ISO 9000:2015
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Quality management systems — Fundamentals and vocabulary |
ISO 10012:2003
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Measurement management systems — Requirements for measurement processes and measuring equipment |
ISO/IEC 90003:2014
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Software engineering Guidelines for the application of ISO 9001:2008 to computer software |
ISO/TS 11139:2006
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Sterilization of health care products Vocabulary |
ISO 22442-3:2007
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Medical devices utilizing animal tissues and their derivatives — Part 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents |
ISO 11135-1:2007
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Sterilization of health care products Ethylene oxide Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices |
ISO 10018:2020
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Quality management — Guidance for people engagement |
ISO 10008:2013
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Quality management — Customer satisfaction — Guidelines for business-to-consumer electronic commerce transactions |
ISO 14971:2019
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Medical devices Application of risk management to medical devices |
ISO/TR 10017:2003
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Guidance on statistical techniques for ISO 9001:2000 |
ISO/TR 10013:2001
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Guidelines for quality management system documentation |
ISO 31000:2018
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Risk management — Guidelines |
ISO/TR 80002-2:2017
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Medical device software — Part 2: Validation of software for medical device quality systems |
ISO 9004:2018
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Quality management — Quality of an organization — Guidance to achieve sustained success |
ISO 11607-2:2019
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Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes |
IEC 62366-1:2015
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Medical devices - Part 1: Application of usability engineering to medical devices |
ISO 9001:2015
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Quality management systems — Requirements |
ISO 10005:2018
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Quality management — Guidelines for quality plans |
ISO 14040:2006
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Environmental management Life cycle assessment Principles and framework |
ISO 11607-1:2019
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Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems |
ISO 14160:2011
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Sterilization of health care products Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives Requirements for characterization, development, validation and routine control of a sterilization process for medical devices |
ISO 14006:2020
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Environmental management systems Guidelines for incorporating ecodesign |
IEC 60300-1:2014
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Dependability management - Part 1: Guidance for management and application |
IEC 31010:2019
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Risk management - Risk assessment techniques |
ISO 17665-1:2006
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Sterilization of health care products — Moist heat — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices |
ISO 10006:2017
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Quality management — Guidelines for quality management in projects |
ISO/IEC 27001:2013
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Information technology — Security techniques — Information security management systems — Requirements |
ISO 20857:2010
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Sterilization of health care products Dry heat Requirements for the development, validation and routine control of a sterilization process for medical devices |
ISO 37500:2014
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Guidance on outsourcing |
ISO 11137-2:2013
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Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose |
IEC 61160:2005
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Design review |
ISO 10019:2005
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Guidelines for the selection of quality management system consultants and use of their services |
ISO 22442-1:2015
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Medical devices utilizing animal tissues and their derivatives Part 1: Application of risk management |
ISO 19011:2018
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Guidelines for auditing management systems |
ISO 22442-2:2015
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Medical devices utilizing animal tissues and their derivatives Part 2: Controls on sourcing, collection and handling |
ISO 14001:2015
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Environmental management systems — Requirements with guidance for use |
ISO 14155-1:2003
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Clinical investigation of medical devices for human subjects Part 1: General requirements |
ISO 10015:2019
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Quality management — Guidelines for competence management and people development |
ISO 10007:2017
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Quality management — Guidelines for configuration management |