How to Integrate ISO 17025 with current QMS

BradM

Staff member
Admin
#1
Hello all! I have some questions on the beginning phase of ISO 17025.

Our calibration lab is under a mature QMS (ISO9001- 10+ years; regulated industry; 1000-4000 employees). For discussion, I will specify the current, comprehensive sytem as the "large" system, and the calibration activities program as the "small" system.

As we sit, my assessment is we have a good program (small and large). There is interest, for various reasons, to fall under the 17025.

For the most part, most of the components specified is 17025 are encompassed within the larger system. We already have procedures in place to handle:

Purchasing
Calibration records
Management/ management review
Nonconforming product
Corrective action program
Document control....
Among others

There does not appear on the surface to be any reason why these would be deficient within the "small" system.

NOTE: There are a few I have identified that need addressing.

Currently (and in the foreseeable future) there will only be internal customers.

So, am I hearing that in the end, it will be better to create a new quality system within the system? So, do I "pretend" that the larger umbrella system does not exist, and create from scratch?

Too, I cannot imagine that the quality professionals responsible for the large system would be completely OK with creating a small system independent of the large. That is my thought; but nothing verified on that one.

Your thoughts, input, and opinions are welcome.:)
 
Last edited:
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CliffK

#2
Re: Drafting Quality Manual for ISO17025

For the most part, most of the components specified is 17025 are encompassed within the larger system. We already have procedures in place to handle:

Purchasing
Calibration records
Management/ management review
Nonconforming product
Corrective action program
Document control....
Among others

There does not appear on the surface to be any reason why these would be deficient within the "small" system.
Brad, the devil is halfway in the details (I'll come to the other half later). You really want to do a careful gap analysis of your, for example, Purchasing procedure against the requirements of 17025.

If your procedure dots all the i's and crosses all the t's, you're home free. If not, you have an interesting choice: amend your large-system procedure (and possibly burden the folks who can still operate by the large-system document), or create a supplemental procedure for the small system only.

Beware of the words "policy and procedure." According to A2LA, at least, they literally mean you need both a policy and a procedure. And that brings me to the other half of the devil. A2LA (others may be different) loads heaps and heaps of interpretation on top of the standard. Fortunately for such as you and me, they also provide ample documentation warning you about their interpretations.
NOTE: There are a few I have identified that need addressing.
If by that you mean you have identified procedures that need expansion because of expanded requirements in 17025, then you're OK. Just be sure to do the gap analysis.
Currently (and in the foreseeable future) there will only be internal customers.
That distinction loses a lot of meaning if your lab releases product.

So, am I hearing that in the end, it will be better to create a new quality system within the system? So, do I "pretend" that the larger umbrella system does not exist, and create from scratch?
No. Use the larger system. For example, slip in the one or two minor 17025 points into the management review agenda. Don't have a separate review just for the lab.

But you will probably find yourself creating supplemental documents, such as a separate quality manual supplement (I call it a compliance guide, or something similar) for the lab.

Go to the A2LA website and check out the document finder. There are about ten categories of documents, with three or four documents of interest in most categories. Download 'em and read 'em. If you are going to use another accreditation body, get as much reference documentation from them as you can.
 

BradM

Staff member
Admin
#3
Re: Drafting Quality Manual for ISO17025

Ken, thank you so much. Let me carry on your thoughts, here.

Brad, the devil is halfway in the details (I'll come to the other half later). You really want to do a careful gap analysis of your, for example, Purchasing procedure against the requirements of 17025.
A gap analysis will definitely be in the works. Those attachments here at the Cove will be very helpful.

If your procedure dots all the i's and crosses all the t's, you're home free. If not, you have an interesting choice: amend your large-system procedure (and possibly burden the folks who can still operate by the large-system document), or create a supplemental procedure for the small system only.
Ahh.. the devil as you suggested. I don't think I can exert influence on the large system. It sounds like I will need to create procedures for the small system, and assure compliance within the large system. That, may be the tricky tightrope to walk.
 
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CliffK

#4
Re: Drafting Quality Manual for ISO17025

Brad,

Who is your accreditation body?

Or have you selected one yet?
 
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CliffK

#5
Re: Drafting Quality Manual for ISO17025

Ahh.. the devil as you suggested. I don't think I can exert influence on the large system. It sounds like I will need to create procedures for the small system, and assure compliance within the large system. That, may be the tricky tightrope to walk.
Brad, it may not be as bad as all that. Just be careful how you state the scope and purpose. To beat up on Purchasing as a quick example:

This work instruction describes the policy and procedures by which the small quality system conforms to the purchasing requirements of ISO/IEC 17025.

The scope of this work instruction includes only services and supplies for laboratories operating according to ISO/IEC 17025.
Or words to similar effect.

Also, why don't you start a separate thread for this question so it can get the attention it deserves.
 

BradM

Staff member
Admin
#6
Re: Drafting Quality Manual for ISO17025

Brad,

Who is your accreditation body?

Or have you selected one yet?
No, I have not selected one yet, Cliff. I am still in the information gathering phase on this. My boss will probably want a scope. I'm in Texas, suggestions are welcome. If any of you are skittish about conflict of interest and all, PM me with your suggestions.

Brad, it may not be as bad as all that. Just be careful how you state the scope and purpose. To beat up on Purchasing as a quick example:

This work instruction describes the policy and procedures by which the small quality system conforms to the purchasing requirements of ISO/IEC 17025.​

The scope of this work instruction includes only services and supplies for laboratories operating according to ISO/IEC 17025.​
Or words to similar effect.

Also, why don't you start a separate thread for this question so it can get the attention it deserves.
Ok, will do.
 

BradM

Staff member
Admin
#7
What depth of procedure needed in small system

Brad, it may not be as bad as all that. Just be careful how you state the scope and purpose. To beat up on Purchasing as a quick example:

This work instruction describes the policy and procedures by which the small quality system conforms to the purchasing requirements of ISO/IEC 17025.​
The scope of this work instruction includes only services and supplies for laboratories operating according to ISO/IEC 17025.​
Or words to similar effect.
Ok, so this is the essence of the gap analysis. Determine where the existing large system is deficient (in the requirements of 17025) and address those in the small system. If I understood Jennifer's (and the others) post on the other thread, there is no need to have formal "this is in accordance with ..... large system reference). We willl need to focus on gaps in the small system documents.
 
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Ken K

#8
Re: ISO17025- How to Integrate with current QMS

Brad, we went through a similar scenario in 2001. After some discussion with our auditor, we decided to keep our ISO17025 accreditation separate from our TS QMS.

We do reference certain parts of it but thats about it. It has worked well for us and we have had no problems keeping the lab separate. It drives our TS auditor nuts, but he spends very little time in the lab now:agree1:
 
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crendfrey

#9
Re: ISO17025- How to Integrate with current QMS

Greetings Brad,
If I may make a suggestion…..

I know very little about 9000

Do your comparison with your existing documents and the 17025:2005 standard.
Then start cutting and pasting. Add what you need, throw out the rest. KEEP IT SIMPLE. Small entities need less convolutions due to their size which simplifies the communication requirements even right down to streamlining corrective, preventive actions and improvement.
Pay particular attention ( as stated previously)to Purchasing calibrations for equipment standards, consumables for calibration/testing if you use them, and standards themselves. This part is unforgiving.
Training and qualifications are a big issue.
Section 5 should be different than just a management system that you have.
You must also pay attention to the notes as they will be scrutinized. Not to the point of “Shall” but needs to be incorporated “where practical”
Uncertainty can be a bear. You must understand your budgets.:bonk:
Proficiency testing seems like a pain but actually turns into an excellent tool.
You will do just fine.
Remember the all important “what does this mean to us”
9 times out of 10 you will already be doing the requirement as a mater of rote. The trick is to document it in an acceptable way.
 

Hershal

Metrologist-Auditor
Staff member
Super Moderator
#10
Re: ISO17025- How to Integrate with current QMS

OK.....take a deep breath.....you identified some good procedures.....but in the QMS there are differences between 9K and ANS/ISO/IEC 17025, in that 9K is NOT meant specifically for a laboratory, and 17025 is.....

The purchasing is one example, for example, under 17025 you need to identify and control the critical consummables and services.....

Two other and more crucial components are Management Review and internal audit.....Management Review has a prescriptive agenda that must be followed.....now, depending on accrediting bodies (ABs), and I can't speak for A2LA, L-A-B, NVLAP, or ACLASS, only for the one I work for on this.....you can combine or rename the topics, so long as all are addressed identifiably and the minutes reflect that.....internal audit has two parts, the QMS and the technical part, and both must be audited.....

Now, the heart of 17025 is the technical aspects of the laboratory operations.....that is where the rubber meets the road as it were.....

Someone earlier mentioned selecting an AB, and to do yourself justice you should get quotes from ALL the ABs, and talk to the Staff person at the AB before signing with any AB.....the five in the U.S. that are internationally recognized are: IAS, L-A-B, A2LA, NVLAP, and ACLASS (I use the more known name for ACLASS, they may have changed names, not sure about that)

Keep putting the questions up and the discussion going.....
 
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