Functional Safety & RAMS


Functional Safety describes the absence of unreasonable risk caused by malfunctions of any electronic or electric system. Hardware and software of potentially dangerous systems, may it be cars, industrial machinery or other automated systems, can display erroneous behaviour that may threaten lives or cause injuries. Potential causes for failure are manyfold, including flaws in specification, design, testing and production. Especially in complex systems and distributed development setups, they can be hard to identify – therefore, the definition of a solid development process and the accurate elaboration of design and testing concepts are crucial.
CertX Provides independent, internationally recognized certification and inspection services of products and processes to identify possible flaws before they can cause hazards in field operation.

An independent Functional Safety evaluation supports the early identification of potential failure sources in processes and products

General Services

Functional Safety for Automotive

The Functional Safety standard for the automotive industry, ISO 26262:2018, defines a set of process requirements and provides methods for analysis, development, verification and testing of functional safety relevant items. In addition to other functional safety standards, the ISO 26262:2018 provides guidance on the split of safety activities between vehicle integrator and suppliers.


In the terms of ISO 26262:2018, CertX offers independent confirmation reviews, assessments and audits, which can be either carried out as single inspections for critical work products or as a certification for a complete item, proofing that the entire content of the standard has been considered in the product development.

Functional Safety for Machinery

In the area of industrial machinery, several standards define the requirements to achieve functional safety.. Depending on the product type, one of the following standards can be used to carry out Functional Safety Inspections or Certifications:


The ISO 12100 defines general requirements for risk analysis of machinery. ISO 13849 and ISO 62061 provide guidance on the design, validation and integration of safety relevant controls on a basic level of complexity, while the IEC 61508 provides requirements on development processes as well as on the design and testing of more complex hardware-software systems.


ISO 25119 and ISO 19014 define the functional safety requirements for earthmoving and agricultural vehicles. The principal is based on the standards for machinery while the nature of the equipment is closer to the azutomotive, we offer a combined in-depth experinece from both domains.


CertX is a EU-notified body for machinery safety and can provide the required safety evidences for the CE marking required to sell safety relevant machinery on the European market. Our inspections products and processes will ease the integration of your components for your clients  and increase the “sellability”.


In the railway area, considerations for safety are extended by an analysis of reliability (the achievable periods of uninterrupted operation), availability (the percentage in which a system is operable) and maintainability, forming the term RAMS as defined in the EN 5012x series of standards.


CertX is a provider of independent safety assessments (ISA) in the railway sector and can certify standard compliance in order to release railway products to the European market.

Swiss Quality

Located centrally in Switzerland and centrally in Europe. A local network of experienced experts as well as close to world class research. Swiss quality; innovation focussed. A toolset well established and applied. See our customer testimonials below or ask us for further references

“The ISO26262 is a key topic for Kalray, pioneer of processors for intelligent systems, such as autonomous vehicles.
The CertX experts, led by Mr. Amin Amini, worked closely with the Kalray team to rapidly build a consistent framework meeting the requirements of ISO 26262.
The high quality of the CertX services has efficiently updated the Kalray team to the latest version of the ISO 26262:2018 and SOTIF standards.

Gerard Morin, Kalray SA


“Nachdem die Functional Safety Red Belt Schulung von CertX in unserer internen Schulungsauswertung mit Bestnoten hervorstach, konnte ich mich persönlich davon überzeugen, dass:

  • die Trainer von CertX mit grosser Motivation und Kompetenz unterrichten,
  • die Unterlagen praktische Umsetzungsbeispiele enthalten, und
  • die Prüfungen ohne Zeitdruck das erlernte Wissen bewerten.

Dr. Robert Fritsch, Head of Safety & Security Office, Brusa