Regulatory Open Forum

Hi,

If a consulting company servicing the pharmaceutical and medical device industries conducts a test within a micro-laboratory of a university. Do they need to be ISO 17025 or equivalent certified? Additionally, do the micro-labs in the university setting require ISO accreditation?

Thanks!

Hi Shikha,

As I know, for academic research, ISO accreditation is generally not mandatory except if the tests are for regulatory purposes, to meet industry standards, or if required.<o:p></o:p>

Best,<o:p></o:p>

Shahrokh<o:p></o:p>

Hi,

If a consulting company servicing the pharmaceutical and medical device industries conducts a test within a micro-laboratory of a university. Do they need to be ISO 17025 or equivalent certified? Additionally, do the micro-labs in the university setting require ISO accreditation?

Thanks!

Hello Shikha,

It depends on what the testing is, what the results are being used for, and if an ISO 17025 certified laboratory is needed.  As an example, if there is a testing laboratory in a University doing biocompatibility testing and the company needs it to be "under" Good Laboratory Practices (GLP), then ISO 17025 really helps with that compliance.  If the testing laboratory in Uni is doing a formative usability study, then no probably not.  So it depends on what the testing is and whether the certification is needed.

Hi Shikha,

As I know, for academic research, ISO accreditation is generally not mandatory except if the tests are for regulatory purposes, to meet industry standards, or if required.<o:p></o:p>

Best,<o:p></o:p>

Shahrokh<o:p></o:p>

Hi,

If a consulting company servicing the pharmaceutical and medical device industries conducts a test within a micro-laboratory of a university. Do they need to be ISO 17025 or equivalent certified? Additionally, do the micro-labs in the university setting require ISO accreditation?

Thanks!

Hi Shikha.

Completely agree with Richard on this - the questions that matter here are "What?" and "Why?" when reviewing this situation.  If the answer to the why is anything that even remotely looks like it might become (or need to become) part of the submission - then ISO is a good solid starting point to provide evidence of compliance to a recognized international standard.  If the answer to what is generally not something that is going to end up in a product application - then probably not.  But you need to analyze case-by-case or provide a bit more detail here for a more specific answer.

Hello Shikha,

It depends on what the testing is, what the results are being used for, and if an ISO 17025 certified laboratory is needed.  As an example, if there is a testing laboratory in a University doing biocompatibility testing and the company needs it to be "under" Good Laboratory Practices (GLP), then ISO 17025 really helps with that compliance.  If the testing laboratory in Uni is doing a formative usability study, then no probably not.  So it depends on what the testing is and whether the certification is needed.

Hi Shikha,

As I know, for academic research, ISO accreditation is generally not mandatory except if the tests are for regulatory purposes, to meet industry standards, or if required.<o:p></o:p>

Best,<o:p></o:p>

Shahrokh<o:p></o:p>

Hi,

If a consulting company servicing the pharmaceutical and medical device industries conducts a test within a micro-laboratory of a university. Do they need to be ISO 17025 or equivalent certified? Additionally, do the micro-labs in the university setting require ISO accreditation?

Thanks!

Hi Shikha

I will go just a bit beyond Richard and Vincent and say, as you consider what the results are used for, what is the risk to the results and product if your chosen lab is sloppy in testing or doesn't document well.

I really do appreciate a lab who knows what they are doing and follows a quality system, regardless if it is going into a submission.  ISO 17025 is my expectation unless you are only in early screening and will repeat at a certified lab for final design tests.

Hi Shikha.

Completely agree with Richard on this - the questions that matter here are "What?" and "Why?" when reviewing this situation.  If the answer to the why is anything that even remotely looks like it might become (or need to become) part of the submission - then ISO is a good solid starting point to provide evidence of compliance to a recognized international standard.  If the answer to what is generally not something that is going to end up in a product application - then probably not.  But you need to analyze case-by-case or provide a bit more detail here for a more specific answer.

Hello Shikha,

It depends on what the testing is, what the results are being used for, and if an ISO 17025 certified laboratory is needed.  As an example, if there is a testing laboratory in a University doing biocompatibility testing and the company needs it to be "under" Good Laboratory Practices (GLP), then ISO 17025 really helps with that compliance.  If the testing laboratory in Uni is doing a formative usability study, then no probably not.  So it depends on what the testing is and whether the certification is needed.

Hi Shikha,

As I know, for academic research, ISO accreditation is generally not mandatory except if the tests are for regulatory purposes, to meet industry standards, or if required.<o:p></o:p>

Best,<o:p></o:p>

Shahrokh<o:p></o:p>

Hi,

If a consulting company servicing the pharmaceutical and medical device industries conducts a test within a micro-laboratory of a university. Do they need to be ISO 17025 or equivalent certified? Additionally, do the micro-labs in the university setting require ISO accreditation?

Thanks!

I would add one comment to Ginger's point.  Just because a lab has ISO 17025 doesn't mean their quality system is great and they are competent in testing. 

We have many clients that go to EMC test labs that don't follow the standard.  For one example the standard (IEC 60601-1-2) asks that the client provide the test plan and if the client doesn't the test lab conducts the tests without the client's test plan having ISO 17025 doesn't help anyway. The test report most of the time says the time even says the client is supposed to provide it but that it wasn't provided and that the test lab generated the test plan. 
Another example is essential performance has to be determined and written into the test plan and clearly defined it is really unusual to not have any Essential Performance as that would mean the product has not clinical functions by definition of EP.  I have seen many EMC reports that say the product has no EP where we know the client's product does have EP and that means the product would have to redo do testing and may require redesign.

So, the competence of the lab is extremely critical and this is something that needs to be figured out ahead of choosing a test lab and a lab just having an ISO 17025 does not determine competence.  Also, a lab having ISO 17025 doesn't mean their QMS is in great shape I have audited several test labs that their QMS were not in great shape and had issues lacking as accreditors will issue certificates and issues may still be in the system just like a QMS certification such as ISO 13485 or ISO 9001, etc.

Hi Shikha

I will go just a bit beyond Richard and Vincent and say, as you consider what the results are used for, what is the risk to the results and product if your chosen lab is sloppy in testing or doesn't document well.

I really do appreciate a lab who knows what they are doing and follows a quality system, regardless if it is going into a submission.  ISO 17025 is my expectation unless you are only in early screening and will repeat at a certified lab for final design tests.

Hi Shikha.

Completely agree with Richard on this - the questions that matter here are "What?" and "Why?" when reviewing this situation.  If the answer to the why is anything that even remotely looks like it might become (or need to become) part of the submission - then ISO is a good solid starting point to provide evidence of compliance to a recognized international standard.  If the answer to what is generally not something that is going to end up in a product application - then probably not.  But you need to analyze case-by-case or provide a bit more detail here for a more specific answer.

Hello Shikha,

It depends on what the testing is, what the results are being used for, and if an ISO 17025 certified laboratory is needed.  As an example, if there is a testing laboratory in a University doing biocompatibility testing and the company needs it to be "under" Good Laboratory Practices (GLP), then ISO 17025 really helps with that compliance.  If the testing laboratory in Uni is doing a formative usability study, then no probably not.  So it depends on what the testing is and whether the certification is needed.

Hi Shikha,

As I know, for academic research, ISO accreditation is generally not mandatory except if the tests are for regulatory purposes, to meet industry standards, or if required.<o:p></o:p>

Best,<o:p></o:p>

Shahrokh<o:p></o:p>

Hi,

If a consulting company servicing the pharmaceutical and medical device industries conducts a test within a micro-laboratory of a university. Do they need to be ISO 17025 or equivalent certified? Additionally, do the micro-labs in the university setting require ISO accreditation?

Thanks!

Hi,

If a consulting company servicing the pharmaceutical and medical device industries conducts a test within a micro-laboratory of a university. Do they need to be ISO 17025 or equivalent certified? Additionally, do the micro-labs in the university setting require ISO accreditation?

Thanks!