CILLEO - Your guide in risk management process 


Risk management



Risk management during the life cylce of your products

Essential component of the technical file within the framework of the EC marking, the risk management is one of elements of demonstration of the conformity of the product with the essential requirements of the directives and the regulations.

Risk management

Applicable to every kind of product, the process of analysis and risk management has for main goal to identify the dangerous phenomena and the dangerous situations during all the product life cycle, to reduce at a minimum level the risk and supply to the user the information necessary for a use in complete safety.

The ISO 31000 standard defines, in a general way, the principles, the organizational frame and the process of the management of risks. These elements are resumed and adapted in the standards of risk management appropriate to every product line (EN ISO 14971 for medical devices, EN ISO 12100 for machines), or of analysis of failure modes (EN 60812).

CILLEO helps you to build and to apply a structured and rigorous process of analysis and risk management, and guides you in its main stages:

● identification of the context,

● identification of the dangerous phenomena and dangerous situations,

● risk analysis and assessment,

● definition and implementation of measures to reduce the risk,

● evaluation and acceptability of the residual risks,

● writing of the risk management report.

Contact us to take advantage of our experience through an offer adapted to your context.


Standards of risk management

● General principles

NF ISO 31000

● Medical devices

NF EN ISO 14971

● Machinery

NF EN ISO 12100

● FMEA

NF EN 60812

 
July 20, 2018