DIN EN ISO IEC 17025 2018-03 PDF

Full title and description

STB DIN EN ISO/IEC 17025:2018-03 — General requirements for the competence of testing and calibration laboratories. This document is the German/English adoption of the international ISO/IEC 17025:2017 standard and sets out management and technical requirements laboratories must meet to demonstrate competence, impartiality and consistent operation for testing, calibration and associated sampling activities leading to testing or calibration.

Abstract

ISO/IEC 17025 (as adopted in DIN EN ISO/IEC 17025:2018-03) provides a consolidated framework of management and technical requirements for laboratories that perform testing, calibration and related tasks. The 2017 international revision (published and adopted by DIN in March 2018) introduced a stronger emphasis on risk-based thinking, information technology/electronic data, impartiality and confidentiality, clearer treatment of sampling linked to testing/calibration, and updated requirements for metrological traceability and measurement uncertainty.

General information

• Status: Published / Current (national adoption of ISO/IEC 17025:2017).
• Publication date: March 2018 (DIN adoption: 01/03/2018).
• Publisher: DIN — Deutsches Institut für Normung (German language and English language versions; based on the ISO/IEC 17025:2017 international standard).
• ICS / categories: 03.120.20 (Laboratory practice), 19.020 (Quality control).
• Edition / version: National adoption of ISO/IEC 17025:2017 (edition published internationally 2017; DIN EN ISO/IEC 17025 published March 2018).
• Number of pages: 65 pages (DIN published bilingual version includes national forewords/annexes; international ISO document reference also available).

Scope

The standard specifies general requirements for the competence, impartiality and consistent operation of laboratories that perform testing and/or calibration, including sampling where the sampling leads to subsequent testing or calibration. It applies to all laboratory activities regardless of the number of personnel or the extent of the laboratory’s scope of activities. The document is intended to support laboratory accreditation and mutual recognition of results. The 2017 revision clarified the status of pure sampling (not normally within accreditation scope unless followed by testing/calibration) and strengthened requirements around management responsibilities, IT/data, and risk-based approaches.

Key topics and requirements

• Management requirements: organization, responsibilities of leadership, document control, management of risks and opportunities, continual improvement.
• Technical requirements: competence of personnel, method validation/verification, sampling (when applicable), traceability of measurements, equipment, environmental conditions, and quality assurance of results.
• Measurement uncertainty and metrological traceability: explicit requirements for establishing traceability and reporting uncertainty.
• Impartiality and confidentiality: stronger, clearer obligations to identify and manage risks to impartiality and to protect confidential information.
• Information technology and electronic data: acknowledgement of laboratory information management systems (LIMS) and electronic records as part of conformity and data integrity.
• Relationship to accreditation: criteria used by accreditation bodies for assessment and recognition of laboratory competence.

Typical use and users

This standard is used by testing and calibration laboratories seeking accreditation, by accreditation bodies when assessing laboratories, and by organizations that rely on laboratory results (regulatory authorities, manufacturers, inspection bodies, research institutions). It is applicable across sectors including medical testing (where complementary standards such as ISO 15189 may also apply), industrial testing, environmental monitoring, food testing, calibration services and forensic laboratories.

Related standards

Commonly referenced and related standards include ISO/IEC 17025:2017 (international base document), ISO 9001 (quality management), ISO 15189 (medical laboratories), ISO/IEC 17020 (inspection bodies), ISO/IEC 17021 series (conformity assessment bodies), and ILAC/EA guidance documents on accreditation and mutual recognition.

Keywords

laboratory competence, testing, calibration, accreditation, management requirements, technical requirements, measurement uncertainty, metrological traceability, impartiality, confidentiality, LIMS, sampling, ISO/IEC 17025.

FAQ

Q: What is this standard?

A: It is the national (DIN EN) adoption of ISO/IEC 17025:2017 — the international standard specifying general requirements for the competence of testing and calibration laboratories.

Q: What does it cover?

A: It covers both management-system requirements and technical requirements needed for laboratories to produce valid results: organization and leadership responsibilities, personnel competence, methods and method validation, equipment and calibration, traceability and uncertainty, sampling (when linked to testing/calibration), and controls to ensure impartiality and confidentiality.

Q: Who typically uses it?

A: Testing and calibration laboratories seeking accreditation or aiming to demonstrate technically valid and internationally accepted results; accreditation bodies; regulators and organizations that depend on laboratory data.

Q: Is it current or superseded?

A: The international ISO/IEC 17025:2017 edition is the current edition of the standard; the DIN adoption (DIN EN ISO/IEC 17025:2018-03) is the national publication of that edition (March 2018). The ISO entry indicates the 2017 edition has been reviewed and confirmed in subsequent maintenance activity. Users should always check their national standards body or accreditation body for the latest confirmations or national supplements.

Q: Is it part of a series?

A: It is part of the family of conformity assessment and laboratory-related standards (ISO/IEC 17000 series and related standards such as ISO 9001, ISO 15189, ISO/IEC 17020 and ISO/IEC 17021). It replaces earlier editions of ISO/IEC 17025 (e.g., the 2005 edition) as the current reference for laboratory competence.

Q: What are the key keywords?

A: laboratory competence, accreditation, testing, calibration, measurement uncertainty, metrological traceability, impartiality, management requirements, LIMS, sampling.