Who is it for?

ISO 17025 provides guidelines for all types of testing and calibration laboratories, regardless of their size, number of staff or scope of activities, which may include, for example:

• sampling,
• calibration,
• and the development of test methods.

The standard is useful both for independent bodies and those forming part of a specific organisation, including universities, research centres, government bodies and regulatory authorities.

The ISO 17025 standard was developed with laboratories developing their own quality systems in mind. It may be particularly useful for those entities that need to demonstrate that all testing or calibration they perform complies with the standards applicable to the chosen method, and that the results obtained are reliable and valid.

Information about the standard

The ISO 17025 standard (more precisely, ISO/IEC 17025) provides guidelines on quality management and technical requirements for testing and calibration laboratories. Its first edition was developed by the International Organisation for Standardisation (in collaboration with the International Electrotechnical Commission – IEC) in 1999, with the aim of harmonising quality and technical requirements for laboratories worldwide.

ISO 17025 sets out requirements for a laboratory management system, including work organisation, control of documentation, internal audits, corrective and preventive actions, procurement and customer service. The ISO 17025 standard also describes technical requirements relating, for example, to staff qualifications, premises, testing/calibration methods, testing/calibration equipment and the handling of collected samples.

The ISO 17025 standard is based on the ISO 9001 quality management system and meets all its requirements. ISO 17025 can be regarded as a technical supplement to ISO 9001, as it contains guidelines regarding the technical soundness of laboratory operations. The ISO 17025 and ISO 9001 standards are independent of one another. Implementation of the ISO 9001 system can be crowned with certification, which signifies compliance with the international quality management standard. Implementation of ISO 17025, on the other hand, culminates in the granting of accreditation, i.e. recognition by an independent accreditation body of a given laboratory’s competence to carry out specific activities.

Benefits of implementation

ISO 17025 accreditation serves as proof that a laboratory operates in accordance with the highest quality standards, is technically competent, and can deliver test or calibration results of high accuracy and reliability. Implementation of the ISO 17025 standard enhances the laboratory’s prestige, which encourages various organisations to work with an accredited body.

The direct benefits of implementing the ISO 17025 standard include:

• overall improvement in the laboratory’s operations,
• the possibility of continuous quality improvement through procedures for risk analysis and corrective actions,
• greater precision in testing/calibration,
• the use of appropriate equipment,
• improved staff qualifications (both managerial and technical),
• clearly defined areas of staff responsibility,
• easier exchange of information and experience with related institutions worldwide (due to standardised operating procedures).