ISO 17025

ISO/IEC 17025 was developed by the International Organization for Standardization (ISO) and is an international standard that defines the requirements for testing and calibration laboratories. These requirements ensure that laboratories maintain a quality management system, guarantee their technical competence, and provide reliable results.

ISO/IEC 17025 can be applied by any laboratory (private or public), regardless of size, number of employees, type of tests or calibrations performed, or the purpose for which they serve (first-, second-, or third-party laboratories).

Development of the system involves the following phases:

1. Determining criteria and guidelines relevant to the laboratory’s activities and tests/calibrations.
2. Evaluating the laboratory’s facilities, equipment, and testing or calibration practices in relation to the standard’s requirements.
3. Identifying how to correct any deviations.
4. Reviewing current procedures and records where discrepancies exist and creating new procedures and records where none exist.
5. Training staff on system requirements.
6. Implementing the system.
7. Reviewing and updating the system if necessary.
8. Conducting an internal audit.

ISO/IEC 17025 does not mandate the exclusive use of standard methods; non-standard or laboratory-developed methods may be used, provided they are validated. The laboratory may choose the scope of activity, products/materials, type of tests/calibrations, and measurement properties to be included in the system.

Key prerequisites for effectively implementing ISO/IEC 17025 include participation in proficiency testing schemes, calibration of measuring equipment, and assessment of measurement uncertainty. Collaboration with a specialized consultant is usually necessary to develop a functional, efficient system tailored to the laboratory’s needs and in line with the standard’s requirements. ISO/IEC 17025 can be combined with other standards the laboratory uses or plans to implement, allowing for a unified management system.

In Greece, accreditation is carried out exclusively by the Hellenic Accreditation System (ESYD), supervised by the Ministry of Development. The accreditation process involves assessing the laboratory’s compliance with legal requirements relevant to its operation and accreditation criteria, evaluating technical competence (staff, facilities, equipment), and reviewing both the management system and its implementation.

After successfully completing the evaluation, the Accreditation Body issues a four-year Accreditation Certificate. In the event of deviations, the laboratory must implement corrective actions before the certificate is issued.

The Accreditation Certificate details the accreditation scope. Testing laboratories must list materials/products tested, test types/measured properties, and methods; calibration laboratories must list the measured quantities/objects, measurement range, uncertainty, and methods.

The certificate remains valid as long as periodic evaluations (at least annual) are conducted by the Accreditation Body to ensure the laboratory maintains compliance with defined requirements.

Key reasons a laboratory seeks accreditation include:

• Ensuring reliability and validity of results
• Obtaining formal recognition for carrying out tests and/or calibrations with documented competence and impartiality
• Improving internal organization and process effectiveness
• Facilitating business with customers who require collaboration with accredited laboratories
• Strengthening the laboratory’s competitive position
• Making cooperation between laboratories and other bodies easier, for exchanging information and expertise
• Heightening staff awareness of the importance of the work performed