Knowledge of the upcoming ISO 17025 Revision

[Brizilla]

So, second day in my new quality manager role. We have to transition to ISO 2015 by February, fine. Oh and next after that IATF16949, maybe next year and oh yeah, we want our gage lab to be accredited to ISO 17025. Hmmm, I do have a copy of that standard and I'm just starting to look into it. I hear they're changing it in October. I'm studying the 2005 version now. Anyone know what the affects of 2017 will be on the old standard?

 

[howste]

If you have the other standards to work on, I'd wait until the new 17025 standard is released. I have a copy of the December 2016 DIS version, but I haven't spent much time on it since there were a lot of comments on that version that needed to be resolved before publication. If you really want get started, there's a presentation here that you may want to look at from May 2017. It will give you some idea of what's going on without being too detailed (36 page PowerPoint).

 

[Sidney Vianna]

In addition to Howste's comments, after release of the new edition, laboratories will be given 36 months to attain accreditation to the new version of the standard. So, you can procrastinate wait.

 

[dwperron]

I recently received my copy of the Final Draft of the new 17025 version. It is now out to be voted on, with voting closing on 10/09/2017. This is an up or down vote this time, no comments, so we will know then the final document status.

The big changes are the layout of the document (it doesn't look anything like the copy you have), and 2 options for dealing with the management system (ISO 9001 vs. setting up your own system). The revision team says:

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

 

[Sidney Vianna]

From ISO's press release:

The revision of ISO/IEC 17025 takes into account the activities and new ways of working of laboratories today. The main changes are as follow:

• The process approach now matches that of newer standards such as ISO 9001 (quality management), ISO 15189 (quality of medical laboratories) and ISO/IEC 17021-1 (requirements for audit and certification bodies). The revised standard puts the emphasis on the results of a process instead of the detailed description of its tasks and steps.
  
  
• With a stronger focus on information technologies, the standard now recognizes and incorporates the use of computer systems, electronic records and the production of electronic results and reports. Modern-day laboratories work increasingly with information and communication technologies and the working group felt it was necessary to develop a chapter on this topic.
  
  
• The new version of the standard includes a chapter on risk-based thinking and describes the commonalities with the new version of ISO 9001:2015, Quality management systems – Requirements.
  
  
• The terminology has been updated to be more in step with today’s world and the fact that hard-copy manuals, records and reports are slowly being phased out in favour of electronic versions. Examples include changes to the International Vocabulary of Metrology (VIM)and alignment with ISO/IEC terminology, which has a set of common terms and definitions for all standards dedicated to conformity assessment.
  
  
• A new structure has been adopted to align the standard with the other existing ISO/IEC conformity assessment standards such as the ISO/IEC 17000 series on conformity assessment.
  
  
• The scope has been revised to cover all laboratory activities including testing, calibration and the sampling associated with subsequent calibration and testing.

 

[Brizilla]

Thanks everyone for the replies. Our ownership has been appraised of the details and have shelved the project this year.