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Reference Material
Reference documents and regulatory information relevant to ISO 17025 compliance.
ISO/IEC 17025:2017
Structured integration of ISO/IEC 17025:2017, providing a reference for testing and calibration laboratory requirements. The official ISO PDFs remain the primary authoritative source.
3 Terms and Definitions
This section defines the terms used in this document. It references ISO/IEC Guide 99 and ISO/IEC 17000, along with additional terms specific to this standard.
3.9 Validation
Verification where the specified requirements are adequate for an intended use.

Reference Material
Reference documents and regulatory information relevant to ISO 17025 compliance.
- ISO/IEC 17025:2017
  Structured integration of ISO/IEC 17025:2017, providing a reference for testing and calibration laboratory requirements. The official ISO PDFs remain the primary authoritative source.
  - Foreword
  - Introduction
    This document establishes requirements for laboratories to ensure competence, confidence, and valid results, aligning with ISO 9001 principles. It emphasizes risk-based planning, cooperation, and harmonization of standards while outlining key terminology usage.
  - 1 Scope
    This document defines the general requirements for laboratory competence, impartiality, and consistent operation, applicable to all organizations conducting laboratory activities.
  - 2 Normative References
    This section lists documents that are referenced in the text as requirements. Dated references apply to specific editions, while undated references apply to the latest version, including amendments.
  - 3 Terms and Definitions
    This section defines the terms used in this document. It references ISO/IEC Guide 99 and ISO/IEC 17000, along with additional terms specific to this standard.
    - 3.1 Impartiality
      Presence of objectivity, ensuring that conflicts of interest do not exist or are managed appropriately.
    - 3.2 Complaint
      Expression of dissatisfaction by any person or organization to a laboratory, relating to its activities or results, where a response is expected.
    - 3.3 Interlaboratory Comparison
      Organization, performance, and evaluation of measurements or tests on the same or similar items by two or more laboratories in accordance with predetermined conditions.
    - 3.4 Intralaboratory Comparison
      Organization, performance, and evaluation of measurements or tests on the same or similar items within the same laboratory in accordance with predetermined conditions.
    - 3.5 Proficiency Testing
      Evaluation of participant performance against pre-established criteria by means of interlaboratory comparisons.
    - 3.6 Laboratory
      A body that performs one or more of the following activities: testing, calibration, or sampling associated with subsequent testing or calibration.
    - 3.7 Decision Rule
      A rule that describes how measurement uncertainty is accounted for when stating conformity with a specified requirement.
    - 3.8 Verification
      Provision of objective evidence that a given item fulfills specified requirements.
    - 3.9 Validation
      Verification where the specified requirements are adequate for an intended use.
  - 4 General requirements
  - 5 Structural requirements
  - 6 Resource requirements
  - 7 Process requirements
  - 8 Management system requirements
  - Annex A (Informative) Metrological Traceability
  - Annex B (Informative) Management System Options
    This annex provides additional information on the management system options available to laboratories, ensuring conformity to ISO 9001 while fulfilling the requirements of this document.

3.9 Validation

Verification where the specified requirements are adequate for an intended use.

Definition

Validation: Verification (3.8), where the specified requirements are adequate for an intended use.

Measurement Procedure Validation

A measurement procedure, ordinarily used for the measurement of mass concentration of nitrogen in water, may be validated also for measurement of mass concentration of nitrogen in human serum.

Source

Note:

Source: ISO/IEC Guide 99:2007, 2.45.