Medical laboratory services are essential to patient care and must be able to meet the needs of all patients and the clinical staff responsible for the care of patients. Such care includes:
- Requests for examinations
- Patient preparation
- Patient identification
- Collection of samples
- Validation, interpretation and reporting of examination results
IANZ Accreditation is applicable to all organisations providing medical examinations, including community laboratories and those in the public hospital system. With accreditation, medical laboratories receive formal recognition of the organisation’s technical competency after assessment of their processes, resources, facilities, staff and other key factors and skills which relate to, and impact on the quality of the service provided.
Most medical testing laboratories in the private sector and in hospitals around the country are accredited by IANZ, giving assurance that tests essential for human health are carried out accurately and competently.
Bodies engaged in the recognition of the competence of medical laboratories will also be able to use this Standard as the basis for their activities. Demonstrated conformity to this Standard does imply conformity of the quality management system within which the laboratory operates to all the requirements of ISO 9001. This International Standard is not intended to be used for the purposes of certification.
- ISO 15189 Medical laboratories – Requirements for quality and competence. This standard is based upon ISO/IEC 17025 and ISO 9001.
- ISO 15189: 2012 Transition document
Scopes of Accreditation/Classes of Test
The scopes of accreditation for medical laboratories are, in general, classified according to disciplines of pathology. These general classes include: