Review: Policies, procedures and guidelines for point-of-care testing

Appendix 3. International and Australian standards which define or are associated with laboratory and POCT quality procedures.

Page last updated: 14 May 2013

ISO 22870

Point-of-care testing – requirements for quality and competence.

ISO 15197

In vitro diagnostic test systems – requirements for blood glucose monitoring systems for self-testing in managing diabetes mellitus.

ISO 17593

Clinical laboratory testing and in vitro medical devices – requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy.

AS 4633 / ISO 15189

Medical laboratories – particular requirements for quality and competence.

NPAAC

Requirements for Pathology Laboratories, 2007

NPAAC

Requirements for the supervision of Pathology Laboratories, 2007

NPAAC

Requirements for quality management in medical laboratories, 2007

NPAAC

Requirement for Participation in External Quality Assessment, 2009

AS/NZ 4308

Procedures for specimen collection and the detection and quantitation of drugs of abuse in urine.

AS 4760

Procedures for specimen collection and the detection and quantitation of drugs in oral fluid.

Quality use of pathology committee for POCT in general practice trial

Interim standards for point of care testing in general practice.