ISO/IEC 17025:2005 General requirements for the competence of testing and calibration laboratories moves to FDIS version.
ISO/IEC 17025:2005 General requirements for the competence of testing and calibration laboratories published jointly by ISO and IEC (International Electrotechnical Commission) specifies the general requirements for the competence to carry out tests and/or calibrations, including sampling. It covers testing and calibration performed using standard methods, non-standard methods, and laboratory-developed methods.
It is applicable to all companies performing tests and/or calibrations. These include, for example, first-, second- and third-party laboratories, and laboratories where testing and/or calibration constitutes part of inspection and product certification.
The standard is used by laboratories in developing their management system for quality, administrative and technical operations. Laboratory customers, regulatory authorities and accreditation bodies may also use it in confirming or recognizing the competence of laboratories.
The laboratory management system standard is in the process of being revised and has now reached the Final Draft International Standard (FDIS) stage, the last leg of development before publication. It is scheduled for publication at the end of this year.
The laboratory environment has changed dramatically since the standard was last published in 2005, leading to the decision to revise the standard and integrate significant changes. The revisions cover all the technical changes, technical developments and developments in IT techniques that the industry has seen since the last version.
The revised standard has adopted a process approach, which matches that of other standards such as the quality management system standard ISO 9001: 2015, ISO 15189:2012 Medical laboratories – Requirements for quality and competence and ISO/IEC 17021-1:2015 Conformity assessment – Requirements for bodies providing audit and certification of management systems – Part 1: Requirements. The revised standard puts the emphasis on the results of a process instead of the detailed description of its tasks and steps. The process approach involves the systematic definition and management of processes, and their interactions, so as to achieve the intended results in accordance with the strategic direction of the company.
The standard now recognizes and incorporates the use of computer systems, electronic records and the production of electronic results and reports in recognition of technical developments within the industry.
The FDIS version of the standard includes a chapter on risk-based thinking in line with ISO 9001:2015, Quality management systems – Requirements. An implementing company needs to plan and implement actions to address risks and opportunities. Addressing both risks and opportunities establishes a basis for increasing the effectiveness of the laboratory management system, achieving improved results and preventing negative effects.
The terminology has been updated to reflect the fact that paper-based manuals, procedures and records are being phased out in favour of electronic versions.
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 of the standard has been revised to cover all laboratory activities including testing, calibration and the sampling associated with subsequent calibration and testing.