ISO/IEC 17025:2017 - Major changes compared to the old version (ISO/IEC 17025:2005)

transition to iso 17025 2017 E3lW5BW
transition to iso 17025 2017 E3lW5BW
   ISO/IEC 17025 “General requirements for the competence of testing and calibration laboratories” is a quality management system (QMS) standard for testing and calibration laboratory, published by the International Organization for Standardization (ISO). It provides management and technical requirements that laboratory and calibration laboratories must be in conformity to demonstrate that they have the technical and organizational competence as well as the capacity to operate effectively to produce reliable and valid test/calibration results.
    This standard was developed in 1990 and ISO/IEC 17025:2017 is the latest version which was published in 2017. 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).
     ISO/IEC 17025 is developed to be in line with ISO 9001 “Quality management systems – Requirements”, and the management requirement in part 4 of ISO/IEC 17025 is equivalent to ISO 9001. Therefore, the testing or calibration laboratories which accredited to be in conformity with ISO/IEC 17025 will also meet the requirement of the quality management system under ISO 9001.

     The main changes in ISO/IEC 17025:2017 version are:
·       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 emphasizes on the result of a process instead of describing the tasks and its steps in details.
·       The new version now has a stronger focus on information technologies and incorporates the use of computer systems, electronic records and the production of electronic results and reports.
·       The new version of ISO/IEC 17025 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, including 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.
    Developed jointly by ISO and IEC in the Committee on conformity assessment (CASCO), the new version of ISO/IEC 17025 will replace the 2005 version. Laboratories that are accredited under ISO/IEC 17025:2005 need to perform a transition of the quality management system to be in conformity with ISO/IEC 17025:2017 within 3 years since its publish in Nobvermber, 2017.
    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, as Warren Merkel, another Convenor of the working group, explains. “ISO/IEC 17025 impacts the results delivered by laboratories in a number of ways. 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
 

Source: AOSC

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