Training on ISO 17025 - Paragraphs 4.1.1 thru 4.1.4

Are you learning from this Training Session on ISO 17025?

  • Yes-It is very useful information

    Votes: 7 100.0%
  • No

    Votes: 0 0.0%

  • Total voters
    7

Hershal

Metrologist-Auditor
Staff member
Super Moderator
#1
4.1.1 requires an entity that can be held legally responsible.....

I have seen incorporation, LLC, even a business license.....laws differ some so what may work in one spot may not work in another......

4.1.2 requires the organization to carry out its work in a way that satifies the requirements of the standard, customers, regulaory authorities, and/or those providing recognition.....

That is to me an open door for lots of interpretation.....basically i appears to me that if the lab meets the requirements of the standard and any additional regulators, generally they meet customer requirements.....but I suspect that may not always be true.....

4.1.3 requires tht the management system cover work at the lab, away from the lab, and so on.....what is covered has to be defined.....

usually everything gets covered, but I believe it is OK to cover specific locations and not others too, so long as the other locations are not on the scope.....

4.1.4 requires responsibilities of key people to be defined to prevent conflict of interest.....

There are numerous other clauses that go with this one, including 5.2.5, 4.1.5 (all sub-clauses), and 4.2.6 among others.....it is best to address all the requirements at one time in one section rather than all over, in my opinion.....
 
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BradM

Staff member
Admin
#2
Re: Training on ISO 17025-Paragraphs 4.1.1 thru 4.1.4

4.1.1 requires an entity that can be held legally responsible.....

I have seen incorporation, LLC, even a business license.....laws differ some so what may work in one spot may not work in another......
That does seem quite interesting. As you alluded it may be a location thing, but it's hard for me to envision any entity conducting business/trade that cannot be held legally responsible for it's actions.

And yes... as with most every one of your posts, it is quite informative. Thanks for taking the time to prepare it.
 
A

amanbhai

#3
Re: Training on ISO 17025-Paragraphs 4.1.1 thru 4.1.4

I would be very very greatful to you for explaining things in more detail. I mean with examples.
BTW you are doing great job. :applause:
 

Hershal

Metrologist-Auditor
Staff member
Super Moderator
#4
Re: Training on ISO 17025-Paragraphs 4.1.1 thru 4.1.4

I appreciate the compliments.....just keep in mind this is not the normal teacher-student thing.....this is also a discussion.....what have you seend or done in some of these requirements? What issues have you encountered? What were the solutions? Everyone can participate.....
 

Ajit Basrur

Staff member
Admin
#5
Re: Training on ISO 17025-Paragraphs 4.1.1 thru 4.1.4

Hershal,

Fisrtly thanks for deliberating on each point of the standard. I have one question -

Assume a scenario where there is an analytical lab within an organization and this lab tests the samples provided by the Operations department. The top boss of this plant is a General Manager who is eventually responsible for Quality and Operations.

In this sceanrio, how can the "involvement or influence" be eliminated - can it be demonstrated by the Organization structure that the lab personnel report independently to the Regional Quality instead of the Plant Quality Manager ?
 
Last edited:

Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#6
Re: Training on ISO 17025-Paragraphs 4.1.1 thru 4.1.4

Bump.....
 

Hershal

Metrologist-Auditor
Staff member
Super Moderator
#8
Sorry.....was travelling and also under the weather.....should be able to do the next installment shortly.....
 
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