ISO/IEC 17025, general requirements for the competence of testing and calibration laboratories, is the international reference for the testing and calibration of laboratories wanting to demonstrate their capacity to deliver trusted results.
The International Standard, published jointly by the International Organization for Standardization (ISO) and the International Electrotechnical Commission (IEC), contains a set of requirements that enable laboratories to improve their ability to produce consistently valid results. However, the laboratory environment has changed dramatically since the standard was last published in 2005, leading to the need to update the standard and integrate important changes.
Changes to the standard:
- Improvements to the standard cover technical changes, technical developments and developments in IT techniques that the industry has adopted since the last version of the standard was released more than 10 years ago. The new version of ISO/IEC 17025 replaces the 2005 version and the main changes include the following:
- The new standard adopts a process-focused approach which 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 an emphasis on the results of processes instead of the detailed descriptions of tasks and steps.
- Modern-day laboratories work increasingly with information and communication technologies. The standard now recognizes and addresses the use of computer systems, electronic records and the production of electronic results and reports.
- The new version of the standard incorporates a risk-based approach 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.
The new version of ISO/IEC 17025 will be adopted and used by laboratories in Canada. Canadian laboratories have until the end of 2020 to conform to the revised ISO/IEC 17025 standard. Read the FAQs here.