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Following the 'rule book'

Published: 10 July 2020 - Michelle Lea

Many instruments and devices need to be calibrated, tested or sampled. Users must have confidence in the performance of their instruments to ensure expected results are realised. The dependence on achieving such validation may be critical to industrial processes, control elements or, in particular, addressing safety concerns. Calibration and testing laboratories offer their services to meet these requirements and support trade and industry both in quality and confidence. The single most important ‘rule book’ is the International Standard ISO/IEC 17025, “General requirements for the competence of testing and calibration laboratories.”

Calibration is the comparison of a device‘s response to that of a reference device or system, which has a better accuracy. This response can then be adjusted to correct the output when in use. Testing, on the other hand, is the process of checking a device’s conformity to an agreed process and level; where the unit may “pass” or “fail.” For both areas, the laboratories must conduct unbiased and rigorous examination to produce valid results. 

The Standard (usually pronounced “17” “oh” “2” “5”) provides the essential structure of a laboratory to provide impartial, consistent and dependable results in any country throughout the world. An estimated 100,000 laboratories follow its demanding principles across many sectors: from pharmacology to physical sciences. Practically any laboratory, where something is being scientifically studied, measured or assessed, comes within the scope of the Standard.

Unfortunately, the “general” scope of 17025 has a downside because it moves responsibility onto the laboratory itself to thoroughly understand, interpret and apply the clauses within the Standard according to their own work and practises in their daily routines. Whereas other Standards, when addressing specific areas, can be more explicit in their requirements and describe clear expectations. So, 17025 requires extra effort by the laboratory to implement and maintain.

For accreditation, a laboratory must be regularly audited by a nationally recognised body (for example, UKAS in the UK) and clearly demonstrate their consistent technical competence. With this ‘license’ (or ‘schedule’), the laboratory can offer services on a ‘level playing field’ against other competitors. From the customer’s point of view, the published lists of accredited laboratories guarantee the same quality level and allows them to compare cost of service to their budget.

Laboratories, under 17025, must also prove their results by comparison with other institutes, which is an unusual exercise to carry out with your competitors. However, such ‘intercomparison’ exercises, sometimes bilateral, but more commonly involving a number of international laboratories, confirm uniformity of competence and measurement uncertainty. This comparison, and agreement of technical ability, provides confidence to industries in the world-wide arena where measurements are essential to trade and commerce. A company’s product can be assessed in one country and its certification is recognised, without the need and expense of further testing, by the receiving nation. Therefore, 17025 promotes international quality agreements and avoids businesses incurring crippling delays and unfair financial costs which hinder productivity and damage profits in a modern world which expects an increasingly faster response

Over the past decade, technology has progressed, particularly in computerised systems, where data is processed, stored and interpreted with more modern tools and methods. ISO 17025 has been revised to recognise such new approaches and support the changes in market conditions. The publication date of the new version is 2017, although laboratories have been allowed three years to implement transitions from the original 2005 issue. In addition, 17025 has been re-structured into a more realistic flow of stages for preparation (in staff and equipment readiness), application, assessment, reporting and the overall management of these areas. This leads to ISO 17025 and ISO 9001, which covers an organisation’s quality management system (QMS), having a considerable overlap within a laboratory, but with a different focus. The updates to 17025 are now aligned with the current release of 9001 (2015).

A major emphasis in the new 17025 covers the risk assessment of producing a poor result and its impact on the service. The proper recognition of problems (or potential issues) and their reporting, resolution and management have gained more importance. The shift in emphasis may not be appreciated by laboratories that have been slow to enforce updates in their staff training, procedures, equipment records and methodology. The generous transition period has allowed laboratories to discuss the changes, understand the effects and adjust their practices. The costs of now failing accreditation, including even well-established organisations, may not be apparent until it is too late: complacency causes casualties.

The modifications in the updated Standard are beneficial to the customer although this may not be immediately apparent, since the laboratory is improving their internal procedures behind the scenes. However, with this modernised quality foundation, the laboratories are continuing their impartial calibration and testing capabilities for the future.

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