Differences - ISO17025:1999 vs. ISO17025:2005 - The addition of "Improvement" in 4.10

K

Ken K

#1
I've finally had a chance to compare the two to see what exactly has changed.

The one thing that I found in Management Requirements is the addition of "Improvement", section 4.10 which used to be "Corrective Actions".

Wouldn't it have made more sense to add Improvement as section 4.15? It's only a three sentence paragraph for continual improvement. Instead of making ones work easier we now have to change sections 4.10 - 4.15:confused:

Have you seen anything that has left you scratching your head wondering why?
 
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Hershal

Metrologist-Auditor
Staff member
Super Moderator
#2
I disagree.....however, I do think that it would have been better placed under Preventive Action, Clause 4.11, as continuous improvement is what preventive action tires to achieve. Creating a whole new Clause would have - in my opinion - been an error.

It should also be included as part of the preventive action provisions required during management review, Clause 4.14.1.....

Hershal
 
K

Ken K

#3
I must also disagree Hershal since the clause takes more into account than just PA. Continual improvement is echoed, IMO, too often through the changes that have been added to 2005. Clause 4.10 should have been adequate.


4.10 Improvement

The laboratory shall continually improve the effectiveness of its management system through the use of the quality policy, quality objectives, audit results, analysis of data, corrective and preventive actions and management review.


Clause 4.11 is now corrective action
Clause 4.12 is now preventive action
Clause 4.13 is now control of records
Clause 4.14 is now internal audits
Clause 4.15 is now management review

My point is that improvement should have been designated 4.15 instead of shifting each clause up.
 
G

Graeme

#4
There's the right way, the wrong way and the Marine Corps way ...

Ken K said:
My point is that improvement should have been designated 4.15 instead of shifting each clause up.
Ah, Ken, now you're trying to apply rational thinking and logical planning to a bureaucratic multinational and multi-organizational working group of volunteers ... that's how we all may have done it, but with "them" I think all bets are off. :D
 
K

Ken K

#6
Isn't that the truth Graeme:bonk:

I'm not sure if our auditor worked on this revision or not, but you can bet there will be some discussion concerning the changes with her come February.

I'm sort of curious on finding out how their minds work...but that feeling shall also pass:lol:
 

Hershal

Metrologist-Auditor
Staff member
Super Moderator
#7
Ken K said:
I'm not sure if our auditor worked on this revision or not, but you can bet there will be some discussion concerning the changes with her come February.

I'm sort of curious on finding out how their minds work...but that feeling shall also pass:lol:
Each AB has their own policy, although APLAC/ILAC have an implementation cycle, I am not sure how long it is though.

By "their" do you mean the accreditation assessors? If so, then certainly talk to your assessor and find out the AB's policy/approach, and timetable.

Hershal
 

Hershal

Metrologist-Auditor
Staff member
Super Moderator
#8
I have just been doing a bit more reading on the 2005 revision of 17025.....besides 4.10 (and the subsequent shifting up of other section four clauses), there is also changes in clauses 4.1.5, specifically the sub-clause j, and in 4.2.3 through 4.2.7, and boosting a note to a requirement in 4.7.2

Accredited laboratories should discuss with their accrediting body what the changes mean to them.

Hershal
 

Hershal

Metrologist-Auditor
Staff member
Super Moderator
#10
Thanks Sidney,

That provides a good thumnail for the differences.

There are actually two hard requirements in the 2005 revision.....4.7.2 and 5.9.2.

Clause 4.7.2 takes a note from the 1999 revision and elevates it to an actual requirement. For this particular clause this is the right move. Labs (both test and cal) are now REQUIRED to seek customer feedback, both positive and negative, analyze it to figure out how to become better, and then actually put steps in place to become better, where possible.

Clause 5.9.2 requires the lab to take information obtained from Assurance of Quality steps that the lab has taken, then analyze that information and assure that any issues don't recur. For labs accredited by ILAC/APLAC/EA/IAAC, they are required to participate in proficiency testing or inter-laboratory comparison (PT/ILC) if it exists. In the case where there is PT/ILC then an "outlier" as it is known will require the lab to employ its corrective and preventive action system to investigate, resolve, and prevent recurrence of the outlier. An outlier means that the results of the information plus the measurement uncertainty is outside the limits of the reference norm.

The other clauses that change (e.g. 4.10, 4.1.5.k) are taken primarily to lign 17025 with 9K. These clauses may - at least in short term - create issues with both implementation and assessment. The reason is that they involve a substantial degree of subjectivity Time will tell how these clause shake out.

Hershal
 
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