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  • ISO 9000-3:1997

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    Withdrawn A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
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    Quality management and quality assurance standards Part 3: Guidelines for the application of ISO 9001:1994 to the development, supply, installation and maintenance of computer software

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

    Withdrawn date:  20-03-2019

    Language(s):  English, French

    Published date:  18-12-1997

    Publisher:  International Organization for Standardization

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    Development Note The revised ISO 9000, 9001 and 9004 have taken into account this and other guideline documents of the ISO 9000 family and are intended to eliminate the need for guideline documents. This document currently under review by ISO/TC 176 (11/2000)
    Document Type Standard
    Publisher International Organization for Standardization
    Status Withdrawn
    Superseded By
    Supersedes

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

    AQAP 169 : 1 NATO GUIDANCE ON THE USE OF AQAP 160 EDITION 1
    DEFSTAN 05-95/2(1992) : 1992 QUALITY SYSTEM REQUIREMENTS FOR THE DEVELOPMENT, SUPPLY AND MAINTENANCE OF SOFTWARE
    BS EN 62138:2009 Nuclear power plants. Instrumentation and control important for safety. Software aspects for computer-based systems performing category B or C functions
    CEI EN 61131-6 : 2013 PROGRAMMABLE CONTROLLERS - PART 6: FUNCTIONAL SAFETY
    DEFSTAN 00-55(PT2)/2(1997) : 1997 ERRATUM 1997 REQUIREMENTS FOR SAFETY RELATED SOFTWARE IN DEFENCE EQUIPMENT - PART 2: GUIDANCE
    DD CEN/TS 15224:2005 Health services. Quality management systems. Guide for the use of EN ISO 9001:2000
    I.S. ISO 9000-2:1994 QUALITY MANAGEMENT AND QUALITY ASSURANCE STANDARDS - PART 2: GENERIC GUIDELINES FOR THE APPLICATION OF ISO 9001, ISO 9002 AND ISO 9003
    DEFSTAN 05-96/1(1994) : INTERIM GUIDANCE ON QUALITY SYSTEM REQUIREMENTS FOR THE IMPLEMENTATION OF DEF STAN 05-95/ISSUE 2
    PD 0026:2003 Software and systems quality framework. A guide to the use of ISO/IEC and other standards for understanding quality in software and systems
    02/647837 DC : DRAFT OCT 2002 PD 0026 - SOFTWARE AND SYSTEM QUALITY FRAMEWORK
    CSA ISO 10993-12 : 98(R2002) BIOLOGICAL EVALUATION OF MEDICAL DEVICES - SAMPLE PREPARATION AND REFERENCE MATERIALS
    CSA ISO 14971 : 2007 MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES
    TR 9109 : 1 AEROSPACE SERIES - GUIDELINES FOR SOFTWARE QUALITY MANAGEMENT
    ASTM E 2239 : 2012 : R2016 Standard Practice for Record Keeping and Record Preservation for Lead Hazard Activities
    CSA Z17665-1 : 2009 : FR STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - PART 1: REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
    I.S. CWA 14172-2:2004 EESSI CONFORMITY ASSESSMENT GUIDANCE - PART 2: CERTIFICATION AUTHORITY SERVICES AND PROCESSES
    DEFSTAN 00-55(PT1)/2(1997) : 1997 REQUIREMENTS FOR SAFETY RELATED SOFTWARE IN DEFENCE EQUIPMENT - PART 1: REQUIREMENTS
    AAMI ISO 14971 : 2007 : INC : ERR 1 : 2007 MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES
    ASTM E 2239 : 2012 Standard Practice for Record Keeping and Record Preservation for Lead Hazard Activities
    I.S. CWA 14172-7:2004 EESSI CONFORMITY ASSESSMENT GUIDANCE - PART 7: CRYPTOGRAPHIC MODULES USED BY CERTIFICATION SERVICE PROVIDERS FOR SIGNING OPERATIONS AND KEY GENERATION SERVICES
    ISO/IEC Guide 62:1996 General requirements for bodies operating assessment and certification/registration of quality systems
    EN 62138 : 2009 NUCLEAR POWER PLANTS - INSTRUMENTATION AND CONTROL IMPORTANT FOR SAFETY - SOFTWARE ASPECTS FOR COMPUTER-BASED SYSTEMS PERFORMING CATEGORY B OR C FUNCTIONS
    CEN/TS 15224:2005 Health services - Quality management systems - Guide for the use of EN ISO 9001:2000
    EN 61209:1999 Maritime navigation and radiocommunication equipment and systems - Integrated bridge systems (IBS) - Operational and performance requirements, methods of testing and required test results
    EN 61131-6:2012 Programmable controllers - Part 6: Functional safety
    EN 60936-1 : 2000 AMD 1 2002 MARITIME NAVIGATION AND RADIOCOMMUNICATION EQUIPMENT AND SYSTEMS - RADAR - PART 1: SHIPBORNE RADAR - PERFORMANCE REQUIREMENTS - METHODS OF TESTING AND REQUIRED TEST RESULTS
    CR 13576 : 1999 IMPLEMENTATION OF EN 729 ON QUALITY REQUIREMENTS FOR FUSION WELDING OF METALLIC MATERIALS
    I.S. EN 62138:2009 NUCLEAR POWER PLANTS - INSTRUMENTATION AND CONTROL IMPORTANT FOR SAFETY - SOFTWARE ASPECTS FOR COMPUTER-BASED SYSTEMS PERFORMING CATEGORY B OR C FUNCTIONS
    04/30090382 DC : DRAFT NOV 2004 ISO 13408-5 - ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 5: CLEANING IN PLACE
    BS 5724-1.4(1997) : 1997 MEDICAL ELECTRICAL EQUIPMENT - PART 1-4: GENERAL REQUIREMENTS FOR SAFETY - COLLATERAL STANDARD - GENERAL REQUIREMENTS FOR PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS
    BS EN 61131-6:2012 Programmable controllers Functional safety
    DEFSTAN 00-54(PT1)/1(1999) : 1999 REQUIREMENTS FOR SAFETY RELATED ELECTRONIC HARDWARE IN DEFENCE EQUIPMENT - PART 1: REQUIREMENTS
    DEFSTAN 00-54(PT2)/1(1999) : 1999 REQUIREMENTS FOR SAFETY RELATED ELECTRONIC HARDWARE IN DEFENCE EQUIPMENT - PART 2: GUIDANCE
    BS EN 60936-1:2000 Maritime navigation and radiocommunication equipment and systems. Radar Shipborne radar. Performance requirements. Methods of testing and required test results
    00/202803 DC : DRAFT JUN 2000
    IEC 61506:1997 Industrial-process measurement and control - Documentation ofapplication software
    PD6677 : 2002 (R12) IMPLEMENTATION GUIDE FOR NATO AQAP-160 INCORPORATING ALL AQAP-160 TEXT AND RELEVANT ISO TEXT
    CSA E61496.1 :2004 SAFETY OF MACHINERY - ELECTRO-SENSITIVE PROTECTIVE EQUIPMENT - PART 1: GENERAL REQUIREMENTS AND TESTS
    AAMI TIR32 : 2004 : R2016 MEDICAL DEVICE SOFTWARE RISK MANAGEMENT
    04/30090379 DC : DRAFT MAR 2004 BS ISO 13408-4 - ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 4: CLEAN-IN-PLACE TECHNOLOGIES
    04/30048205 DC : DRAFT JUL 2004 BS EN ISO 17665 - STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
    04/19985217 DC : DRAFT NOV 2004 ISO 19903 - PETROLEUM AND NATURAL GAS INDUSTRIES - FIXED CONCRETE OFFSHORE STRUCTURES
    AAMI 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
    BS EN 60872-3:2001 Maritime navigation and radiocommunication equipment and systems. Radar plotting aids Electronic plotting aid (EPA). Performance requirements. Methods of testing and required test results
    CEI EN 50155 : 2008 RAILWAY APPLICATIONS - ELECTRONIC EQUIPMENT USED ON ROLLING STOCK
    CEI UNI EN 45510-8-1 : 2000 GUIDE FOR PROCUREMENT OF POWER STATION EQUIPMENT - PART 8-1: CONTROL AND INSTRUMENTATION
    ASTM E 2066 : 2000 Standard Guide for Validation of Laboratory Information Management Systems
    ASTM E 1884 : 1997 Standard Guide for General Requirements for Bodies Operating Assessment and Certification/Registration of Quality Systems (Withdrawn 2004)
    ISO 14971:2007 Medical devices Application of risk management to medical devices
    CEI UNI EN ISO 14971 : 2013 MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES
    I.S. EN ISO 14971:2012 MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES (ISO 14971:2007, CORRECTED VERSION 2007-10-01)
    DIN EN ISO 17665-1:2006-11 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 17665-1:2006)
    DIN EN ISO 14971:2013-04 MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES (ISO 14971:2007)
    I.S. EN ISO 10007:1997 QUALITY MANAGEMENT - GUIDELINES FOR CONFIGURATION MANAGEMENT
    ASME B16.5 : 2017 PIPE FLANGES AND FLANGED FITTINGS: NPS 1/2 THROUGH NPS 24 METRIC/INCH STANDARD
    BS 3598:1998 Fissile materials. Criticality safety in handling and processing. Recommendations
    CSA ISO/IEC 90003 : 2004 SOFTWARE ENGINEERING - GUIDELINES FOR THE APPLICATION OF ISO 9001:2000 TO COMPUTER SOFTWARE
    04/30040790 DC : DRAFT MARCH 2004 ISO/IEC DTR 15443-2 - INFORMATION TECHNOLOGY - SECURITY TECHNIQUES - A FRAMEWORK FOR IT SECURITY ASSURANCE - PART 2 - ASSURANCE METHODS
    I.S. EN 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
    03/315684 DC : DRAFT SEP 2003 ISO 10019 - GUIDELINES FOR THE SELECTION OF QUALITY MANAGEMENT SYSTEM CONSULTANTS AND USE OF THEIR SERVICES
    AQAP 160 : 1 NATO INTEGRATED QUALITY REQUIREMENTS FOR SOFTWARE THROUGHOUT THE LIFE CYCLE
    ISO 9000-1:1994 Quality management and quality assurance standards — Part 1: Guidelines for selection and use
    CSA CEI/IEC 300.2 : 0 DEPENDABILITY MANAGEMENT - PART 2: DEPENDABILITY PROGRAMME ELEMENTS AND TASKS
    DEFSTAN 05-95/3(1995) : 1995 QUALITY SYSTEM REQUIREMENTS FOR THE DESIGN, DEVELOPMENT, SUPPLY AND MAINTENANCE OF SOFTWARE
    BS EN 60601-1-4:1997 Medical electrical equipment. General requirements for safety Collateral standard. General requirements for programmable electrical medical systems
    BS ISO/IEC 21827:2008 Information technology. Security techniques. Systems security engineering. Capability maturity model (SSE- CMM)
    02/706744 DC : DRAFT MAY 2002 ISO/DIS 8178-1 - RECIPROCATING INTERNAL COMBUSTION ENGINES - EXHAUST EMISSION MEASUREMENT - PART 1: TEST-BED MEASUREMENT OF GASEOUS AND PARTICULATE EXHAUST EMISSIONS
    CSA E61496.1 : 2004 : R2013 SAFETY OF MACHINERY - ELECTRO-SENSITIVE PROTECTIVE EQUIPMENT - PART 1: GENERAL REQUIREMENTS AND TESTS
    BS ISO/IEC TR 13233:1995 Information technology. Interpretation of accreditation requirements in ISO/IEC Guide 25. Accreditation of information technology and telecommunications testing laboratories for software and protocol testing services
    SAE AS 9006 : 2013 DELIVERABLE AEROSPACE SOFTWARE SUPPLEMENT FOR AS9100A - QUALITY MANAGEMENT SYSTEMS - AEROSPACE - REQUIREMENTS FOR SOFTWARE
    CSA ISO/IEC 21827 : 2009 INFORMATION TECHNOLOGY - SECURITY TECHNIQUES - SYSTEMS SECURITY ENGINEERING - CAPABILITY MATURITY MODEL (SSE-CMM)
    CSA Z17665-1:09 (R2019) Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices (Adopted ISO 17665-1:2006, first edition, 2006-08-15, with Canadian deviations)
    ANSI/AAMI ISO 17665-1:2006(R2013) STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - PART 1: REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
    ASTM E 2066 : 2000 : R2007 Standard Guide for Validation of Laboratory Information Management Systems (Withdrawn 2015)
    DIN EN ISO 9241-11:2016-01 (Draft) ERGONOMIC REQUIREMENTS FOR OFFICE WORK WITH VISUAL DISPLAY TERMINALS (VDTS) - PART 11: GUIDANCE ON USABILITY
    ISO/IEC 21827:2008 Information technology Security techniques Systems Security Engineering Capability Maturity Model (SSE-CMM)
    ISO 9002:1994 Quality systems — Model for quality assurance in production, installation and servicing
    BS EN ISO 14971:2012 Medical devices. Application of risk management to medical devices
    IEC 61249-2-19:2001 Materials for printed boards and other interconnecting structures - Part 2-19: Reinforced base materials, clad and unclad - Epoxide cross-plied linear fibreglass-reinforced laminated sheets of defined flammability (vertical burning test), copper clad
    IEC 62138:2004 Nuclear power plants - Instrumentation and control important for safety - Software aspects for computer-based systems performing category B or C functions
    NASA GB 8719.13 : 0 NASA SOFTWARE SAFETY GUIDEBOOK
    NASA-STD-8739.8A : 2020 SOFTWARE ASSURANCE AND SOFTWARE SAFETY STANDARD
    EN 45510-8-1:1998 Guide for procurement of power station equipment - Part 8-1: Control and instrumentation
    NASA STD 8739.8 : 2004 SOFTWARE ASSURANCE STANDARD
    BS IEC 61511-1 : 2003 AMD 15776 FUNCTIONAL SAFETY - SAFETY INSTRUMENTED SYSTEMS FOR THE PROCESS INDUSTRY SECTOR - PART 1: FRAMEWORK, DEFINITIONS, SYSTEM, HARDWARE AND SOFTWARE REQUIREMENTS
    CEI EN 62138 : 2011 NUCLEAR POWER PLANTS - INSTRUMENTATION AND CONTROL IMPORTANT FOR SAFETY - SOFTWARE ASPECTS FOR COMPUTER-BASED SYSTEMS PERFORMING CATEGORY B OR C FUNCTIONS
    BS ISO 17894:2005 Ships and marine technology. Computer applications. General principles for the development and use of programmable electronic systems in marine applications
    ISA 84.00.01-1 : 2004 FUNCTIONAL SAFETY: SAFETY INSTRUMENTED SYSTEMS FOR THE PROCESS INDUSTRY SECTOR - PART 1: FRAMEWORK, DEFINITIONS, SYSTEM, HARDWARE AND SOFTWARE REQUIREMENTS
    PREN 45001 : DRAFT 1997 GENERAL REQUIREMENTS FOR THE COMPETENCE OF TESTING AND CALIBRATION LABORATORIES
    03/314215 DC : DRAFT OCT 2003 ISO TR 14969 - MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - GUIDANCE ON THE APPLICATION OF ISO 13485:2003
    UNI CEI EN ISO 14971 : 2012 MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES
    TR NWT 000179 : ISSUE 2 QUALITY SYSTEM GENERIC REQUIREMENTS FOR SOFTWARE
    BS EN ISO 9000-1:1994 Quality management and quality assurance standards Guidelines for selection and use
    AAMI TIR32 :2004 MEDICAL DEVICE SOFTWARE RISK MANAGEMENT
    AAMI ISO 14971 : 2007 : R2010 MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES
    BS EN ISO 9241-11:1998 Ergonomic requirements for office work with visual display terminals (VDTs) Guidance on usability
    ISO 8402:1994 Quality management and quality assurance — Vocabulary
    CSA Z17665-1 : 2009 : R2014 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 9003:1994 Quality systems Model for quality assurance in final inspection and test
    ISO 15161:2001 Guidelines on the application of ISO 9001:2000 for the food and drink industry
    EN ISO 14971:2012 Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)
    EN ISO 9241-11:1998 Ergonomic requirements for office work with visual display terminals (VDTs) - Part 11: Guidance on usability (ISO 9241-11:1998)
    ISO/IEC TR 13233:1995 Information technology Interpretation of accreditation requirements in ISO/IEC Guide 25 Accreditation of Information Technology and Telecommunications testing laboratories for software and protocol testing services
    ISO 17894:2005 Ships and marine technology Computer applications General principles for the development and use of programmable electronic systems in marine applications
    ISO 9004-1:1994 Quality management and quality system elements Part 1: Guidelines
    I.S. CWA 14172-6:2004 EESSI CONFORMITY ASSESSMENT GUIDANCE - PART 6: SIGNATURE-CREATION DEVICE SUPPORTING SIGNATURES OTHER THAN QUALIFIED
    S.R. CR 12804:1997 CONCEPTUAL MODEL AND TAXONOMY FOR INFORMATION SYSTEMS ENGINEERING
    I.S. CWA 14172-1:2004 EESSI CONFORMITY ASSESSMENT GUIDANCE - PART 1: GENERAL INTRODUCTION
    I.S. CWA 14172-8:2004 EESSI CONFORMITY ASSESSMENT GUIDANCE - PART 8: TIME-STAMPING AUTHORITY SERVICES AND PROCESSES
    IEC 61739:1996 Integrated circuits - Part 1: Procedures for manufacturing line approval and quality management
    GEIA HB 649 : 2005 CONFIGURATION MANAGEMENT STANDARD IMPLEMENTATION GUIDE
    BS EN ISO 15541:2001 Ships and marine technology. Fire resistance of hose assemblies. Requirements for the test bench
    BS EN ISO 17665-1:2006 Sterilization of health care products. Moist heat Requirements for the development, validation and routine control of a sterilization process for medical devices
    IEC 61131-6:2012 Programmable controllers - Part 6: Functional safety
    00/565497 DC : DRAFT DEC 2000 BS IEC 60601-1 MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR SAFETY AND ESSENTIAL PERFORMANCE
    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
    BS EN 45510-8-1:1998 Guide for the procurement of power station equipment Control and instrumentation
    BS EN 45012:1998 General requirements for bodies operating assessment and certification/registration of quality systems
    EN ISO 10007 : 1996 QUALITY MANAGEMENT - GUIDELINES FOR CONFIGURATION MANAGEMENT
    EN ISO 9000-1 : 1994 QUALITY MANAGEMENT AND QUALITY ASSURANCE STANDARDS - PART 1: GUIDELINES FOR SELECTION AND USE (ISO 9000-1:1994)
    EN 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 17665-1:2006)
    CSA ISO/IEC 90003 : 2004 : R2014 SOFTWARE ENGINEERING - GUIDELINES FOR THE APPLICATION OF ISO 9001:2000 TO COMPUTER SOFTWARE
    12/30264224 DC : 0 BS EN 61511-1 ED.2 - FUNCTIONAL SAFETY - SAFETY INSTRUMENTED SYSTEMS FOR THE PROCESS INDUSTRY SECTOR - NORMATIVE - PART 1: FRAMEWORK, DEFINITIONS, SYSTEM, HARDWARE AND SOFTWARE REQUIREMENTS
    BS ISO 15161:2001 Guidelines on the application of ISO 9001:2000 for the food and drink industry
    BS IEC 60300-3.6 : 1997 DEPENDABILITY MANAGEMENT - APPLICATION GUIDE - SOFTWARE ASPECTS OF DEPENDABILITY
    I.S. EN 45012:1998 GENERAL REQUIREMENTS FOR BODIES OPERATING ASSESSMENT AND CERTIFICATION/REGISTRATION OF QUALITY SYSTEMS
    DEFSTAN 05-95/1(1991) : INTERIM QUALITY SYSTEM REQUIREMENTS FOR THE DEVELOPMENT, SUPPLY AND MAINTENANCE OF SOFTWARE
    BS IEC 62138 : 2004 NUCLEAR POWER PLANTS - INSTRUMENTATION AND CONTROL IMPORTANT FOR SAFETY - SOFTWARE ASPECTS FOR COMPUTER-BASED SYSTEMS PERFORMING CATEGORY B OR C FUNCTIONS
    98/402025 DC : DRAFT JAN 1998 BS ISO 13448-1 - ACCEPTANCE SAMPLING PROCEDURES BASED ON THE ALLOCATION-OF-PRIORITIES PRINCIPLE (APP) - PART 1: GUIDE TO THE APP APPROACH
    I.S. CEN TS 15224:2006 HEALTH SERVICES - QUALITY MANAGEMENT SYSTEMS - GUIDE FOR THE USE OF EN ISO 9001:2000
    CSA ISO/IEC 21827 : 2009 : R2014 INFORMATION TECHNOLOGY - SECURITY TECHNIQUES - SYSTEMS SECURITY ENGINEERING - CAPABILITY MATURITY MODEL (SSE-CMM)
    97/402277 DC : DRAFT APR 1997 PREN 45001 - GENERAL REQUIREMENTS FOR THE COMPETENCE OF TESTING AND CALIBRATION LABORATORIES
    CSA ISO 14971 : 2007 : R2017 MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES
    CSA ISO 14971 : 2007 : R2012 MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES
    I.S. EN 61131-6:2012 PROGRAMMABLE CONTROLLERS - PART 6: FUNCTIONAL SAFETY (IEC 61131-6:2012 (EQV))
    I.S. EN ISO 9241-11:1998 ERGONOMIC REQUIREMENTS FOR OFFICE WORK WITH VISUAL DISPLAY TERMINALS (VDTS) - PART 11: GUIDANCE ON USABILITY
    I.S. EN CWA 14172-5:2004 EESSI CONFORMITY ASSESSMENT GUIDANCE - PART 5: SECURE SIGNATURE CREATION DEVICES
    I.S. EN ISO 9000-1:1994 QUALITY MANAGEMENT AND QUALITY ASSURANCE STANDARDS - PART 1: GUIDELINES FOR SELECTION AND USE
    I.S. EN ISO 9003:1994 QUALITY SYSTEMS - MODEL FOR QUALITY ASSURANCE IN FINAL INSPECTION AND TEST
    I.S. CWA 14172-4:2004 EESSI CONFORMITY ASSESSMENT GUIDANCE - PART 4: SIGNATURE CREATION APPLICATIONS AND GENERAL GUIDELINES FOR ELECTRONIC SIGNATURE VERIFICATION
    CR 12804 : 1997 CONCEPTUAL MODEL AND TAXONOMY FOR INFORMATION SYSTEMS ENGINEERING
    EN 45510-8-1:1998 GUIDE FOR PROCUREMENT OF POWER STATION EQUIPMENT - PART 8-1: CONTROL AND INSTRUMENTATION
    EN 60872-3:2001 Maritime navigation and radiocommunication equipment and systems - Radar plotting aids - Part 3: Electronic plotting aid (EPA) - Performance requirements - Methods of testing and required test results
    EN 60601-1-4:1996/A1:1999 MEDICAL ELECTRICAL EQUIPMENT - GENERAL REQUIREMENTS FOR SAFETY - COLLATERAL STANDARD: PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS
    DIN EN 45012:1990-05 GENERAL REQUIREMENTS FOR BODIES OPERATING ASSESSMENT AND CERTIFICATION/REGISTRATION OF QUALITY SYSTEMS

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

    ISO 8402:1994 Quality management and quality assurance — Vocabulary
    ISO 9001:2015 Quality management systems — Requirements
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