Is ISO 17025 accreditation required under 21 CFR 820?

[ManTheDan88]

My company was recently audited by an outside vendor. The auditor was adamant that the companies we employ to calibrate our equipment must be ISO 17025 certified. He also cited 21 CFR 820.72 as the regulation for his claim
Most or even all of the companies that issue calibration certificates for us, calibrate using NIST traceable standards. So my first question is, under 21 CFR 820 is NIST standards enough for certification?
Also, we calibrate our balances and scales using NIST traceable weight standards that are certified by the state of New Jersey. Would it be enough through our own verification process with these weights, that we would not need an outside source for a second verification?
Our procedure states that all equipment should be calibrated on a annual basis.

 

[BradM]

Re: Is 17025 accreditation required under 21 CFR 820?

Welcome to the forum!

I don't have the Reqs in front of me. Did you look in the section and see what it says?

Now... Does the vendor have it specified in their purchasing requirements the calibration vendors are to be accredited?

 

[db]

Re: Is 17025 accreditation required under 21 CFR 820?

From 21CFR Part 820

Sec. 820.72 Inspection, measuring, and test equipment. ...
(1)Calibration standards. Calibration standards used for inspection,
measuring, and test equipment shall be traceable to national or
international standards. If national or international standards are
not practical or available, the manufacturer shall use an independent reproducible standard. If no applicable standard exists, the manufacturer shall establish and maintain an in-house standard.​

NIST would meet the national or international standards. 17025 is not mentioned, nor implied.

Edited for layout issues

 

[BradM]

Re: Is 17025 accreditation required under 21 CFR 820?

From 21CFR Part 820

Sec. 820.72 Inspection, measuring, and test equipment. ...
(1)Calibration standards. Calibration standards used for inspection,
measuring, and test equipment shall be traceable to national or
international standards. If national or international standards are
not practical or available, the manufacturer shall use an independent reproducible standard. If no applicable standard exists, the manufacturer shall establish and maintain an in-house standard.​

NIST would meet the national or international standards. 17025 is not mentioned, nor implied.

Edited for layout issues

Dave, thanks. I thought that was the case.

 

[Boingo-boingo]

The auditor was adamant that the companies we employ to calibrate our equipment must be ISO 17025 certified. He also cited 21 CFR 820.72 as the regulation for his claim

Unless the auditor found a customer requirement for you to flow down ISO 17025 accreditation to your suppliers, he is incorrect. The FDA QSR does NOT mandate laboratory accreditation to ISO 17025 for either internal nor external labs.

You can get some good guidance on FDA expectations concerning calibration systems @ (broken link removed)

 

[db]

...

You can get some good guidance on FDA expectations concerning calibration systems @ (broken link removed)

Excellent Link!

 

[ManTheDan88]

Awesome, thanks a bunch guys.