UNE-EN ISO/IEC 17025 General Requirements for the Competence of Testing and Calibration Laboratories
This standard has been developed with the aim of promoting confidence in the operation of laboratories. It contains requirements that allow laboratories to demonstrate that they operate competently and have the capability to generate valid results.
The ISO 17025 standard has become the international reference standard for testing and calibration laboratories that want to demonstrate their ability to obtain reliable results and develop management systems for their quality, administrative, and technical activities.
01. Objective
This standard specifies the general requirements for technical competence, impartiality, and consistent operation of laboratories. It establishes general requirements such as impartiality and confidentiality, as well as requirements related to the structure, resources, processes, and management system.
02. Structure
The standard was updated in 2017 to cover technical changes in laboratories and computer techniques. The main changes in the ISO 17025 standard were:
- The scope has been revised to encompass all laboratory activities, including testing, calibration, and sampling.
- A new structure has been adopted to align the new standard with the rest of the conformity assessment standards in the ISO/IEC 17000 series.
- Inclusion of the general requirements section addressing confidentiality and impartiality.
- Terminology update: Changes in the International Vocabulary of Metrology (VIM) have been included, and the new standard aligns with ISO terminology, which has a series of common terms and definitions for all conformity assessment standards. A definition of “laboratory” has been included.
- Alignment with ISO 9001:2015: The process approach now matches that developed in newer standards such as ISO 9001 (quality management), ISO 15189 (for clinical laboratories), and the ISO/IEC 17000 series (for conformity assessment activities), emphasizing process outcomes rather than detailed descriptions of tasks and steps.
- Inclusion of the concept of “Risk-Based Thinking” in line with the new version of ISO 9001 on quality management systems, allowing a less prescriptive and more performance-based formulation of requirements. The laboratory is now responsible for deciding which risks to address and how to manage them.
- Incorporation of new sections on result analysis and declaration of conformity, as well as new considerations on measurement uncertainty and traceability.
- Increased flexibility in requirements for processes, procedures, documented information, and organizational responsibilities.
- Integration of computerized systems for data and information management. The standard is more focused on the use of information technologies. As manuals, records, and paper reports are being gradually phased out, it incorporates the use of computer systems, electronic records, and the production of electronic results and reports.
Main Sections of the Standard
The current version of the standard is structured into five groups of requirements:
- General Requirements: Impartiality and confidentiality.
- Structural Requirements: The laboratory must be a legal entity, define its organization and management structure, and have personnel with the authority and resources necessary to carry out their tasks.
- Resource Requirements: Including personnel, facilities and environmental conditions, equipment, metrological traceability, and externally provided products and services.
- Process Requirements: Including the review of requests, tenders, and contracts, selection, verification and validation of methods, sampling, handling of test or calibration items, technical records, evaluation of measurement uncertainty, ensuring the validity of results, reporting of results, complaints, non-conforming work, and control of data and information management.
- Management System Requirements: The laboratory must establish, document, implement, and maintain a management system capable of supporting and demonstrating consistent achievement of the requirements of this document and ensuring the quality of laboratory results.
03. Advantages
Demonstrate technical competence and ensure excellence in the services offered. It guarantees the validity and technical reliability of results and diagnostics.
- Opens doors to new markets: accredits the quality of your laboratory nationally and internationally.
- Provides the opportunity for continuous improvement: constantly evaluates personnel, methods, equipment, calibration, and report preparation.
- Gains recognition and improves your organization’s image and reputation.
- Competitive advantage: technical reliability helps differentiate you from the competition.
- Acts as a reference for implementing new accreditations and quality management standards.
- Increases customer and regulatory body confidence.
- Reduces some costs, for example, by decreasing the need for test repetition.
- Increases productivity: improves operational efficiency and reduces errors.
- Meets the demands of both private and public clients.
04. Frequently Asked Questions
Any testing and calibration laboratory, regardless of the activities it performs or its size.
ENAC (Entidad Nacional de Acreditación) is the body designated by the Government in application of Regulation (EC) No 765/2008, which regulates the operation of accreditation in Europe based on five fundamental principles: Non-profit; Independence; Non-competition; International evaluation; Mutual recognition.
A Technical Committee of experts reviews the current standard and proposes changes and improvements to adapt it to technical and scientific advancements. The update of the standard in a new version requires accredited laboratories to comply with the new requirements included in the latest version.
Certification guarantees compliance with the requirements of a standard, while accreditation is a process in which an organization performing evaluation activities submits those activities to inspection by an external body (accreditation entity). Accreditation verifies the compliance and conformity of these evaluation activities with established standards.
This standard establishes the requirements to demonstrate the technical competence of testing and calibration laboratories, regardless of their size and scope of operation.
ISO 9001 focuses on general quality management, ISO 17025 addresses the technical competence of testing and calibration laboratories, and ISO 17020 pertains to the technical competence of inspection bodies.
