Functional safety services
Huld has long experience in developing with safety and mission critical systems. Our services are based on proven concepts that have been used from product concepting to all the way to product certification.
We support our clients in all aspect of dealing with functional safety for safety critical systems. Our services cover everything from concept development to product validation. We also support our clients with different kinds of assessment of their readiness to develop safety critical products.
The first step in developing a safety critical product, which meets functional safety standards such as the IEC 61508, is to develop a high-level solution called the functional safety concept. The functional safety concept defines the key safety requirements, the high-level hardware and software architecture and the diagnostics approach.
Huld can take the full responsibility of developing safety concept for your system. We have extensive experience of standards such as the IEC 61508, EN ISO 13849 and ISO 26262. The concept development will follow our standardized approach, which ensures that the end result will be a compliant safety concept that also meets your other requirements.
Verification and validation assessments
With Huld assessment you can reduce risks, increase technical quality and extend the lifetime & value of your product. Independent technical system and software assessments includes the following work packages:
- System failure mode and risk analysis
- Design assessment
- Code analysis
- Identifying gaps in testing
The outcomes of the V&V service are: Findings, recommendations and solutions report & workshop with the customer.
Huld conducts safety assessments in the technology fields, where functional safety plays a role: for example, automotive industry, nuclear industry, railway industry and medical industry. The purpose of Functional Safety Assessments 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 the relevant standards, against which functional safety assessments are conducted are: ISO 26262, IEC 61508, EN 5012X.
Huld has been accredited by FINAS to be a type C Independent Safety Assessor (ISA) inspection body, accreditation number I051. Specifically, we can perform standard based safety assessments for Railway control, command and signalling subsystem (CCS) and Rolling Stock subsystems (RST). Independent safety assessments aim at assessing whether the target system meets its specified safety requirements and whether the system is compliant to the relevant standards. The standards in the scope of assessments include EN 50126, EN 50128, EN 50129, EN 50159 and IEC 61508. The SFS-EN ISO/IEC 17020:2012 standard is the accreditation requirement for inspection bodies.
- Independent Safety Assessments (ISA body), railways (regulatory directives and standards: EN 50126, EN 50128, EN 50129, EN 50159, IEC 61508)
- Other assessments / gap analyses:
- 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),
- marine (regulatory guides and standards: IEC 61508),
- automotive (regulatory directives and standards: ISO 26262, Automotive SPICE)
- tractors and machinery for agriculture and forestry (regulatory directives and standards: ISO25119)
OEM’s in the area of medical device development, automotive, and energy sector sometimes need support in assessing what are the necessary measures that need to be taken to ensure the compliance against the ISO 26262/ ISO 13485 / FDA / ECSS / DO178 or other similar regulations.
If the safety compliance built in the development process and engineering it to the product development as an afterthought is laborious and expensive. Huld safety services help OEM’s and suppliers to endure the compliance of their products throughout the product development lifecycle.