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ISO 13485 Medical devices -- Quality management systems -- Requirements for regulatory purposes is a voluntary standard, [1] published by International Organization for Standardization (ISO) for the first time in 1996, and contains a comprehensive quality management system for the design and manufacture of medical devices.
Software quality assurance (SQA) is a means and practice of monitoring all software engineering processes, methods, and work products to ensure compliance against defined standards. [1] It may include ensuring conformance to standards or models, such as ISO/IEC 9126 (now superseded by ISO 25010), SPICE or CMMI .
The first software configuration management was a manual operation. With the advances in language and complexity, software engineering, involving configuration management and other methods, became a major concern due to issues like schedule, budget, and quality. Practical lessons, over the years, had led to the definition, and establishment, of ...
Top level Configuration Management Activity model. Configuration management (CM) is a management process for establishing and maintaining consistency of a product's performance, functional, and physical attributes with its requirements, design, and operational information throughout its life.
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ISO 9000:2005 provides information on the fundamentals and vocabulary used in quality management systems. ISO 9004:2009 provides guidance on a quality management approach for the sustained success of an organization. Neither of these standards can be used for certification purposes as they provide guidance, not requirements.
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