zip ICH Q10

A zip file containing 136 QMS templates relevant to the International Council for Harmonisation (ICH Q10) Pharmaceutical Quality System

zip ISO17025

A zip file containing 15 QMS templates relevant to the International Standard Organisation (ISO) standard 17025 – General Requirements for the Competency of Testing and Calibration Laboratories

zip ICH GCP

A zip file containing 53 QMS templates relevant to the International Council for Harmonisation Good Clinical Practice standard

zip ISO15189

A zip file containing 137 QMS templates relevant to the International Standard Organisation (ISO) standard 15189: Medical laboratories — Requirements for quality and competence

zip ISO13485

A zip file containing 147 QMS templates relevant to the International Standard Organisation (ISO) standard 13485: Medical devices — Quality management systems — Requirements for regulatory purposes

zip ISO14971

A zip file containing 64 QMS templates relevant to the International Standard Organisation (ISO) standard 14971: Medical devices — Application of risk management to medical devices

zip ISO9001

A zip file containing 134 QMS templates relevant to the International Standard Organisation (ISO) standard 9001: Quality management systems — Requirements

zip NPAAC

A zip file containing 19 QMS templates relevant to the National Pathology Accreditation Advisory Council (NPAAC) Standards

zip PICs GMP medicines

A zip file containing 78 QMS templates relevant to the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S) standard for Good Manufacturing Practice

zip TGA cGMP Human Blood and Tissues

A zip file containing >200 QMS templates relevant to the Therapeutic Goods Administration standards for Good Manufacturing Practice (Human Blood and Tissues)

zip FACT

A zip file containing 159 QMS templates relevant to the Foundation for the Accreditation of Cellular Therapy (FACT) standards