Once upon a QMS - Is a Statement of Uncertainty a must for ISO 17025 accredited labs?

[UncertainInTbilisi]

Hi:
This is my first post. Please pardon me if i am on the wrong forum for this. I am a self taught misguided voice for quality in a emereging economy where ISO is something relatively new.
I am working in facility without a active QMS and my task is to set up a calibration program. Sounds simple until you have no authority for implementation; or a mentor to argue the finer points of compliance with. I have been invited to provide some guidance to a outside entity related to their recent audit findings.

In my past experience at a 13485 lab we used something called verification to side step the requirement for statements of uncertainty on in-house "calibration" documents. I need to find out if this is a generally accepted practice or if it was a the result of an agreement with our clients. Could it be used to defend the same practice in 17025 lab that is not engaged in providing calibration services for outside parties?

I am also curious about BSC certification reports. I did not speak with the auditor but I believe there may have been a question of uncertainty statements for BSC certification reports. In my past life, I hired a reputable company to do the BSC certification work, reviewed the report and filed it; without questioning anything beyond pass fail status. Our BSC template is one provided by a certified NSF 49 trainer, also lacking a statement of uncertainty. What is the rationale I can use to explain this away?

Thanks,
Dazed and Confused

 

[t.PoN]

Re: Once upon a QMS - Is a Statement of Uncertainty a must for ISO 17025 accredited l

Verification is one thing and calibration is another. refer to this thread

you need to have uncertainty in your calibration report to ensure your traceability (ILAC P-10 Clause 1.4).

beside, how would you reflect the equipment uncertainty in your uncertainty budget (ISO 17025 clause 5.4.6)?

for the Biosafety cabinet,
if it is used for something like a fumehood - i.e. for your own safety and not to control test conditions - , then verification/testing report will be enough, but i would not call it a "calibration Report".

unless your method require you to have something like a UV light within +- X. then u r ok

however, there is one important note here, selecting your calibration supplier should meet the iLac policy, i.e. accredited lab, cmc or national lab ...etc

 

[BradM]

Re: Once upon a QMS - Is a Statement of Uncertainty a must for ISO 17025 accredited l

Hi there! Thanks for posting.

Is this going to be an 17025 accredited facility? Do you have a requirement to have uncertainty calculated for all your measurement processes?

As part of developing your calibration program, I would start by developing a master procedure. In that, I would define what the terms calibration, maintenance (corrective/preventive) performance verification, etc. are. They mean different things to different people.

Once those are identified, I would assess the equipment in your facility based on risk/potential product impact and determine which type of activity is required. Also, remember to label appropriately, but... try to label once. So plan your program up front so you aren't having to repeat things.

Are you going to be performing air particle/ HEPA filter testing in-house, or by an outside vendor?

 

[UncertainInTbilisi]

Re: Once upon a QMS - Is a Statement of Uncertainty a must for ISO 17025 accredited l

Thank you both. Brad, you are preaching to the choir, the one that has been ignored until now. I arrived here fat dumb and happy hoping to set up a good system with meaningful SOPs and reliable methods. could whine for hours but right now what i need is some quality speak. Yes we are performing our own certification of BSCs. We are trying to arrange NFS accreditation for local nationals here at our facility. The lab i am assisting will be 17025 Accredited. There is American money involved in the project which brings up NSF. I have argued against accreditation because we are only certifying our own equipment and none of the guys speak English fluently. Providing service for another lab makes accreditation of the technician more important.
Back to the point; can you argue against the uncertianty statement if (and only if) it is in-house verification by compairison to a traceable master gauge?

My lab? Accreditation? We dont need no ... (yet, but the day will come

 

[BradM]

Re: Once upon a QMS - Is a Statement of Uncertainty a must for ISO 17025 accredited l

I guess I'm not sure what you're asking. Any measurement system is going to have uncertainty associated with it, if nothing else, no two people do anything identical.

I would consult with your Accreditation Body regarding what they will expect to see.

 

[jleond]

Re: Once upon a QMS - Is a Statement of Uncertainty a must for ISO 17025 accredited l

Hello all,

We are developing an internal calibrations system (for micrometers, calipers, digital indicators) and AFAIK reporting the Uncertainty is not mandatory for internal or in-house calibrations unless we were a 17025 certified lab.

Is there a standard or something "official" that mentions or states that the uncertainty reporting isn?t required / mandatory for internal calibration?

TIA

 

[UncertainInTbilisi]

Re: Once upon a QMS - Is a Statement of Uncertainty a must for ISO 17025 accredited l

Hi the answer that BradM provided above is the very best advice.
You can address this requirement in your calibration SOPs or in your Quality manual. Don't forget your customer may require it.

I hope this helps some.

 

[Hershal]

Re: Once upon a QMS - Is a Statement of Uncertainty a must for ISO 17025 accredited l

Short answer to the question is YES, there must be a statement of uncertainty.

However, that does not necessarily mean specific uncertainty. Clause 5.10.4.2.b allows use of a metrological specification. In the US, the 4:1 TUR is such a specification under the American National Standard ANSI/NCSL Z540.3-2006.

 

[jleond]

Re: Once upon a QMS - Is a Statement of Uncertainty a must for ISO 17025 accredited l

Thanks, UncertainInTbilisi and Hershal!