CE marked medical device - do they need UKAS certified calibration provider

[MarkWSmith]

Hi Everyone,

I'm just new to the forum - looks amazing amount of information. Don't know its take so long find it

Background A company's medical device is CE marked and through an audit I conducted found that the calibration provider is not UKAS certified, however they do work to 17025 guidelines and have ISO9001 and showed me a GAP analysis to get them to 17025 - however its a few years old so I don't have confidence they are actively working toward it
So, my Question is: Is having a UKAS certification a requirement for this supplier since the medical device manufacturer has ISO13485 and ships devices world wide?

Any guidance much appreciated.

Now, Im off to read the forums

 

[Ed Panek]

I am assuming this is a supplier of yours.

We handle suppliers as follows:

The supplier risk category
Our ability to audit suppliers technically
Any mitigation provided by certifications (ISO 17025)

For example, if it was a very low risk supplier we might just do a survey on their QMS -Done

A more complicated supplier we could do a partial survey audit with a copy of their certification

A very critical and highly technical supplier we could perform an onsite audit and focus on key areas that control the Quality of the parts they supply for our product. We might also require ISO 13485/17025/9001 certification as well and a VERY detailed SQA.

 

[Enghabashy]

Hi Everyone,

I'm just new to the forum - looks amazing amount of information. Don't know its take so long find it

Background A company's medical device is CE marked and through an audit I conducted found that the calibration provider is not UKAS certified, however they do work to 17025 guidelines and have ISO9001 and showed me a GAP analysis to get them to 17025 - however its a few years old so I don't have confidence they are actively working toward it
So, my Question is: Is having a UKAS certification a requirement for this supplier since the medical device manufacturer has ISO13485 and ships devices world wide?

Any guidance much appreciated.

Now, Im off to read the forums

if the accreditation is requirement of your management system ' therefore you should refer to UKAS web.; search about accredit bodies regarding Lab. calibration , you can find : 1- the valid list of current Labs. , 2- the withdraw list , --& so on ; the certificate of accreditation is not enough to check only but you must refer to accreditation scope as well for each lab. scope.
* remember that : 1- many labs have limited accredit scope but providing many service out of scope of accreditation ; 2- the calibration certificate issued from any lab. must reflect the accreditation number & the logo of accreditation ; otherwise if not'---, the certificate should be without the logo & the accreditation number , if you find any deviation ' you shall stop the relation & raise notification / complaint to UKAS.

 

[dwperron]

Hi Everyone,

I'm just new to the forum - looks amazing amount of information. Don't know its take so long find it

Background A company's medical device is CE marked and through an audit I conducted found that the calibration provider is not UKAS certified, however they do work to 17025 guidelines and have ISO9001 and showed me a GAP analysis to get them to 17025 - however its a few years old so I don't have confidence they are actively working toward it
So, my Question is: Is having a UKAS certification a requirement for this supplier since the medical device manufacturer has ISO13485 and ships devices world wide?

Any guidance much appreciated.

Now, Im off to read the forums

OK, let's view the vagueries here.
ISO 13485 does not reference ISO 17025, there is no requirement there.
ISO 13485, when it comes to adequacy of calibrations in section 7.6, has a guidance note:
"NOTE Further information can be found in ISO 10012. "

So lets see what ISO 10012 has to say.
In section 6.4 Outside Suppliers, there is a Guidance note that reads:
"Guidance
If an outside supplier is used for testing or calibration, the supplier should be able to demonstrate technical
competence to a laboratory standard such as ISO/IEC 17025. Products and services provided by outside
suppliers might require verification to the specified requirements. "
The verbiage is a bit mushy here, with the "should be able to" and "might require" wording.
There is no statement requiring accreditation to ISO 17025, just that they should be competent like a 17025 laboratory.

Basically, my guidance would be that if you are using an ISO 17025 accredited laboratory you will be safe in audits.
If you choose some other laboratory you should be prepared to have to provide "verification to the specified requirements" of ISO 10012 on your own.

 

[MarkWSmith]

Sorry it took me a while to come back and say thank you for the guidance. Our supplier should have the certification so I'm working with them on an implementation plan for this year.

Thanks everyone for the advice - very much appreciated.