Take the ISO 9001 course exam and get the ISO 14001 or ISO 13485 course exam for free
LIMITED-TIME OFFER – VALID UNTIL SEPTEMBER 30, 2021

Expert Advice Community

Guest

Should we go for ISO 17025 compliance?

  Quote
Guest
Guest user Created:   Mar 16, 2021 Last commented:   Mar 17, 2021

Should we go for ISO 17025 compliance?

One question: we want to offer testing from our laboratory facility to, for example, the retail pharmacy sector (a previous clinical laboratory I ran was CPA- compliant (now UKAS of course).

I went through the ISO options and determined we need to go for ISO 17025 compliance. Do you agree ?

0 0

Assign topic to the user

ISO 17025 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 17025 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

Expert
Tracey Evans Mar 17, 2021

If you are referring to pharmaceutical product testing, or equipment calibration, then ISO 17025 is applicable. There are two important considerations. Firstly the regulatory authority in the country / region may have supplementary, mandatory requirements in addition to ISO 17025. Secondly, the companies in the retail sector have been expanding their services, so it will depend on what services you plan to offer them.

Besides usual main-stream medicines (e.g. scheduled drugs) and complementary health products (e.g. vitamin supplements); many retail pharmaceutical stores have clinics that administer vaccines. There is a need for calibration testing for vaccine storage as well as temperature monitoring equipment by ISO 17025 accredited calibration laboratories.  If you are referring to onsite diagnostic testing point-of-care testing (POCT), where rapid tests are used (ranging in complexity form dipsticks to more complex benchtop analyzers), accreditation to ISO 22870:2016 Point-of-care testing (POCT) - Requirements for quality and competence will be required. The associated standard that is used in conjunction with ISO 22870 is ISO 15189:2012 for Medical laboratories. There are many harmonized (aligned) requirements between these standards and ISO 17025.

I suggest you contact your national accreditation body for more information. For example, in the UK, see https://www.ukas.com/accreditation/standards/poct/. Note that typically, there are additional regulatory requirements for SARS-CoV-2 Point-of-Care and Rapid Testing.

Quote
0 0

Comment as guest or Sign in

HTML tags are not allowed

Mar 16, 2021

Mar 17, 2021