As far as ISO 9001:2000 is concerned, does the word "determine" mean that I have to have documented proof (records and such) that the accompanying requirement(s) have been determined?

Thanks,

Brett Roundy
Reliability/Quality Engineering, CRE, CQE
Cascade Engineering Services, Inc.

Sorry Brett but could you be a bit more specific and maybe quote the reference?

Thanks

Sorry Brett but could you be a bit more specific and maybe quote the reference?

Thanks

For example:

6.1 Provision of resources
The organization shall determine and provide the resources needed
a) to implement...
b) to enhance...

My question is how do you show evidence of determining something? The standard uses the word quite often. Is this a trigger for documented proof?

Interesting question.

I presume you mean "for an auditor to view" when making a registration audit.

The simple answer is "no" for the documents you do determine you need. (The simple fact they exist is proof you made the determination.) If there is something called for in a Standard which you determine you do NOT need, then you ought to be prepared to show how you arrived at that determination.

:topic: I suspect you are allowing yourself to be caught in an "analysis paralysis" situation. The Standard is intended to be a "common sense" scheme for a Quality Management System, not some "red tape nightmare" of prescription and proscription as many compained about the 1994 version.

Good luck. Feel free to come back often with questions. We want to help you have an easy transition.

Actually I'm trying to take a minimalistic approach for our contract manufacturing division and this is my first exposure to 9001:2000...I've done quality systems to 9001:1994 abd QS9000 (what a mess) and my involvement latey has been 17025 and 13485...

my concern is more with product specific requirements (should have stated that earlier) such as 7.1 and 7.2...do I have to show proof for each requirement that needs to be determined?

Actually I'm trying to take a minimalistic approach for our contract manufacturing division and this is my first exposure to 9001:2000...I've done quality systems to 9001:1994 abd QS9000 (what a mess) and my involvement latey has been 17025 and 13485...

my concern is more with product specific requirements (should have stated that earlier) such as 7.1 and 7.2...do I have to show proof for each requirement that needs to be determined?
Same answer: NO! for ISO9001:2000.

In TS16949, an offshoot of ISO9001:2000, customer requirements cloud the picture somewhat, because customers may require procedures like PPAP (Production Part Approval Process) which do require a determination of how your organization arrives at a process to make a product. A third party auditor for TS16949 will want to know you have processes in place to satisfy customer requirements, but will not want to see the actual PPAP report.

Unfortunately, many auditors expect to see a "record" for each shall. They expect to see some “record” that 5.3 d) – communication of the quality policy has been fulfilled. “I want to see some sort of sign-off where each employee affirms they have received, read and understand the quality policy.” What a crock! If it makes sense for you to have some documented “proof” things have been determined, then develop your proof. If not, then follow Wes’ advice (well, you could follow Wes’ advice either way—he is generally right – except when he disagrees with me :rolleyes: )

A third party auditor for TS16949 will want to know you have processes in place to satisfy customer requirements, but will not want to see the actual PPAP report.
Just out of curiousity, if a customer requires PPAP, how can an auditor verify that 7.3.6.3 of 16949 has been satisfied without seeing a PPAP "report"?

Thanks all, this is great input.

Just out of curiousity, if a customer requires PPAP, how can an auditor verify that 7.3.6.3 of 16949 has been satisfied without seeing a PPAP "report"?
I'm pretty sure all the auditors I have met are content to look at the outside of a file folder which says "PPAP" without ever reading it - many would not be competent to judge the efficacy of the PPAP, since that is between supplier and customer. Most would be satisfied merely with seeing the Procedure for doing a PPAP without making any judgment whether the Procedure was a reasonable one, and NEVER seeing an actual PPAP.

I'm not trying to defend 3rd party auditors nor to devalue their worth. I happen to be one of the guys who would prefer "compliance" monitored by actual customers than "registration" by 3rd party auditors, since I feel customers do themselves and their own customers further up the supply chain a disservice by abdicating the job of looking at BOTH system and product compliance. The 3rd party registrar merely looks at the system and ignores the product. Worse - the registrar only checks on the presence of a system, not on the efficacy of the system. Why not? That's all he is paid to do.

In practice, many registrars also ignore post-registration reports of system misfeasance and malfeasance of registrants as more than one thread here in the Cove has shown.

Bottom line:
If a registrant wanted to "game" the 3rd party registration system, it would be relatively easy to accomplish. If anecdotal evidence of various posts is given any weight, many of our Covers have witnessed such "gaming" first hand.