by Sandrine Tranchard
Testing and analyzing samples and calibration are daily practices at more than 60,000 laboratories worldwide, but how can they reassure customers about the reliability of their results?
Over the years, ISO/IEC 17025, General requirements for the competence of testing and calibration laboratories, has become the international reference for testing and calibration laboratories wanting to demonstrate their capacity to deliver trusted results. The international standard, published jointly by ISO and International Electrotechnical Commission (IEC), contains a set of requirements enabling laboratories to improve their ability to produce consistently valid results.
However, the laboratory environment has changed dramatically since the standard was last published, leading to the decision to revise the standard and integrate significant changes. Steve Sidney, one of the convenors of the working group revising the standard, explains: “The last version of ISO/IEC 17025 was published in 2005. Since then, market conditions have changed and we felt we could bring some improvements to the standard.”
Heribert Schorn, working group convenor who also participates in the System of Conformity Assessment Schemes for Electrotechnical Equipment and Components (IECEE), adds: “The revision was needed to cover all the technical changes, technical developments and developments in IT techniques that the industry has seen since the last version. Additionally, the standard takes into consideration the new version of ISO 9001.”
This standard is of high significance for the IEC conformity assessment community, as it outlines the basic requirements for testing within all conformity assessment schemes and programs operating within the IECEE, IECE, IECQ, and IECRE conformity assessment systems.
The review was started in February 2015 as a result of a joint proposal by the International Laboratory Accreditation Cooperation and the South African Bureau of Standards, which is a member of ISO and hosts the IEC national committee. The standard’s revision process has now reached the final draft international standard (FDIS) stage, the last leg of development before publication.
The main changes
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 favor of electronic versions. Examples include changes to the International Vocabulary of Metrology 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.
Using ISO/IEC 17025 facilitates cooperation between laboratories and other bodies. It assists in the exchange of information and experience and helps harmonize standards and procedures.
“ISO/IEC 17025 impacts the results delivered by laboratories in a number of ways,” explains Warren Merkel, another convenor of the working group. “The standard requires them to meet criteria for competence of their personnel, the calibration and maintenance of their equipment, and the overall processes they use to generate the data. This requires laboratories to think and operate in a way that ensures their processes are under control and their data are reliable.”
Results also gain wider acceptance between countries when laboratories conform to the standard. Developed jointly by ISO and IEC in the committee on conformity assessment, the new version of ISO/IEC 17025 will replace the 2005 version and is scheduled for publication at the end of this year.
This article first appeared on the ISO website and is published here with permission. Please visit the ISO Website www.iso.org for more information.