Quality management systems

Key standards:

StandardsDescription
BS EN ISO 15378:2017 Primary packaging materials for medicinal products. Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP)
BS EN ISO 22870:2016 Point-of-care testing (POCT). Requirements for quality and competence
BS EN ISO 11073-10425:2019 Health informatics. Personal health device communication
BS EN ISO 13120:2019 Health informatics. Syntax to represent the content of healthcare classification systems. Classification Markup Language (ClaML)
BS EN ISO 13606-1:2019 Health informatics. Electronic health record communication
BS EN ISO 13606-5:2019 Health informatics. Electronic health record communication
PD ISO/TS 11633-1:2019 Health informatics. Information security management for remote maintenance of medical devices and medical information systems
BS EN ISO 27799:2016 Health informatics. Information security management in health using ISO/IEC 27002
BS EN ISO 12052:2017 Health informatics. Digital imaging and communication in medicine (DICOM) including workflow and data management
BS EN ISO 11073-20601:2016 Health informatics. Personal health device communication
BS EN ISO 11238:2018 Health informatics. Identification of medicinal products. Data elements and structures for the unique identification and exchange of regulated information on substances
BS EN ISO 11615:2017 Health informatics. Identification of medicinal products. Data elements and structures for the unique identification and exchange of regulated medicinal product information
BS EN ISO 11616:2017 Health informatics. Identification of medicinal products. Data elements and structures for unique identification and exchange of regulated pharmaceutical product information
PD CEN ISO/TS 19844:2017 Health informatics. Identification of medicinal products. Implementation guidelines for data elements and structures for the unique identification and exchange of regulated information on substances
BS EN ISO 23500-4:2019 Preparation and quality management of fluids for haemodialysis and related therapies
PD ISO GUIDE 30:2015 Reference materials. Selected terms and definitions
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