System Assessment

The purpose of Functional Safety System Assessment is twofold: to ensure that all the activities and documentation for the particular Safety Lifecycle phase have been completed as per requirements (presenting a safety case), and to help prevent systematic failures from being introduced. Examples of relevant standards, against which functional safety assessments are conducted are ISO 26262, IEC 61508, EN 5012X.

In addition to Independent Safety Assessments (ISA), we also do other assessments and gap analyses to support our clients in the following sectors:

• general industry where IEC61508 is applicable
• nuclear (regulatory guides and standards: YVL, IEC 61513 / 60880 / 62138 / 60987 / 60780),
• machinery (regulatory directives and standards: ISO 13849),
• medical (regulatory directives and standards: Medical Device Directive 93/42/EEC, Directive 80/181/EEC, ISO 14971, ISO 13485, IEC 62304, EN IEC 62366-1, IEC 60601-1, EN 1041),
• automotive (regulatory directives and standards: ISO 26262, Automotive SPICE)
• tractors and machinery for agriculture and forestry (regulatory directives and standards: ISO25119)

Where we are good at:

• helping you to reduce your safety and certification risks, to increase the technical quality and to extend the lifetime & value of your product
• gap analysis vis-à-vis functional safety standards (IEC 61508, ISO 26262, ISO 61511, etc.)
• system failure mode and risk analysis
• design assessment
• code analysis
• Verification & Validation assessment