8.2. What about certification ? 

As far as functional safety is concerned, there is no regulatory framework requiring IEC 61508 or IEC 61511 certification. The adoption of these standards is strictly voluntary. Compliance with IEC 62061 is, however, imperative for CE marking, as the standard is harmonized. Regarding, the pharmaceutical industry, regulated, respect of the GAMP is the best guarantee of success qualifications and validation. The standards do not provide for the certification of applications or installations or systems. Certification of components have never been a requirement of IEC 61508 and IEC 61511.

Equipment covered by the CE marking is self-certified on the basis of type certification most often. Most national legislation provides for the possibility of creating commercial certification labels. Examples in France are "Label Rouge" for chickens, or "Qualibat" for the building or "Qualifelec" for electrical installation. Many companies use this possibility to create a private and commercial "IEC61508" certification of products or services, but never complete systems or applications: one can note among the known actors TÜV, EXIDA, INERIS. This certification can provide greater visibility into a component or product and a greater degree of confidence in the data contained in the data sheets.

But it should never be forgotten that this certification:

  • Is a commercial act: the manufacturer has paid the certification body to evaluate and certify are produced.
  • It is never compulsory: the manufacturer has invested in an evaluation and a certification because he found an interest there, usually commercial
  • Does not affect the performance and behavioral characteristics of the system constituted by these certified products and does not provide any warranty
  • Does not replace the engineering and quality assurance work necessary for the realization of a system or application