ISO/IEC 17025 laboratory accreditation – what is it and how does it differ from certification?

Testing and calibration laboratories operate in an environment where the reliability of results is an absolute priority. Every analysis, every measurement and every test result may have legal, health or technical implications. ISO/IEC 17025 is a standard that sets out the requirements for laboratories wishing to demonstrate that their results are reliable, accurate and reproducible. The process for confirming this competence – accreditation – differs fundamentally from the certification used in other management systems.

What is ISO/IEC 17025 and what does accreditation mean?

ISO/IEC 17025 (full title: ‘General requirements for the competence of testing and calibration laboratories’) is a standard developed by the International Organisation for Standardisation in collaboration with the International Electrotechnical Commission. The current version – PN-EN ISO/IEC 17025:2018 – is the third edition of the standard and was incorporated into Polish standards in February 2018. The standard is intended for all types of laboratories – regardless of their size, field of activity or organisational form. It can be applied by both independent laboratories and those forming part of institutions such as universities, research centres, government bodies, industrial plants and inspection bodies.

The standard contains two types of requirements. The first relate to the management system – organisation of work, control of documentation, internal audits, corrective actions and customer service. The second set concerns technical requirements – staff qualifications and competence, premises and environmental conditions, measuring equipment and its calibration, test and calibration methods, measurement consistency, sampling and reporting of results. It is precisely the inclusion of technical requirements that distinguishes ISO/IEC 17025 from ISO 9001 – the laboratory standard not only requires good management, but also confirmation of the technical competence to carry out specific tests or calibrations.

These competences are confirmed by accreditation – formal recognition by an independent accreditation body that the laboratory meets the requirements of the standard and is competent to carry out specific activities within a defined scope. In Poland, the only national body authorised to grant accreditation is the Polish Centre for Accreditation (PCA), operating under the Act on the Conformity Assessment System. The PCA is a signatory to multilateral agreements on the mutual recognition of accreditation within the framework of the EA (European co-operation for Accreditation) and ILAC (International Laboratory Accreditation Cooperation), which means that certificates issued by accredited laboratories are recognised in over 100 countries worldwide.

Accreditation versus certification – key differences

The terms ‘accreditation’ and ‘certification’ are often confused – even within industry circles. However, the difference between them is of fundamental legal and practical importance.

Certification (e.g. ISO 9001, ISO 14001, ISO 45001) is confirmation by a certification body that an organisation’s management system meets the requirements of a given standard. A certificate relates to the system – the management approach – rather than to specific products, services or results. A certificate is issued for three years and can be obtained by any organisation, regardless of sector.

Accreditation is confirmation of technical competence – that a laboratory is capable of carrying out specific tests or calibrations with a defined level of accuracy and reliability. Accreditation relates to the scope of the laboratory’s activities, precisely defined in the accreditation certificate – e.g. specific test methods, measured parameters and measurement ranges. It is therefore not possible to obtain ‘general’ accreditation – each laboratory is accredited within a strictly defined scope, which must be regularly confirmed through the surveillance process.

The practical implication of this distinction is significant: test results issued by a laboratory accredited by the PCA are recognised by courts, government bodies, inspection authorities and business partners as evidence of particular weight. Test results from a laboratory holding only a management system certificate (e.g. ISO 9001) do not formally carry such weight.