Is accreditation to ISO 17025 really necessary?

I work for a medical device manufacturer and am undergoing an ISO 9001 and ISO 13485 audit this week. We have 4 calibration labs on the AVL. 2 of them are registered to ISO 9001 but not 17025. It is not in our documented policy to require 17025, other than for a few pieces of equipment. The equipment that requires calibration to 17025 is noted on the calibration log. The auditor is saying that even though certification to 17025 is not required in the standards that he is being advised by his reviewers to write action requests for company's using labs that are certified. Have you heard of this? What is the industry norm? Should I look to replace the labs even though I am happy with thier work?

Re: Is certification to ISO 17025 really necessary?

You would be better served going to 17025 labs exclusively, better results, true measurements, certified technians,

But the auditor is branching into the realm of opinion and is out of scope. If the standards and your procedures do not state that your outside cal labs needs to be 17025 then their is no non-conformance. IMO when 3rd party auditors and their employers start making these "suggestions" they have crossed the line to consulting. In an audit it conforms or it does not.

1. We don't have a lot of choices when it comes to some of the equipment, but I agree with using 17025 labs when possible.
2. That is what I thought.

I always bristle at the "because I said so" approach and I'd want to see this directive of theirs. Show me the shall...

I just saw a typo in my OP. It should say....
"The auditor is saying that even though certification to 17025 is not required in the standards that he is being advised by his reviewers to write action requests for company's NOT using labs that are certified."
Sorry for that.

I asked him to show me where he said that we are required to use certified labs and that is when he said that he was "advised" to write the action request. In addition, he would only write an observation now but other auditors are likely to write an action request.

Since when are auditors writing action requests based on the reviewers opinion?

Bunny said:

I work for a medical device manufacturer and am undergoing an ISO 9001 and ISO 13485 audit this week. We have 4 calibration labs on the AVL. 2 of them are registered to ISO 9001 but not 17025. It is not in our documented policy to require 17025, other than for a few pieces of equipment. The equipment that requires calibration to 17025 is noted on the calibration log. The auditor is saying that even though certification to 17025 is not required in the standards that he is being advised by his reviewers to write action requests for company's using labs that are certified. Have you heard of this? What is the industry norm? Should I look to replace the labs even though I am happy with thier work?

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If the use of ISO 17021 accredited labs is not required, then you should not have to worry. The auditor can not even advise or suggest!

Stijloor.

Bunny said:

Since when are auditors writing action requests based on the reviewers opinion?

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If "action requests" are the same as nonconformities, they can't. The definition of nonconformity is "non-fulfilment of a requirement" in ISO 9000, the normative reference for ISO 13485 terms. By definition, if there is no requirement for ISO 17025 accreditation there is no nonconformity. If they write one anyway, it's time to use the CB's appeals process.

So far, he said it will be an observation and we are not required to act on an observation. But I do not want an observation if it doesn't warrant it.

This isn't, by any stretch of the imagination, "consulting". It is nothing more than an idea, based on the fact that some labs are accredited to ISO/IEC 17025.

If the companies you currently use aren't accredited, and there's little choice, then the auditor may not know this fact - they just spout a 'nice' comment without consideration of what the effects of that are. No harm, no foul...

Bunny said:

I work for a medical device manufacturer and am undergoing an ISO 9001 and ISO 13485 audit this week. We have 4 calibration labs on the AVL. 2 of them are registered to ISO 9001 but not 17025. It is not in our documented policy to require 17025, other than for a few pieces of equipment. The equipment that requires calibration to 17025 is noted on the calibration log. The auditor is saying that even though certification to 17025 is not required in the standards that he is being advised by his reviewers to write action requests for company's using labs that are certified. Have you heard of this? What is the industry norm? Should I look to replace the labs even though I am happy with thier work?

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Bunny, I have never heard of such a requirement. Now... I have heard of allowing the accreditation to take the place of some lengthy supplier evaluation, questionnaire and such. But not sure what value it would be to make such an action.

The medical device industry has some very unique systems and equipment. To state that all your equipment will be calibrated by an accredited source, might 'paint yourself into a corner' so to speak. Sometimes the only individual to verify an instrument is the MFG. And many of them (judging by their certificates ) are a long way from 17025 requirements.

So I would take it as a suggestion, document that you will seek an accredited provider when it meets your business/process decisions, and move on.