ISO 17025, Laboratory Scope and Certifications Requests

[Joe.cmspin]

Good day to all, I am new to the QC Standards and ISO environment and have been tasked with rectifying a couple Minor NC's that were noted.

My question is, when requesting (CQI 9, CQI 11, ISO 17025, Lab Scopes, and ISO) Certifications from outside vendors, what verbiage do you use?

And can someone post examples of what is an acceptable form for audits?

Also, any information that would point me in the right direction for completing these tasks would be greatly appreciated.

Thank you in advance for your assistance, and have a great day!

J Rich

 

[dwperron]

Re: ISO 17025, Lab Scope and Certifications Requests

Welcome to our world!

First, when you are requesting a calibration from a vendor you need to do your due diligence. Not only do they need to be 17025 accredited (not just "compliant"!), the calibration you are seeking must be in their scope of accreditation. You can normally find a link to their scope of accreditation on the company web site, otherwise you need to find out who their accrediting body is and check on their web site for the scope.

When you find a lab that is accredited in the measurements you require, contact them requesting a 17025 accredited calibration. This is sufficient for most labs, but just to be safe you may need to request "with measurement uncertainties".

Ask the vendor if they would supply you with an example calibration certificate. Check it for the accreditation logo - this is what your auditors will be looking for. It is also good to send a copy to your auditor to see if they find it sufficient. In a perfect world any accredited calibration would be acceptable, but this isn't a perfect world.

Your calibration vendor should be glad to work with you. He should understand what your requirements are, but in specialized cases like AMS2750 or CQI it will be up to you to get things like calibration intervals and required calibration test points clearly stated so that you get the calibration data that you need. Let the vendor know what standards you are attempting to meet.

Good luck!

 

[Joe.cmspin]

Re: ISO 17025, Lab Scope and Certifications Requests

Thank you so very much! Been reading these manuals for a while and understandably they are very disjointed.

 

[BoardGuy]

Re: ISO 17025, Lab Scope and Certifications Requests

First, when you are requesting a calibration from a vendor you need to do your due diligence. Not only do they need to be 17025 accredited (not just "compliant"!), the calibration you are seeking must be in their scope of accreditation.

First of all this is not correct. Calibration providers only need to be ISO 17025 accredited if you or your customer require this. There is no magic requirement stating that calibration providers must be accredited. Having said this, when possible, you should use a accredited provider. BUT that does not mean they are any better at performing calibrations than a non-certified provider.

As related to ISO 17025 accredited providers, their full certification will list all calibration capabilities under their accredited . If they only send you the one page of the certification ask for scope attachments. Non ISO 17025 calibration providers should be able to supply a list of their capabilities for the service they perform. This should be part of your approval process to obtain this information.

 

[dwperron]

Re: ISO 17025, Lab Scope and Certifications Requests

I made the assumption that since he was asking about Lab Scopes, ISO 17025, CQI, and outside vendors that he was dealing with required accredited calibrations. This may not be a magic requirement, but the CQI standard now requires use of accredited labs:

New to this edition of CQI-9 is the requirement that external sources
providing calibrations shall be accredited to ISO/IEC17025 or other
national equivalent. Internal sources providing calibrations neednʼt be
accredited to ISO/IEC17025 however the calibrations they
provide must be done so in accordance with the intent of ISO/IEC17025
or other national equivalent.

Finally, the 17025 accredited lab may not provide a "better" calibration, but they will sure get you through an audit better.