General requirements for the competence of testing and calibration laboratories
What is ISO 17025?
ISO 17025 specifies the management and technical requirements to be met by organisations involved testing and calibration of laboratory equipment. It contains all the requirements needed to be met in order to demonstrate that the organisation are technically competent and are able to generate valid results.
The standard was first introduced in 1999. Prior to this date, there was no internationally accepted standard for quality systems that could provide a globally accepted basis for accreditation. Accreditation was based on national standards.
ISO 17025 was a result of implementing the ISO/IEC Guide 25 :1990 (general requirements for the competence of testing and calibration laboratories) and EN 45001:1989 (general criteria for the operation of testing laboratories). Special attention was given to introduce as much compatibility as possible with the generic quality management system, ISO 9001, which in 1999, was also under revision.
The intention was to to create a logical connection between the two standards where ISO 9001 was the master standard and ISO 17025 would be more specific and dedicated to organisations engaged in testing and calibration.
ISO 17025 is broadly split into two categories: Management requirements and technical requirements. Both these categories cover many aspects including but not limited to:
- Document control
- Corrective action
- Service to the customer
- Control of records
- Management reviews
- Internal audits
- Control of non-conforming testing and/or calibration work
- Test and calibration methods
- Testing equipment
- Measurement traceability
- Handling of test and calibration items
- Assuring the quality of test and calibration results
Henderson Biomedical and ISO 17025
Henderson Biomedical is fully accredited to ISO 17025 by the United Kingdom Accreditation Service (UKAS). We are an accredited test house for centrifuge speed and temperature as well as heat sealer temperature and pressure. We can also supply a UKAS calibration certificate for temperature of incubators, fridges, freezers and water baths.
We are able to offer UKAS calibrations both on-site and in our workshop. This means that you can benefit from a UKAS calibration regardless if you have a visit from one of our Service Engineers or whether you take advantage of our lower ‘back to base’ workshop rate.
For pathology laboratories who are looking for ISO 15189 accreditation, using our services combined with regular UKAS calibrations will satisfy your auditor and ensure you comply.
The benefits of using an ISO 17025 accredited service provider
Using a service provider such as Henderson Biomedical to provide you with UKAS calibrations of your medical devices has a number of benefits for your laboratory. Not only does it greatly assist with complying with ISO 15189 but other also provide you with valid and documented results that you can trust. This gives you greater confidence at the time of an external audit.
A UKAS accredited service provider such as Henderson Biomedical will also offer:
- Proven traceability to National Standards.
- Assurance that the equipment you are using is suitable for the measurements, properly maintained and frequently checked.
- Recognition of the Service Engineer’s abilities (technicians who visit your site and those who operate from our workshop are both inspected by an external auditor).