The quality of testing and calibration systems can make or break the reputation of a laboratory. Correct and rightful results are everything for these types of organisations. To eliminate chance from the equation, you can count on a specific management standard: ISO/IEC 17025.
What is ISO 17025?
ISO/IEC 17025 – General requirements for the competence of testing and calibration laboratories enables laboratories to demonstrate that they operate competently and provide valid results.
In 2017, ISO published a new version of the standard in order to respond to technical changes and new developments within IT and the market. The latest version of ISO 17025 also considers the most recent version of ISO 9001 (2015), the standard for quality management.
What has changed?
- The standard now applies to all laboratory activities, including testing, calibration and sampling.
- There is a new structure that brings the standard into line with the other existing ISO/IEC conformity assessment standards, such as the ISO/IEC 17000 series (conformity assessment standards).
- The process approach is more results oriented, as is the case with ISO 9001 (quality management), ISO 15189 (quality of medical laboratories) and the ISO/IEC 17000 series (conformity assessment standards).
- Because laboratory administration is increasingly handled digitally, the standard contains guidelines for the use of computer systems, electronic files and the production of electronic results and reports.
- The new version includes risk-based thinking, in accordance with the new version of ISO 9001:2015 – Quality management systems – Requirements.
- The terminology has been updated.
How can ISO/IEC 17025 benefit your laboratory’s quality management system?
ISO/IEC 17025 enables laboratories to demonstrate that they operate competently and provide valid results, thereby promoting confidence in their work both nationally and globally.
The standard also facilitates cooperation between laboratories and other bodies by ensuring the wider acceptance of results between countries. Test reports and certificates originating from other countries can be accepted without the need for further tests which, in turn, benefits international trade.
Mandatory accreditation in Belgium
Belgian laboratories which apply the ISO/IEC 17025 standard must undergo an external audit via BELAC, the Belgian accreditation body. If the audit is passed, the laboratory will be issued an official certificate that is valid for 5 years and will boost the laboratory’s image.
What type of organisation is ISO/IEC 17025 intended for?
ISO/IEC 17025 is useful for any organisation that carries out testing, sampling or calibration and wants to guarantee reliable results. These include all types of laboratories, whether they are owned and operated by the government, industry or by another organisation.
The standard is also useful for:
- universities and research centres;
- inspection bodies;
- product certification organisations and other conformity assessment bodies which carry out testing, sampling or calibration.
How should you go about implementing the standard?
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