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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
8.5 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.

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.

8.5 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.

8.5.1 Consideration of Risks and Opportunities

The laboratory shall consider the risks and opportunities associated with its activities to:

Give assurance that the management system achieves its intended results.
Enhance opportunities to achieve the purpose and objectives of the laboratory.
Prevent, or reduce, undesired impacts and potential failures in laboratory activities.
Achieve improvement.

8.5.2 Planning Actions

The laboratory shall plan:

Actions to address these risks and opportunities.
How to:
- Integrate and implement these actions into its management system.
- Evaluate the effectiveness of these actions.

Note:

Although this document specifies that the laboratory plans actions to address risks, there is no requirement for formal methods for risk management or a documented risk management process. Laboratories may decide whether to develop a more extensive risk management methodology than required, such as through the application of other guidance or standards.

8.5.3 Proportionality of Actions

Actions taken to address risks and opportunities shall be proportional to the potential impact on the validity of laboratory results.

Note:

Options to address risks can include identifying and avoiding threats, taking risk in order to pursue an opportunity, eliminating the risk source, changing the likelihood or consequences, sharing the risk, or retaining risk by informed decision.

Note:

Opportunities can lead to expanding the scope of the laboratory activities, addressing new customers, using new technology, and other possibilities to address customer needs.