A testing lab within an organization

#1
We have a small testing lab affiliated to an organization. We only test the products from this organization.
I understand we would be facing challenges on impartiality if the lab would like to get ISO 17025 accredited.
Can someone comment on this?
  1. What should we do to address the impartiality of the lab?
  2. Can QA/QC personnel of the organization concurrently perform lab quality manager role?
  3. Who should do the internal audit for the lab? can a senor manager of the organization do it?
  4. Who should do the management review for the lab? cab the organization management team do it?
  5. I know it sounds wired, but please understand this is a small lab with limited headcount.....
 
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John C. Abnet

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#2
Good day @Bigwatch ;
I once established/implemented an accredited lab in just such an example.

1. Ensure the teams understand...have an open "free discussion" culture....emphasize during internal audits...etc... Not a problem for an ethical team in an ethical work environment.
2. Yes
3,
a) Whomever your organization chooses. Nice to change that individual if/when possible. Also, contracting to have internal audits done is another option and really helps with impartiality (the biggest "gap" related to impartiality I have experienced is simply defensiveness. The process owner/team is proud of what/how they do their work and can become defensive to any challenges. A contract internal audit can help with that.).
b) Yes, if they are 'competent' and 'impartial' (the only true requirements).
4. ?? Management review is intended to be input to, and review by, and necessary actions by Top Management. If your organization is ISO 9001 certified. (or not), ..then why do it different/separate? Just input into the normal Management Review activity.
NOTE: It concerns me that the term used is "...thE..." management review. While this does not violate the standard, the 'end of year....stale donut....rehash of what everyone already knows' management review meeting (a WAY too common scenario in my experience), is akin to looking at the scoreboard after the match is over. Considering aggregating existing review actions that all become part of an ongoing "management review". We can discuss outside of this post (there are also other forum posts discussing that).
5. One reason I am counseling to not perform these activities ...
- separate from
- uniquely to
- fragmented from
- in addition to....

.....what I will assume are current/normal/existing practices.

Hope this helps.
Be well.
 

LabCat

Registered
#3
We have a small testing lab affiliated to an organization. We only test the products from this organization.
I understand we would be facing challenges on impartiality if the lab would like to get ISO 17025 accredited.
Can someone comment on this?
  1. What should we do to address the impartiality of the lab?
  2. Can QA/QC personnel of the organization concurrently perform lab quality manager role?
  3. Who should do the internal audit for the lab? can a senor manager of the organization do it?
  4. Who should do the management review for the lab? cab the organization management team do it?
  5. I know it sounds wired, but please understand this is a small lab with limited headcount.....

What should we do to address the impartiality of the lab?
We drew up a risk analysis detailing how we address the risks to impartiality

Can QA/QC personnel of the organization concurrently perform lab quality manager role?
Who should do the internal audit for the lab? can a senor manager of the organization do it?
Who should do the management review for the lab? cab the organization management team do it?

The main way we have addressed it is to separate roles and to have two branches in the organisation structure, with the parent company (the lab's customer) on one side and the lab on the other. The personnel on the "customer" side have no roles in anything related to lab testing or auditing. They only submit items for testing. In truth we all interact with each other, but I (as the Quality Manager) heavily emphasise impartiality and reinforce that at certain times you have your "customer" hat on and at other times you have your "lab" hat on. You can wear different hats for different projects, but not within the same project.

I know it sounds wired, but please understand this is a small lab with limited headcount.....
It doesn't sound weird to me at all, this is the exact situation in my company. We have less than 20 people.
 

LabCat

Registered
#5
In my experience, the overwhelming majority of times, such "risk analysis" are just a paperwork façade concocted by biased people trying to convince other people they are not biased. Just check
Oh. Ok.

"Risk analysis" is also part of ISO 17025. So we are applying the methods stipulated in the standard.

I take my role and impartiality very seriously. The result is the result. We uphold ethics and standards to deliver results within the confines of our situation.
 

Gus

Involved In Discussions
#6
Hi, im managing a small lab within an organization as well that does testing for company products with certification validity and also tests for external customers (for example our competitors that dont have an accredited lab themselves) so i might know a thig or 2 of what you are going/will go through
  1. What should we do to address the impartiality of the lab?
    1. in our case we have our factory manager sign a sort of "release" for the lab where he ensures no financial or professional pressure shall be exerted to influence the results of the lab, it a full one pager but that's the gist of it.
    2. as head of the lab I no longer answer to R&D but the factory lead itself (the past manager used to be the head of R&D but i was appointed supervisor of the lab at the time, it is pretty much MY Job to keep impartiality by executing under that organizational strucutre)
  2. Can QA/QC personnel of the organization concurrently perform lab quality manager role?
    1. Of course and it works pretty good if you already have an ISO 9001 implemented because QA should already have a system in place for internal audits, you just have to expand that to include ISO 17025
  3. Who should do the internal audit for the lab? can a senor manager of the organization do it?
    1. i recommend you appoint a lab QA commisionate form the QA dept. to do this, you should have evidence of his/her training in ISO 17025 and auditing capabilities, its usually hard to get managers to make time to actually do the required competence training and also perform your internal audits
  4. Who should do the management review for the lab? cab the organization management team do it?
    1. Head of the lab, QA commisionate, and management (your direct legal representative for accreditation purposes), just my suggestion
  5. I know it sounds wired, but please understand this is a small lab with limited headcount.....
    1. i get it... my lab Head count 1 admin (myself) and 3 lab technicians, i know its hard, but do-able, best of Luck!
 
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