Quality Assurance, system safety integration

Walsh, K., Antony, J., Improving on Patient Safety and Quality What Are the Challenges and Gaps in Introducing an Integrated Electronic Adverse Incident and Record System within Health Care Industry., International Journal of Health Care Quality Assurance, Vol. 20, No. 2,2007, pp. 107-115. 

ISO 14001, OHSAS 18001, and ISO 9000 (Quality) together to create an integrated management assurance system. Interestingly, the international safety community is doing just that. 

FIG. 40. Objective tree for Level 1 of defence in depth (RCS, reactor coolant system QA, quality assurance). Safety principle (209) reactor coolant system integrity. 

A complete lEC 61508 assessment includes a FMEDA, a study of Prior Use and adds an assessment of all fault avoidance and fault control measures during hardware and software development as well as detail study of the testing, modification, user documentation and manufacturing processes. The objective of all this effort is to provide a high level of assurance that an instrument has sufficient quality and integrity for a safety instrumented system application. This is clearly more important for products containing software as many end users have the strong opinion that software is "bad... 

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