ISO/IEC 17025:2017 Transition: Impact on Labs and Customers

ISO/IEC 17025:2017 Structure

This is the first in a series of posts about the recently published ISO/IEC 17025:2017, General requirements for the competence of testing and calibration laboratories, the global reference for laboratories carrying out calibration and testing activities worldwide.

The requirements of the standard are applicable to any organization that performs the activities of testing and/or calibration and/or sampling associated with subsequent testing or calibration.

The standard can be used for accreditation purposes, laboratory self-assessment and laboratory customer assessments, or organizations using peer-assessment.

The revised standard includes principles of the ISO/IEC directives to enhance its compatibility and alignment with ISO management system standards. The standard is written to support the directives of ISO in developing a harmonized approach to management standards. The format is similar to other new standards, such as ISO/IEC 17020, ISO 17034, and ISO/IEC 17065. A laboratory under an ISO 9001:2015 certified facility can easily integrate the technical requirements of the standard to its management system with minimal changes for additional standard specificity or use of a separate quality manual.

The new standard is structured as follows:

  1. Scope
  2. Normative references
  3. Terms and definitions
  4. General requirements
  5. Structural requirements
  6. Resource requirements
  7. Process requirements
  8. Management requirements
    • Annex A – Metrological Traceability (Informative)
    • Annex B – Management System (Informative)
    • Bibliography

The foreword identifies the main changes to the previous revision of the standard as follows:

  • Application of risk-based thinking, which reduced the number of prescriptive requirements and replaced them with performance-based requirements.
  • Greater flexibility in requirements for processes, procedures, documented information, and organizational responsibilities.
  • Inclusion of a definition of laboratory.

This is the first part of a six part series that discusses each clause of ISO/IEC 17025:2017 and the impact on laboratories and their customers. Learn more about clauses 3-5 of ISO/IEC 17025:2017 here.

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