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ISO 15189 Accreditation: A new framework for Medical Laboratories

Author: John Mills
by John Mills
Posted: Mar 27, 2020
iso 15189

In the world of laboratory medicine, the achievement of ISO 15189 accreditation illuminates the expectations of

laboratory professionals about the possibility of demonstrating the importance of their role in providing medical treatment and improved performance.

The global standard ISO 15189 for the accreditation of medical laboratories, which includes both management and

technical criteria required for the evaluation of medical laboratories and that the personnel is actually proficient to generate technically valid results and suitable

information for the intended use of each test.

In order to meet the requirements of ISO 15189, a strong participation of laboratory practitioners is needed in order

to recognize the best practices necessary to fulfill the requirements according to the availability of current technology and methods, scientific articles, but also

time and cost constraints. Laboratory staff's competence can be conveyed across different domains, i.e. scientific,

Nevertheless, the success of the accreditation process depends on a thorough understanding of the reasoning under ISO 15189, the

expertise of the visiting auditors, the accreditation process being handled by the accreditation body and the in-vitro diagnostic medical device (IVD) manufacturers '


Technical and clinical competence is focused on a quality framework (in terms of target definition, tracking records, standard

operating procedures, quality assurance methods, etc.), which meets ISO 15189 management criteria, to emphasize the degree of conformity with best laboratory practices

to ensure better patient outcome.

A new opportunity in the accreditation process needs to be heralded. A particular purpose should be decided to by all laboratories: the

laboratory knowledge resulting from the test procedures must eventually be acceptable and efficient for driving or affecting treatment pathways. For certain sections

of the document the ISO 15189 specification includes compliance with the intended intent of each test. Such as, it instructs laboratory personnel to determine the

suitability of the test procedures ' performance characteristics and whether the laboratory can handle potential limitations, so that a detrimental effect on patient

results can be avoided.

It is therefore essential that the laboratory personnel clearly recognize their position and provide evidence of work, not just in

relation to

  • What criteria or procedures of ISO 15189:2012 are followed,
  • How the procedures are carried out,
  • What level of adequateness the quality assurance tools have,
  • What performance is achieved with the examination procedures, but also
  • How choices are integrated abreast of progress of medical profession and technology or methodology commercially


Therefore, It is a much broader perspective around the issue of laboratory quality. The ISO 15189 accreditation body plays a crucial

role in informing and preparing the auditors correctly. Punyam Academy’s interactive Online ISO 15189 auditor training will concentrate on procedures & records required by ISO 15189:2012 as well

as the methodology of the ISO 15189 audit, but above all on how to emphasize the quality standard of the laboratory, not only in compliance with the criteria of

conformity, but also in relation to improvement measures and projects, which should be clearly seen as an added value.

About the Author

We are ISO consultants and industry leader in the global market for selling online ISO documentation kits as well as ISO system awareness and auditor training kits. With a presence in more than 36 countries,

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Author: John Mills

John Mills

Member since: Aug 30, 2013
Published articles: 42

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