What is the ISO 17025?
The ISO 17025 (DIN EN ISO 17025) defines the requirements for the competence of laboratories that conduct tests and / or calibrations. Reading this, you first think about contract laboratories that test samples as independent service providers or perform calibrations. The ISO 17025 however applies to organizations that perform tests for quality control or calibration during a manufacturing process as well. Tests or calibrations can include standardized as well as non-standardized methods or tests developed in the laboratory, as well as the method of collecting samples. The ISO 17025 was updated most recently in 2005 (ISO 17025:2005).
Why is the ISO 17025 so important?
The ISO 17025 is addressed to all laboratories with the motivation to develop and continuously improve their quality by a quality management system. Unlike other ISO norms, it focuses primarily (exclusively) on the reliability and quality of methods and not on work and customer safety.
The compliance with ISO 17025 isn’t compulsory, but it still contributes to the respectability and acceptance of the laboratory. Especially contract laboratories offering independent calibrations and sample analysis need a certification according to ISO 17025 as proof of their ability to produce consistently reliable and trustworthy results. These trustworthy results certified by ISO 17025 are the key to customer satisfaction and the acceptance of the laboratory as an independent test facility.
What makes the ISO 17025 special?
The ISO 17025 has much in common with the quality management system of the ISO 9001. In both cases, the continual evaluation of opportunities for improvement is necessary. This requires a documented quality management system (QMS) and regular internal audits. In the course of this, it’s expected that the laboratory orients itself to up-to-date methods and is always eager to stay on top of scientific and technological innovations.
The ISO 17025 gets more specific regarding the competence to conduct testing methods and calibrations professionally. It puts a focus on the effective involvement and compliance with the quality management system in the laboratory. This means, in detail, that the devices used need to be qualified and the conducted methods need to be validated regarding their accuracy, robustness and reproducibility. A sufficiently trained staff is obviously the prerequisite for professionally conducting the tests.
In order to ensure that the norm conformity of the laboratory is confirmed over time as well, it’s a requisite for the certification according to ISO 17025 that the quality is checked (accredited) regularly by an external audit. It differs from other norms like the ISO 9001 or ISO 13485 by the following fact: For this, official accreditation bodies and not certification companies are responsible, the Deutsche Akkreditierungsstelle (DAkkS) in Germany for example or the European Accreditation Cooperation (EA) throughout Europe. The accreditation body audits all points of ISO 17025 and verifies if the requirements of the norm have been fulfilled sufficiently.
Do you want to make your laboratory ready for the ISO 17025? Please don’t hesitate to contact us. We’re going to help you with that!