Do Microbiology Testing Labs need to use ISO 17025 accredited vendors?

[Suchitra]

Hi,

I want to know if we need ISO 17025 accreditation for in-house Microbiology testing lab for Medical Device Company ?
Is it ok to comply with ISO 13485 and GMP instead ?

Thanks
Suchitra

 

[John Broomfield]

Re: Should companies that perform calibration services be ISO 17025 accredited?

Hi,

I want to know if we need ISO 17025 accreditation for in-house Microbiology testing lab for Medical Device Company ?
Is it ok to comply with ISO 13485 and GMP instead ?

Thanks
Suchitra

Suchitra,

Not really.

Why GMP instead of GLP? For example: https://www.mhra.gov.uk/Howweregulate/Medicines/Inspectionandstandards/GoodLaboratoryPractice/ or the equivalent in your country.

And why not conform to ISO 17025 instead of immediately seeking accreditation?

As you know, ISO 13485 is not designed for lab services neither is certification.

ISO 17025 focuses on the competence of the lab as well as the effectiveness of its management system.

John

 

[BradM]

Suchitra,

I took your post you made here and created your own thread.

That way you can have responses specifically for your purpose.