ISO/IEC 17025 in practice – which laboratories is it for, and what benefits does it offer?

ISO/IEC 17025 is a universal standard – its requirements are formulated in sufficiently general terms to allow for application in any laboratory, regardless of sector, size or scope of activity. In practice, however, each type of laboratory faces specific challenges when implementing the standard and derives different kinds of benefits from accreditation. Below, we discuss the most common areas of application for the standard and the benefits that accreditation brings in each of them.

Types of laboratories covered by the standard

The ISO/IEC 17025 standard applies to testing and calibration laboratories – but these two categories encompass an extremely broad and diverse range of organisations.

Testing laboratories carry out tests on samples of materials, products, food, water, soil, air, industrial goods and many other items in order to determine their properties or compliance with requirements. These include environmental laboratories testing water and air quality, food laboratories carrying out microbiological and physico-chemical analyses, construction laboratories testing the properties of construction materials and products, medical and clinical laboratories, pharmaceutical laboratories, as well as forensic and court laboratories.

Calibration laboratories are responsible for calibrating measuring instruments – confirming that the readings of a given instrument are in accordance with a measurement standard with documented traceability to national and international standards. These are laboratories that calibrate thermometers, balances, pressure gauges, electrical meters, and control and measurement equipment used in industry and medicine.

In addition to these two main categories, the standard also applies to laboratories involved in sampling as an integral part of the testing process, and since the 2018 version, it explicitly refers to laboratories issuing opinions and interpretations of results, which is of particular significance for expert and forensic laboratories.

Legal and regulatory benefits

For many laboratories, PCA accreditation is not a choice – it is a legal or regulatory requirement, without which it is impossible to operate within a specific scope.

• Test results issued by accredited laboratories are recognised by the ordinary and administrative courts as evidence of particular weight in civil, criminal and administrative proceedings
• The Environmental Protection Inspectorate, the Sanitary Inspectorate, the Veterinary Inspectorate and other supervisory bodies require that tests carried out for the purposes of official control be conducted by laboratories accredited by the PCA
• EU regulations concerning food, drinking water, construction materials and many other product categories require testing to be carried out in accredited laboratories
• Public procurement contracts increasingly stipulate that a tenderer must have access to an accredited laboratory or hold accreditation in the relevant scope
• PCA Accreditation is a signatory to the EA and ILAC agreements, which means that the test results of accredited Polish laboratories are recognised in over 100 countries – without the need for retesting upon export

Business and market benefits

For laboratories operating in the commercial sector, accreditation is, above all, a tool for building credibility and a competitive advantage.

How does accreditation influence customer confidence? A customer commissioning a test from an external laboratory is unable to assess the quality of its work independently – they do not know the staff, the equipment or the methods used. A PCA accreditation certificate is objective, verifiable proof that the laboratory meets the requirements of a recognised standard and has been assessed by an independent third party. This is a decisive factor when institutional clients – particularly those operating in regulated sectors – choose a laboratory.

Does accreditation open up access to new markets? Yes – in two ways. The first is domestic markets, where legal or contractual requirements exclude non-accredited laboratories. The second is international markets: a Polish laboratory accredited by the PCA can issue reports recognised by contractors and regulatory bodies in EA and ILAC countries without the need for further verification. For laboratories serving clients who export products to Western markets, this is a decisive factor.

In-house laboratories – does accreditation make sense?

A separate category comprises laboratories integrated into the structures of industrial, food, pharmaceutical or construction organisations – in-house laboratories whose main task is to monitor the quality of their own production. For them, the question of whether accreditation makes sense is more complex.

On the one hand, accreditation of an in-house laboratory brings the same benefits in terms of credibility and formal recognition of results – which is important in disputes with customers, during inspections and when demonstrating product compliance with regulatory requirements. On the other hand, it involves the costs of maintaining the system and undergoing regular assessments by the Polish Centre for Accreditation (PCA), which, in the case of a small in-house laboratory, may be disproportionate to the benefits.

A practical alternative to full accreditation is to implement the requirements of ISO/IEC 17025 without applying for accreditation – as a tool for internal improvement and for demonstrating technical competence to customers and certification bodies auditing the facility. This approach allows the laboratory to reap the benefits of systematic management without incurring the full costs of the accreditation process.

A well-prepared system compliant with ISO/IEC 17025 not only enables the laboratory to meet accreditation requirements, but also helps to streamline laboratory processes and enhance the reliability of test results.