ISO/IEC 17025:2017 : Homework for readiness

Posted on: January 8th, 2018  /  By:  /  Posted in: ISO, ISO/IEC 17025:2017, Laboratory management system, Uncategorized  /  Comment: 38

It was just a more than a month for release of new edition of ISO/IEC 17025:2017, General requirements for the competence of testing and calibration laboratories. It is interesting to do some homework on this new edition of ISO/IEC 17025:2017, studying highlights, main changes and focus area. Highlights are, This standard ,ISO/IEC 17025:2017 was developed jointly by ISO , IEC (International Electrotechnical Commission) under the responsibility of ISO CASCO working group 44(CASCO/WG 44)
  • This standard published by ISO on 30th November 2017
  • There will be a three year transition period from date of publication.
  • ISO & IEC agreed that during this transition period ISO / IEC 17025:2005 and ISO/IEC 17025:2017 are equally valid and applicable.
  • Accreditation to ISO / IEC 17025:2005 will be till 30th November 2020
In new edition of ISO/IEC 17025:2017 the main focus with respect to changes are on,
  1. Technical part
  2. Vocabulary
  3. In area of IT techniques
With above three parts, changes are made to make this standard in line with ISO 9001:2015 which is the latest version. The main changes are in:
  1. Scope
  2. New structure
  3. Process approach
  4. IT techniques
  5. Risk base thinking
  6. Option A and Option B
  1. Scope:
In ISO / IEC 17025:2005 there are six different sub clauses and two foot notes under scope, in new edition this has been replaced with single main clause so that it cover all laboratory activity.
  1. New Structure:
In ISO / IEC 17025:2005 there are five main clauses and there sub clause and to make this standard ISO/IEC 17025:2017 in line with other standard such as ISO 9001:2015 there are eight main clauses and sub clauses.
  1. Process Approach:
Process approach has been match with requirement of ISO 9001:2015(Quality Management), ISO/IEC 17000 series and ISO 15189(Quality of medical Laboratories) and emphasis given on result of process instead of task and steps.
  1. Information Technology:
Keeping in view, world is changing and there is more focus on utilization of information technology and use of digitization, this has been well taken care in the new edition ISO/IEC 17025:2017 under clause 7.11 , control of data and information management , contain in computerized and non-computerization. In earlier edition of ISO / IEC 17025:2005 this is under clause 4.13 Control of records, record may be in hard copy or in electronic media.
  1. Address on risk and opportunity:
The emphasis has been give on concept of risk and opportunity to make this standard in line with requirement of ISO 9001:2015(Quality Management), will help to improve the effectiveness of management system. Besides above points, it is interesting to see clause 8, Management system requirement, This clause has been added very well and in simplified way to full fills the requirement of clause 4 to 7 of new edition ISO/IEC 17025:2017 by maintaining the management system in accordance with the requirement of ISO 9001:2015. This clause 8 have categorized in two option, Option A and Option B.
  1. Option A is regarding, minimum, the management system of the laboratory shall address, and,
  2. Option B is applicable where laboratory have management system according to ISO 9001 and fulfill requirement of clause 4 to 7 also fulfills at least the intent of the management system requirement specified in Option A.
By the way, there is lots of learning (e.g. terminology) in this new edition ISO/IEC 17025:2017 clause by clause.