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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.
7 Process requirements
7.8 Reporting of results
7.8.6 Reporting Statements of Conformity
When a statement of conformity is provided, the laboratory shall document and apply the decision rule, taking into account the associated risks and ensuring the statement clearly identifies applicable results, specifications, and the decision rule applied.

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
    - 7.1 Review of Requests, Tenders, and Contracts
      The laboratory shall establish a procedure for reviewing requests, tenders, and contracts to ensure customer requirements are met, resources are available, and contract deviations are managed appropriately.
    - 7.2 Selection, verification and validation of methods
    - 7.3 Sampling
      The laboratory shall have a sampling plan and method to ensure the validity of subsequent testing or calibration results.
    - 7.4 Handling of Test or Calibration Items
      The laboratory shall establish procedures to ensure the integrity of test or calibration items during transportation, receipt, handling, storage, and disposal.
    - 7.5 Technical Records
      The laboratory shall maintain technical records that document laboratory activities, results, and sufficient information to ensure traceability, facilitate identification of factors affecting measurement results, and allow for repetition of the activity under conditions as close as possible to the original.
    - 7.6 Evaluation of Measurement Uncertainty
      Laboratories shall identify and evaluate contributions to measurement uncertainty using appropriate methods of analysis, ensuring accurate and reliable results in calibration and testing.
    - 7.7 Ensuring the Validity of Results
      The laboratory shall establish procedures for monitoring the validity of results, applying statistical techniques where appropriate, and taking corrective actions when necessary to maintain result accuracy and reliability.
    - 7.8 Reporting of results
      - 7.8.1 General
        The laboratory shall review, authorize, and provide results accurately, clearly, and objectively in an agreed format, ensuring that necessary information is included for proper interpretation.
      - 7.8.2 Common Requirements for Reports (Test, Calibration, or Sampling)
        Each report shall include specific information to ensure clarity, minimize misunderstanding, and maintain the integrity of results.
      - 7.8.3 Specific Requirements for Test Reports
        In addition to the general reporting requirements, test reports shall include additional details necessary for interpreting test results.
      - 7.8.4 Specific Requirements for Calibration Certificates
        In addition to general reporting requirements, calibration certificates shall include additional details necessary for interpreting calibration results.
      - 7.8.5 Reporting Sampling – Specific Requirements
        Where the laboratory is responsible for sampling, reports shall include additional details necessary for interpreting the results, in addition to general reporting requirements.
      - 7.8.6 Reporting Statements of Conformity
        When a statement of conformity is provided, the laboratory shall document and apply the decision rule, taking into account the associated risks and ensuring the statement clearly identifies applicable results, specifications, and the decision rule applied.
      - 7.8.7 Reporting Opinions and Interpretations
        The laboratory shall ensure that opinions and interpretations in reports are based on test or calibration results, clearly identified as such, and released only by authorized personnel.
      - 7.8.8 Amendments to Reports
        When a report needs to be changed, amended, or re-issued, all modifications must be clearly identified, documented, and meet all applicable requirements.
    - 7.9 Complaints
      The laboratory shall establish a documented process for receiving, evaluating, and making decisions on complaints, ensuring appropriate tracking, resolution, and communication with complainants.
    - 7.10 Nonconforming Work
      The laboratory shall have a procedure that shall be implemented when any aspect of its laboratory activities or results of this work do not conform to its own procedures or the agreed requirements of the customer.
    - 7.11 Control of Data and Information Management
      The laboratory shall establish and maintain control over data and information management systems, ensuring data integrity, protection, validation, and compliance with applicable 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.

7.8.6 Reporting Statements of Conformity

When a statement of conformity is provided, the laboratory shall document and apply the decision rule, taking into account the associated risks and ensuring the statement clearly identifies applicable results, specifications, and the decision rule applied.

7.8.6.1 Decision Rule Documentation and Application

When a statement of conformity to a specification or standard is provided, the laboratory shall:

Document the decision rule employed.
Consider the level of risk associated with the decision rule, including:
- False accept risks.
- False reject risks.
- Statistical assumptions.
Apply the decision rule accordingly.

Note:

Where the decision rule is prescribed by the customer, regulations, or normative documents, further consideration of the level of risk is not necessary.

7.8.6.2 Reporting Statements of Conformity

The laboratory shall report on the statement of conformity in a way that clearly identifies:

To which results the statement of conformity applies.
Which specifications, standards, or parts thereof are met or not met.
The decision rule applied, unless it is inherently part of the requested specification or standard.

Note:

For further information, see ISO/IEC Guide 98-4.