Compliance

Compliance, in the context of functional safety, refers to adhering to established rules, standards, or laws. It involves documenting and providing evidence that demonstrates adherence to the process described by the corresponding safety standards.

Achieving compliance demonstrates that a product, process, or system has been developed and validated according to recognized safety principles, ultimately aiming to prevent unreasonable risks due to hazards caused by malfunctions.

Compliance involves adhering to the procedures and methodologies outlined in safety standards. These standards typically focus on defining the processes required to ensure safety, rather than prescribing specific, measurable outcomes.

Demonstrating compliance means showing that these processes have been followed and that the general objectives of the standard have been met.

Compliance must be considered carefully because failure to meet safety standards can have severe consequences, ranging from product recalls and financial penalties to serious injuries or even fatalities.

In the automotive industry, non-compliance with ISO 26262 can lead to vehicles with undetected defects that could cause accidents. Beyond the immediate safety risks, non-compliance can damage a company's reputation, lead to legal liabilities, and hinder market access, especially in regulated industries.

Compliance and tool qualification are closely connected in functional safety. To meet the requirements, companies must show that the tools used in development, such as compilers, static analyzers, or test frameworks, are reliable and won’t introduce or overlook errors. Tool qualification provides the evidence that these tools are suitable for safety-related development.

Since compliance is scoped to specific goals or standard sections (e.g., ISO 26262 Part 8, Clause 11 for tool qualification in the automotive industry), the compliance report must include argumentation showing how tool qualification supports the overall safety objectives.

Beyond automotive, other industries have their own compliance frameworks, such as IEC 61508 for general industrial applications, DO-178C for aerospace, and EN 50128 for railway applications.