ISO/IEC 17025:2017 3rd Ed. Changes from 2nd Ed.

Douglas E. Purdy

Quite Involved in Discussions
#1
"This third edition cancels and replaces the second edition (ISO/IEC 17025:2005), which has been technically revised.
The main changes compared to the previous edition are as follows:
— the risk-based thinking applied in this edition has enabled some reduction in prescriptive requirements and their replacement by performance-based requirements;
— there is greater flexibility than in the previous edition in the requirements for processes, procedures, documented information and organizational responsibilities;
— a definition of “laboratory” has been added (see 3.6)."

I do not know the ISO/IEC Directives, Part 1 & 2 Directives and Policies but I wonder if the above changes as given in the Forward would 'pass mustard' in dealing with document / revision control. If this is the Example by ISO/IEC and CASCO, then I don't think I would be expecting much in regards to 8.2.3 c).

ISO/IEC 17025:2017
"8.3.2 The laboratory shall ensure that:
a) documents are approved for adequacy prior to issue by authorized personnel;
b) documents are periodically reviewed, and updated as necessary;
c) changes and the current revision status of documents are identified;
d) relevant versions of applicable documents are available at points of use and, where necessary, their distribution is controlled;
e) documents are uniquely identified;
f) the unintended use of obsolete documents is prevented, and suitable identification is applied to them if they are retained for any purpose.
 
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dwperron

Trusted Information Resource
#2
I'm really not sure what you are driving at here.

8.3.2 says that changes and revision status of documents are identified. How your organization chooses to accomplish it is based on what you need for controls, and what risk it presents. Simple and straightforward.

The 17025:2005 covers this in section 4.3.3. That throws in many requirements on how to control a document:
* Changes shall be reviewed and approved by the same function that performed the original review...
* altered or new text shall be identified in the new document...
* amendment of documents by hand....
* procedure to describe how changes in documents in computerized systems are maintained...

Some of these "requirements" are outdated. Few add value to the process.
The new edition moves away from these "prescriptive requirements", we are now given flexibility to determine our own best practices.

Would this "pass muster" under the old system? No.
That's why we needed a new system.
 

Douglas E. Purdy

Quite Involved in Discussions
#3
I'm really not sure what you are driving at here.

8.3.2 says that changes and revision status of documents are identified. How your organization chooses to accomplish it is based on what you need for controls, and what risk it presents. Simple and straightforward.

The 17025:2005 covers this in section 4.3.3. That throws in many requirements on how to control a document:
* Changes shall be reviewed and approved by the same function that performed the original review...
* altered or new text shall be identified in the new document...
* amendment of documents by hand....
* procedure to describe how changes in documents in computerized systems are maintained...

Some of these "requirements" are outdated. Few add value to the process.
The new edition moves away from these "prescriptive requirements", we are now given flexibility to determine our own best practices.

Would this "pass muster" under the old system? No.
That's why we needed a new system.
Thanks for catching my mistake on the idiom!

What I mean is that the Forward indicated a change where the Term 'laboratory' was defined. In actuality the 3rd Ed added 9 Terms, of course 6 of those have 'Source' referenced, but what about the term 'decision rule'? Granted that the 3rd Ed gives you a link to the Online Browsing Platform https://www.iso.org/obp - which is great! Oops that is a change! Are the expanded requirements for Complaints [Clause 7.9] a change? Were these changes identified to your satisfaction? Does that 'pass muster'?
 

dwperron

Trusted Information Resource
#4
Looking over your comments again I think I am getting what you are looking for, but I'm not sure.

Are you expecting the authors of the 17025 revision to have and apply the same document control rules found in 17025?
 

Douglas E. Purdy

Quite Involved in Discussions
#5
Looking over your comments again I think I am getting what you are looking for, but I'm not sure.

Are you expecting the authors of the 17025 revision to have and apply the same document control rules found in 17025?
All I know is that if you do not maintain a detailed 'revision history' one tends not to remember what has changed. Are the 3 'main changes' listed in the Forward adequate in identifying what changed in the 3rd Edition? Do they 'pass muster' for you?

What is good for the goose should be good for the gander.

Besides isn't there a saying about what may happen if you forget your history?
 

dwperron

Trusted Information Resource
#6
I was afraid that was what you were getting at.

This document is not a "revision" of the 2005 edition:
"This third edition cancels and replaces the second edition (ISO/IEC 17025:2005)"

Any changes to this new original document should have standard document control and revision control. But these ISO documents tend to stand as is until they are replaced, not revised.
 

Douglas E. Purdy

Quite Involved in Discussions
#7
Thanks for enlightening me! I never actually had any formal training as to the differences between Revisions and Editions. Apparently it is not like the differences between 'editing' VS 'revising'. I guess I have shown my ignorance enough.
 
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