ISO/IEC 17025:2017, General requirements for the competence of testing and calibration laboratories, is the international reference for laboratories carrying out calibration and testing activities around the world.
Producing valid results that are widely trusted is at the heart of laboratory activities. ISO/IEC 17025:2017 allows laboratories to implement a sound quality system and demonstrate that they are technically competent and able to produce valid and reliable results.
ISO/IEC 17025 also helps facilitate cooperation between laboratories and other bodies by generating wider acceptance of results between countries. Test reports and certificates can be accepted from one country to another without the need for further testing, which, in turn, improves international trade.
In order to reflect the latest changes in market conditions and technology, the new edition of the standard encompasses the activities and new ways of working of laboratories today. It covers technical changes, vocabulary and developments in IT techniques and takes into consideration the latest version of ISO 9001 on quality management.
The three Convenors of CASCO working group 44 (CASCO/WG 44) that revised the standard tell us why the new version of ISO/IEC 17025 is so important for laboratories:
Laboratories already accredited to ISO/IEC 17025:2005 will need to transition their processes to the new version within a three-year period from the publication date of the new standard. The Joint ILAC-ISO Communiqué explains this timeframe transition.
ISO/IEC 17025:2017 was developed jointly by ISO and the International Electrotechnical Commission (IEC) under the responsibility of the ISO Committee on conformity assessment (CASCO).
What are the main changes in the 2017 version?
- The scope has been revised to cover testing, calibration and sampling associated with subsequent calibration and testing.
- 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 standard has now a stronger focus on information technologies and incorporates the use of computer systems, electronic records and the production of electronic results and reports.
- A new chapter introduces the concept of risk-based thinking.