ISO 17025 Testing & Calibration Labs

What is ISO 17025?

ISO/IEC 17025 is the global recognized standard that was developed specifically for testing and calibration laboratories that intended seeking accreditation. It is also the basis for accreditation from an accreditation body. The current release was published in 2005. It covers testing and calibration performed using standard methods, non-standard methods, and laboratory-developed methods.

There are two main clauses in ISO/IEC 17025 – Management Requirements and Technical Requirements. Management requirements are related to the operation and effectiveness of the quality management system within the laboratory, and this clause has similar requirements to ISO 9001. Technical requirements includes factors which determines the correctness and reliability of the tests and calibrations performed in laboratory namely competence of staff; environment control; testing methodology; equipment and measurement traceability; and reporting of test and calibration results.

Global adoption

Following the increasing number of accreditation bodies representing various countries around the world joining as member of ILAC or APLAC by signing Mutual Recognition Agreements (MRAs) and continue efforts by ILAC and APLAC in promoting the acceptance of laboratories accreditation schemes across countries, the accreditation numbers to ISO/IEC 17025 has been steadily increasing.

As of to date, over 40 laboratory accreditation bodies have signed a multi-lateral recognition agreement called the ILAC Arrangement, which greatly enhances the acceptance of data across the national borders of the signatory countries. Full details for the ILAC Arrangement and the list of signatories can be found on the ILAC website.

Benefits of Implementation / Accreditation

  1. Increase of confidence in Testing/ Calibration data and of personnel performing work.
  2. Better control of laboratory operations and feedback to laboratories as to whether they have sound Quality Assurance System and are technically competent.
  3. Potential increase in business due to enhanced customer confidence and satisfaction.
  4. Customers can search and identify the laboratories accredited by The Accreditation Member Body for their specific requirements from their website or Directory of Accredited Laboratories.
  5. Users of accredited laboratories will enjoy greater access for their products, in both domestic and international markets, when tested by accredited laboratories.
  6. Savings in terms of time and money due to reduction or elimination of the need for re-testing of products.
  7. Improved national and global reputation and image of the laboratory.
  8. Continually improving data quality and laboratory effectiveness

Key Elements of Consulting ISO 17025

  • Gap Assessments
  • Awareness Training to Staff
  • Project Planning and Organization
  • Process Identification and Documentation
  • System Development and Implementation
  • Internal Audit Training to core Team of ISO 17025
  • Uncertainty Measurement Training
  • Management System Documentation
  • Documentation Reviews
  • Pre-Assessments
  • Support during the Certification Process
  • Continual Improvement Process
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