Calibration system must meet ISO 10012, ISO 17025 or ANSI/NCSL Z540?

Big Jim

Admin
(1) I have a customer that is flowing down the requirement: "...test and measurement equipment services shall have a calibration system in compliance with the requirements of ISO10012, ISO17025 or ANSI/NCSL Z540..."

(2) ISO sect 7.6 states "where necessary to ensure valid results, measuring equipment shall (a) be calibrated or verified, or both, at specified intervals, or prior to use, against measurement standards traceable to international or national measurement standards."

So, can I choose not to calibrate measurement equipment but rather "verify prior to use..against measurement standards traceable to international or national measurement standards." and remain compliant with the customer requirement in point (1)?
cheers

Verifying that a measuring tool is in calibration is a calibration activity. It is my belief that the intent of the portion of 7.6 a that you cited indicates that ("calibrated or verified or both").

You can choose to do that activity at specified intervals or prior to use, whichever seems most appropriate for you. Don't forget that either way you do it, records are needed to show that it has been done.
 

Hershal

Metrologist-Auditor
Trusted Information Resource
Hi Jim, Brad,

Thank you for your response. The question stems from a customers view point that notes ISO9001:2008 as a requirement.

That being said we have equipment that gets repaired and overhauled which may need the use of calibrated inspection, measuring and test equipment.

Clause 7.6 of the standard does not reflect the use of calibration standards such as 17025 or Z540 that would be imposed upon an certified external calibration organization.

I'm not saying the contracted organization needs to be certified to the aforementioned standards but meets those requirements.

I believe the same requirements imposed on an external calibration centre should be followed by an in-house calibration centre. This would ensure consitent accurate results.

Bob, I tend to agree with you that management of the internal to the same principles of ISO/IEC 17025 as external accredited labs will certainly help strengthen your program.

You should obtain the ISO/IEC 17025 standard, then also get training in the standard and in uncertainty analysis, a requirement for traceability.

To assure traceability, you will need to have a chain of comparison to National standards held by NRC, and uncertainty at each step. For internal cal, you only need to have your standards calibrated by an external lab, such as accredited by CLAS to establish the chain, and also calculate the uncertainty of each type of internal cal.

To find a lab and maybe some additional information, this link may help you.

https://www.nrc-cnrc.gc.ca/eng/solutions/advisory/clas_index.html
 

RCW

Quite Involved in Discussions
Back to the originally topic of this post.....

Customer Purchase Order Conditions state:
Calibration Systems shall meet the applicable requirements of ISO 10012, ISO 17025 or ANSI/NCSL Z540-1.

I am reviewing requirements from my customer and it has the same statement as listed above with the exception of it requiring Z540.3, which is the newer edition of the ANSI spec.

The thing that has me confused the most is "meet the applicable requirements". So I can tell my customer, for anything he points out, "Oh that's not applicable." I really don't get the purpose of this whole requirement. Why throw out specific calibration spec requirements and leave a weasel way out of them? Maybe a lack of knowledge by the customer as to what they really want or need?
 
K

Ken11

As the Quality mgr. for an ISO 17025 accredited calibration and testing lab I would like to join this conversation. Many of our customers are facing this situation/problem right now.

As an accredited lab we have historically offered 2 types of calibrations to our customers. One is a 17025 accredited calibration and the other is a non-accredited "standard" calibration. Accredited calibration comes with an accredited calibration certificate. The certificate for "standard" calibration is not an accredited cert. There is a calibration cost difference with us doing more and charging more for an accredited calibration and cert. As an example, we have many customers manufacturing for the auto industry (some TS16949 certified and others not at that level), some want accredited calibrations and certs while others only want the standard level calibration.

About 3 years ago most accredited labs had their butts kicked over methods for calculating and reporting measurement uncertainties. Methods and reporting was, in reality, not standardized from lab to lab. Most of the accreditation bodies have improved this with most labs.

Most customers purchase orders to us state NIST traceability. NIST has stated that there are 6 requirements for meeting “traceability” from using traceable standards for the calibration to verified procedures/methods and verified technician training. NIST numbers don’t count. This isn’t a problem for us but where does the traceability requirement stop for most customers?

In the process of our lab staying in compliance with 17025 over the changes in measurement uncertainties, etc. and staying in business, we had to find out whether our customers needed 17025 accredited calibrations due to their certifications or customer requirements. Our calibrations are traceable to the SI through a National Laboratory. Most of our customers did not know if they needed accredited calibrations and certificates. Most still don’t know. We are now starting to get calls from customers who purchased standard calibrations as a cost savings and their auditors are stating they need accredited certs and writing a nonconformance. Many times these customers are a little upset.

I’m sorry for the long post. I hope to hear from some quality personnel and auditors about what is being expected from our manufacturing customers.
Thanks. :cool:
 

Big Jim

Admin
As the Quality mgr. for an ISO 17025 accredited calibration and testing lab I would like to join this conversation. Many of our customers are facing this situation/problem right now.

As an accredited lab we have historically offered 2 types of calibrations to our customers. One is a 17025 accredited calibration and the other is a non-accredited "standard" calibration. Accredited calibration comes with an accredited calibration certificate. The certificate for "standard" calibration is not an accredited cert. There is a calibration cost difference with us doing more and charging more for an accredited calibration and cert. As an example, we have many customers manufacturing for the auto industry (some TS16949 certified and others not at that level), some want accredited calibrations and certs while others only want the standard level calibration.

About 3 years ago most accredited labs had their butts kicked over methods for calculating and reporting measurement uncertainties. Methods and reporting was, in reality, not standardized from lab to lab. Most of the accreditation bodies have improved this with most labs.

Most customers purchase orders to us state NIST traceability. NIST has stated that there are 6 requirements for meeting “traceability” from using traceable standards for the calibration to verified procedures/methods and verified technician training. NIST numbers don’t count. This isn’t a problem for us but where does the traceability requirement stop for most customers?

In the process of our lab staying in compliance with 17025 over the changes in measurement uncertainties, etc. and staying in business, we had to find out whether our customers needed 17025 accredited calibrations due to their certifications or customer requirements. Our calibrations are traceable to the SI through a National Laboratory. Most of our customers did not know if they needed accredited calibrations and certificates. Most still don’t know. We are now starting to get calls from customers who purchased standard calibrations as a cost savings and their auditors are stating they need accredited certs and writing a nonconformance. Many times these customers are a little upset.

I’m sorry for the long post. I hope to hear from some quality personnel and auditors about what is being expected from our manufacturing customers.
Thanks. :cool:

I appreciate your post and adding some personal insight to the concern. Thank you for posting.

I'm amazed at how many times customers make requirements without understanding the impact of them. TS16949, I understand, requires that those that are certified to it use ISO 17025 accredited calibration companies. I'm not aware of any other standard that requires that level.

If you are not a TS 16949 certified company, and particularly if the customers is not either, you should ask why they need it and point out that having things calibrated to the 17025 level may add to the expense of a project which they would need to pass on.
 
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masinmike

mike perrine
I can tell you that I purchased and am using this standard right now to write my calibration procedure for our company. It is truly helping me structure my thoughts and sift our existing procedures into this one. Not using all of the items but most.

Mike
 

dwperron

Trusted Information Resource
Mike,

The customer requirement:
Customer Purchase Order Conditions state:
Calibration Systems shall meet the applicable requirements of ISO 10012, ISO 17025 or ANSI/NCSL Z540-1

This is the usual boilerplate that a commercial lab sees from customers. This is why most certificates include that same boilerplate in their certificates, stating that they do indeed meet those "applicable" requirements. Purchasing reads that on the certs and they are happy.

As for actually meeting customer requirements.... therein lies the rub. If the lab doesn't make the effort to determine what are "applicable requirements" they don't know what the customer really wants or needs. That takes time and effort, and often the customer doesn't have a clue as to what their requirements are!

As for making a calibration procedure for your company that uses one of those standards ("ISO 17025 Compliant" or some such verbiage), this will work until you run into a customer / auditor who asks you to prove that you are compliant. That can end up being like a 17025 audit. It might be better to just go all the way and become accredited instead of "compliant".
 

Hershal

Metrologist-Auditor
Trusted Information Resource
As a former accreditation assessor (over 500 assessments) and metrologist, and veteran, this at once rubs me raw and amuses me.

The contracting individual is working with legacy and current. It is unlikely that the one drawing up the contract actually knows this. Hence, the lab manager or one responsible for meeting contracts, MUST be up to date.

The standards do not support each other. Hence, the best option is to go to the most stringent standard, meaning any minor issues can be dealt with. But before an accreditation assessor, was Corporate, so I see both views.
 
M

Motol

We now have exactly the same requirement from one of our customers. We have chosen to meet the requirements of 10012, but I would like get quotes from consultants in the Chicago area to assist us with this. Web searches have produced no clear llinks. If anyone can provide leads, please contact me through Personal Message tool- Thanks!
 
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