Easing the burden of transition to new laboratory standards

Any changes in legislation can prove to be a burden on the laboratory, both in terms of administration and in terms of methods of working. In the UK, for example, the introduction of the new

ISO 17025 standard has brought with it major headaches.

UKAS, the United Kingdom Accreditation Service, is the sole national body recognised by government for the accreditation of testing and calibration laboratories, certification and inspection bodies.

Having its accreditation is formal recognition that a laboratory is technically competent to carry out specific calibrations or types of calibration and tests. Accreditation also provides independent assurance of: u Technical competence. u Operation of quality system. u Use of appropriate, experienced staff. u Use of appropriate and calibrated equipment. u Use of appropriate sample handling and up-to-date technical methods.

UKAS has stipulated that all its laboratories must be accredited to the new standard by 2003. This means that all accredited laboratories, plus those currently seeking accreditation, face the same issues of creating and operating compliant systems.

Accreditation to ISO 17025 gives customers assurance that a laboratory's test and calibration results are reliable. Such results are extremely valuable to a wide range of organisations including government departments, manufacturers and health services.

ISO 17025 has many changes from its predecessor M10, with some old requirements dropped and newer ones added.

A major change is that this is now an international standard, and the requirement is for the laboratory itself to demonstrate compliance. This means that UKAS can neither be prescriptive nor impose additional requirements.

Now only the technical manager and quality manager job descriptions need be contained in the quality manual, provided job descriptions for other staff can be referred to.

It is no longer the prerogative of UKAS to approve operators and signatories ­ it is for the laboratories to decide on what is an appropriate competence level and then satisfy UKAS that this is the case.

Records no longer have to be kept for six years, but for an appropriate period. This is generally being interpreted as a minimum of four years, but again it is for the laboratory to justify what it does.

New or enhanced requirements include more attention to technical management, with the possibility of multiple technical managers or a board of management and with deputies for all key managerial positions. The main idea here seems to be to avoid delays in decisions and to bring about a balance to decision making.

Test laboratories have to give more thought to declaring the uncertainty of measurement on results. There is also much more emphasis on agreeing customer requirements, for instance negotiating with the customer the test method and programme.

Some matters addressed in M10 such as the use of the logo and the layout of the calibration certificate will no doubt appear in other UKAS documents but are not in ISO 17025.

To help laboratory managers and their employees quickly assimilate these changes, Sira Test and Certification has added a new two-day course on laboratory accreditation to its existing training programme for 2002. The course offers a arapid' education in the principles and methods that need to be applied to satisfy UKAS and is aimed at all technical and laboratory staff, whether they have experience of accreditation already or are new to this subject. It covers principles and requirements of accreditation, preparation of technical procedures, testing and recording, and administration procedures.

"Because we have major testing and calibration laboratories, and are already accredited to ISO 17025, Sira is in a unique position to assess changes in the standard and to pass these on to laboratories which urgently need to absorb them in order to demonstrate compliance,“ explained Sira managing director David Lewis. "The laboratory accreditation course consists of a comprehensive checklist of changes in the standard to assist delegates in areas that need further work,“ he added.

One very useful aspect of Sira's course is a session advising laboratories on how to prepare for the UKAS assessment visit. This addresses everything from what a UKAS assessor will want to see, through to managing staff before and during the assessment. Among other benefits, the course will clarify understanding of UKAS accreditation and allow observation of a UKAS calibration or testing laboratory. The first course takes place on 17th­18th September at Chislehurst in Kent. u

More information about the new standard can be found at www.ukas.com. Sira can be contacted on www.siraservices.com, or tel +44 (0)20 8467 2096. A free brochure about all the company's training courses is available from on the above number, or email siratraining@siratc.co.uk.

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