ISO/IEC 90003:2014
Withdrawn
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
View Superseded by
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Withdrawn date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
Superseded by
Language(s)
English
Published date
09-12-2014
Important note : Users cannot be edited or removed once added to your Multi user PDF.
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.
| DevelopmentNote |
Supersedes ISO 9000-3. (02/2004)
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| DocumentType |
Standard
|
| Pages |
54
|
| PublisherName |
International Organization for Standardization
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| Status |
Withdrawn
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| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| BS ISO/IEC 90003:2014 | Identical |
| UNI CEI ISO/IEC 90003 : 2005 | Identical |
| IEEE 90003-2015 | Identical |
| NS ISO/IEC 90003 : 2004 | Identical |
| GOST R ISO/IEC 90003 : 2014 | Identical |
| CEI UNI 700-42 : 2015 | Identical |
| NBN ISO/IEC TR 90003 : 2014 | Identical |
| SN ISO/IEC 90003:2015 | Identical |
| NEN ISO/IEC 90003 : 2014 | Identical |
| PN ISO/IEC 90003 : 2007 | Identical |
| CEI UNI ISO/IEC 90003 : 2009 | Identical |
| CSA ISO/IEC 90003 : 2004 | Identical |
| CSA ISO/IEC 90003 : 2004 : R2014 | Identical |
| UNE-ISO/IEC 90003:2005 | Identical |
| 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 AS9120B | 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 |
| I.S. 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 |
| 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 |
| BS ISO/IEC IEEE 24765:2010 | Systems and software engineering. Vocabulary |
| BS ISO/IEC 26511:2011 | Systems and software engineering. Requirements for managers of user documentation |
| 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 |
| 14/30287226 DC : 0 | BS EN ISO 15378 - PRIMARY PACKAGING MATERIALS FOR MEDICINAL PRODUCTS - PARTICULAR REQUIREMENTS FOR THE APPLICATION OF ISO 9001:2008, WITH REFERENCE TO GOOD MANUFACTURING PRACTICE (GMP) |
| ANSI/AAMI/ISO 14160:2011(R2016) | 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 |
| EN 50126-2:2017 | Railway Applications - The Specification and Demonstration of Reliability, Availability, Maintainability and Safety (RAMS) - Part 2: Systems Approach to Safety |
| DIN EN 15224:2016-04 (Draft) | QUALITY MANAGEMENT SYSTEMS - EN ISO 9001:2015 FOR HEALTHCARE |
| PD ISO/IEC TR 90006:2013 | Information technology. Guidelines for the application of ISO 9001:2008 to IT service management and its integration with ISO/IEC 20000-1:2011 |
| 16/30302485 DC : 0 | BS EN ISO 11737-1 - STERILIZATION OF HEALTH CARE PRODUCTS - MICROBIOLOGICAL METHODS - PART 1: DETERMINATION OF A POPULATION OF MICROORGANISMS ON PRODUCT |
| NF EN 50128 : 2011 | RAILWAY APPLICATIONS - COMMUNICATION, SIGNALLING AND PROCESSING SYSTEMS - SOFTWARE FOR RAILWAY CONTROL AND PROTECTION SYSTEMS |
| 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 |
| SAE AS9110C | Quality Management Systems – Requirements for Aviation Maintenance Organizations |
| AAMI ISO 13408-5 : 2006 | ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 5: STERILIZATION IN PLACE |
| 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 |
| ISO/TR 27809:2007 | Health informatics Measures for ensuring patient safety of health software |
| SAE AS9100D | 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 |
| BS ISO 14885:2014 | Large yachts. Diesel engines for main propulsion and essential auxiliaries. Safety requirements |
| 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 |
| BS ISO 15378 : 2006 AMD 17315 | PRIMARY PACKAGING MATERIALS FOR MEDICINAL PRODUCTS - PARTICULAR REQUIREMENTS FOR THE APPLICATION OF ISO 9001:2000, WITH REFERENCE TO GOOD MANUFACTURING PRACTICE (GMP) |
| 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 |
| ISO/IEC 27034-7:2018 | Information technology — Application security — Part 7: Assurance prediction framework |
| 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 |
| ISO 15541:2016 | Ships and marine technology — Fire resistance of non-metallic hose assemblies and non-metallic compensators — Requirements for the test bench |
| UNE-EN ISO 9001:2015 | Quality management systems - Requirements (ISO 9001:2015) |
| I.S. EN 50128:2011 | RAILWAY APPLICATIONS - COMMUNICATION, SIGNALLING AND PROCESSING SYSTEMS - SOFTWARE FOR RAILWAY CONTROL AND PROTECTION SYSTEMS |
| 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 |
| ISO 13408-5:2006 | Aseptic processing of health care products Part 5: Sterilization in place |
| ISO 13408-6:2005 | Aseptic processing of health care products Part 6: Isolator systems |
| ISO/TS 29001:2010 | Petroleum, petrochemical and natural gas industries Sector-specific quality management systems Requirements for product and service supply organizations |
| ISO 19859:2016 | Gas turbine applications Requirements for power generation |
| IEC 61511-1:2016 RLV | Functional safety - Safety instrumented systems for the process industry sector - Part 1: Framework, definitions, system, hardware and application programming requirements |
| I.S. EN 50155:2017-11 | RAILWAY APPLICATIONS - ROLLING STOCK - ELECTRONIC EQUIPMENT |
| I.S. 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 |
| I.S. 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 |
| UNI EN ISO 11737-2 : 2010 | STERILIZATION OF MEDICAL DEVICES - MICROBIOLOGICAL METHODS - PART 2: TESTS OF STERILITY PERFORMED IN THE DEFINITION, VALIDATION AND MAINTENANCE OF A STERILIZATION PROCESS |
| UNE-ISO/IEC 20000-2:2015 | Information technology. Service management. Part 2: Guidance on the application of service management systems |
| BIS IS/ISO/TS 16949 : 2009 | QUALITY MANAGEMENT SYSTEMS - PARTICULAR REQUIREMENTS FOR THE APPLICATION OF ISO 9001:2008 FOR AUTOMOTIVE PRODUCTION AND RELEVANT SERVICE PART ORGANIZATIONS |
| 15/30329378 DC : 0 | BS EN 9110 - AEROSPACE SERIES - QUALITY MANAGEMENT SYSTEMS - REQUIREMENTS FOR AVIATION MAINTENANCE ORGANIZATIONS |
| 08/30135847 DC : DRAFT AUG 2008 | BS ISO 9004 - MANAGING FOR THE SUSTAINED SUCCESS OF AN ORGANIZATION - A QUALITY MANAGEMENT APPROACH |
| ANSI/AAMI/ISO 20857:2010(R2015) | STERILIZATION OF HEALTH CARE PRODUCTS - DRY HEAT - REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES |
| 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 |
| BS EN 50657:2017 | Railways Applications. Rolling stock applications. Software on Board Rolling Stock |
| 13/30268559 DC : 0 | BS ISO/IEC 15026-1 - SYSTEMS AND SOFTWARE ENGINEERING - SYSTEMS AND SOFTWARE ASSURANCE - PART 1: CONCEPTS AND VOCABULARY |
| UNE-ISO/TS 9002:2017 | Quality management systems -- Guidelines for the application of ISO 9001:2015 |
| 07/30135834 DC : 0 | ISO 9001 - QUALITY MANAGEMENT SYSTEMS - REQUIREMENTS |
| 03/317065 DC : DRAFT NOV 2003 | ISO/IEC 17025 - GENERAL REQUIREMENTS FOR THE COMPETENCE OF TESTING AND CALIBRATION LABS - AMENDMENT 1 |
| 17/30309594 DC : 0 | BS IEC 62138 - NUCLEAR POWER PLANTS - INSTRUMENTATION AND CONTROL SYSTEMS IMPORTANT TO SAFETY - SOFTWARE ASPECTS FOR COMPUTER-BASED SYSTEMS PERFORMING CATEGORY B OR C FUNCTIONS |
| 17/30313889 DC : DRAFT AUG 2017 | BS EN ISO 19903 - PETROLEUM AND NATURAL GAS INDUSTRIES - CONCRETE OFFSHORE STRUCTURES |
| BS TICKIT GUIDE : ISSUE 5.5 | A GUIDE TO SOFTWARE QUALITY MANAGEMENT SYSTEM CONSTRUCTION AND CERTIFICATION TO ISO 9001:2000 |
| 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 |
| AAMI ISO 13408-2 : 2003 | ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 2: STERILIZING FILTRATION |
| 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) |
| AAMI ISO 11135-1 : 2007 | STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - PART 1: REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES |
| AAMI ISO 11737-1 : 2006 : R2011 | STERILIZATION OF MEDICAL DEVICES - MEDICAL DEVICES - PART 1: DETERMINATION OF THE POPULATION OF MICROORGANISMS ON PRODUCT |
| CEN/TR 15640:2007 | Health informatics - Measures for ensuring the patient safety of health software |
| IEC 61511-1:2016+AMD1:2017 CSV | Functional safety - Safety instrumented systems for the process industry sector - Part 1: Framework, definitions, system, hardware and application programming requirements |
| IEC 62279:2015 | Railway applications - Communication, signalling and processing systems - Software for railway control and protection systems |
| 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/IEC/IEEE 24748-4:2016 | Systems and software engineering — Life cycle management — Part 4: Systems engineering planning |
| I.S. EN 62304:2006 | MEDICAL DEVICE SOFTWARE - SOFTWARE LIFE-CYCLE PROCESSES |
| ONORM EN ISO 13408-6 : 2013 | ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 6: ISOLATOR SYSTEMS (ISO 13408-6:2005 + AMD 1:2013) |
| BS EN ISO 19903:2006 | Petroleum and natural gas industries. Fixed concrete offshore structures |
| UNE-EN ISO 14160:2012 | 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) |
| I.S. 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 |
| EN 50155:2017 | Railway applications - Rolling stock - Electronic equipment |
| CSA N290.14 : 2015 | QUALIFICATION OF DIGITAL HARDWARE AND SOFTWARE FOR USE IN INSTRUMENTATION AND CONTROL APPLICATIONS FOR NUCLEAR POWER PLANTS |
| EN ISO 19903:2006 | Petroleum and natural gas industries - Fixed concrete offshore structures (ISO 19903:2006) |
| EN 61496-1:2013/AC:2015 | SAFETY OF MACHINERY - ELECTRO-SENSITIVE PROTECTIVE EQUIPMENT - PART 1: GENERAL REQUIREMENTS AND TESTS (IEC 61496-1:2012) |
| UNI 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 |
| EN 50657:2017 | Railways Applications - Rolling stock applications - Software on Board Rolling Stock |
| PREN ISO 14160 : DRAFT 2009 | 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 |
| 11/30247723 DC : 0 | BS IEC 60571 - RAILWAY APPLICATIONS - ELECTRONIC EQUIPMENT USED ON ROLLING STOCK |
| ISO 10005:2005 | Quality management systems Guidelines for quality plans |
| 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 |
| BS ISO/IEC 12207:1995 | Information technology. Software life cycle processes |
| 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 |
| 16/30334735 DC : 0 | BS EN 15224 - HEALTH CARE SERVICES - QUALITY MANAGEMENT SYSTEMS - REQUIREMENTS BASED ON EN ISO 9001:2015 |
| UNE-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) |
| 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 |
| 14/30273523 DC : 0 | BS EN ISO 9001 - QUALITY MANAGEMENT SYSTEMS - REQUIREMENTS |
| 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 |
| 07/30164697 DC : 0 | ISO 20857 - STERILIZATION OF HEALTH CARE PRODUCTS - DRY HEAT - REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF AN INDUSTRIAL STERILIZATION PROCESS FOR MEDICAL DEVICES |
| 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 |
| 15/30330406 DC : 0 | BS EN 50126-2 - RAILWAY APPLICATIONS - THE SPECIFICATION AND DEMONSTRATION OF RELIABILITY,AVAILABILITY, MAINTAINABILITY AND SAFETY (RAMS) - PART 2: SYSTEMS APPROACH TO SAFETY |
| CSA ISO 9004 : 2009 | MANAGING FOR THE SUSTAINED SUCCESS OF AN ORGANIZATION - A QUALITY MANAGEMENT APPROACH |
| UNI CEN ISO/TS 29001 : 2011 | PETROLEUM, PETROCHEMICAL AND NATURAL GAS INDUSTRIES - SECTOR-SPECIFIC QUALITY MANAGEMENT SYSTEMS - REQUIREMENTS FOR PRODUCT AND SERVICE SUPPLY ORGANIZATIONS |
| AAMI ISO 13408-6:2005 | ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 6: ISOLATOR SYSTEMS |
| 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 |
| 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 |
| ISO/IEC TR 90006:2013 | Information technology Guidelines for the application of ISO 9001:2008 to IT service management and its integration with ISO/IEC 20000-1:2011 |
| CSA CEI/IEC 62304:14 (R2019) | Medical device software - Software life cycle processes (Adopted CEI/IEC 62304:2006, first edition, 2006-05) | Logiciels de dispositifs médicaux - Processus du cycle de vie du logiciel (norme CEI/IEC 62304:2006 adoptée, première édition, 2006-05) |
| ISO 13485 - PRACTICAL GUIDE : 2016 | ISO 13485:2016 - MEDICAL DEVICES - A PRACTICAL GUIDE |
| ISO/IEC TR 15026-1:2010 | Systems and software engineering Systems and software assurance Part 1: Concepts and vocabulary |
| UNI CEI ISO/IEC 20000-2 : 2010 | INFORMATION TECHNOLOGY - SERVICE MANAGEMENT - PART 2: CODE OF PRACTICE |
| ISO 14885:2014 | Large yachts Diesel engines for main propulsion and essential auxiliaries Safety requirements |
| 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 |
| EN 61511-1:2017/A1:2017 | FUNCTIONAL SAFETY - SAFETY INSTRUMENTED SYSTEMS FOR THE PROCESS INDUSTRY SECTOR - PART 1: FRAMEWORK, DEFINITIONS, SYSTEM, HARDWARE AND APPLICATION PROGRAMMING REQUIREMENTS |
| EN ISO 13408-5:2011 | Aseptic processing of health care products - Part 5: Sterilization in place (ISO 13408-5:2006) |
| 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 (ISO 11135-1:2007) |
| EN ISO 13408-4:2011 | Aseptic processing of health care products - Part 4: Clean-in-place technologies (ISO 13408-4:2005) |
| 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) |
| IEEE/ISO/IEC 12207-2008 | ISO/IEC/IEEE International Standard - Systems and software engineering -- Software life cycle processes |
| PREN 50657 : DRAFT 2016 | RAILWAY APPLICATIONS - ROLLING STOCK APPLICATIONS - SOFTWARE ON BOARD OF ROLLING STOCK, EXCLUDING RAILWAY CONTROL AND PROTECTION APPLICATIONS |
| 10/30184538 DC : 0 | BS ISO/IEC 20000-2 - INFORMATION TECHNOLOGY - SERVICE MANAGEMENT - PART 2: GUIDANCE ON THE APPLICATION OF SERVICE MANAGEMENT SYSTEMS |
| BS 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 |
| I.S. EN 50657:2017 | RAILWAYS APPLICATIONS - ROLLING STOCK APPLICATIONS - SOFTWARE ON BOARD ROLLING STOCK |
| ISO/TS 16949:2009 | Quality management systems Particular requirements for the application of ISO 9001:2008 for automotive production and relevant service part organizations |
| ANSI/AAMI/ISO 14937:2009(R2013) | 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 |
| PREN ISO 11135 : DRAFT 2011 | STERILIZATION OF HEALTH-CARE PRODUCTS - ETHYLENE OXIDE - REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES (ISO/DIS 11135:2011) |
| PREN 50128 : DRAFT 2009 | RAILWAY APPLICATIONS - COMMUNICATION, SIGNALLING AND PROCESSING SYSTEMS - SOFTWARE FOR RAILWAY CONTROL AND PROTECTION SYSTEMS |
| 09/30180884 DC : 0 | BS EN 50128 - RAILWAY APPLICATIONS - COMMUNICATION, SIGNALLING AND PROCESSING SYSTEMS - SOFTWARE FOR RAILWAY CONTROL AND PROTECTION SYSTEMS |
| ISO/IEC 15026-4:2012 | Systems and software engineering Systems and software assurance Part 4: Assurance in the life cycle |
| EN ISO 13408-2:2018 | Aseptic processing of health care products - Part 2: Sterilizing filtration (ISO 13408-2:2018) |
| 18/30358588 DC : 0 | BS EN ISO 29001 - PETROLEUM, PETROCHEMICAL AND NATURAL GAS INDUSTRIES - SECTOR-SPECIFIC QUALITY MANAGEMENT SYSTEMS - REQUIREMENTS FOR PRODUCT AND SERVICE SUPPLY ORGANIZATIONS |
| S.R. CEN TR 15640:2007 | HEALTH INFORMATICS - MEASURES FOR ENSURING THE PATIENT SAFETY OF HEALTH SOFTWARE |
| CEI UNI ISO/IEC 20000-2 : 2011 | INFORMATION TECHNOLOGY - SERVICE MANAGEMENT - PART 2: CODE OF PRACTICE |
| DIN EN ISO 13408-6:2013-07 | Aseptic processing of health care products - Part 6: Isolator systems (ISO 13408-6:2005 + Amd 1:2013) (includes Amendment A1:2013) |
| BS ISO/IEC 20000-2:2012 | Information technology. Service management Guidance on the application of service management systems |
| BS ISO/IEC/IEEE 29119-3:2013 | Software and systems engineering. Software testing Test documentation |
| PD CEN/TR 15640:2007 | Health informatics. Measures for ensuring the patient safety of health software |
| BS ISO/IEC 15026-1:2013 | Systems and software engineering. Systems and software assurance Concepts and vocabulary |
| PREN 50126-5 : DRAFT 2012 | RAILWAY APPLICATIONS - THE SPECIFICATION AND DEMONSTRATION OF RELIABILITY, AVAILABILITY, MAINTAINABILITY AND SAFETY (RAMS) - PART 5: FUNCTIONAL SAFETY - SOFTWARE |
| BS EN ISO 13408-4:2011 | Aseptic processing of health care products Clean-in-place technologies |
| 15/30329382 DC : 0 | BS EN 9120 - QUALITY MANAGEMENT SYSTEMS - REQUIREMENTS FOR AVIATION, SPACE AND DEFENSE DISTRIBUTORS |
| 16/30332108 DC : 0 | BS EN 50657 - RAILWAY APPLICATIONS - ROLLING STOCK APPLICATIONS - SOFTWARE ON BOARD OF ROLLING STOCK, EXCLUDING RAILWAY CONTROL AND PROTECTION APPLICATIONS |
| PD ISO/IEC TR 24748-3:2011 | Systems and software engineering. Life cycle management Guide to the application of ISO/IEC 12207 (Software life cycle processes) |
| UNE-EN ISO 13408-5:2011 | Aseptic processing of health care products - Part 5: Sterilization in place (ISO 13408-5:2006) |
| 15/30317602 DC : 0 | BS ISO 15541 - SHIPS AND MARINE TECHNOLOGY - FIRE RESISTANCE OF NON-METALLIC HOSE ASSEMBLIES AND NON-METALLIC COMPENSATORS - REQUIREMENTS FOR THE TEST BENCH |
| I.S. EN ISO 13408-2:2018 | ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 2: STERILIZING FILTRATION (ISO 13408-2:2018) |
| AAMI 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 |
| CSA ISO/IEC 12207 : 2009 : R2014 | SYSTEMS AND SOFTWARE ENGINEERING - SOFTWARE LIFE CYCLE PROCESSES |
| CSA ISO 10005 : 2005 : R2010 | QUALITY MANAGEMENT SYSTEMS - GUIDELINES FOR QUALITY PLANS |
| CSA ISO 10005 : 2005 : R2015 | QUALITY MANAGEMENT SYSTEMS - GUIDELINES FOR QUALITY PLANS |
| PD ISO/TS 16949:2009 | Quality management systems. Particular requirements for the application of ISO 9001:2008 for automotive production and relevant service part organizations |
| UNE-EN 15224:2017 | Quality management systems - EN ISO 9001:2015 for healthcare |
| I.S. 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) |
| UNE-EN ISO 15378:2016 | Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2008, with reference to Good Manufacturing Practice (GMP) (ISO 15378:2015) |
| CSA ISO 9004 : 2009 : R2015 | MANAGING FOR THE SUSTAINED SUCCESS OF AN ORGANIZATION - A QUALITY MANAGEMENT APPROACH |
| CSA ISO 10005 : 2005 : R2010 : FR | QUALITY MANAGEMENT SYSTEMS - GUIDELINES FOR QUALITY PLANS |
| CEI UNI ISO/IEC 12207 : 2013 | SYSTEMS AND SOFTWARE ENGINEERING - SOFTWARE LIFE CYCLE PROCESSES |
| UNE 179002:2018 | Health services. Quality management system for health care transport organization. |
| IEEE/ISO/IEC 15026-1-2014 | IEEE Standard Adoption of ISO/IEC 15026-1--Systems and Software Engineering--Systems and Software Assurance--Part 1: Concepts and Vocabulary |
| IEEE 1074-2006 | IEEE Standard for Developing a Software Project Life Cycle Process |
| S.R. ISO/TS 9002:2016 | QUALITY MANAGEMENT SYSTEMS - GUIDELINES FOR THE APPLICATION OF ISO 9001:2015 |
| ISO/IEC/IEEE 29119-2:2013 | Software and systems engineering — Software testing — Part 2: Test processes |
| BS EN 62304 : 2006 | MEDICAL DEVICE SOFTWARE - SOFTWARE LIFE-CYCLE PROCESSES |
| UNI EN ISO 11737-1 : 2006 | STERILIZATION OF MEDICAL DEVICES - MICROBIOLOGICAL METHODS - PART 1: DETERMINATION OF A POPULATION OF MICROORGANISMS ON PRODUCTS |
| 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 |
| ISO/IEC/IEEE 29119-3:2013 | Software and systems engineering Software testing Part 3: Test documentation |
| ISO/IEC/IEEE 24765:2017 | Systems and software engineering — Vocabulary |
| 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) |
| 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 |
| 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 |
| DIN EN ISO 9001:2015-11 | QUALITY MANAGEMENT SYSTEMS - REQUIREMENTS (ISO 9001:2015) |
| DIN EN ISO 11737-2:2010-04 | STERILIZATION OF MEDICAL DEVICES - MICROBIOLOGICAL METHODS - PART 2: TESTS OF STERILITY PERFORMED IN THE DEFINITION, VALIDATION AND MAINTENANCE OF A STERILIZATION PROCESS |
| UNE-EN ISO 11737-2:2010 | 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 9001:2015 | Quality management systems. Requirements |
| BS EN ISO 11135-1:2007 | Sterilization of health care products. Ethylene oxide Requirements for development, validation and routine control of a sterilization process for medical devices |
| IEC 61496-1:2012 | Safety of machinery - Electro-sensitive protective equipment - Part 1: General requirements and tests |
| CEN ISO/TS 29001:2011 | Petroleum, petrochemical and natural gas industries - Sector-specific quality management systems - Requirements for product and service supply organizations (ISO/TS 29001:2010) |
| 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) |
| ISO/IEC/IEEE 16326:2009 | Systems and software engineering Life cycle processes Project management |
| ISO/IEC TR 24748-1:2010 | Systems and software engineering Life cycle management Part 1: Guide for life cycle management |
| ISO/IEC 15504-5:2012 | Information technology Process assessment Part 5: An exemplar software life cycle process assessment model |
| ISO/IEC 25010:2011 | Systems and software engineering — Systems and software Quality Requirements and Evaluation (SQuaRE) — System and software quality models |
| ISO/IEC 15504-3:2004 | Information technology Process assessment Part 3: Guidance on performing an assessment |
| ISO/IEC 15504-4:2004 | Information technology Process assessment Part 4: Guidance on use for process improvement and process capability determination |
| ISO/IEC 20926:2009 | Software and systems engineering — Software measurement — IFPUG functional size measurement method 2009 |
| ISO/IEC/IEEE 29148:2011 | Systems and software engineering Life cycle processes Requirements engineering |
| 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) |
| ISO/IEC 14764:2006 | Software Engineering — Software Life Cycle Processes — Maintenance |
| ISO/IEC 25051:2014 | Software engineering Systems and software Quality Requirements and Evaluation (SQuaRE) Requirements for quality of Ready to Use Software Product (RUSP) and instructions for testing |
| ISO/IEC TR 9126-4:2004 | Software engineering Product quality Part 4: Quality in use metrics |
| ISO/IEC 25040:2011 | Systems and software engineering — Systems and software Quality Requirements and Evaluation (SQuaRE) — Evaluation process |
| ISO/IEC 20968:2002 | Software engineering Mk II Function Point Analysis Counting Practices Manual |
| ISO/IEC TR 14759:1999 | Software engineering Mock up and prototype A categorization of software mock up and prototype models and their use |
| ISO/IEC 14102:2008 | Information technology Guideline for the evaluation and selection of CASE tools |
| ISO/IEC 15504-2:2003 | Information technology Process assessment Part 2: Performing an assessment |
| ISO/IEC 26514:2008 | Systems and software engineering Requirements for designers and developers of user documentation |
| ISO/IEC 16085:2006 | Systems and software engineering — Life cycle processes — Risk management |
| ISO/IEC 12207:2008 | Systems and software engineering — Software life cycle processes |
| ISO/IEC 25001:2014 | Systems and software engineering Systems and software Quality Requirements and Evaluation (SQuaRE) Planning and management |
| ISO/IEC TR 9126-3:2003 | Software engineering Product quality Part 3: Internal metrics |
| ISO 9001:2015 | Quality management systems — Requirements |
| ISO 9000:2015 | Quality management systems — Fundamentals and vocabulary |
| ISO/IEC TR 9126-2:2003 | Software engineering Product quality Part 2: External metrics |
| ISO/IEC 19761:2011 | Software engineering — COSMIC: a functional size measurement method |
| SA HB 13485:2020 | AS ISO 13485:2017 - Medical devices - A practical guide |
| ISO/IEC 15504-1:2004 | Information technology Process assessment Part 1: Concepts and vocabulary |
| ISO 10007:2017 | Quality management — Guidelines for configuration management |
| ISO/IEC 15026-3:2015 | Systems and software engineering — Systems and software assurance — Part 3: System integrity levels |
| ISO/IEC 25041:2012 | Systems and software engineering — Systems and software Quality Requirements and Evaluation (SQuaRE) — Evaluation guide for developers, acquirers and independent evaluators |
| ISO/IEC 15939:2007 | Systems and software engineering Measurement process |
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