​iQDOCs - Quality Documents

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.

IS09001

General requirements of quality systems

ISO13485

​Quality management systems for medical devices

IS015189

Requirements for quality and competence in medical laboratories

ISO17025

Requirements for competence of testing and calibration laboratories

ISO14971

Application of risk management to medical devices

ICH-GCP

International Council for Harmonisation Code of

Good Clinical Practice

ICH-Q10

International Council for Harmonisation  Pharmaceutical quality system

NPAAC

Relevant to National Pathology Accreditation Advisory Council

FACT

Accreditation by Foundation for the Accreditation of Cellular Therapy

PIC/S GMP  Medicines

Pharmaceutical Inspection

Co-operation Scheme guide to Good Manufacturing  Practice for medicinal products

US FDA 21CFR Part 820 QSR

Quality System Regulation (QSR) that outlines Good Manufacturing Practice for medical devices

TGA cGMP Human Blood and Tissues

Therapeutic Goods Administration code of Good Manufacturing Practice  for Human Blood and

Tissues