ISO 17025 Compliance within an ISO 9001 Organization

S

Sarge

#1
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
 
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Phiobi

#2
Re: ISO 17025 within an ISO 9001 organization

I'm not sure if this is the "best" way to do this, but recently I came accross the same situation within a company and they were ISO9001:2008 but had established procedures based on 17925 clause 5. They get the best of both worlds... business system to 9001 and technical controls to 17025.
 

qusys

Trusted Information Resource
#3
Re: ISO 17025 within an ISO 9001 organization

Yes. ISO 17025 requests to have a dedicated manual.
My suggestion is to well undestand the reason why you would like to pursue the certifcation for your Lab.
Do your Lab provide extenal services that other customers buy?
If not, Iso 9001 or ISO TS are sufficient for your purpose.

You can also consider to follow the standards ISO 17025 without being certified from a Registrar.
Hope this helps

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
 

Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#4
Re: ISO 17025 within an ISO 9001 organization

Good morning,

There may be a squeamishness about making a quality manual within a quality manual so to speak, but in the case of 17025 I would support such an idea because the standard does have specific requirements.

An alternative is an appendix in the existing quality manual, and/or attachments dealing with the technical processes/unique elements.

I generally find that my organization's ISO/TS requirements are in general more strict than 17025. So there are a great many elements that can, and do say llittle more than "See ___ (site procedure for the subject)." I would certainly not advise duplicating element descriptionsin a new manual, lest you have to change two manuals when one subject gets updated. That could be a mess, IMO.

I hope this helps!
 

suildur

Involved In Discussions
#5
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.
 
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S

Sarge

#6
Re: ISO 17025 within an ISO 9001 organization

Thanks for the quick responses!

My suggestion is to well undestand the reason why you would like to pursue the certifcation for your Lab.
Do your Lab provide extenal services that other customers buy?
If not, Iso 9001 or ISO TS are sufficient for your purpose.

You can also consider to follow the standards ISO 17025 without being certified from a Registrar.
Hope this helps
We are the product test lab for a manufacturer of a government regulated (international) product line. We design, manufacture and sell safety devices, so to do our testing right is not optional.

As I stated in my original post, we plan to align with 17025 but not seek accredidation at this time. Just use 17025 as a "best practice" and at some later date actually seek accreditation if and when it makes good business sense. To that end, we want to set everything up according to the spec the first time.
 

Hershal

Metrologist-Auditor
Staff member
Super Moderator
#7
Re: ISO 17025 within an ISO 9001 organization

Practical basis: First, compare the standards, and by that I mean specific requirements.

An example is Management Review, which has a prescriptive agenda in ISO/IEC 17025:2005 Clause 4.15.1; and also requires the top management in charge of the lab participate in the review. Such a review can be included in the ISO9001 review, but the laboratory must be specifically addressed and the minutes (however kept) must reflect that.

Another is purchasing. When you eventually seek accreditation, any vendors you are using for the lab must be able to support your accreditation. That is, meet appropriate requirements. As an example, a manufacturer that is ISO9001 would be adequate and appropriate, but a calibration lab that is only ISO9001 would not be, unless you had also assessed them, and then make sure you have the auditors qualifications (including technical) handy.

As to the separate manual, a smaller manual can then be written for the lab that addresses requirements of ISO/IEC 17025:2005 that are not addressed by ISO9001.

Hope this helps.
 
J

JodiB

#8
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?
 
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Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#9
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?
Since 17025 includes all the essentials such as control of documents, supplier control, training etc., it is meant to accomplish QMS development and maintenance independent of 9001. So, the quality manual doesn't need to include activities covered under 17025, and your 17025 facility doesn't need to refer to the parent organization's 9001 quality manual; it would have its own.

However: if you are like my people, some of your processes (such as document control and training) are shared. If there is any particular or special treatment in those processes for this lab, such should be included in their documentation on a process-by-process basis.
 
J

JodiB

#10
Re: ISO 17025 within an ISO 9001 organization

Since 17025 includes all the essentials such as control of documents, supplier control, training etc., it is meant to accomplish QMS development and maintenance independent of 9001. So, the quality manual doesn't need to include activities covered under 17025, and your 17025 facility doesn't need to refer to the parent organization's 9001 quality manual; it would have its own.

However: if you are like my people, some of your processes (such as document control and training) are shared. If there is any particular or special treatment in those processes for this lab, such should be included in their documentation on a process-by-process basis.
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.
 
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