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Product Overview - Quality Management - Software Engineering
ISO 9001 Quality Management Development Tools
ISO/IEC 27001:2013 - Security Requirements
ISO/IEC 27002:2013 Security Code of Practice
ISO/IEC 27018:2014 - Security Management
Software Security ISO/IEC 27001, ISO/IEC 27002, ISO/IEC 27018
For Medical Devices, Checklists, Guides for FDA Related Software
ISO 13485:2016 - Medical Devices, Software Requirements
ISO 9003 - ISO/IEC 90003
ISO 9004:2009 for a Successful Quality Management Approach
IEC 62304:2015 Medical Device Software - Life Cycle Process
ISO/TS 16949:2009 Documentation Model, Requirements Checklist
FDA Software Validation
System and Software Engineering, Tools, Guides, Checklists
Templates for Software Configuration Mgmt. and Maintenance
Templates for System - Software - Document Management
Guide to Software Eng. Standards Development and Maintenance
ISO/IEC 15288:2008 Compliance
ISO/IEC 20000-1:2011 Information Technology
FDA 21 CFR Compliance Requirements
ISO/IEC/IEEE 42010:2011 - Architecture Description Checklist
FDA Off-the-Shelf Software in Medical Devices
Quality Software Standard Checklist Kit
ANSI/UL 1998:2004 Compliance Guide
Reference
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Product Overview - Quality Management - Software Engineering
ISO 9001 Quality Management Development Tools
ISO/IEC 27001:2013 - Security Requirements
ISO/IEC 27002:2013 Security Code of Practice
ISO/IEC 27018:2014 - Security Management
Software Security ISO/IEC 27001, ISO/IEC 27002, ISO/IEC 27018
For Medical Devices, Checklists, Guides for FDA Related Software
ISO 13485:2016 - Medical Devices, Software Requirements
ISO 9003 - ISO/IEC 90003
ISO 9004:2009 for a Successful Quality Management Approach
IEC 62304:2015 Medical Device Software - Life Cycle Process
ISO/TS 16949:2009 Documentation Model, Requirements Checklist
FDA Software Validation
System and Software Engineering, Tools, Guides, Checklists
Templates for Software Configuration Mgmt. and Maintenance
Templates for System - Software - Document Management
Guide to Software Eng. Standards Development and Maintenance
ISO/IEC 15288:2008 Compliance
ISO/IEC 20000-1:2011 Information Technology
FDA 21 CFR Compliance Requirements
ISO/IEC/IEEE 42010:2011 - Architecture Description Checklist
FDA Off-the-Shelf Software in Medical Devices
Quality Software Standard Checklist Kit
ANSI/UL 1998:2004 Compliance Guide
Reference
Temp
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Publishing
Translations
Consulting
Products
ISO 9003 - ISO/IEC 90003
ISO/IEC 90003:2014 Guidelines for Application of ISO 9001 (docx)
ISO/IEC 90003:2014 “Software Engineering: Guidelines for the Application of ISO 9001:2008 to Computer Software” (.docx)
Download, MS Word (.docx) format, 1,717 KB, 128 pages (also available in .pdf format), Item No.: RCG049AWSEP, published April 2015
...more information
ISO/IEC 90003:2014 Guidelines for Application of ISO 9001 (PDF)
ISO/IEC 90003:2014 “Software Engineering: Guidelines for the Application of ISO 9001:2008 to Computer Software” (.pdf)
Download, PDF (.pdf) format, 1,375 KB, 128 pages
(also available in .docx format)
Item No.: RCG049ASEP, published April 2015
...more information
Supplier Assessment Checklist
Checklist for Assessment of Software Suppliers according to the satndard ISO/IEC 90003:2014
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(MSWORD format)
, 1,433 KB, 33 Pages
Item No.: RCG052AWSEP, published August 2015, also available in PDF format
...more information
Supplier Assessment Checklist (PDF)
Checklist for Assessment of Software Suppliers according to the satndard ISO/IEC 90003:2014
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(PDF format)
, 946 KB KB, 33 Pages
Item No.: RCG052ASEP, published August 2015, also available in PDF format
...more information
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