Practical Application of ISO 15189 by Accreditation Bodies -: A comparison with ISO/IEC 17025.
Year: 2004
Type: article
Abstract: ISO 15189:2003 is an international standard developed particularly for the medical laboratories. Though it is based upon ISO/IEC 17025:1999 and ISO 9000:2000, it is a standalone standard for medical laboratories with a title particularly referred to “quality and competence”. The ISO 15189 requirements are however, harmonised with those of ISO/IEC 17025. Under the International Laboratory Accreditation Cooperation (ILAC) Multilateral Mutual Recognition Arrangement (MLA), accreditation of medical laboratories against ISO 15189 and ISO/IEC 17025 are both acceptable.
The standard, since its publication in 2003, is gaining more and more acceptance by accreditation bodies worldwide as the standard for medical laboratories and has been adopted as the accreditation criteria used by many economies, including New Zealand, Canada, Israel, Hong Kong, Thailand, etc. It is also known that many economies including Malaysia, China, Japan, are also planning to start accreditation of medical laboratories using this new standard. A number of accreditation bodies currently offering accreditation for medical laboratories against ISO/IEC 17025 are also planning to start using this new standard in the next few years.
The Hong Kong Accreditation Service is among one of the accreditation bodies first adopting the use of ISO 15189 to accredit medical laboratories. As the accreditation of medical laboratories is a new area of service offered by the Hong Kong Accreditation Service, application documents have been prepared to guide the laboratories in seeking for accreditation. Though ISO 15189 has been developed based on ISO/IEC 17025 and that the essential requirements in ISO/IEC 17025 are also included in ISO 15189, there are differences in emphasis and the latter has been written in a language more familiar to the medical community.
For those economies where the medical laboratories are not yet accredited to any ISO standards, ISO 15189 represents a good start. For those that have been using ISO/IEC 17025 for accrediting medical laboratories for some years, accreditation to ISO 15189 is a lot easier and the key is to know the difference. A detailed comparison of ISO/IEC 17025:1999 and ISO 15189:2003 is given in Annex A.
Source: PubMed Central
Author: Bella Ho
Language: English
Subfield: Medical Laboratory Technology
Field: Health Professions
Domain: Health Sciences
Open Access status: green
OpenAlex ID: W2995345340