Scope Of ISO 17025 Certification - 3000 to 5000 pieces of equipment in the field

G

grantmaker

#1
Hi guys. I'm new to the forum and pretty new to the industry. I am very grateful to have this great resource available and my thanks to all who make it work so well.

I work for an ISO consulting firm but have not been exposed to a lot of 17025 issues other than reading the standard and related publications. My question involves the calculation of uncertainty where repeated measurements are taken at two or more load levels to calculate an expanded uncertainty. Budgets may also include uncertainties for wind, temperature, etc.

The calculations seem straightforward. My question has to do with the scope of the standard. What if someone has 3000 - 5000 pieces of equipment in the field that are calibrated annually or semi-annually? Perhaps only 1000 of these may be for 'quality critical' measurements. You can imagine the additional time and cost required to make the repeatibility studies. Many of the balance owners do not need (read 'will not pay for') any additional precision information these measurements provide so the service company would bear the expense of most of the additional cost.

Does the standard/registrar require a full blown budget for all 5000 instruments or does it require a budget and expanded uncertainty measurement for only the quality critical instruments?

Is is kosher to forego any physical measurements and instead use estimated uncertainties for most of the instruments?

Does the standard dictate what measurements must be made or does the customer (balance owner) dictate what levels of uncertainty, if any, are required.

The few people I've asked thus far seem to have differing opinions on this. Thanks in advance for your comments.

JR
 
Last edited by a moderator:
Elsmar Forum Sponsor
#2
Welcome to the Cove. You'll be in great hands with our ISO/IEC 17025 experts here.

Just a small point for your use in front of clients - it's not certification and registrars who service the 17025 standard, it's called accreditation and they're accreditation bodies. A small but significant difference and will help you look less like a 'newbie'.....;)
 

BradM

Staff member
Admin
#3
Hello, JR! Welcome to the Cove!:bigwave:

I went to a training session with some of Hershal's cohorts (that's one of our moderators here) and they stated that when you are being audit under 17025, they will expect you to demonstrate proficiency doing uncertainty analysis. That's not to say you will have it in place for every instrument that you do.

We are not 17025 accredited (yet); but have procedures and guidelines that are much in line with requirements outlined in the specification. We have chosen to perform risk analysis on all our measurement processes, and based on risk, determined which processes required an uncertainty analysis.

We are working on an optical measurement system that we deemed needed a risk uncertainty analysis.

Another trainer mentioned this: If your accuracy ratio is less than 4 to 1, you need to do an uncertainty analysis.

My suggestion: perform a risk analysis. On the critical processes, perform the uncertainty analysis, as that is where your payback will be.

We are glad you found the Cove!:bigwave:
 

Hershal

Metrologist-Auditor
Staff member
Super Moderator
#4
Grantmaker, welcome to the Cove!

You are right about various opinions being offered, that is the nature of uncertainty. The best thing to do is to take a good uncertainty course. It will not answer all the questions, but will help with the understanding. Also, take a course in ISO/IEC 17025 as that will help you understand the requirements better, which in turn will help your customers. There are likely entries for both courses in the calendar.

The situation you present is intriguing. The first idea I would present would be a thorough uncertainty study for each type of calibration and perhaps a shorter version for each model of equipment, but even that may be a significant challenge.

Just some iniial thoughts, hope this helps.
 
B

blueicecube

#5
Hi Grantmaker,

(para 2) - Are you saying that repeated repeating measurements for each 'calibration' point will increase your time & cost?

(para 3) - Do you calibrate the same instrument over and over again (yearly or semi-annually)?

(para 4) - Full blown budget is required for each calibration, yes.

"Is is kosher to forego any physical measurements and instead use estimated uncertainties for most of the instruments?"
- It's not kosher, but there is a way. Refer to GEUM Guide and you'll see there are 3 ways to treat the Repeatibility

"Does the standard dictate what measurements must be made or does the customer (balance owner) dictate what levels of uncertainty, if any, are required?"
- Nope, the owner must decide for themselves what level of uncertainty is acceptable to them.

Hope this helps.
 
Last edited by a moderator:
G

grantmaker

#6
Hey everyone. I have not checked this since I posted on Friday. Thanks so much for the comments. They are very, very helpful, especially about the need to take an uncertainty course or two.

To blueicecube. My comments on cost were related to the additional time required to do reapeatability measurements on the large number of quality-critical instruments (if needed). And yes, the instruments and scales will be calibrated at least annually. Many of them semi-annually, depending on the customer contract requirements.

JR
 
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