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 US FDA 21CFR Part 820 QSR
A zip file containing 112 QMS templates relevant to the US FDA 21CFR Part 820 QSR
zip FACT
A zip file containing 159 QMS templates relevant to the Foundation for the Accreditation of Cellular Therapy (FACT) standards