Re: ISO 17025 within an ISO 9001 organization
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.
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.
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.
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.