Download Zip archives containing documents relevant to codes of practice by clicking on the icons below.

Note: Each archive contains an excel spreadsheet named for the code of practice that lists the name, filename and type of each document.

ISO9001
General requirements of quality systems
ISO13485
ISO14971
Quality management systems for medical devices
Application of risk management to medical devices
ISO15189
ISO17025
Requirements for quality and competence in medical laboratories
Requirements for competence of testing and calibration laboratories
ICH-GCP
ICH-Q10
International Council for Harmonisation Code of Good Clinical Practice
International Council for Harmonisation Pharmaceutical quality system
NPAAC
PIC/S GMPMedicines
Relevant to National Pathology Accreditation Advisory Council
Pharmaceutical Inspection Co-operation Scheme guide to Good Manufacturing Practice for medicinal products
TGA cGMP Human Blood and Tissues
US FDA 21CFR Part 820 QSR
Therapeutic Goods Administration code of Good Manufacturing Practice for Human Blood and Tissues
Quality System Regulation (QSR) that outlines Good Manufacturing Practice for medical devices
FACT
Accreditation by Foundation for the Accreditation of Cellular Therapy

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