What is the ISO 17025 Certified Laboratory Requirement for External Calibration?

[Sean Kelley]

We are planning to make a change to our procedure and allow calibration of safety and environmetal equipment by non 17025 sources when the equipment is determined not to impact product quality. We will encourage them but in some cases it is difficult to find a certified calibration service for certain devices. Examples of equipment that do not affect product quality and would not fall under this accredited requirement include emission equipment, safety related confined space / atmospheric, monitoring equipment, industrial hygiene sampling equipment and medical testing equipment.

 

[Stijloor]

A Quick Bump!

Can someone help Sean?

Thank you very much!!

 

[AndyN]

We are planning to make a change to our procedure and allow calibration of safety and environmental equipment by non 17025 sources <snip>

Before you make a blanket statement about being difficult to find a source, have you contacted the accreditation bodies to see if they can help locate a lab? A significant part of calibration of any equipment is knowing how well it was done - hence accreditation. You might want to ask yourself - if getting an accurate result isn't so important, why spend the money with a supplier who can't demonstrate an accurate result? If the labs you are using don't want to be accredited (who knows how many other customers like you are asking?) then make them deliver their uncertainties etc. so you can have some confidence in their results...

 

[TTE Pipette guy]

We are planning to make a change to our procedure and allow calibration of safety and environmental equipment by non 17025 sources <snip>

Hey Sean,

As an accredited pipette calibration lab in XXXXXXX. Be careful of labs accredited to ISO 17025. In summary, ISO 17025 requires labs to have a process and follow it. ISO 17025 can leave labs room enough to design their own PROCEDURES that may or may not comply with the way that certain instruments are to be appropriately and correctly serviced. When shopping for a company, be sure to look over their actual procedures, and choose a reputable company based on this.

 

[AndyN]

Hey Sean,

As an accredited pipette calibration lab in XXXXXXX. Be careful of labs accredited to ISO 17025. In summary, ISO 17025 requires labs to have a process and follow it.

To be accredited to ISO/IEC 17025 is more than "say what you do, do what you say"! The lab must demonstrate competency in the discipline. The accreditation auditor is competent/experienced in the calibration/testing done by the lab and must have determined their measurement uncertainty etc.

I can't agree with your statement that they can have a process/procedure and that's all!

 

[BradM]

Before you make a blanket statement about being difficult to find a source, have you contacted the accreditation bodies to see if they can help locate a lab? A significant part of calibration of any equipment is knowing how well it was done - hence accreditation. You might want to ask yourself - if getting an accurate result isn't so important, why spend the money with a supplier who can't demonstrate an accurate result? If the labs you are using don't want to be accredited (who knows how many other customers like you are asking?) then make them deliver their uncertainties etc. so you can have some confidence in their results...

Along with Andy's good suggestion, you can check some accredited calibration sources to see their range of who they have site-sourced. Sometimes they may know of vendors who can perform services that may not be known to you.

 

[jelly1921]

We are planning to make a change to our procedure and allow calibration of safety and environmetal equipment by non 17025 sources when the equipment is determined not to impact product quality. We will encourage them but in some cases it is difficult to find a certified calibration service for certain devices. Examples of equipment that do not affect product quality and would not fall under this accredited requirement include emission equipment, safety related confined space / atmospheric, monitoring equipment, industrial hygiene sampling equipment and medical testing equipment.

If you re-read 7.6, you will find "The organization shall determine the monitoring and measurement to be undertaken and the monitoring and measuring equipment needed to provide evidence of conformity of product to determined requirements"

All sub-clauses under it have the same purpose. I, personally, don't think 7.6.3.2 is a mandatory requriement for EHS equipment, unless your procedure want to. But there are some statutory and regulatory requirements for EHS equipment calibration you have to follow.

Jelly

 

[Jen Kirley]

We are planning to make a change to our procedure and allow calibration of safety and environmetal equipment by non 17025 sources when the equipment is determined not to impact product quality. We will encourage them but in some cases it is difficult to find a certified calibration service for certain devices. Examples of equipment that do not affect product quality and would not fall under this accredited requirement include emission equipment, safety related confined space / atmospheric, monitoring equipment, industrial hygiene sampling equipment and medical testing equipment.

TS 16949 allows using a non-accredited calibration lab if the customer approves it. You could rightfully claim safety system and emission devices are outside the scope of your system under TS16949, but instruments used in your QMS would be expected to follow the accredited lab requirement unless you get approval not to.

 

[Hershal]

We are planning to make a change to our procedure and allow calibration of safety and environmetal equipment by non 17025 sources when the equipment is determined not to impact product quality. We will encourage them but in some cases it is difficult to find a certified calibration service for certain devices. Examples of equipment that do not affect product quality and would not fall under this accredited requirement include emission equipment, safety related confined space / atmospheric, monitoring equipment, industrial hygiene sampling equipment and medical testing equipment.

Sean, although you may have the requirement for some fields, accredited labs exist in several of the fields listed. However, calibration will typically focus on disciplines, NOT specifics. Therefore, the focus must be on the discipine involved, not specific equipment or even specific application.