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

Big Jim

Super Moderator
#31
(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.
 
Elsmar Forum Sponsor

Hershal

Metrologist-Auditor
Staff member
Super Moderator
#32
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.

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

RCW

Quite Involved in Discussions
#33
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

#34
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

Super Moderator
#35
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.
 
#36
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
#37
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
Staff member
Super Moderator
#38
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

#39
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!
 
Thread starter Similar threads Forum Replies Date
M Accredited Calibration Sevice Provider using computerized system to issue calibration certificate Qualification and Validation (including 21 CFR Part 11) 3
M Accredited Calibration Sevice Provider using computerized system to issue calibration certificate General Measurement Device and Calibration Topics 2
G ISO 9001 and ISO 17025 - Measuring tools not in calibration system General Measurement Device and Calibration Topics 3
W Equipment for Oven Calibration, Uniformity and System Accuracy Tests AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6
Gman2 The current state of our Calibration System General Measurement Device and Calibration Topics 28
H Measurement System in Control if the Equipment requires Daily Calibration? Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 3
R Incorporating New Electronic Test Equipment into our Calibration System Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 5
J AS9100C Calibration System Compliance Requirements General Measurement Device and Calibration Topics 8
S QMS (Quality Management System) and Calibration Procedure ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 20
W Calibration Register - Traceability - Data Transfer to a New System General Measurement Device and Calibration Topics 7
3 Vision System Optical Calibration Standard General Measurement Device and Calibration Topics 6
F Calibration Issue - Continuous Temperature Monitoring System was not Acceptable General Measurement Device and Calibration Topics 7
M Druck DPI 620 Advanced Modular Calibration System General Measurement Device and Calibration Topics 1
AnaMariaVR2 Laboratory Equipment Quality System - Calibration, Maintenance and Inspection Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 10
S Do you include Penetremeters used in Radiography in your Calibration System General Measurement Device and Calibration Topics 2
T System Calibration vs. Component Calibration Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 3
R 3 Wire Thread Measuring System - Gage Calibration General Measurement Device and Calibration Topics 8
D Looking for a "User Friendly" calibration system software package Calibration and Metrology Software and Hardware 18
M Constant for thread gage calibration with the three wire system General Measurement Device and Calibration Topics 7
A TS16949 Calibration system - Concerned with Qualification of Administrator. IATF 16949 - Automotive Quality Systems Standard 3
K TS 16949 Calibration System Audit - What questions will they ask me? General Measurement Device and Calibration Topics 11
S Calibration System was In-House now Outside (External Service Provider) General Measurement Device and Calibration Topics 14
J Advice on Handling a Camera Vision System Calibration Master General Measurement Device and Calibration Topics 7
M How to implement a proper Calibration System? General Measurement Device and Calibration Topics 5
C Vision System which verifies the correct part is present - Calibration / Verification Calibration Frequency (Interval) 9
H Employee owned gages not entered in calibration system - AS9100 Clause 7.6 AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 16
F Digital Multimeter - Verification vs. Calibration MSA (Measurement System Analysis) Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 3
V Poke Yoke Gage Calibration - Do you have them in your calibration system? General Measurement Device and Calibration Topics 8
D Calibration - Out of Tolerance - Trace Back System General Measurement Device and Calibration Topics 1
M Calibration System - Finding Product Made with Out of Tolerance Torque Drivers General Measurement Device and Calibration Topics 7
J UPS owned shipping carton weight scales - Include this in my Calibration system? General Measurement Device and Calibration Topics 9
J Should weigh count scales be in the Calibration System? QS-9000 - American Automotive Manufacturers Standard 4
J Do Process gauges need to be in Calibration control system? QS-9000 - American Automotive Manufacturers Standard 2
I Calibration Items - Necessary to include the hand crimp tools into the system? General Measurement Device and Calibration Topics 10
lanley liao Question regarding the calibration of monitoring and measure equipment. Oil and Gas Industry Standards and Regulations 0
N IATF Calibration Lean in Manufacturing and Service Industries 3
Q Do these certificates of calibration meet ISO 9001 requirements for traceability to NIST? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
T Plug Gage Calibration Calibration and Metrology Software and Hardware 1
M Load Cell Calibration using a totalizer on a flow meter General Measurement Device and Calibration Topics 0
E Calibration Records needed ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
D Limited Range Calibration - 5000 lb Industrial floor scale General Measurement Device and Calibration Topics 3
D Calibration of Small Scales General Measurement Device and Calibration Topics 26
C How to Establish the Calibration & Measurement Capability (CMC)? ISO 17025 related Discussions 1
I IQOQ or just initial calibration required? General Measurement Device and Calibration Topics 3
B Calibration in real life ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
J Calibration cycle for monitoring & measuring tools used in medical device manufacturing General Measurement Device and Calibration Topics 5
A Is calibration of test weight required General Measurement Device and Calibration Topics 4
S Calibration Frequency for Slip Gauge Kit used for CMM Calibration? General Measurement Device and Calibration Topics 0
S Calibration/Verification of customer fixtures IATF 16949 - Automotive Quality Systems Standard 6
Ron Rompen Calibration by manufacturer ISO 17025 related Discussions 4

Similar threads

Top Bottom