Laboratory networks are a group of laboratory organisations that operate under a single quality management system (QMS). A laboratory network is defined in Regulation 1.3 of the MD Regulations.
The QMS must be managed centrally, and applied uniformly across all work locations which manufacture and use the in-house IVD. However, some local work instructions may be necessary due to location-specific requirements.
As a minimum requirement, the following elements of the QMS must be managed centrally:
internal quality audits
corrective and preventive action
changes to the quality system documentation for key elements.
Laboratory organisations with appropriate NATA corporate accreditation can be considered a laboratory network, and can manufacture and distribute in-house IVDs within their network.
The Department of Health and Aged Care acknowledges First Nations peoples as the Traditional Owners of Country throughout Australia, and their continuing connection to land, sea and community. We pay our respects to them and their cultures, and to all Elders both past and present.