posted 05 November 1999 12:11 PM               

Date: Wed, 27 Oct 1999 16:42:50 -0400
From: "Ned, Gravel" [email protected]
To: 'Greg Gogates' [email protected]
Subject: RE: Quality Manual for ISO 9000 & DIS 17025

Just a short note from a member of CASCO WG 10. I was able to participate in the last CASCO WG 10 meeting and represented Canada and the SCC at that meeting. I have been following some of the discussion on this forum and the issue of compatibility of ISO 9000 and ISO/IEC Guide 25 and their replacements is one of interest to me.

It had been reported that ISO/IEC Guide 25 and ISO 9000-1994? had only about 30% common language. I have seen that the FDIS for ISO/IEC 17025 increases that commonality to about 60%. The parts that are not common are the technical requirements which are unique to the lab accreditation document.

I am not familiar with the new language of ISO 9000-2000? but I know that there was some concern with the issuance of 17025 being out of phase with the issuance of the new 9000. The issue was called "leapfrogging" and TC 176 (the ISO 9000 Technical Committee) was concerned that the new 17025 would have its QMS language based on the old version of 9000. To fix this would probably have required TC 176 participation in the development of 17025 and it never was decided which committee had the final say over the QMS language in 17025.

So the document was reviewed (I think) in TC 176 and CASCO finally agreed to letting WG 10 go ahead with the development of a standard that had QMS language in it that had not been approved by TC 176 - against ISO/CASCO rules on the issue of commonality.

So how do our labs solve the problem in developing and implementing one QMS for both? We, at the SCC, make use of a lab checklist that is a verbatim adoption of the standard. That said, it is easy for us to see which parts of the standard are not met by a lab's QMS. When labs apply for accreditation, and already enjoy registration to ISO 9000 or one if its derivatives or variants, they can apply the checklist against their QMS and then have indication of which "holes" need to be filled in. Result - one QMS to meet the requirements of both standards.

J.E.J. (Ned) Gravel, P.Eng.
Senior Program Officer/Agent principal de programme
Standards Council of Canada/Conseil canadien des normes
1200-45 O'Connor
Ottawa, Ontario
Canada K1P 6N7

Tel (613)238-3222 Fax (613)569-7808
E-mail/courrier Žlectronique: mailto:[email protected] Web site: http://www.scc.ca

-----Original Message-----
From: Greg Gogates [mailto:[email protected]]
Sent: 26 October, 1999 11:46 AM
To: [email protected]
Subject: Quality Manual for ISO 9000 & DIS 17025

Moderator Note,

All the labs that I have seen with both have had seperate Quality Systems. The only thing I've seen is that they share some policies and processes. Now with 17025 and the ISO9000 2000 edition, they are supposed to be in allignment.

It will probabley be best to continue keeping them seperate. Greg

From: "Maroney-Benassi, Patricia" [email protected]
To: "'[email protected]'" [email protected]
Subject: Quality Manual for ISO 9000 & DIS 17025
Date: Mon, 25 Oct 1999 15:34:52 -0400
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Anyone with experience in IS0 9000 organizations with ISO G25/17025 in-house labs? Is there one Quality Manual or two?

Our organization as a whole is building a quality system to conform to ISO 9001--we are not planning to register. At the same time, our in-house analytical labs are planning to conform to DIS 17025 as well and we may seek 3rd party accreditation. Our labs are integrated into our overall business practices; they are not wholly independent.

Both standards require a quality manual. Our current approach is "one organization, one quality system, one Manual." Our plan is to write a Manual which includes requirements from both standards. Since the quality system part of 17025 is almost the same as 9000, we anticipate a fairly straightforward integration of the two standards. In some cases where a requirement applies only to the lab, the Quality Manual would address the specific scope of the policy. We would develop a Manual cross-reference to show any external parties how we are meeting the two standards.