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  Quality Manual for ISO 9000 & DIS 17025

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Author Topic:   Quality Manual for ISO 9000 & DIS 17025
Marc Smith
Cheech Wizard

Posts: 4119
From:West Chester, OH, USA
Registered:

posted 05 November 1999 12:11 PM     Click Here to See the Profile for Marc Smith   Click Here to Email Marc Smith     Edit/Delete Message   Reply w/Quote
Subject: Quality Manual for ISO 9000 & DIS 17025 RE7
Date: Thu, 28 Oct 1999 09:01:40 -0400 (EDT)
From: Greg Gogates iso25@fasor.com
To: iso25@quality.org

Date: Wed, 27 Oct 1999 16:42:50 -0400
From: "Ned, Gravel" ngravel@scc.ca
To: 'Greg Gogates' iso25@fasor.com
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:ngravel@scc.ca Web site: http://www.scc.ca

-----Original Message-----
From: Greg Gogates [mailto:iso25@fasor.com]
Sent: 26 October, 1999 11:46 AM
To: iso25@quality.org
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" PMaroney@ora.fda.gov
To: "'iso25@quality.org'" iso25@quality.org
Subject: Quality Manual for ISO 9000 & DIS 17025
Date: Mon, 25 Oct 1999 15:34:52 -0400
MIME-Version: 1.0
X-Mailer: Internet Mail Service (5.5.2448.0)
Content-Type: text/plain

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.

Not everyone agrees. As best I can represent their viewpoint, they feel that lab accreditation will require a 3rd party audit of the entire Quality Manual which would pull in non-lab portions of the organization. They would like to have a separate Lab Manual. However the labs are not independent - other parts of our organization determine sampling plans and collect samples, other parts "own" the lab results as part of their work processes.

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Marc Smith
Cheech Wizard

Posts: 4119
From:West Chester, OH, USA
Registered:

posted 05 November 1999 12:29 PM     Click Here to See the Profile for Marc Smith   Click Here to Email Marc Smith     Edit/Delete Message   Reply w/Quote
Subject: Re: Quality Manual for ISO 9000 & DIS 17025 RE2
Date: Fri, 05 Nov 1999 12:26:24 -0500
From: Marc Smith
Organization: Cayman Systems
To: Greg Gogates
References: 1

A simple example of Larry Gradin's suggested matrix is at /pdf_files/ The file name is QS-Req.pdf

I first used this methodology successfully back in 1993. While this does not include guide 25 or DIS 17025, it illustrates a matrix such as Larry Gradin suggested. The original actually had a number of Ford, GM and BMW requirements. The quality manual that went with it was laid out in accordance with the matrix.

Greg Gogates wrote:

> Date: Wed, 27 Oct 1999 01:49:13 -0400
> From: LGradin
> Reply-To: LGradin
> To: Greg Gogates , iso25@quality.org
> Subject: Re: Quality Manual for ISO 9000 & DIS 17025
>
> Integrated Quality Systems have been successfully established with a format
> established to follow ISO 9000 series or ISO/IEC Guide 25 or EN 45001, ANSI
> NQA-1, MILQ9858A, AS9000, Good Laboratory Practice or even the draft ISO
> 17025 that integrated the elements of all these systems.
>
> Such quality system have successfully (with very little discrepancies or
> deficiencies) withstood 1st, 2nd, or 3rd party assessment/audit. The key is
> to completely fill out a checklist traceable to the international or other
> quality standards of interest and ensure all the required elements are
> addressed and referenced to a users quality system reference.
>
> Placing these checklists in a cross-reference matrix (e.g. ISO/IEC Guide
> 25 to Quality Manual), (e.g. EN45001 to Quality Manual), (ISO 17025 to
> Quality Manual) , (MIL Q9858A to Quality Manual), (ANSI NQA-1 to Quality
> Manual), etc. as Appendices or Annexes does at least six things:
>
> 1- Assure completeness of documentation by virtue of finding and assuring
> the required element is addressed, and
>
> 2- Providing a roadmap for the audit/assessment that minimizes the
> assessment process by auditors/assessors with minimal panic in responding to
> audit/assessment questions, and
>
> 3- Minimizes the true expertise necessary for the responsible staff to
> respond to assessor/auditor concerns user audit pressure, and
>
> 4- Provides a written definition for the entire staff to understand the
> program requirements and the requirements of the standards imposed upon them
> by customers or commitments to specific standards, and
>
> 5- Minimizes non-conformity that usually develops when a procedure/method is
> only used for compliance with one or another standard, and
>
> 6- Can point to indications in the quality documentation where the
> non-applicability for a certain standard provision is referenced precluding
> deficiencies where an assessor/auditor may indicate no objective evidence
> exists that XXX in the required standard is addressed.
>
> Although this starts as a lot of work, it is done initially and usually
> prevents repeated findings of nonconformity with the standards.
>
> ***************************************************************
> * Larry Gradin, PE, QMS-LA
> * Email: LGradin@Integrity-Solutions.org & L.Gradin@ieee.org
> * Integrity Solutions Group, Inc.
> * 6419 Bridgewood Terrace
> * Boca Raton, FL 33433
> * Phone 561-289-9137
> * Efax: 978-285-6589
> * Email to Mobile Phone: 5612899137@mobile.att.net
> * Web Page http//www.Integrity-Solutions.Org
> _______________________________________________________
> Remember - Quality depends on Integrity, Attention To Detail,
> Cost-Effective Action, and Commitment -- not buzzwords.
> *****************************************************************

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