Report on the ISO 15189 Stakeholder Survey - Nov 06
In 2003, ISO 15189 Medical laboratories-Particular requirements for quality and competence, was published by The International Organisation for Standardisation (ISO). The availability of the standard brought with it a level of interest and apparent acceptance of the need for some form of standardisation in practice from the medical laboratory community. This therefore indicated a need to investigate the success (or otherwise) of the standard in its day-to-day use. The interest in the standard also indicated a need for ISO and ILAC (the International Laboratory Accreditation Cooperation) to seek information on any difficulties associated with the application or implementation of the standard with a view to developing further standards or guides for accreditation, or other means by which the implementation of ISO 15189 could be enhanced or made more effective. Hence, a survey document was prepared by Working Group 1 of ISO/Technical Committee 212 Clinical laboratory Testing and In Vitro Diagnostic Test Systems, and distributed to the stakeholders identified by members of Working Group 1, and by as many other means as possible.
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