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TS 16949 In-House Calibration Requirements - Certification Required?

G

Goddess of Quality

#11
Re: In-House Calibration - Certification Required?

I have written into our procedures that some of our "measuring devices" can be "validated" in house. We have a set of devices (gauges) that are used daily on the production floor and a "master" set that is secured in the Quality Department. (This Master set is Calibrated annually by a Certified 3rd party) The production set is validated quarterly against the Master set and is deemed acceptable if found within the preset tolerances. I have never had any auditor take issue with this method. As an added bonus it helps my company save a substantial amount of money in calibration costs :)
 
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A

amanbhai

#12
Re: In-House Calibration - Certification Required?

The scope of ISO/IEC 17025:2005 says" Subclause 1.2 this International Standard is applicable to all orgs. performing tests and/ or calibrations. These incluse, for example 1st-, second and thrird party labs, and labs where testing and/ or calibrations forms part of inspection and product crtification."
:thanks:
 

Helmut Jilling

Auditor / Consultant
#13
Re: In-House Calibration - Certification Required?

There are still some auditors that believe an internal lab should be "Accredited" to 17025.
Auditors may "believe" anything they wish, but it is not a requirement. Auditors may express opinions if they are helpful to a client, but cannot impose them on the auditee, nor write nonconformities against them. This sounds like an inexperienced auditor.
 
D

dbzman

#14
Re: In-House Calibration - Certification Required?

Auditors may "believe" anything they wish, but it is not a requirement. Auditors may express opinions if they are helpful to a client, but cannot impose them on the auditee, nor write nonconformities against them. This sounds like an inexperienced auditor.
I have encountered this type of auditor before, hence this thread. I was worried that an auditor would pick apart our attempt.

In the past I have appealed findings but not always won.

Thanks!
:thanx:
 

qusys

Trusted Information Resource
#15
Re: In-House Calibration - Certification Required?

Simple rules...;)

An in-house (calibration) lab does not need to be accredited, but must have a scope statement.

An external lab must be ISO 17025 accredited.

(The word is "accredited", not certified ;))

Stijloor.
Hi Stijloor
What could be the difference between "accredited" and " certified"?

Certified external lab shall have the certificate of 17025 released by a CB, while accredited no, but they should demonstrate they are compliant to ISO 17025, is it true??
Sometimes people uses certified and accredited with the same meaning.

Thks for clarifying:bigwave:
 

Stijloor

Staff member
Super Moderator
#16
Re: In-House Calibration - Certification Required?

Hi Stijloor
What could be the difference between "accredited" and " certified"?

Certified external lab shall have the certificate of 17025 released by a CB, while accredited no, but they should demonstrate they are compliant to ISO 17025, is it true??
Sometimes people uses certified and accredited with the same meaning.

Thks for clarifying:bigwave:
This article from Quality Magazine explains it nicely.

Stijloor.
 
G

gfreely

#18
Re: In-House Calibration - Certification Required?

:2cents:

I created an in-house calibration program for a previous employer. I was the internal metrologist, documentation specialist, and program/lab manager for the project.
I obtained manufacturer specs and procedures (free) for all of the equipment I would be calibrating. For those items with no procedures (everything has SOME sort of specs from the mfg), I wrote them. I created a database (free - until we decided to go with Fluke's MET-Track) and got with our Quality Manager to work out the procedural issues to comply with our 9001:2000 requirements. We planned and bought a few standards. Most of the expensive ones were used but we had them cal'd at a 17025 lab so I could keep the data on file each year for uncertainty, etc. I got labels (cheap), supplies (alcohol, leads, batteries, etc - also fairly cheap), and created a Cert with all the required info therein (which pulled from the Fluke database so it was sweet).
We used outside vendors for items which required expensive standards (RF, power, etc) but ended up saving nearly $50k the first year on calibration costs.
It takes some requirement research, but if you have someone qualified to do it, it can be a huge money-saver in the long run.
The company, before I got there, was using a local company and had a contract "program manager" and was spending mega-bucks to cal what was primarily basic, bench-top TMDE (Fluke 45s, calipers, etc).
It's not a fast process, and not something to be taken lightly as it can really put a kink in your day if all the bases aren't covered come audit time. Our first audit after I got it up and running went smoothly when I explained everything to the auditor and showed him my documentation. :agree1:

Unless your "guiding document" spells out something in particular, creating and setting up this type of program can meet all of most typical requirements, such as 9001.
 
D

Dave Dunn

#19
Re: In-House Calibration - Certification Required?

I worked for a company that was TS16949 for a long time that calibrated many of its gages internally. The big things the auditors looked for were that procedures for the calibration were in place, that the master standards used to do the calibration were within calibration themselves at the time of gage calibration, and that the calibration of the masters was traceable to a national certification body such as NIST. I also found it to be good to document when a gage was taken out of use if it could not be calibrated before its due date. As noted above too, make sure any gages you calibrate are in your lab scope.
 
A

abcauto

#20
What is mean by IMTE?

Dear all,
Please tell me What is mean by IMTE? It is regarding to Gauges?

Thanks
:agree:

ANAND
 
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