Customer Support: 131 242

  • There are no items in your cart
We noticed you’re not on the correct regional site. Switch to our AMERICAS site for the best experience.
Dismiss alert

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Withdrawn
Withdrawn

A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.

View Superseded by
withdrawn

A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.

Software engineering Guidelines for the application of ISO 9001:2008 to computer software
Available format(s)

Hardcopy , PDF 1 User , PDF 3 Users , PDF 5 Users , PDF 9 Users

Withdrawn date

11-03-2019

Language(s)

English

Published date

09-12-2014

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)
DocumentType
Standard
Pages
54
PublisherName
International Organization for Standardization
Status
Withdrawn
SupersededBy
Supersedes

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
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
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
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
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
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
DIN EN ISO 20857 E : 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)
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
EN ISO 13408-6:2011/A1:2013 ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 6: ISOLATOR SYSTEMS (ISO 13408-6:2005/AMD 1:2013)
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
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
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)

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

View more information
$118.72
Including GST where applicable

Access your standards online with a subscription

Features

  • Simple online access to standards, technical information and regulations.

  • Critical updates of standards and customisable alerts and notifications.

  • Multi-user online standards collection: secure, flexible and cost effective.

Need help?
Call us on 131 242, then click here to start a Screen Sharing session
so we can help right away! Learn more