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  • ISO/IEC 90003:2014

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    Withdrawn A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
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    Software engineering Guidelines for the application of ISO 9001:2008 to computer software

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

    Withdrawn date:  11-03-2019

    Language(s):  English

    Published date:  09-12-2014

    Publisher:  International Organization for Standardization

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    Abstract - (Show below) - (Hide below)

    ISO/IEC 90003:2014 provides guidance for organizations in the application of ISO 9001:2008 to the acquisition, supply, development, operation and maintenance of computer software and related support services. ISO/IEC 90003:2014 does not add to or otherwise change the requirements of ISO 9001:2008.

    The guidelines provided in ISO/IEC 90003:2014 are not intended to be used as assessment criteria in quality management system registration/certification.

    The application of ISO/IEC 90003:2014 is appropriate to software that is

    part of a commercial contract with another organization,

    a product available for a market sector,

    used to support the processes of an organization,

    embedded in a hardware product, or

    related to software services.

    Some organizations may be involved in all the above activities; others may specialize in one area. Whatever the situation, the organization's quality management system should cover all aspects (software related and non-software related) of the business.

    ISO/IEC 90003:2014 identifies the issues that should be addressed and is independent of the technology, life cycle models, development processes, sequence of activities and organizational structure used by an organization. Additional guidance and frequent references to the ISO/IEC JTC 1/SC 7 software engineering standards are provided to assist in the application of ISO 9001:2008, in particular ISO/IEC 12207:2008.

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

    Development Note Supersedes ISO 9000-3. (02/2004)
    Document Type Standard
    Publisher International Organization for Standardization
    Status Withdrawn
    Superseded By
    Supersedes

    Standards Referenced By This Book - (Show below) - (Hide below)

    I.S. EN 50126-2:2017 RAILWAY APPLICATIONS - THE SPECIFICATION AND DEMONSTRATION OF RELIABILITY, AVAILABILITY, MAINTAINABILITY AND SAFETY (RAMS) - PART 2: SYSTEMS APPROACH TO SAFETY
    SAE AS 9120 : 2016 QUALITY MANAGEMENT SYSTEMS - REQUIREMENTS FOR AVIATION, SPACE AND DEFENSE DISTRIBUTORS
    BS EN 15224:2016 Quality management systems. EN ISO 9001:2015 for healthcare
    DIN EN ISO 11135-1:2007-08 STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - PART 1: REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
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    PD ISO/TR 27809:2007 Health informatics. Measures for ensuring patient safety of health software
    ANSI/AAMI/ISO 13408-4:2005(R2014) ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 4: CLEAN-IN-PLACE TECHNOLOGIES
    04/30089749 DC : DRAFT DEC 2004 BS EN 62304 - MEDICAL DEVICE SOFTWARE - SOFTWARE LIFE-CYCLE PROCESSES
    BS ISO 19903 : 2006 AMD 16926 PETROLEUM AND NATURAL GAS INDUSTRIES - FIXED CONCRETE OFFSHORE STRUCTURES
    DIN EN ISO 13408-4:2011-09 Aseptic processing of health care products - Part 4: Clean-in-place technologies (ISO 13408-4:2005)
    I.S. ISO 10005:2005 QUALITY MANAGEMENT SYSTEMS - GUIDELINES FOR QUALITY PLANS
    BS ISO/IEC 16326:2009 Systems and software engineering. Life cycle processes. Project management
    12/30248997 DC : 0 BS ISO/IEC 15026-4 - SYSTEMS AND SOFTWARE ENGINEERING - SYSTEMS AND SOFTWARE ASSURANCE - PART 4: ASSURANCE IN THE LIFE CYCLE
    I.S. EN ISO 11737-1:2018&LC:2018 STERILIZATION OF HEALTH CARE PRODUCTS - MICROBIOLOGICAL METHODS - PART 1: DETERMINATION OF A POPULATION OF MICROORGANISMS ON PRODUCTS (ISO 11737-1:2018)
    10/30235503 DC : 0 BS EN 61496-1 AMD 2 - SAFETY OF MACHINERY - ELECTRO-SENSITIVE PROTECTIVE EQUIPMENT - PART 1: GENERAL REQUIREMENTS AND TESTS
    UNI CEI ISO/IEC 12207 : 2013 SYSTEMS AND SOFTWARE ENGINEERING - SOFTWARE LIFE CYCLE PROCESSES
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    BS EN 50126-2:2017 Railway Applications. The Specification and Demonstration of Reliability, Availability, Maintainability and Safety (RAMS) Systems Approach to Safety
    DIN EN ISO 11135:2014-10 STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES (ISO 11135:2014)
    BS ISO/IEC 15026-4:2012 Systems and software engineering. Systems and software assurance Assurance in the life cycle
    07/30157769 DC : DRAFT DEC 2007 BS EN ISO 11737-2 - STERILIZATION OF MEDICAL DEVICES - MICROBIOLOGICAL METHODS - PART 2: TESTS OF STERILITY PERFORMED IN THE VALIDATION OF A STERILIZATION PROCESS
    DD ISO/TS 29001 : 2010 PETROLEUM, PETROCHEMICAL AND NATURAL GAS INDUSTRIES - SECTOR-SPECIFIC QUALITY MANAGEMENT SYSTEMS - REQUIREMENTS FOR PRODUCT AND SERVICE SUPPLY ORGANIZATIONS
    NF EN ISO 13408-6 : 2011 AMD 1 2013 ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 6: ISOLATOR SYSTEMS
    IEEE 20000-2-2013 IEEE Standard -- Adoption of ISO/IEC 20000-2:2012, Information technology -- Service management -- Part 2: Guidance on the application of service management systems
    CSA Z11135-1 :2009 STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - PART 1: REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
    CSA Z11135 : 2015 STERILIZATION OF HEALTH-CARE PRODUCTS - ETHYLENE OXIDE - REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
    CSA ISO/TS 16949 : 2009(R2015) QUALITY MANAGEMENT SYSTEMS - PARTICULAR REQUIREMENTS FOR THE APPLICATION OF ISO 9001:2008 FOR AUTOMOTIVE PRODUCTION AND RELEVANT SERVICE PART ORGANIZATIONS
    CSA ISO 9001 : 2016 QUALITY MANAGEMENT SYSTEMS - REQUIREMENTS
    CSA ISO TS 16949 : 2009 QUALITY MANAGEMENT SYSTEMS - PARTICULAR REQUIREMENTS FOR THE APPLICATION OF ISO 9001:2008 FOR AUTOMOTIVE PRODUCTION AND RELEVANT SERVICE PART ORGANIZATIONS
    CSA ISO 14937 : 2011 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
    CAN/CSA-ISO 19903:07 (R2017) Petroleum and natural gas industries - Fixed concrete offshore structures (Adopted ISO 19903:2006, first edition, 2006-12-01)
    ISO 11737-1:2018 Sterilization of health care products — Microbiological methods — Part 1: Determination of a population of microorganisms on products
    IWA 1:2005 Quality management systems Guidelines for process improvements in health service organizations
    AAMI 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
    CAN/CSA-ISO/IEC/IEEE 24748-4:18 Systems and software engineering — Life cycle management — Part 4: Systems engineering planning (Adopted ISO/IEC/IEEE 24748-4:2016, first edition, 2016-05-15)
    SAE AS 9110 : 2016 QUALITY MANAGEMENT SYSTEMS - REQUIREMENTS FOR AVIATION MAINTENANCE ORGANIZATIONS
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    ANSI/AAMI/ISO 11135:2014 STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
    PD ISO/IEC/TR 15026-1:2010 Systems and software engineering. Systems and software assurance Concepts and vocabulary
    UNI EN ISO 13408-6 : 2013 ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 6: ISOLATOR SYSTEMS
    NSAI/ISO Guide to ISO 9001:2015 ISO 9001:2015 FOR SMALL ENTERPRISES - WHAT TO DO? - ADVICE FROM ISO/TC 176
    PD ISO/TS 9002:2016 Quality management systems. Guidelines for the application of ISO 9001:2015
    I.S. EN ISO 13408-6:2011 ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 6: ISOLATOR SYSTEMS (ISO 13408-6:2005)
    CEI UNI EN ISO/IEC 17025 : 2008 GENERAL REQUIREMENTS FOR THE COMPETENCE OF TESTING AND CALIBRATION LABORATORIES
    CCS GUIDE FOR SAFETY AND RELIABILITY : 2017 GUIDE FOR SAFETY AND RELIABILITY ASSESSMENT FOR SHIPBOARD SOFTWARE
    ISO/IEC TR 90005:2008 Systems engineering Guidelines for the application of ISO 9001 to system life cycle processes
    ISO 13408-2:2018 Aseptic processing of health care products — Part 2: Sterilizing filtration
    I.S. EN ISO 9001:2015 QUALITY MANAGEMENT SYSTEMS - REQUIREMENTS (ISO 9001:2015)
    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
    BS EN 50155:2017 Railway applications. Rolling stock. Electronic equipment
    BS EN 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
    16/30282633 DC : 0 BS EN 50155 - RAILWAY APPLICATIONS - ELECTRONIC EQUIPMENT USED ON ROLLING STOCK
    14/30244780 DC : 0 BS ISO 19859 - GAS TURBINE APPLICATIONS - REQUIREMENTS FOR POWER GENERATION
    EN 62304:2006/A1:2015 MEDICAL DEVICE SOFTWARE - SOFTWARE LIFE-CYCLE PROCESSES (IEC 62304:2006/A1:2015)
    EN 61162-402:2005 Maritime navigation and radiocommunication equipment and systems - Digital interfaces - Part 402: Multiple talkers and multiple listeners - Ship systems interconnection - Documentation and test requirements
    CEN/TR 15592:2007 Health services - Quality management systems - Guide for the use of EN ISO 9004:2000 in health services for performance improvement
    EN 15224:2016 Quality management systems - EN ISO 9001:2015 for healthcare
    UNI EN 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
    DIN EN 15224:2017-05 QUALITY MANAGEMENT SYSTEMS - EN ISO 9001:2015 FOR HEALTHCARE
    UNE 179008:2016 Quality management system for liver transplantation units
    I.S. EN ISO 13408-5:2011 ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 5: STERILIZATION IN PLACE
    15/30328933 DC : 0 BS EN 9100 - QUALITY MANAGEMENT SYSTEMS - REQUIREMENTS FOR AVIATION, SPACE AND DEFENSE ORGANIZATIONS
    PLUS 9001 (5th ed. pub. 2017) The ISO 9000 essentials: A practical handbook for implementing the ISO 9000 family of standards
    ISO/TR 27809:2007 Health informatics Measures for ensuring patient safety of health software
    SAE AS 9100D : 2016 QUALITY MANAGEMENT SYSTEMS - REQUIREMENTS FOR AVIATION, SPACE AND DEFENSE ORGANIZATIONS
    BS ISO/IEC/IEEE 29119-2:2013 Software and systems engineering. Software testing Test processes
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    17/30347919 DC : 0 BS ISO 10005 - QUALITY MANAGEMENT SYSTEMS - GUIDELINES FOR QUALITY PLANS
    12/30236660 DC : 0 BS ISO/IEC 29119-3 - SOFTWARE AND SYSTEMS ENGINEERING - SOFTWARE TESTING - PART 3: TEST DOCUMENTATION
    04/30115148 DC : DRAFT JUNE 2004 ISO/IEC 14764 ED.2 - SOFTWARE ENGINEERING - SOFTWARE LIFE CYCLE PROCESSES - MAINTENANCE
    ISO/IEC 15026-1:2013 Systems and software engineering Systems and software assurance Part 1: Concepts and vocabulary
    08/30195548 DC : 0 DD ISO/TS 16949: 2009 - QUALITY MANAGEMENT SYSTEMS: PARTICULAR REQUIREMENTS FOR THE APPLICATION OF ISO 9001:2008 FOR AUTOMOTIVE PRODUCTION AND RELEVANT SERVICE PART ORGANIZATIONS
    14/30287753 DC : 0 BS EN 62304 AMENDMENT 1 - MEDICAL DEVICE SOFTWARE - SOFTWARE LIFE CYCLE PROCESSES
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    DD CEN ISO/TS 29001:2011 Petroleum, petrochemical and natural gas industries. Sector-specific quality management systems. Requirements for product and service supply organizations
    BS ISO/IEC/IEEE 24748-4:2016 Systems and software engineering. Life cycle management Systems engineering planning
    14/30271159 DC : 0 BS ISO/IEC 24748-4 - SYSTEMS AND SOFTWARE ENGINEERING - LIFE CYCLE MANAGEMENT - PART 4: SYSTEMS ENGINEERING PLANNING
    BS EN 61511-1 : 2017 FUNCTIONAL SAFETY - SAFETY INSTRUMENTED SYSTEMS FOR THE PROCESS INDUSTRY SECTOR - PART 1: FRAMEWORK, DEFINITIONS, SYSTEM, HARDWARE AND APPLICATION PROGRAMMING REQUIREMENTS (IEC 61511-1:2016 + COR1:2016)
    11/30244091 DC : 0 BS EN ISO 11135 - STERILIZATION OF HEALTH-CARE PRODUCTS - ETHYLENE OXIDE - REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
    DIN EN ISO 13408-5:2011-09 Aseptic processing of health care products - Part 5: Sterilization in place (ISO 13408-5:2006)
    12/30259316 DC : 0 BS ISO 14885 - SHIPS AND MARINE TECHNOLOGY - LARGE YACHTS - AUXILIARY DIESEL ENGINES - SAFETY REQUIREMENTS
    UNI EN ISO 13408-5 : 2011 ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 5: STERILIZATION IN PLACE
    16/30327034 DC : 0 BS ISO/IEC 27034-7 - INFORMATION TECHNOLOGY - SECURITY TECHNIQUES - APPLICATION SECURITY - PART 7: APPLICATION SECURITY ASSURANCE PREDICTION MODEL
    UNE-EN ISO 11135:2015 Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 11135:2014)
    CSA ISO TS 16949 : 2009 : R2015 QUALITY MANAGEMENT SYSTEMS - PARTICULAR REQUIREMENTS FOR THE APPLICATION OF ISO 9001:2008 FOR AUTOMOTIVE PRODUCTION AND RELEVANT SERVICE PART ORGANIZATIONS
    CSA ISO/IEC 12207 :2009 SYSTEMS AND SOFTWARE ENGINEERING - SOFTWARE LIFE CYCLE PROCESSES
    CSA ISO 19903 : 2007 : R2013 PETROLEUM AND NATURAL GAS INDUSTRIES - FIXED CONCRETE OFFSHORE STRUCTURES
    CSA ISO 19903 : 2007 PETROLEUM AND NATURAL GAS INDUSTRIES - FIXED CONCRETE OFFSHORE STRUCTURES
    I.S. EN 61511-1:2017 FUNCTIONAL SAFETY - SAFETY INSTRUMENTED SYSTEMS FOR THE PROCESS INDUSTRY SECTOR - NORMATIVE (UON) - PART 1: FRAMEWORK, DEFINITIONS, SYSTEM, HARDWARE AND SOFTWARE REQUIREMENTS
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    UNE-EN ISO 13408-6:2011 Aseptic processing of health care products - Part 6: Isolator systems (ISO 13408-6:2005)
    CAN/CSA-C22.2 NO. 61511-1:17 Functional safety — Safety instrumented systems for the process industry sector — Part 1: Framework, definitions, system, hardware and application programming requirements (Adopted IEC 61511-1:2016, second edition, 2016-02, with Canadian deviations) | Sécurité fonctionnelle — Systèmes instrumentes de sécurité pour le secteur des industries de transformation — Partie 1 : Cadre, définitions, exigences pour le système, le matériel et la programmation d’application (norme IEC 61511-1:2016 adoptée, deuxième édition, 2016-02, avec exigences propres au Canada)
    IEEE 24748-3-2012 IEEE Guide--Adoption of ISO/IEC TR 24748-3:2011,Systems and Software Engineering--Life Cycle Management-- Part 3: Guide to the Application of ISO/IEC 12207 (Software Life Cycle Processes)
    AAMI ISO 11737-2 : 2009 : R2014 STERILIZATION OF MEDICAL DEVICES - MICROBIOLOGICAL METHODS - PART 2: TESTS OF STERILITY PERFORMED IN THE DEFINITION, VALIDATION AND MAINTENANCE OF A STERILIZATION PROCESS
    BS EN 61496-1:2013 Safety of machinery. Electro-sensitive protective equipment General requirements and tests
    AAMI ISO 11737-2 :2009 STERILIZATION OF MEDICAL DEVICES - MICROBIOLOGICAL METHODS - PART 2: TESTS OF STERILITY PERFORMED IN THE DEFINITION, VALIDATION AND MAINTENANCE OF A STERILIZATION PROCESS
    BS EN ISO 13408-6 : 2011 ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 6: ISOLATOR SYSTEMS
    I.S. EN ISO 13408-4:2011 ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 4: CLEAN-IN-PLACE TECHNOLOGIES
    AAMI ISO 13408-2 : 2003 : R2013 ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 2: STERILIZING FILTRATION
    CSA ISO/IEC TR 15026-1 : 2013 SYSTEMS AND SOFTWARE ENGINEERING - SYSTEMS AND SOFTWARE ASSURANCE - PART 1: CONCEPTS AND VOCABULARY
    NF EN ISO 13408-4 : 2011 ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 4: CLEAN-IN-PLACE TECHNOLOGIES
    UNI ISO TS 16949 : 2009 QUALITY MANAGEMENT SYSTEMS - PARTICULAR REQUIREMENTS FOR THE APPLICATION OF ISO 9001:2008 FOR AUTOMOTIVE PRODUCTION AND RELEVANT SERVICE PART ORGANIZATIONS
    CSA ISO/IEC 15026-1 : 2015 SYSTEMS AND SOFTWARE ENGINEERING - SYSTEMS AND SOFTWARE ASSURANCE - PART 1: CONCEPTS AND VOCABULARY
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    UNE-EN ISO 9001:2015 Quality management systems - Requirements (ISO 9001:2015)
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    EN ISO 9001:2015 Quality management systems - Requirements (ISO 9001:2015)
    EN ISO 14937:2009 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 14937:2009)
    BS EN ISO 11737-2:2009 Sterilization of medical devices. Microbiological methods Tests of sterility performed in the definition, validation and maintenance of a sterilization process
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    UNE-ISO/IEC 20000-2:2015 Information technology. Service management. Part 2: Guidance on the application of service management systems
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    BS EN 50128:2011 Railway applications. Communication, signalling and processing systems. Software for railway control and protection systems
    ISO/IEC/IEEE 16326:2009 Systems and software engineering Life cycle processes Project management
    BS EN 61162-402:2005 Maritime navigation and radiocommunication equipment and systems. Digital interfaces Multiple talkers and multiple listeners. Ship systems interconnections. Documentation and test requirements
    04/30092984 DC : DRAFT JAN 2004 ISO 10005 - QUALITY MANAGEMENT SYSTEMS - GUIDELINES FOR QUALITY PLANS
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    03/317065 DC : DRAFT NOV 2003 ISO/IEC 17025 - GENERAL REQUIREMENTS FOR THE COMPETENCE OF TESTING AND CALIBRATION LABS - AMENDMENT 1
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    17/30313889 DC : DRAFT AUG 2017 BS EN ISO 19903 - PETROLEUM AND NATURAL GAS INDUSTRIES - CONCRETE OFFSHORE STRUCTURES
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    UNE-EN 62304:2007 Medical device software - Software life-cycle processes (IEC 62304:2006)
    PD CEN/TR 15592:2007 Health services. Quality management systems. Guide for the use of EN ISO 9004:2000 in health services for performance improvement
    UNE-EN ISO 13408-4:2011 Aseptic processing of health care products - Part 4: Clean-in-place technologies (ISO 13408-4:2005)
    S.R. CEN/TR 15592:2007 HEALTH SERVICES - QUALITY MANAGEMENT SYSTEMS - GUIDE FOR THE USE OF EN ISO 9004:2000 IN HEALTH SERVICES FOR PERFORMANCE IMPROVEMENT
    BS EN ISO 13408-5:2011 Aseptic processing of health care products Sterilization in place
    BIS IS/ISO/IEC 17025 : 2005 AMD 1 GENERAL REQUIREMENTS FOR THE COMPETENCE OF TESTING AND CALIBRATION LABORATORIES
    PD ISO/IEC TR 90005:2008 Systems engineering. Guidelines for the application of ISO 9001 to system life cycle processes
    EN ISO 11135:2014 Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 11135:2014)
    CSA ISO/IEC 20000-2 : 2013 : R2017 INFORMATION TECHNOLOGY - SERVICE MANAGEMENT - PART 2: GUIDANCE ON THE APPLICATION OF SERVICE MANAGEMENT SYSTEMS
    CSA Z11135-1 : 2009 : R2014 STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - PART 1: REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
    CSA ISO 14937 : 2011 : R2016 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
    AAMI ISO 13408-6 : 2005 : INC : AMD 1 : 2013 ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 6: ISOLATOR SYSTEMS
    AAMI IEC 62304 : 2006 MEDICAL DEVICE SOFTWARE - SOFTWARE LIFE CYCLE PROCESSES
    ISO/IEC/IEEE 26511:2011 Systems and software engineering Requirements for managers of user documentation
    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)
    CEI EN 50657 : 1ED 2018 RAILWAYS APPLICATIONS - ROLLING STOCK APPLICATIONS - SOFTWARE ON BOARD ROLLING STOCK
    AAMI ISO 14937:2009 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
    AAMI ISO 13408-5:2006(R2015) ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 5: STERILIZATION IN PLACE
    I.S. EN 15224:2016 QUALITY MANAGEMENT SYSTEMS - EN ISO 9001:2015 FOR HEALTHCARE
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    UNI EN ISO 11135 : 2014 STERILIZATION OF HEALTH-CARE PRODUCTS - ETHYLENE OXIDE - REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
    AAMI ISO 11737-1 : 2006 STERILIZATION OF MEDICAL DEVICES - MEDICAL DEVICES - PART 1: DETERMINATION OF THE POPULATION OF MICROORGANISMS ON PRODUCT
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    UNI EN ISO 13408-4 : 2011 ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 4: CLEAN-IN-PLACE TECHNOLOGIES
    10/30204688 DC : 0 BS ISO/IEC 26511 - SOFTWARE AND SYSTEMS ENGINEERING - REQUIREMENTS FOR MANAGERS OF USER DOCUMENTATION
    09/30184534 DC : DRAFT JAN 2009 BS ISO/IEC 20000-1 - INFORMATION TECHNOLOGY - SERVICE MANAGEMENT - PART 1: SERVICE MANAGEMENT SYSTEM REQUIREMENTS
    I.S. EN 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
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    I.S. EN ISO 20857:2013 STERILIZATION OF HEALTH CARE PRODUCTS - DRY HEAT - REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES (ISO 20857:2010)
    17/30302489 DC : DRAFT MAR 2017 BS EN ISO 13408-2 - ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 2: STERILIZING FILTRATION
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    09/30157765 DC : 0 BS EN ISO 14160 REV - 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
    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 ISO 10005:2005 Quality management systems. Guidelines for quality plans
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    IEEE 15026-4-2013 IEEE Standard Adoption of ISO/IEC 15026-4--Systems and Software Engineering--Systems and Software Assurance--Part 4: Assurance in the Life Cycle
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    CSA ISO/IEC 20000-2:2013 INFORMATION TECHNOLOGY - SERVICE MANAGEMENT - PART 2: GUIDANCE ON THE APPLICATION OF SERVICE MANAGEMENT SYSTEMS
    EN 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 14160:2011)
    CSA ISO 10005 : 2005 QUALITY MANAGEMENT SYSTEMS - GUIDELINES FOR QUALITY PLANS
    UNI EN ISO 20857 : 2013 STERILIZATION OF HEALTH CARE PRODUCTS - DRY HEAT - REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
    PREN 9100 : 200P4 QUALITY MANAGEMENT SYSTEMS - REQUIREMENTS FOR AVIATION, SPACE AND DEFENCE ORGANIZATIONS
    CSA Z11135-1 : 2009 : FR STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - PART 1: REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
    IEC 61511-1 REDLINE : 2ED 2016 FUNCTIONAL SAFETY - SAFETY INSTRUMENTED SYSTEMS FOR THE PROCESS INDUSTRY SECTOR - PART 1: FRAMEWORK, DEFINITIONS, SYSTEM, HARDWARE AND APPLICATION PROGRAMMING REQUIREMENTS
    ANSI/AAMI/ISO 13408-6:2005(R2013)&A1:2013 ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 6: ISOLATOR SYSTEMS
    DIN EN ISO 20857:2013-08 Sterilization of health care products - Dry heat - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 20857:2010)
    UNE-EN 50128:2012 Railway applications - Communication, signalling and processing systems - Software for railway control and protection systems
    BS EN ISO 11135:2014 Sterilization of health-care products. Ethylene oxide. Requirements for the development, validation and routine control of a sterilization process for medical devices
    AAMI ISO 13408-4 : 2005 ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 4: CLEAN-IN-PLACE TECHNOLOGIES
    PREN 15224 : DRAFT 2016 HEALTH CARE SERVICES - QUALITY MANAGEMENT SYSTEMS - REQUIREMENTS BASED ON EN ISO 9001:2015
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    ISO/IEC 12207:2008 Systems and software engineering Software life cycle processes
    DIN EN ISO 14160:2011-10 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 14160:2011)
    ISO 14937:2009 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 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 13408-4:2005 Aseptic processing of health care products — Part 4: Clean-in-place technologies
    EN ISO 11737-2:2009 Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process (ISO 11737-2:2009)
    BS EN ISO 14937:2009 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
    IEC 61162-402:2005 Maritime navigation and radiocommunication equipment and systems - Digital interfaces - Part 402: Multiple talkers and multiple listeners - Ship systems interconnection - Documentation and test requirements
    BS ISO 19859:2016 Gas turbine applications. Requirements for power generation
    ISO 19903:2006 Petroleum and natural gas industries Fixed concrete offshore structures
    ISO/IEC 20000-2:2012 Information technology Service management Part 2: Guidance on the application of service management systems
    UNE-EN ISO 14937:2010 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 14937:2009)
    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 9001:2015 Quality management systems — Requirements
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    I.S. EN ISO 13408-2:2018 ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 2: STERILIZING FILTRATION (ISO 13408-2:2018)
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    BS EN 62304 : 2006 MEDICAL DEVICE SOFTWARE - SOFTWARE LIFE-CYCLE PROCESSES
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    S.R. CEN ISO TS 29001:2011 PETROLEUM, PETROCHEMICAL AND NATURAL GAS INDUSTRIES - SECTOR-SPECIFIC QUALITY MANAGEMENT SYSTEMS - REQUIREMENTS FOR PRODUCT AND SERVICE SUPPLY ORGANIZATIONS
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    I.S. EN 61496-1:2013 SAFETY OF MACHINERY - ELECTRO-SENSITIVE PROTECTIVE EQUIPMENT - PART 1: GENERAL REQUIREMENTS AND TESTS
    I.S. 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) (ISO 15378:2017)
    IEC 62304:2006+AMD1:2015 CSV Medical device software - Software life cycle processes
    EN 50128:2011/AC:2014 RAILWAY APPLICATIONS - COMMUNICATION, SIGNALLING AND PROCESSING SYSTEMS - SOFTWARE FOR RAILWAY CONTROL AND PROTECTION SYSTEMS
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