Pathology Standards
The National Pathology Accreditation Advisory Council (NPAAC) accreditation materials include pathology standards that protect the Australian public from harm and ensure consistency of pathology services.
New resources
Notice of Commencement
The amended Requirements for the In-House In Vitro Diagnostic Medical Devices (Fifth Edition, 2025) now includes a standard for Companion Diagnostics. This edition will replace the current edition on 20 April 2026. Until that date, the existing requirements remain in force.
In force March 2026
These editions replace the Requirements for medical testing for human genetic variation (Third Edition) and Requirements for laboratory testing for human immunodeficiency virus (HIV) and hepatitis C virus (HCV) (Fourth Edition).
2025Publication or report
About the Standards
NPAAC is responsible for developing and maintaining the standards for assessing pathology laboratories. The standards are categorised into four main tiers as follows:
More information
- National Pathology Accreditation Scheme
The National Pathology Accreditation Scheme (NPAS) provides for the Australia-wide coordination of accreditation processes for pathology laboratories in Australia.
- Resources for the pathology standards
Resources that support clinicians, service providers and accrediting agencies by providing guidance on the requirements for pathology laboratories to be accredited.
- National Pathology Accreditation Advisory Council
The National Pathology Accreditation Advisory Council (NPAAC) is responsible for developing and maintaining the accreditation standards for pathology laboratories in Australia.
- Safety and Quality Advice Centre
The Advice Centre provides support for pathology services, assessors and accrediting agencies on pathology accreditation standards implementation.
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