copying words out of a Standard into one's own manual doesn't take even a tiny step toward that.

 

[Asherlee]

To all of you who posted a reply,

Thanks for the input.When we post a thread, we strive to be brief and therefore we make some assumptions without spelling them out. We all agree that the intent of the standard is important and that we want our products to satisfy the customer, be safe, be free of defects, etc.; however, if the people who revised ISO 9001:2000 spent several years doing so, and if one of the changes involved (for example) adding the word “statutory” to “regulatory”, then the additional word must have some meaning not covered by the term “regulatory”.

I drew up the table for those of us who, for better or worse, quoted (verbatim or by paraphrasing) from ISO 9001 in their procedures. I assume that using updated terminology and definitions is SOP’s is important if the revised or additional terminology adds a meaning or scope or explanation not covered by the replaced text. Obviously, one has to be flexible and use common sense, but to go the other extreme, and say that semantic changes are meaningless, does not seem to be correct, nor the intention of the revisers. \

Regards,

Asherlee

 

[al40]

Just went through my recertification audit and my Auditor commented that we had exceeded the requirements of ISO 9001:2008 and no changes were needed to my documentation.

Best regards,
Al40

 

[Paul Simpson]

Just went through my recertification audit and my Auditor commented that we had exceeded the requirements of ISO 9001:2008 and no changes were needed to my documentation.

Best regards,
Al40

Hi, Al.Congratulations on the recommendation to transfer your certification to 9k08!

Next time you speak to your auditor perhaps you could ask him / her how an organization exceeds the requirements of 9k08?

The way I understand it if your organization needs a wide range of tools and techniques (because it suits your purpose) then the QMS has to stretch to accommodate - hey presto it is now an 9k08 requirement!

 

[Coury Ferguson]

Hi all,
In reading this thread I am reminded of a finding from our last audit (re-registeration to ISO9001 / AS9100).
"Right of entry for regulatory agencies is not stated in terms and conditions."
Objective evidence - ...latest revision of Terms and Conditions is missing statements for I from the AS9100 Standard.
I would like to know what your opinions on this finding are.

Regards,

halfhog

I am moving this post to the AS9100 forum and Retitling it to "AS9100-Right of entry requirement" I will respond in that post. It is now located here: Right of Entry...AS9100

 

[Ateeq]

Yes, Off course you have to change your procedures when new version of standard is generated.