We are ISO 9001 certified - Any guide on how to acquire ISO 17025 accreditation?

M

miwriter

#1
Hi, anyone who can guide me on the basic steps for achieving the ISO 17025 accreditation? We are now ISO 9001 certified, and our company wishes to acquire ISO 17025 accreditation soon ..can anyone help me find useful reference from which I can start with aside from the ISO standards? thank you
 
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Jerry Eldred

Forum Moderator
Super Moderator
#2
I know you spoke of other documents aside from the ISO standards. If that means you have already bought a copy, that is great. There are a variety of resources on the internet. You just have to spend some time searching. I am not familiar with a "magic bullet" document that will for free take you step by step through the whole process. That may be because it is a pretty detailed process that is probably more than could easily be put into a simple document.

The first step should definitely be to get a copy of the ISO document itself.

You can also go to some of the accreditation body websites and get copies for free of the internal audit checklist ( I know aclasscorp.com has one last time I downloaded it; not sure exactly what is available on the others). This will take some time, but you will need to go through each line of that checklist and perform a gap analysis, and begin correcting the gaps. There are a lot of detailed functions that need to be covered. One of the big ones is uncertainty budgets. This will take quite a bit of work, unless you already have them.

Another thought related to the above would be to peruse the various accreditation body websites for all of their free downloads. There are a variety of guidance documents (which can't substitute for the training needed to properly run an accredited lab facility).

The other thing I would recommend is to consider bringing in an ISO17025 consultant. I am not in that business, so this is not a commercial endorsement for anyone. First, I would get the standard and guidance documents, begin going through the audit checklist, and begin documenting and fixing the deficiencies. This will likely take at least a few months (depending how compliant your laboratory already is). I am not familiar with testing laboratory particulars, as I am involved in the calibration laboratory side.

That will make it an easier task to bring in the consultant. It will probably make his or her visit cheaper, as they will only be there to help you fine tune the work you have started, as opposed to beginning from square one (a major endeavor).

Once you pick out an accreditation body (A2LA, NVLAP, ACLASS, IAS, PJL, LAB, etc. - if in the U.S.), maybe have a phone conversation with them. They have to stay pretty neutral, but they might be able to give you some basic inputs.
 

BradM

Staff member
Admin
#3
Not really much to add to Jerry's excellent post. Just do recall, 17025 is kind of two parts- quality management and technical management. So you are probably in decent shape for the quality management portion. There is a gap analysis in the attachment list here that can help you with assessing your current program. If you need some help finding that attachment, let me or another moderator know or something.:agree1:

The technical portion may be where you will need to focus more of your attention. While I'm sure you have training records and such, you might need to document technical training a bit more detailed. Too, not sure if you have worked with measurement uncertainty. If you haven't, that might be some money well spent in training for you and your team.

I learned this from Hershal. The Accreditation Bodies for 17025 are slightly different. Contact them all and get quotations. They can be a lot of assistance with this also.

I know you know this already, but, well.... I'll go ahead and say it.:tg: When you add up all the costs, training costs, returning audit visits, etc., it is not inexpensive. Do assure your management understands it's going to be an investment, and will tighten up processes more so than it is currently.:agree1:
 

John Broomfield

Staff member
Super Moderator
#4
Hi, anyone who can guide me on the basic steps for achieving the ISO 17025 accreditation? We are now ISO 9001 certified, and our company wishes to acquire ISO 17025 accreditation soon ..can anyone help me find useful reference from which I can start with aside from the ISO standards? thank you
miwriter,

Congratulations on upgrading from certification to accreditation.

You will find the ISO 17025 assessments by A2LA (for example) more demanding than your ISO 9001 certification audits because the assessors are looking for evidence of competence per your more tightly defined scope of tests or calibrations.

Start with defining the (narrower?) scope of your first accreditation then you can focus on the actions necessary to fulfill that scope.

John
 
M

miwriter

#5
I know you spoke of other documents aside from the ISO standards. If that means you have already bought a copy, that is great. There are a variety of resources on the internet. You just have to spend some time searching. I am not familiar with a "magic bullet" document that will for free take you step by step through the whole process. That may be because it is a pretty detailed process that is probably more than could easily be put into a simple document.

The first step should definitely be to get a copy of the ISO document itself.

You can also go to some of the accreditation body websites and get copies for free of the internal audit checklist ( I know aclasscorp.com has one last time I downloaded it; not sure exactly what is available on the others). This will take some time, but you will need to go through each line of that checklist and perform a gap analysis, and begin correcting the gaps. There are a lot of detailed functions that need to be covered. One of the big ones is uncertainty budgets. This will take quite a bit of work, unless you already have them.

Another thought related to the above would be to peruse the various accreditation body websites for all of their free downloads. There are a variety of guidance documents (which can't substitute for the training needed to properly run an accredited lab facility).

The other thing I would recommend is to consider bringing in an ISO17025 consultant. I am not in that business, so this is not a commercial endorsement for anyone. First, I would get the standard and guidance documents, begin going through the audit checklist, and begin documenting and fixing the deficiencies. This will likely take at least a few months (depending how compliant your laboratory already is). I am not familiar with testing laboratory particulars, as I am involved in the calibration laboratory side.

That will make it an easier task to bring in the consultant. It will probably make his or her visit cheaper, as they will only be there to help you fine tune the work you have started, as opposed to beginning from square one (a major endeavor).

Once you pick out an accreditation body (A2LA, NVLAP, ACLASS, IAS, PJL, LAB, etc. - if in the U.S.), maybe have a phone conversation with them. They have to stay pretty neutral, but they might be able to give you some basic inputs.

Thank you for your help..this information will be a good guide for me to start :)
 
M

miwriter

#6
Not really much to add to Jerry's excellent post. Just do recall, 17025 is kind of two parts- quality management and technical management. So you are probably in decent shape for the quality management portion. There is a gap analysis in the attachment list here that can help you with assessing your current program. If you need some help finding that attachment, let me or another moderator know or something.:agree1:

The technical portion may be where you will need to focus more of your attention. While I'm sure you have training records and such, you might need to document technical training a bit more detailed. Too, not sure if you have worked with measurement uncertainty. If you haven't, that might be some money well spent in training for you and your team.

I learned this from Hershal. The Accreditation Bodies for 17025 are slightly different. Contact them all and get quotations. They can be a lot of assistance with this also.

I know you know this already, but, well.... I'll go ahead and say it.:tg: When you add up all the costs, training costs, returning audit visits, etc., it is not inexpensive. Do assure your management understands it's going to be an investment, and will tighten up processes more so than it is currently.:agree1:
thanks for the inputs :)
 
B

bazboy

#7
Annex A of 17025 is a cross-reference of the 17025 and 9001 requirements.

Barry Quinlan
ISO/IEC 17025 and ISO Guide 65 assessor
 

Hershal

Metrologist-Auditor
Staff member
Super Moderator
#8
Some exceptionally good responses here.

The biggest single difference is the technical aspect of ISO/IEC 17025 compared to ISO9001, but there are some other differences also. One for example is the prescriptive requirements for Management Review.

As has been mentioned, a gap analysis is a good step. When ready to select an accrediting body then talk to all six ILAC signatory bodies that are based in the US before sending money to either one.
 
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