Laboratory Accreditation

What is the value of laboratory accreditation? Whom does it benefit? And what are those benefits? What is the standard of competence? What value does accreditation have from an internationally recognized body such as the American Association for Laboratory Accreditation?

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Beneficiaries include the users of lab services, specifiers and the public

Besides laboratories, there are three groups that benefit from accreditation, perhaps more so than laboratories themselves. These three groups are users of laboratory services, specifiers (private and public bodies that need accurate test data to make decent decisions), and the general public.

Testing and calibration laboratories gain a great deal from a technically sound assessment and accreditation by an internationally recognized accreditation body. Here are some of those benefits:

  • By going through the accreditation process, a laboratory gains by necessarily building a quality management system (based on principles listed later in this article), which functions to reduce procedural errors and prevent errors from “going out the door.”
  • A “credential” that designates the laboratory as qualified and competent to provide services in the field or fields in which it is accredited.
  • A regular, objective “checkup” that helps a laboratory’s management make continual improvements in its operation.
  • In an increasing number of instances, entrée to a given market that would otherwise be closed to the laboratory.
  • Increased laboratory productivity, resulting from a decrease in the number of clients who insist on having their own staff audit the laboratory. More of these clients now base their confidence on a third-party accreditation.
  • International recognition of the accredited laboratory’s competence, if the accreditation body is a signatory to the mutual recognition arrangement of the International Laboratory Accreditation Cooperation (ILAC).
  • Accreditation assessments help the laboratory staff stay on the cutting edge of technology developments in their field.
  • Significant discounts in liability insurance premiums are not uncommon, when the insurer appreciates the verification-of-competence that accreditation represents.
  • Improved performance by laboratory staff. Undergoing regular assessments enhances staff discipline and sense of professionalism. Employees are more likely to be committed to complying with the firm’s quality management system and standards of performance.
  • For calibration laboratories, accreditation by an internationally recognized accreditation body validates their pivotal place in the unbroken chain of traceability to national and international measurement standards.

Users of laboratory services are also beneficiaries of laboratory accreditation. Users have greater confidence in the accuracy of the test or calibration report they are purchasing because it has been generated by a competent facility. This is particularly true for an educated client, one who is conscious of the scope of the laboratory’s accreditation. Accredited laboratory data underpins product certification decisions.

Clients can make use of information sources such as the ILAC Website (www.ilac.org) and its links to the online directories of ILAC Arrangement signatories to identify laboratories qualified in their area of need.

Manufacturers also gain efficiency because of accreditation; instead of their own on-site assessments, they can defer to the assessments of competent accrediting authorities. Other manufacturers that have in-house testing or calibration facilities can reduce or eliminate these overhead costs and subcontract with confidence to outside accredited laboratories.

Specifiers, such as government regulators, have come to appreciate the importance of credible accreditation programs that are based on internationally recognized standards. With restricted budgets, many government agencies can no longer do it all themselves; increasingly, they must rely on third-party laboratories to support their regulatory efforts. When they do so, they need a fair and meaningful basis for identifying qualified providers.

Accreditation provides that. Accreditation also has a positive impact on the general public by stimulating higher standards of quality within laboratories. This leads to more consistently reliable test data, thereby contributing to more effective health and safety regulation and to products of more consistent quality. Because the science of accreditation continues to improve, holding laboratories to even higher standards, these public benefits will continue to accrue.

Internationally recognized accreditation bodies around the globe are committed to this improved accreditation system and to maximizing the benefits of laboratory accreditation for all stakeholders.

ISO/IEC 17025 – The standard for laboratory competence

The general requirements for laboratory competence are described in the ISO/IEC 17025 standard. This standard establishes a global baseline for the accreditation of all types of laboratories. Since its origin in the late 1970s, ISO/IEC 17025 (formerly known as ISO Guide 25) emphasizes competence of laboratories to perform specified tests, not just mere compliance with requirements.

Recognition of such competence generally requires that laboratories obtain accreditation. Accreditation involves on-site and performance assessments as well as ongoing proficiency testing. Assessment of competence requires persons who not only understand the requirements of the standard, but have a sufficient depth of understanding about the specified tests to make judgments of competence. The assessors must also understand the principles underlying the requirements of ISO/IEC 17025, which are not always obvious.

Blind adherence by a laboratory to the requirements of the standard, while better than no system at all, is not an approach that instills confidence in its ability to produce valid test results. Nor is it the best approach to acquire recognition of such competence.

Principles

Several important principles are imbedded in the requirements of the standard:

  • Responsibility
  • Scientific approach
  • Objectivity and impartiality
  • Metrological traceability
  • Reproducibility
  • Transparency
  • Capacity

Responsibility. A laboratory must have persons in its organization who have the authority to execute specific functions within its overall scope of work—and can demonstrate accountability for their results.

Scientific Approach. A laboratory should carry out its work based on accepted scientific principles, preferably following consensus-based methods or standards, and deviations from accepted methods must be substantiated in a manner considered generally acceptable by experts in the field.

Objectivity and Impartiality. The results produced should be based on measurable quantities. If results are subjective, they must be produced by people deemed qualified to make subjective judgments. The pursuit of reliable results through the use of accepted scientific principles is the primary and overriding influence on the persons carrying out the testing. All other influences are secondary and not permitted to take precedence.

Metrological Traceability. The results produced are based on a recognized system of measurement that derives from accepted known quantities (SI system if units of measurement) or other well-characterized references. The chain of comparison of measurements between these accepted, known quantities and the device providing the objective result is unbroken for the transfer of measurement characteristics, including uncertainty, for the whole of the measurement chain.

Reproducibility. The test method used to produce results will produce results within an acceptable spread or range during future testing and within the constraints of using the same procedures, equipment, and persons used for a prior execution of the test.

Transparency. The processes within a laboratory producing objective results must be open to external as well as internal scrutiny, so that factors that may adversely affect the laboratory’s pursuit of objective results based on scientific principles can be easily identified and mitigated.

Capacity. A laboratory must have the resources (people with the required skills and knowledge; environment with the required facilities, equipment, and instruments; procedures to ensure consistency of test processes; and quality control for the key steps in the testing processes) necessary to carry out the tests and produce reliable results.

These principles do not cover every requirement of the standard, but they are comprehensive enough to allow laboratories and assessors to appreciate the reasons behind most of the individual requirements. They enable assessors to exercise their professional judgment in evaluating whether a laboratory meets the requirements for recognition of its competence to perform specified tests.

Conclusion

Laboratory accreditation within the United States and worldwide is gaining favor for procurement and regulatory purposes. Confidence in test data is paramount to product acceptance. Users are looking for assurance of high-quality products and the means to evaluate suppliers without incurring the costs associated with auditing each supplier. Reliance on third-party accreditation to perform this function for suppliers of test data is an attractive option. The use of ISO/IEC 17025 as the accreditation criteria is also considered valuable for international acceptance of test data.

Categories: Business Management

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