ISO 17025 Compliance within an ISO 9001 Organization

Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#11
Re: ISO 17025 within an ISO 9001 organization

So the quality manual for the labs 17025 is independent and doesn't have to reference any other quality system and therefore is its own Level 1.... Correct? That's what I was hoping for. The quality manager in charge of the 9001 program was trying to tell me that my 17025 manual would be a Level II since it was specific to the laboratories.

But the laboratories have never been included in the 9001 certification so I didn't see how that could be true.

Seems to me that the labs will have our own stand-alone accreditation and essentially be just a supplier to the rest of the organization. (Our testing is done to support our own internal operations.) We may closely mirror some of the activities used in the 9001 certification (such as doc control), but there is no requirement that we do things exactly the same way since it is a separate accreditation.
I don't know exactly what you mean by Level I and Level II but I am guessing they are document hierarchy.

If that is the case, 17025 is its own independent system and as such its quality manual is the same level of hierarchy as your parent organization quality manual. In my view, doing differently would seem confusing.

Let us consider if we were talking about safety and environmental management systems manuals. They would also be at the same level as the quality manual, yes? Same goes for 17025; I hope it helps to look at it that way.

Accreditation is indeed stand alone, otherwise the 17025 standard would be more like the automotive standard TS 16949, which lists all the ISO 9001 requirements but adds some specific, more detailed requirements placed by automotive groups.

Certainly there will be some unique requirements, for example 17025 specifies a master list/equivalent is required that lists current revision status; ISO 9001 doesn't go into that much detail.

The intent seems obvious: to avoid the hassle and expense of redundant certifications to ISO 9001 and ANSI/ISO/IEC 17025.
 
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Hershal

Metrologist-Auditor
Staff member
Super Moderator
#12
Re: ISO 17025 within an ISO 9001 organization

Resurrecting this discussion thread to keep all info in one place, as my question is somewhat similar to the original poster's....

My org has multiple certifications for ISO 9001 (different functional groups had their own), but the certifications have never specifically included the operational group that operates the field analytical labs that I am now trying to bring into 17025 accreditation. The quality group intends to merge the multiple ISO 9001 certifications into only 2 multi-site certs and has republished the quality manual as the Level 1 for both multi-site certs. The ISO 9001 quality manual states that it is intended to be applicable to the entire organization.

I am writing a quality manual for the ISO 17025 accreditation of the labs. I'm a bit hung up on where our quality manual falls in the documentation hierarchy. Are we supposed to consider the ISO 9001 manual as a higher level governing document, which would put the 17025 manual as a Level II doc? Or do we disregard the quality group's 9001 manual and place our own 17025 manual as our Level I? ( I don't mean disregard, as in ignoring some of their basic requirements, but disregard in terms of how our 17025 quality system is set up..)

Does an accreditation for 1702 somehow fall "under" the company's ISO 9001 certification? Or are they two separate things? Would the labs need to be specifically listed on the scope of the company's ISO 9001 certification for the 9001 to apply?
The 17025 manual is technically higher than the ISO9001 manual as accreditation is higher in the ISO heirarchy than ISO9001 (Registration).

Having said that, on a practical basis they will be considered equal, but with different application.
 

Hershal

Metrologist-Auditor
Staff member
Super Moderator
#13
One or two other thoughts.

Jennifer is correct that you need to watch specific requirements in both Sections 4 and 5. The specific revision list she mentioned is one, but there are many more.

Best thing for you to do is have yourself, and key personnel in the lab, take training in ISO/IEC 17025 and in measurement uncertainty. Many organizations offer one or both, including some ABs and private organizations.

You may not need to have an internal lab accredited, but it is something to consider. After all, having an internationally recognized accrediting body say that your lab meets the requirements for accreditation may be beneficial.

If you go down that path, select your AB with care, and not just the first one you talk to.

Then once the lab is accredited, do not let the ISO9001 auditor inside the lab, unless the auditor can prove s/he has the same technical qualifications as the accreditation assessor.
 
E

Eric Ho

#14
One key feature of 17025 is that it consists of 2 main sections - Management Requirements and Technical requirements. Hence i think this is something folks will need to consider when working on the documentation especially if you have an existing ISO 9001 system already in place. My previous experience was that i actually maintain standalone quality manuals (for ISO 9001 and ISO/IEC 17025). However as ISO/IEC 17025 also meets the basic quality mgt principles of ISO 9001, certain supporting procedures(for instance, doc control, Internal audit etc) may be shared between both systems..
 
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