How to Integrate ISO 17025 with current QMS

BradM

Staff member
Admin
#11
First, a big thank you :agree1: goes out to all who have provided assistance so far; online and offline. It truly is appreciated. For those offering help, beware! I’ll probably take you up on it! :lol:

While I do have knowledge on many areas that I am asking about, I am also way too close to this one. Thus, I need some objectivity on this, so I do appreciate the input from all!

1. Policies/ procedures

Now, what I am envisioning is writing a sub-QMS for the “small” system. I also see it as a three-tiered system. The top procedures would outline the quality system. The middle section would encompass purchasing, management responsibility, and uncertainty calculations. Finally, the third tier would be the work instructions. At some point in the system, I will need to meet with our quality folks in charge of our QMS on this, as I believe they will need to accept the 17025 in lieu of the 9001 QMS.

2. Uncertainty calculations

I would like to see if it is feasible to go with what we currently have for the technical portion. We have established at least 4 to 1 accuracy ratios for our standards. We have a few less than 4 to 1, as the current technology limits the possible standards. This is the fundamental comparison of the tolerance of our standard, compared to the tolerance of the U.U.T.

We have not performed extensive uncertainty calculations. This is due to two components- 1) Assuring proper accuracy ratios has been deemed sufficient; 2) we have somewhere between 75-175 standards.:tg: Of course, these (accuracies) are documented in several places within the system. I do need to get these into one document.

3. AB/ consultant

You state to get an AB sooner rather than later. But, if there is really no known robust system even close to 17025 requirements in-place, what value is gained in the initial stage? It seems to me you would want, say a consultant’s help, to develop the system. Then comes the work of the auditor by identifying initial gaps, efficacy of the system, etc. What value comes from getting the AB involved so early in the game?


Your comments, input, are welcome!:bigwave:
 
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BradM

Staff member
Admin
#12
Hello all!

As follow-ups to the above questions, another question (in addition to that question :tg:) came to mind. I realize who you use for your higher-order calibration needs to be scrutized. However, I'm pretty happy with who we currently use. Can you 'grandfather' calibration sources into the program?
 
B

Benjamin28

#13
It wouldn't fly with an AB auditor to hear "we grandfathered this company in due to their outstanding and consistent performance", you would still need to show evidence of their compliance with ISO 17025, either through audits conducted, third party approvals, or similar methods.

*The laboratory shall maintain a register of all subcontractors that it uses for tests and/or calibrations and a record of the evidence of compliance with this International Standard for the work in question.

*The laboratory shall evaluate suppliers of critical consumables, supplies and services which affect the quality of testing and calibration, and shall maintain records of these evaluations and list those approved.

As to your question regarding MU calculations, I don't believe an ISO 17025 AB will let you approach Measurement Uncertainty in this manner. In the past the 4:1 ratio was often used as a way out from calculating UOM, however, the industry has moved away from allowing this and more stress has been put on calculating realistic values for measurement uncertainty. From reading ISO 17025 there is very little wiggle room when it comes to UOM. From my scope of experience, if you calibrate anything in house you are required to have a procedure for estimating UOM and you must apply that procedure to your calibrations.
 

BradM

Staff member
Admin
#14
Thanks, Benjamin. Let me clarify the vendor question. For example, we have a lot of equipment that has to go to the mfg. for calibration, as we have not found suitable calibration sources for that equipment. Thus, I have to use them.

Too, I have another vendor that is not certified to 17025. However, they do excellent work, shows uncertainty, etc. They have been site-certified, but not under the extra scrutiny of 17025 (if extra scrutiny exists).

I just want to practice what I preach. I believe in improvement, but I don't feel the organization should be strapped for extra expenses and limited calibration vendors solely attributed to having to comply with the requirements. I hope that comes across appropriately..:D
 
C

CliffK

#15
Too, I have another vendor that is not certified to 17025. However, they do excellent work, shows uncertainty, etc. They have been site-certified, but not under the extra scrutiny of 17025 (if extra scrutiny exists).

I just want to practice what I preach. I believe in improvement, but I don't feel the organization should be strapped for extra expenses and limited calibration vendors solely attributed to having to comply with the requirements. I hope that comes across appropriately..:D
Benjamin28 pretty much has it right.

A2LA (can't speak about other AB's) does permit exceptions to the 17025-only requirement, but usually only in the case of unavailability of accredited calibrators.

If you want to save money on calibration, maybe you can stretch the interval. Twelve months is the generally accepted interval, but there's no science behind it. If you can show little or no drift (in comparison to your uncertainty budget) between intervals, you might be able to justify extending the interval.

This would be even more true if you used quality control activities such as repeated runs on a single sample or retesting of retains. Such activities could allow you to detect instrument problems real time and schedule an early calibration if applicable.

To answer your other question, 17025 is a much higher bar than 9001.
 

BradM

Staff member
Admin
#16
Thank you guys.:yes:

I don't think the issue is paying for a good calibration. Quality is not questioned. When I spoke of expense, that would be the additional expense of having to replace existing vendors that are adequately serving our business needs solely based on a stringent (but voluntary) requirement.

We have a lot of equipment, and much of it is not mainstream. I want to improve our operation, and not put ourselves in a corner, so to speak, by limiting who can perform work.

Keep the thoughts coming.
 
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CliffK

#17
Thank you guys.:yes:

I don't think the issue is paying for a good calibration. Quality is not questioned. When I spoke of expense, that would be the additional expense of having to replace existing vendors that are adequately serving our business needs solely based on a stringent (but voluntary) requirement.

We have a lot of equipment, and much of it is not mainstream. I want to improve our operation, and not put ourselves in a corner, so to speak, by limiting who can perform work.

Keep the thoughts coming.
I see your point. Unfortunately the AB guys seem to be pretty hard-headed about this:(.

Is it a conflict of interest? I think so.
 

Hershal

Metrologist-Auditor
Staff member
Super Moderator
#18
This is the kind of question to use to help select your AB.

Yes, ANS/ISO/IEC 17025 does in fact allow use of non-accredited calibration providers; in fact under the standard accreditation is not a requirement - BUT - your calibration providers need to be able to support your accreditation, so you must be able to show they can do that.....

One way is to audit them yourself, taking along a metrology professional with experience in that discipline, and have the associated costs and time and so forth, or if an accredited provider is avaialable, then that becomes easier and less expensive.....and if there is no other provider for that, then the due diligence and documentation and (depending on the AB) you should be OK.

AB assessors can be a bit hard-headed as one wrote further down, and we have a requirement to be, up to a point.....but where the standard gives some leeway then the assessor needs to remember that also.....

So remember all this when you start shopping for your AB, and please DO ask the tough questions.....

Who will be assigned to shepherd your file?
Can you speak to the Staff who will be your contact and even be at the assessment?

Come up with other questions also and use them.
 

BradM

Staff member
Admin
#19
Three days were spent in training covering IS017025. A few observations:
  • IAS did a very professional job of covering the standard. Also, several representatives for IAS were there. I think that provides a good strong image that the company generally agrees with philosophy and approach, there is a united front, and they are able to add to the discussion.
  • As to the specification itself, seems to be a decent-enough document. One of the sections that surprised me regarding internal audit reports:
4.14.3 The area of activity audited, the audit findings and corrective actions that arise from them shall be
recorded.
I thought “Corrective Action” was reserved language, and would not seem appropriate to appear on an auditors report.

I realize the standard is meant to be broad; to say what to do, and not how to do it. Do you feel that the standard should be a little more vociferous on the qualifications of the internal auditors?
4.14.1 Such audits shall be carried out by trained and qualified personnel who are, wherever
resources permit, independent of the activity to be audited.
Contrast that to the near absolute requirement that all calibration vendors must be accredited labs. Are we suggesting that is it much more egregious to- use a vendor that may have a good program but hasn’t “paid” for 17025; than having woefully inept internal auditors?

It was explained to be that most accreditors will cite for using a non-accredited lab, then the customer “appeals” through the Corrective Action for the nonconformance. Why would I want (and why would you want a system) to enter with a known problem? I agree it should be highly preferred, but seems a bit aggressive to mandate it. Your thoughts…
 
C

CliffK

#20
I thought “Corrective Action” was reserved language, and would not seem appropriate to appear on an auditors report.
The audit report includes all audit activity, including follow up, presumably by the auditor. The auditor can explain how he cleared the NC
Contrast that to the near absolute requirement that all calibration vendors must be accredited labs. Are we suggesting that is it much more egregious to- use a vendor that may have a good program but hasn’t “paid” for 17025; than having woefully inept internal auditors?
A2LA, for one, reads audit reports closely and will not hesitate to comment on auditor qualifications. Woefully inept internal auditors will certainly attract unfavorable attention.
It was explained to be that most accreditors will cite for using a non-accredited lab, then the customer “appeals” through the Corrective Action for the nonconformance. Why would I want (and why would you want a system) to enter with a known problem?

It is not always possible to find an accredited calibration lab for all equipment. In that case you have no choice but to go through the silly citation-appeal-appeal granted cycle. Sometimes repeatedly.
 
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