Quality Manual for ISO 9001 & ISO 17025

[Marc]

Date: Wed, 27 Oct 1999 16:42:50 -0400
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

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"
Subject: Quality Manual for ISO 9000 & DIS 17025
Date: Mon, 25 Oct 1999 15:34:52 -0400

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.

[Marc]

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 Elsmar Cove Free Files Directory 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
> 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.

[Logic]

Here is a question I have for all you experienced auditors and auditees out there to move this from the theoretical discussion to actual practice.

If a company is seeking certification under 9001 for the entire organization and has testing laboratories needing accreditation under 17025, how commonplace is it to have one Quality Manual to cover it all? Is it really practical? What lab-specific documents end up being written to supplement the manual to make the quality elements important enough to the laboratory staff to encourage buy-in?

[SilverHawk]

The ISO 9001 part of the QM would probably have addressed the Clause 4.0 of the ISO/IEC 17025 requirements. An ISO 9001 company cannot be accredited for ISO/IEC 17025 unless and until the organization has addressed the technical competency part - Clause 5.0 of the ISO/IEC 17025.

Most interestingly it is easier for an ISO/IEC 17025 accredited organization to meet the requirements of ISO 9001 but an ISO 9001 certified organization will not meet the requirements of ISO/IEC 17025. An organization is accredited to ISO/IEC 17025 and an organization can be certified to ISO 9001. These are two different approach of accreditation and certification of an organization
A two kettle of fish, so to say!

[Hershal]

Logic, great question.....

Having one manual for both ISO 9001:2000 and ISO/IEC 17025:2005 is very workable and properly done, is beneficial.....there are many common areas between the two standards and those can easily be addressed in a common manual.....however, 17025 has additional requirements not found in 9001 on both the QMS side and of course the technical side.....I see this arrangement from time to time.....

The worst is that you then have an ISO 9K Registrar, and you have an Accrediting Body.....each body will have different approachs and different things they want to see.....the technical side is obvious, but take Management Review for example.....17025 has a prescriptive agenda that must be documented.....anything else is good too, but the required topics must be there.....Purchasing has some specific requirements also.....records.....complaints.....

Just some things to think about.....and don't forget.....selection of both the Registrar and the AB.....don't just lock into one.....get quotes from each and ask to talk to the auditor for each that will be assigned to you.....then consider selecting the registrar and AB.....

Hope this helps.

Hershal

[Logic]

Thank you for the comments so far!

To follow-up on Hershal's comments, see italics:

Having one manual for both ISO 9001:2000 and ISO/IEC 17025:2005 is very workable and properly done, is beneficial.....
Do the benefits outweight the drawbacks? Since all staff has to be trained on the Manual, wouldn't it mean that the non-laboratory staff would have to be trained on those areas of the Manual that do not apply to them at all?

there are many common areas between the two standards and those can easily be addressed in a common manual..... Wouldn't it be simpler to create a Manual for 17025 and in it cross-reference to the areas in the 9001 Manual? however, 17025 has additional requirements not found in 9001 on both the QMS side and of course the technical side.....I see this arrangement from time to time..... What about the complication when part of the organization is involved in research that may need to be covered by the GLP standard - to be addressed at a later date?

The worst is that you then have an ISO 9K Registrar, and you have an Accrediting Body.....each body will have different approachs and different things they want to see.....the technical side is obvious, but take Management Review for example.....17025 has a prescriptive agenda that must be documented.....anything else is good too, but the required topics must be there.....Purchasing has some specific requirements also.....records.....complaints..... What are the downsides of putting those prescriptive requirements in the single Quality Manual?

Just some things to think about.....and don't forget.....selection of both the Registrar and the AB.....don't just lock into one.....get quotes from each and ask to talk to the auditor for each that will be assigned to you.....then consider selecting the registrar and AB..... That option will not be available in this case - same organization will do the audit (s) but you raised an interesting point - will they be the same auditors and will it be done at different times. Say for example that the Manual is found deficient for the 17025 audit and clearly states that it is supposed to cover both, can it be considered acceptable against the 9001 standard?

Hope this helps.

Hershal

[Logic]

Anyone else wanting to jump in to this discussion? What will the impact be on training of scientific and non-scientific staff on the Manual if it is combined?

[harry]

If I am a business rival/competitor, I would want to have an idea or 'feel' on your labs capability. What better way than have a copy of your manual + .......??

With that in mind, I would do the following:
1. Common ISO 9001 manual for the whole organization.
2. For the lab section, add in the additional 17025 requirements. (Note the other requirements on top of 9001 as well as different interpretation pointed out by Hershal) The add ins can be in different font or color.

You can streamline a lot of things. After all, the lab is usually a very small fraction of the organization in terms of head count.