Software
Engineering Standards
The implementation of software engineering standards and
the compliance with the standard’s requirements can
often be very time consuming. Using available
checklists, guides and templates will save time and
money, and assists in meeting the requirements of the
applicable standards.
Useful
tools and guides for software development and compliance with
international standards Guides,
checklists and templates for software engineering standards and specifications do
assist with the fundamental software development that
meets the requirements of applicable standards. This
includes software development and maintenance,
configuration management, documentation development,
project management, quality assurance, verification and
validation of standard requirements, case tools,
languages and notations, metrics, privacy, process
improvement, reliability, safety, security, software
reuse, and vocabulary standards.
Using available tools such as checklists,
templates and guides for the development of software
that meets the requirements of applicable standards
saves time and assists that requirements are
met.
For FDA
related standards and Medical Device Firms:
IEC 62304:2006 Medical Device Software – Software Life Cycle Processes... see
more information
IEC
60601-1-4: Medical Electrical Equipment Part 1: General
Requirements for Safety.Part 4. - Programmable Electrical Medical Systems...see
more information
ISO/IEC 12207: 2008 System and software engineering -
Software life cycle processes ... see
more information
ANSI/UL 1998-2004 Standard for Software in Programmable
Components ... see
more information
FDA Document “General Principles of Software
Validation” Final Guidance for Industry and FDA
staff’ ... see
more information
FDA Document “Guidance for Industry, FDA Reviewers and
Compliance on Off-The-Shelf Software Use in Medical
Devices” ... see
more information
ANSI/AAMI/ISO 13485:2003 Medical
devices - Quality management systems-
Requirements for regulatory purposes ... see
more information
ISO/IEC
90003:2004 Software
engineering: Guidelines for the application of
ISO 9001:2000 to computer software ... see
more information
FDA Document “Guidance for the Content of Pre-market
Submissions for Software Contained in Medical Devices
... see
more information
Templates,
checklists and guides for software documentation
development in compliance with applicable standards
Set of Templates for Software
Configuration Management Documents - Version 5.0.
Compliance with IEC 62304, ISO/IEC 15288, ISO/IEC 12207
... more
information
Template
for a Software Maintenance Plan (ISO/IEC 12207, ISO/IEC
14764... more
information
Template
for a Software Documentation Management
Plan ... more
information
Template for a System Documentation Management
Plan, includes ISO/IEC 15288, System Life Cycle
Processes (2002), Section 5.4.8 ...more
information
FDA 21 CFR Part 11 Electronic Records; Electronic
Signatures ... more
information
ISO/IEC 90003:2004
Supplier Assessment Checklist for the evaluation of
software regarding compliance with the standard ISO/IEC
90003:2004 ...more
information
ISO/IEC 27002:2005 information technology – security
techniques -- Code of practice for information security
management
...more
information
ISO/IEC 20000-1:2005 Information technology
–Service management –Part 1: Specification
... more
information
ISO/IEC 15288:2008-Systems and software
engineering-System life cycle processes
... more
information
Guide to Software Engineering Standards and
Specifications -Part I
Software Development and Maintenance Standards ... more
information
Guide to Software Engineering Standards and
Specifications -Part II
Software Development Supporting Process Standards -
(Configuration Management, Documentation, Project
Management, Quality Assurance, and Verification and
Validation Standards) ... more
information
Guide to Software Engineering Standards and
Specifications Part III
Software Engineering Tools and Techniques Standards -
(Case Tools, Languages and Notations, Metrics, Privacy,
Process Improvement, Reliability, Safety, Security,
Software Reuse, and Vocabulary Standards) ... more
information
