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Laboratory Accreditation & Quality

The quality of laboratory drug testing in this field is measured against the international standard ISO/IEC 17025:2005. It is important to note that using a non-accredited laboratory service can leave the testing processes open to legal challenge.

Concateno’s laboratories are all accredited to ISO/IEC 17025:2005. 

• What is ISO/IEC 17025:2005?
• What is UKAS?
• Why is accreditation important?
• What types of accreditation are available?

What is ISO/IEC 17025:2005?

ISO/IEC 17025:2005 is an international quality standard that specifies the general requirements for competence to carry out laboratory tests and/or calibrations. Laboratories accredited to this standard are assessed through regular independent audits to demonstrate that they operate a management system, are technically competent, and are able to generate technically valid results in performing the tests for which they are accredited.The requirements of ISO/IEC 17025:2005 also include the requirements of ISO 9001:2008 which demonstrate a competent internal quality management system.

What is UKAS?

The United Kingdom Accreditation Service (UKAS) is the only national accreditation organisation recognised by the UK Government. UKAS assess organisations and laboratories that provide certification, testing, inspection and calibration services against internationally recognised standards, and accredit them accordingly.

UKAS periodically audit each of the laboratories that they accredit in order to ensure that the laboratories continue to demonstrate the competence and performance capability required to meet these internationally agreed quality levels. Concateno’s oral fluid testing laboratory in Abingdon, Oxfordshire, its urine testing laboratory in Canary Wharf and its hair testing lab in Cardiff are audited by UKAS regularly to demonstrate adherence to the ISO/IEC 17025:2005 laboratory-testing standard.

UKAS is a member of the European co-operation for Accreditation (EA), the International Accreditation Forum (IAF) and the International Laboratory Accreditation Cooperation (ILAC).

Why is accreditation important?

Accreditation ensures clients have robust, reliable, quality test results that are less open to legal challenge in court proceedings. Using a non-accredited laboratory service puts at risk the outcome for such test results, as their methods will not have been subject to the same rigorous, internationally recognised and independently audited standards. Essentially, accreditation provides security and peace of mind to the clients, donors and families involved.

What types of accreditation are available?

To reach the international standard for drug testing, a laboratory’s processes and various other business processes, such as customer feedback and contracting, are subject to an annual audit to ISO/IEC 17025:2005 standards. Many companies have certification to ISO 9001:2008 standards and it's important to note the difference.

ISO 9001:2008 is a standard for internal quality management systems. Certification to this standard doesn’t guarantee the technical competency to test for substance misuse, merely that formal internal management systems are in place.

UKAS's own website emphasises that:

“You can be confident in the technical competence and the results produced by testing and calibration laboratories if they hold UKAS accreditation to ISO/IEC 17025:2005. UKAS accredited certification of a supplier's management system to ISO 9001:2008 tells you that they have arrangements for managing the quality of their product or service, but does not say anything about their technical competence.”

“A laboratory certified to ISO 9001:2008:2000 but without ISO/IEC 17025:2005 should not be considered a suitable alternative. ”

Source: Testing & Calibration – What to Look For, UKAS Delivering Confidence Brochure, p. 6. Available here.

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