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    ISO 13485 - PRACTICAL GUIDE : 2016

    Current The latest, up-to-date edition.

    ISO 13485:2016 - MEDICAL DEVICES - A PRACTICAL GUIDE

    Available format(s):  Hardcopy, PDF, PDF 3 Users, PDF 5 Users, PDF 9 Users

    Language(s):  English

    Published date:  01-01-2016

    Publisher:  International Organization for Standardization

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    Table of Contents - (Show below) - (Hide below)

    Foreword
    Introduction
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 Quality management system
    5 Management responsibility
    6 Resource management
    7 Product realization
    8 Measurement, analysis and improvement
    Annex A - Guidance for small organizations
    Bibliography

    Abstract - (Show below) - (Hide below)

    This International Standard specifies requirements for a quality management
    system where an organization needs to demonstrate its ability toprovidemedical devicesandrelatedservicesthatconsistny meetcustomerand applicable regulatory requirements.

    General Product Information - (Show below) - (Hide below)

    Committee TC 210
    Document Type Guide
    Publisher International Organization for Standardization
    Status Current

    Standards Referencing This Book - (Show below) - (Hide below)

    ISO 11137-1:2006 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 Guidelines for auditing management systems
    ISO 14006:2011 Environmental management systems Guidelines for incorporating ecodesign
    ISO 10015:1999 Quality management Guidelines for training
    ISO 11607-2:2006 Packaging for terminally sterilized medical devices Part 2: Validation requirements for forming, sealing and assembly processes
    ISO/IEC 27001:2013 Information technology — Security techniques — Information security management systems — Requirements
    ISO 14160:2011 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/TR 10017:2003 Guidance on statistical techniques for ISO 9001:2000
    IEC/ISO 31010:2009 Risk management - Risk assessment techniques
    ISO 31000:2009 Risk management Principles and guidelines
    IEC 61160:2005 Design review
    ISO 10019:2005 Guidelines for the selection of quality management system consultants and use of their services
    ISO 14155-1:2003 Clinical investigation of medical devices for human subjects Part 1: General requirements
    ISO 22442-1:2015 Medical devices utilizing animal tissues and their derivatives Part 1: Application of risk management
    ISO 10005:2005 Quality management systems Guidelines for quality plans
    ISO 10008:2013 Quality management — Customer satisfaction — Guidelines for business-to-consumer electronic commerce transactions
    ISO 11135-1:2007 Sterilization of health care products Ethylene oxide Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
    ISO 10006:2003 Quality management systems Guidelines for quality management in projects
    ISO 10018:2012 Quality management Guidelines on people involvement and competence
    ISO 9004:2009 Managing for the sustained success of an organization A quality management approach
    ISO 20857:2010 Sterilization of health care products Dry heat Requirements for the development, validation and routine control of a sterilization process for medical devices
    ISO/TS 11139:2006 Sterilization of health care products Vocabulary
    ISO/TR 10013:2001 Guidelines for quality management system documentation
    IEC 60300-1:2014 Dependability management - Part 1: Guidance for management and application
    ISO 11137-2:2013 Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose
    ISO 14001:2015 Environmental management systems — Requirements with guidance for use
    ISO 10012:2003 Measurement management systems — Requirements for measurement processes and measuring equipment
    ISO 9001:2015 Quality management systems — Requirements
    ISO 22442-2:2015 Medical devices utilizing animal tissues and their derivatives Part 2: Controls on sourcing, collection and handling
    ISO 37500:2014 Guidance on outsourcing
    ISO 9000:2015 Quality management systems — Fundamentals and vocabulary
    ISO 22442-3:2007 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 14971:2007 Medical devices Application of risk management to medical devices
    ISO 11607-1:2006 Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems
    ISO/IEC 90003:2014 Software engineering Guidelines for the application of ISO 9001:2008 to computer software
    ISO 10007:2017 Quality management — Guidelines for configuration management
    ISO 14040:2006 Environmental management Life cycle assessment Principles and framework
    ISO 17665-1:2006 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/TR 80002-2:2017 Medical device software — Part 2: Validation of software for medical device quality systems
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