ISO 13485:2016 is based on the ISO 9001 process model approach and is a management system standard specifically developed for the manufacture of medical devices. Its primary objective is to facilitate harmonized medical device regulatory requirements. The standard contains specific requirements for manufacture, installation, and servicing and calls for:
ISO 22716 is an international standard of good manufacturing practices (GMP) for the cosmetics manufacturing industry and describes the basic principles of applying GMP in a facility that produces finished cosmetic products. This guideline offers organised and practical advice on the management of human, technical and administrative factors affecting product quality.