Re: ISO 17025 within an ISO 9001 organization
I have been tasked with bringing our testing lab into alignment with (as opposed to accredited to) ISO 17025. The lab is part of a larger ISO 9001 registered organization.
Does anyone have any experience with this? Are there any particular pitfalls I should watch out for?
Should there be a separate Quality Manual and such for the lab?
Any input would be appreciated
First of all, you have not stated if there will be an accreditation application; that also have effects on the system which will be established.
Anyway, we, I mean the company in which I am also a shareholder, is going to be accredited according to ISO IEC 17025 as a calibration laboratory. Also, there will be validation and testing of clean rooms in our job according to ISO 14644 series, which also means we will have to apply for ISO 17020 accreditation as an inspection body.
Novadays, I am on the final step of finishing the implemantation of an integrated system, 17025 plus 17020. I have stated that the system is based on ISO 9001 in various procedures. As you may probably have seen, ISO IEC 17025 has a cross table with ISO 9001. In fact, all management systems are parallel to ISO 9001. So, I do not think that it would be wrong to go on as you have proposed.
Yes, there are specific features for documentation, infrastructure, work conditions, data control, monitoring etc. according to ISO IEC 17025, but that doesnot mean you cannot build an integrated system. In Turkey, there are several accredited CBs which are also an NB, inspection body and testing body which use only one manual for all those different systems.
Here you can see my documentation preview for my system too:
UNFORTUNATELY THE LINK DID NOT SURVIVE THE OCTOBER 2018 SOFTWARE MIGRATION
Also, if the lab will not be accredited, but still continue with ISO 9001 certification plus application of the ISO IEC 17025, I can propose something else. First of all, you can state the position of the lab and use of the ISO IEC 17025 in the ISO 9001 manual, then you can establish a separate manual for the lab, which will include all the ISO IEC 17025 specific procedures and the related cross references to ISO 9001 QM and ISO 9001 procedures for common processes (documentation, control of records, purchasing etc.). You can bound the lab's instructions, SOPs, forms etc. to the lab QM. That way, the ISO IEC 17025 specific procedures will not be separate procedures in the ISO 9001 system, and, you will not be expanding your whole system with lots of techically specific procedures, as you will only have a separate QM for the lab and your existing ISO 9001 system at the end.