ISO 15189 is a quality management system standard which also includes requirements for technical competence for medical laboratories. It is the standard used by laboratory accreditation bodies, such as NATA, to evaluate the technical competence and management systems of a medical laboratory.
In Australia, if your laboratory operates under the Medicare framework, then it must be accredited by NATA. There are some additional requirements that your laboratory will need to meet, included in NPAAC and NATA documents.
Getting accreditation is not a simple task and sometimes you have to wade through many additional documents to meet accreditation criteria. The good news is that the requirements are often things you are already doing in your laboratory, such as having trained and competent staff, calibrating equipment and doing QC. Sometimes there are things you don’t understand and that’s where a professional can help.
Read our blog for tips on how to navigate the NATA maze and contact us for help.
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