ISO 10001:2007
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Quality management Customer satisfaction Guidelines for codes of conduct for organizations |
IEC 61025:2006
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Fault tree analysis (FTA) |
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 |
ISO 19011:2011
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Guidelines for auditing management systems |
ISO 10015:1999
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Quality management Guidelines for training |
ISO 14644-8:2013
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Cleanrooms and associated controlled environments Part 8: Classification of air cleanliness by chemical concentration (ACC) |
ISO 14698-2:2003
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Cleanrooms and associated controlled environments Biocontamination control Part 2: Evaluation and interpretation of biocontamination data |
ISO/TR 10017:2003
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Guidance on statistical techniques for ISO 9001:2000 |
ISO 11135:2014
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Sterilization of health-care products Ethylene oxide Requirements for the development, validation and routine control of a sterilization process for medical devices |
IEC 60812:2006
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Analysis techniques for system reliability - Procedure for failure mode and effects analysis (FMEA) |
ISO 14644-2:2015
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Cleanrooms and associated controlled environments Part 2: Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration |
IEC 60601-1:2005+AMD1:2012 CSV
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Medical electrical equipment - Part 1: General requirements for basic safety and essential performance |
ISO 31000:2009
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Risk management Principles and guidelines |
IEC 61160:2005
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Design review |
ISO 13485:2016
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Medical devices Quality management systems Requirements for regulatory purposes |
ISO 14644-5:2004
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Cleanrooms and associated controlled environments — Part 5: Operations |
ISO 14937:2009
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Sterilization of health care products General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices |
ISO 10019:2005
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Guidelines for the selection of quality management system consultants and use of their services |
ISO 10004:2012
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Quality management Customer satisfaction Guidelines for monitoring and measuring |
ISO 10014:2006
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Quality management Guidelines for realizing financial and economic benefits |
ISO 10005:2005
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Quality management systems Guidelines for quality plans |
ISO 10008:2013
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Quality management — Customer satisfaction — Guidelines for business-to-consumer electronic commerce transactions |
ISO 10003:2007
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Quality management Customer satisfaction Guidelines for dispute resolution external to organizations |
ISO 10006:2003
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Quality management systems Guidelines for quality management in projects |
ISO/IEC Guide 99:2007
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International vocabulary of metrology Basic and general concepts and associated terms (VIM) |
ISO 14698-1:2003
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Cleanrooms and associated controlled environments Biocontamination control Part 1: General principles and methods |
ISO 10018:2012
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Quality management Guidelines on people involvement and competence |
ISO 10002:2014
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Quality management Customer satisfaction Guidelines for complaints handling in organizations |
ASTM E 2500 : 2013 : REDLINE
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Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment |
ISO 14644-3:2005
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Cleanrooms and associated controlled environments Part 3: Test methods |
ISO 9004:2009
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Managing for the sustained success of an organization A quality management approach |
ISO/IEC Guide 73:2002
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Risk management Vocabulary Guidelines for use in standards |
ISO/TS 11139:2006
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Sterilization of health care products Vocabulary |
ISO/TR 10013:2001
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Guidelines for quality management system documentation |
IEC 60300-1:2014
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Dependability management - Part 1: Guidance for management and application |
ISO 11137-2:2013
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Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose |
ISO 14001:2015
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Environmental management systems — Requirements with guidance for use |
ISO 10012:2003
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Measurement management systems — Requirements for measurement processes and measuring equipment |
ISO 14644-1:2015
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Cleanrooms and associated controlled environments Part 1: Classification of air cleanliness by particle concentration |
ISO 9001:2015
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Quality management systems — Requirements |
ISO 37500:2014
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Guidance on outsourcing |
ISO 9000:2015
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Quality management systems — Fundamentals and vocabulary |
ISO 14644-4:2001
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Cleanrooms and associated controlled environments — Part 4: Design, construction and start-up |
ISO/IEC Guide 2:2004
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Standardization and related activities General vocabulary |
ISO 14971:2007
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Medical devices Application of risk management to medical devices |
ISO/IEC 90003:2014
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Software engineering Guidelines for the application of ISO 9001:2008 to computer software |
ISO 10007:2017
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Quality management — Guidelines for configuration management |