Permissible Exclusions - ISO 9001

[Helmut Jilling]

Re: ISO 9001:2000 Permissible Exclusions - Need an opinion

Thanks Sidney, I'm very close to conceding defeat although I might still argue about the enforcement of a note in a guidance document.

None of the third party auditors I've worked with have made reference to the TC 176 guidance modules or the Auditing Practices Group documents that you have referenced in other posts (and I appreciate your efforts in this respect). Even if the registrars' administrators are fully conversant with all these interpretations (which I doubt) many quality managers certainly aren't. Is it fair to impose interpretations on us which aren't clearly spelt out in the standard or scheme rules?

Wouldn't it be nice if all the interpretations found necessary for ISO 9001 were to be clearly identified as requirements in the revised version for 2009?

Ok this is seriously I'll give up now.

Many auditors and registrars are aware of the TC 176, and some of the APG documents. I carry them on my laptop. They form and shape some of the interpretations we use. They are definitely informative and useful. But, I don't necessarily trot them out during an audit, because they are not normative additions to the standard.

 

[Helmut Jilling]

Re: ISO 9001:2000 Permissible Exclusions - Need an opinion

What a flurry, I have begun.
In my original post (and in our QM) I stated that ONLY D&D were excluded from our system, and that the others WERE outsourced.

We a unique organization for a number of reasons...

I agree, based on your clarification, that you have a unique situation and I support the approach you detailed. It makes sense and I feel complies with the requirements.

I can not understand why after 3 years our Registrar thinks ....

Lastly, I do not know why they declare and mandate their own interpetations on exclussions. I have looked at our contract, which states that we only exclude D&D requirements, however, were we to determine that any other area of Clause 7 where requirements "cannot be applied due to the nature of our process and/or product" - 9K:2K 1.2 Application; our registrar will not even consider much allow for exclusion.

Not sure where they come up with that narrow requirement. It is clearly a TS specific requirement, not ISO 9001. (there are always other registrars if you cannot have good terms with your current one. Several good ones represented on the Cove here.)

 

[Gary L. Phillips - 2007]

Re: ISO 9001:2000 Permissible Exclusions - Need an opinion

Thanks, Hjilling,

I'll not press their internal interpetations for now. We've had the same assessor on all audits and have had problems each time.
1. He had never seen our Quality Manual before walking in the door for registration.
2. Could not find his way through the 9K:2K standard.
3. Still wants to see the requirements in the QM.
4. Wants a complete listing of all documents - not just the procedures- included in the QM along with doc ID and rev level.
5. Each time he visits, I waste time training him on the ISO requirements.
6. He has steadly complained that our QM is just too little.

I intentionally developed a lean management system so as not to produce a system of documents. As intended this system allows for a robust and changing system...our facility is only four years old...and I knew that there would probably be changes to the senior management team as our weapon program matures. As far as I know, there never has been a requirement to embed requirements into the Quality Manual, although most organizations have always done so. The meat of our QM is just two pages our scope and the Process Interaction chart, and I have placed addendums for the org chart
- another requirement of his.

As it stands, I am going to address the two findings after discussions with his staff. During this last audit, he declared that he wanted procedures that are not required by 9K:2K and I just said the I did not intend to write them and have to put them in our QM. When he protested, I caved in and said that I would write a QM that would completely satisfy him, although it would most likely be around 350 pages long and would take a good bit of time for him to study and understand the contents - he finally backed off !

 

[Paul Simpson]

Re: ISO 9001:2000 Permissible Exclusions - Need an opinion

Many auditors and registrars are aware of the TC 176, and some of the APG documents. I carry them on my laptop. They form and shape some of the interpretations we use. They are definitely informative and useful. But, I don't necessarily trot them out during an audit, because they are not normative additions to the standard.

Why not bring them to the table. We are all here to share knowledge. Perhaps we can take this out to the wider world and let them know this guidance exists.

I know it is not called up in ISO 9001 but if it helps to explain - why not?

 

[Helmut Jilling]

Re: ISO 9001:2000 Permissible Exclusions - Need an opinion

Thanks, Hjilling,

.... We've had the same assessor on all audits and have had problems each time.

2. Could not find his way through the 9K:2K standard.
5. Each time he visits, I waste time training him on the ISO requirements.
6. He has steadly complained that our QM is just too little.

.....During this last audit, he declared that he wanted procedures that are not required by 9K:2K and I just said the I did not intend to write them ...

You may have put up with him a bit too long. Yo are within your rights to request a different auditor assignment.

 

[Antonio Vieira]

Re: ISO 9001:2000 Permissible Exclusions - Need an opinion

Funny, this week I’ve audited one organization that made the exclusion of requirement 7.4.1 Purchasing Process, in what it concerns to evaluation and selection of suppliers.
It’s not usual but...
Their reason for this exclusion was that they only buy products each 8 years. In the mean time they just use what they have bought.
What is their final product?
They make some cork pieces for the wine industry...

 

[Paul Simpson]

Re: ISO 9001:2000 Permissible Exclusions - Need an opinion

Funny, this week I’ve audited one organization that made the exclusion of requirement 7.4.1 Purchasing Process, in what it concerns to evaluation and selection of suppliers.
It’s not usual but...
Their reason for this exclusion was that they only buy products each 8 years. In the mean time they just use what they have bought.
What is their final product?
They make some cork pieces for the wine industry...

Doesn't look like a valid exclusion to me! They may buy only every 8 years but they do purchase so all of 7.4 does apply - just not very often.

 

[Sidney Vianna]

Re: ISO 9001:2000 Permissible Exclusions - Need an opinion

If their cork suppliers are not ISO 9001 certified, I would not consider buying products from that winery.....

It is a MUST.

 

[Paul Simpson]

Re: ISO 9001:2000 Permissible Exclusions - Need an opinion

If their cork suppliers are not ISO 9001 certified, I would not consider buying products from that winery.....

It is a MUST.

Hmmm! I am sure I have a part time quality control job with these guys!

 

[fuzzy]

Re: ISO 9001:2000 Permissible Exclusions - Need an opinion

Doesn't look like a valid exclusion to me! They may buy only every 8 years but they do purchase so all of 7.4 does apply - just not very often.

I totally agree, almost wasn't worth excluding..."we purchase from previous suppliers as long as their goods prove satisfactory". What's so hard about that????