ISO 11137-1:2006
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Sterilization of health care products Radiation Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
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ISO 19011:2011
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Guidelines for auditing management systems
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ISO 14006:2011
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Environmental management systems Guidelines for incorporating ecodesign
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ISO 10015:1999
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Quality management Guidelines for training
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ISO 11607-2:2006
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Packaging for terminally sterilized medical devices Part 2: Validation requirements for forming, sealing and assembly processes
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ISO/IEC 27001:2013
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Information technology — Security techniques — Information security management systems — Requirements
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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
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ISO/TR 10017:2003
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Guidance on statistical techniques for ISO 9001:2000
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IEC/ISO 31010:2009
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Risk management - Risk assessment techniques
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ISO 31000:2009
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Risk management Principles and guidelines
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IEC 61160:2005
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Design review
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ISO 10019:2005
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Guidelines for the selection of quality management system consultants and use of their services
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ISO 14155-1:2003
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Clinical investigation of medical devices for human subjects Part 1: General requirements
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ISO 22442-1:2015
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Medical devices utilizing animal tissues and their derivatives Part 1: Application of risk management
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ISO 10005:2005
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Quality management systems Guidelines for quality plans
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ISO 10008:2013
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Quality management — Customer satisfaction — Guidelines for business-to-consumer electronic commerce transactions
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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
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ISO 10006:2003
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Quality management systems Guidelines for quality management in projects
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ISO 10018:2012
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Quality management Guidelines on people involvement and competence
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ISO 9004:2009
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Managing for the sustained success of an organization A quality management approach
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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
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ISO/TS 11139:2006
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Sterilization of health care products Vocabulary
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ISO/TR 10013:2001
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Guidelines for quality management system documentation
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IEC 60300-1:2014
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Dependability management - Part 1: Guidance for management and application
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ISO 11137-2:2013
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Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose
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ISO 14001:2015
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Environmental management systems — Requirements with guidance for use
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ISO 10012:2003
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Measurement management systems — Requirements for measurement processes and measuring equipment
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ISO 9001:2015
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Quality management systems — Requirements
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ISO 22442-2:2015
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Medical devices utilizing animal tissues and their derivatives Part 2: Controls on sourcing, collection and handling
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ISO 37500:2014
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Guidance on outsourcing
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ISO 9000:2015
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Quality management systems — Fundamentals and vocabulary
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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
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ISO 14971:2007
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Medical devices Application of risk management to medical devices
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ISO 11607-1:2006
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Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems
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ISO/IEC 90003:2014
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Software engineering Guidelines for the application of ISO 9001:2008 to computer software
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ISO 10007:2017
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Quality management — Guidelines for configuration management
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ISO 14040:2006
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Environmental management Life cycle assessment Principles and framework
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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
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ISO/TR 80002-2:2017
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Medical device software — Part 2: Validation of software for medical device quality systems
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