The Role of Quality in Functional Safety
When people think about functional safety, standards like IEC 61508, ISO 26262 (automotive), EN50716 (railway), ISO13849/IEC 62061 (machinery) or IEC 62304 (medical) usually come up first. These standards explain how to make sure systems remain safe, even if faults occur.
But there’s one foundation that often gets less attention: quality management.
Why Quality Matters for Safety
Functional safety is not only about technical solutions, but also about making sure the right processes are followed in a clear and repeatable way. That is where a quality management system (QMS) comes in.
- Repeatability: Work is done the same way each time.
- Traceability: Requirements and results are documented and can be checked later.
- Culture: Teams are used to improving and correcting mistakes.
If quality is weak, safety will not hold up in practice.
How Safety Standards Depend on Quality
Almost every functional safety standard assumes that a strong quality system is already in place:
- IEC 61508 requires a QMS before safety lifecycle work can begin.
- ISO 26262 highlights change management, configuration control, and quality assurance.
- EN 50716 for railway requires an ISO 9001 compliance quality management system (must not be certified, but compliant).
and so on.
Safety builds on quality, it cannot replace it.
Is QM a mere paperwork exercise?
A common problem is that many companies treat quality and safety as a pure paperwork exercise. They write detailed procedures, but these are not followed in real projects. This creates gaps: unclear requirements, poor traceability, and safety arguments that may pass an audit but fail in the field.
A good QMS prevents this by making sure that quality and at the end safety are lived in daily work, not just written in manuals.
At innotec, we support companies in building and supporting certification of management systems that are both compliant with ISO 9001 and sector safety standards and practical in day-to-day use.
We make sure the system is not just “on paper,” but helps teams deliver safe products. Please get in touch with us to learn more.
By combining quality, safety, and continuous improvement, organizations can move beyond simple compliance and build a strong base for systems that are safe, secure, and reliable.
Takeaway: before aiming for SIL or ASIL certification, ask: is our quality system strong enough to support safety every day?
