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UKAS Accreditation Information Latest UKAS Accreditation Information
This information is protected by copyright and may not be copied or reproduced in any form without the written permission of the author(s) Latest UKAS
Accreditation Information P Graham 08AUG11 NWL and
UKAS Accreditation EN ISO/IEC
17025 General requirements for the competence of testing and
calibration laboratories is the internationally recognised standard for testing laboratories. In
the For those seeking to obtaining results from an appropriately accredited source there is room for confusion. Laboratories offering testing in a clinical context often infer operating to a quality standard, but this inference could be misleading. For example certification to ISO 9001 and or ISO 9002, these standards specifically exclude the laboratory from claiming the competence to produce technically valid data and results. You may see reference to GLP (Good Laboratory Practice) compliance. Although this may sound like a general description of proper laboratory conduct it should be noted that GLP is a quality system concerned with the organisational process and the conditions under which non-clinical studies are planned, performed, recorded and archived. GLP does not concern itself with the technical validity of the studies themselves or the competence of the laboratory. It is
interesting to note that following the mix up at the There have been efforts in the past to interest the veterinary profession and associated organisations of the need for establishing a standard for veterinary laboratories. A working party was set up some time ago to address the matter but has yet to deliver a credible standard. As is often the case when diverse interests are involved the original high ideals often become diluted by compromise. If veterinary practitioners require reassurance that their laboratory results meet a recognised standard the solution is simple use an EN ISO/IEC 17025 UKAS accredited laboratory. A list of accredited laboratories can be found on the UKAS web site, www.ukas.org. Last
Updated March 2007
Origins and
Scope of Accreditation of Laboratories UKAS accreditation of laboratories is based on an international standard, ISO 17025:2005, entitled General requirements for the competence of testing and calibration laboratories’. In early 2000 this replaced a whole raft of national standards and so provided a common global basis for laboratory accreditation. In this sense ISO 17025 can be seen as the laboratory equivalent of the generic quality system standard ISO 9000 so organisations who are themselves ISO 9000 certified should use ISO 17025 (UKAS) accredited laboratories as suppliers whenever practicable. What
Assurances Does UKAS Accreditation Give the Customer
? ISO 17025 provides defined requirements which must be met by the laboratory’s quality management system. Customers can obtain the standard, e.g. from BSI, so they can see what the laboratory must be doing in managing quality. The effect of compliance to ISO 17025 by a laboratory can be summed up as providing assurance to the customer that:-
Properly
Maintained and Calibrated Instruments Internal and
External Quality Control Typically UKAS will require laboratories to carry out regular tests on reference material. These may be industry recognised standards or, where available, certified reference materials. The latter are samples where the test results have been established and recognised on an international basis. Interlaboratory proficiency testing is also required to be carried out where this is practicable. In such an exercise the laboratory exchanges samples with a number of other laboratories and compares its own data with theirs. Laboratories
which fail to obtain acceptable data from reference materials or which
perform badly in comparison with their peers in interlaboratory
comparisons must remedy the situation immediately and correct their
procedures. A persistent failure to achieve satisfactory performance
will result in accreditation being withdrawn. International
Recognition
Just because the concept of quality may be undervalued by the general public this is no reason for not addressing the issue. A laboratory should be able demonstrate the quality of the results produced. Life and death decisions can depend on the correctness of a laboratory test result. Clients have a right to expect the results they receive to be valid and relevant. Currently there is no statutory requirement for veterinary laboratories or medical laboratories for that matter, to demonstrate their competence or the validity of their results. Some laboratories have subscribed to the ISO 9001or 9002 quality standard but this can only be applied to administrative and management procedures, these standards specifically do not demonstrate the competence of the laboratory to produce technically valid data and results. Many clinical laboratories claim GLP (Good Laboratory Practice) compliance. Whist this may sound impressive it should be noted that GLP is a quality system concerned with the organizational process and the conditions under which non-clinical studies are planned, performed, recorded and archived. GLP does not concern itself with the technical validity of the studies themselves or the competence of the laboratory. However
there is an international standard for testing laboratories, ISO 17025.
This standard contains all of the requirements that testing
laboratories have to meet if they wish to demonstrate that they operate
a quality system, are technically competent, and able to generate
technically valid results. In the North Western Laboratories was established in 1983 and has grown to be one of the UKs most prominent veterinary laboratories. The laboratory currently has a compliment of four veterinary pathologists and a support staff of 28 scientists and administrative staff. This progressive laboratory has always had a reputation for innovation and a commitment to quality. Joint managing Director and Quality Manager Alistair Parker said “it is one thing having a commitment to quality the difficulty is how do you demonstrate this to your clients. We felt that out of the available options the internationally recognised UKAS accreditation standard was the only way to go. It would enable us to demonstrate to our clients that we do operate a quality system, that we are technically competent, and able to generate valid results. The laboratory selected UKAS accreditation to ISO 17025 because the standard is designed for testing laboratories and not only establishes a measurable standard for quality management and administration systems but the laboratories test methods and procedures as well. The accreditation process is independent, UKAS appoints a team comprised of a lead assessor, usually a full time UKAS employee and a technical assessor for each of laboratories disciplines. In the case of NWL, there were three independent assessors for biochemistry, haematology and microbiology. There is an initial assessment, if accreditation is granted this is followed by further surveillance visits at 6 and then 12 month intervals with a full reassessment every 4 years. NWL is not new to UKAS accreditation it was first accredited for a range of microbiology tests relating to their food safety interest in 1996 and the quality management system has been in place since then. The decision to incorporate the rest of the laboratories activities into the scope of accreditation was one which was not taken lightly. Tom Williams director and Technical Manager said You may think you have a water tight quality system in place but it is not until you have it independently assessed that you realise where the cracks are. There was an enormous amount of work involved for everyone in the organisation. It is a character forming experience which took over 18 months to complete despite having first hand experience of what was required. NWL believes that it is no longer sufficient for veterinary surgeons to assume that a laboratory is technically competent and that the results they produce are valid. Professional reputations and livelihoods are increasingly dependant upon laboratory results. Accreditation is the way forward and NWL are leading the way. Alistair
Parker AIST |
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