ISO 17025 & ISO 15189

ISO/IEC 17025 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 organizations performing tests and/or calibrations. These include, for example, first-, second- and third-party laboratories, and laboratories where testing and/or calibration forms part of inspection and product certification. ISO/IEC 17025 is applicable to all laboratories regardless of the number of personnel or the extent of the scope of testing and/or calibration activities.

ISO/IEC 17025 is for use 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.

Main Benefits of Correctly Implemented ISO/IEC 17025

Implementing ISO/IEC 17025 as part of laboratory quality initiatives provides both laboratory and business benefits such as:

  • Having access to more contracts for testing and/or calibration. Some public and private organizations only give contracts to accredited laboratories. Accreditation will also help to get more contracts from organizations that don’t mandate accreditation, but do give preference to accredited laboratories in competitive situations;
  • Improved national and global reputation and image of the laboratory;
  • Continually improving data quality and laboratory effectiveness;
  • Having a basis for most other quality systems related to laboratories, such as Good Manufacturing Practices and Good Laboratory Practices;

If you are a medical laboratory

You may better to implement quality management system based on ISO 15189, which specifies requirements for quality and competence particular to medical laboratories.

ISO 15189 is for use by medical laboratories in developing their quality management systems and assessing their own competence, and for use by accreditation bodies in confirming or recognizing the competence of medical laboratories.

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