NATA is pleased to advise that from 1 January 2010 the new AS ISO 15189:2009 Medical laboratories - Particular requirements for quality and competence will replace AS 4633:2004 (ISO 15189:2003) as the standard used at assessment.

AS ISO 15189:2009 is a direct text adoption of the 2007 version of ISO 15189.  There are minimal differences between this new Standard and the outgoing AS 4633:2004 (ISO 15189:2003), the main one being the addition of Clause 4.1.6.  A gap analysis showing the differences between the 2003 and 2007 versions of ISO 15189 is available for download.

Laboratories should take this opportunity to update their copy of the NAR (NATA Accreditation Requirements).  The Standard must be obtained either in hard copy or via download from SAI Global.

Laboratories are also advised that the Field Application Document (FAD) will be reviewed in 2010 to update references to the new Standard, among other changes.

If you have any further questions, please do not hesitate to contact NATA in Sydney on (02) 9736 8222 or Melbourne (03) 9329 1633.