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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.
8 Management system requirements
8.4 Control of Records (Option A)
The laboratory shall establish and retain legible records to demonstrate fulfilment of the requirements in this document, implementing necessary controls for record management.

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.
  - 4 General requirements
  - 5 Structural requirements
  - 6 Resource requirements
  - 7 Process requirements
  - 8 Management system requirements
    - 8.1 Options
      The laboratory shall establish, document, implement, and maintain a management system that ensures the consistent achievement of the requirements of this document, following either Option A or Option B.
    - 8.2 Management System Documentation (Option A)
      Laboratory management shall establish, document, and maintain policies and objectives to ensure competence, impartiality, and consistent operation of the laboratory.
    - 8.3 Control of Management System Documents (Option A)
      The laboratory shall control the documents, both internal and external, that relate to the fulfilment of this document.
    - 8.4 Control of Records (Option A)
      The laboratory shall establish and retain legible records to demonstrate fulfilment of the requirements in this document, implementing necessary controls for record management.
    - 8.5 Actions to Address Risks and Opportunities (Option A)
      The laboratory shall consider risks and opportunities associated with its activities to ensure the achievement of management system objectives, prevent failures, and drive improvement.
    - 8.6 Improvement (Option A)
      The laboratory shall identify and select opportunities for improvement and implement necessary actions to enhance its management system, activities, and customer service.
    - 8.7 Corrective Actions (Option A)
      The laboratory shall take appropriate corrective actions when a nonconformity occurs, ensuring effective resolution and prevention of recurrence.
    - 8.8 Internal Audits (Option A)
      The laboratory shall conduct internal audits at planned intervals to ensure conformance to its management system requirements and the requirements of this document.
    - 8.9 Management Reviews (Option A)
      The laboratory management shall review its management system at planned intervals to ensure its continuing suitability, adequacy, and effectiveness.
  - 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.

8.4 Control of Records (Option A)

The laboratory shall establish and retain legible records to demonstrate fulfilment of the requirements in this document, implementing necessary controls for record management.

8.4.1 Establishment and Retention of Records

The laboratory shall establish and retain legible records to demonstrate fulfilment of the requirements in this document.

8.4.2 Record Control Requirements

The laboratory shall implement the controls needed for the following aspects of its records:

Identification
Storage
Protection
Back-up
Archive
Retrieval
Retention time
Disposal

The laboratory shall retain records for a period consistent with its contractual obligations. Access to these records shall be consistent with confidentiality commitments, and records shall be readily available.

Note:

Additional requirements regarding technical records are given in 7.5.