ISO IEC 17025-2017 PDF

Full title and description

ISO/IEC 17025:2017 — General requirements for the competence of testing and calibration laboratories. An international standard that specifies the general requirements laboratories must meet to demonstrate technical competence, impartiality and consistent operation when performing tests, calibrations and associated sampling.

Abstract

ISO/IEC 17025:2017 (3rd edition) defines requirements for laboratory competence, including organizational and technical elements that affect the validity of results. The 2017 revision reorganized the standard into a process-focused structure, introduced risk-based thinking, strengthened requirements on impartiality and confidentiality, and updated requirements for information technologies, electronic records and reporting.

General information

• Status: Published — current (confirmed by ISO review in 2023).
• Publication date: 29 November 2017 (Edition 3, 2017; corrected language versions issued March–April 2018).
• Publisher: International Organization for Standardization (ISO), developed jointly with the International Electrotechnical Commission (IEC) under ISO/CASCO.
• ICS / categories: 03.120.20 (Product and company certification. Conformity assessment).
• Edition / version: 3rd edition — ISO/IEC 17025:2017.
• Number of pages: 30 (English edition; page counts may vary by translation/format).

Scope

Applies to all organizations performing laboratory activities (testing, calibration and associated sampling) regardless of size. It establishes requirements for competence, impartiality and consistent operation so that laboratories can produce valid and reliable results that are accepted nationally and internationally. The standard is used by laboratories, accreditation bodies, regulators and customers to assess and recognize laboratory competence.

Key topics and requirements

• General requirements: impartiality and confidentiality obligations for the laboratory.
• Structural requirements: organization, responsibility and management of laboratory activities.
• Resource requirements: personnel competence, facilities, equipment and environmental conditions.
• Process requirements: method selection, method validation/verification, sampling, handling of test/calibration items, measurement traceability and uncertainty of measurement.
• Management system requirements: documentation (now less prescriptive), continual improvement, corrective actions and risk-based thinking.
• Technical requirements for producing valid results: verification of methods, proficiency testing, calibration and maintenance of equipment, and data integrity.
• Requirements addressing information technology: electronic records, secure reporting and integrity of computer systems.
• Requirements for reporting results and certificates, including content and traceability statements.

Typical use and users

Used by testing and calibration laboratories in industry, government, research institutions, forensic and medical labs, and by any organization that needs to demonstrate technically valid laboratory results. Accreditation bodies use the standard as the primary basis for lab accreditation; regulators and customers use it to decide whether to accept laboratory results without additional testing.

Related standards

Supersedes ISO/IEC 17025:2005. Closely related to standards and documents in conformity assessment and laboratory quality such as ISO 9001 (quality management), ISO 15189 (medical laboratories), ISO/IEC 17011 (accreditation bodies), ISO/IEC 17020 (inspection bodies), ISO/IEC 17043 (proficiency testing) and ILAC/EA guidance documents.

Keywords

laboratory competence, testing, calibration, accreditation, measurement traceability, measurement uncertainty, method validation, impartiality, confidentiality, management system, risk-based thinking, ISO/IEC 17025:2017

FAQ

Q: What is this standard?

A: ISO/IEC 17025:2017 is the international standard specifying general requirements for the competence, impartiality and consistent operation of testing and calibration laboratories.

Q: What does it cover?

A: It covers organizational and technical requirements needed to produce valid laboratory results, including personnel competence, equipment, methods and procedures, measurement traceability and uncertainty, quality management activities and information systems relevant to laboratory work.

Q: Who typically uses it?

A: Testing and calibration laboratories, accreditation bodies, regulators, laboratory customers, research institutions and any organization that relies on laboratory-generated data for decision-making or regulatory compliance.

Q: Is it current or superseded?

A: The 2017 edition (3rd edition) is the current version. It superseded ISO/IEC 17025:2005. ISO formally confirmed the 2017 edition during its periodic review (confirmation noted in 2023).

Q: Is it part of a series?

A: It belongs to the family of conformity assessment and laboratory-related standards and is commonly used alongside ISO/IEC 17011 (accreditation bodies), ISO/IEC 17043 (proficiency testing), ISO 15189 (medical labs) and ISO 9001 (quality management).

Q: What are the key keywords?

A: Laboratory competence, calibration, testing, accreditation, measurement traceability, measurement uncertainty, method validation, impartiality, risk-based thinking, management system.