Risk Management

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European Regulatory Support for Business since 1995
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CE Marking, Health & Safety . . .
Risk Management, Product Safety . . .

Introduction to Risk Management and CE Marking

One of the techniques growing in importance in meeting the CE marking requirements is Risk Management including the steps of Risk Analysis and Risk Assessment. A defined process of assessing and managing risk throughout all stages of the life of a product is an important part of determining whether it is safe, and remains safe, to operate. A Technical File is expected to contain details of the Risk Management undertaken.

Atlantic Bridge can assist you to meet the requirements for Risk Management. As well as providing you with copies of the relevant European Standards, we can provide the necessary procedures and forms most suitable for your products.

 

Risk Assessment for Machinery - EN ISO 12100:2010

EN 12100 should be used as a basis for any risk assessment of Machinery and ATEX equipment. The standard does not specify the precise method but provides detailed guidance as to what should be considered. It covers Hazard Identification providing a list of potential hazards to consider. The elements to be considered in Risk Estimation are listed, and general advice is given on Risk Reduction. The Standard states that the documentation shall demonstrate the procedure and the results.

 

Risk Management for Medical Devices

The Risk Management Standard for Medical Devices is EN ISO 14971:2012. The Standard covers risk management throughout the life of a medical devices and for each phase of that life. It includes the required content of the Risk Management File and in the Annexes lists likely hazards. The standard does not provide documentation or a methodology for Risk Assessment but refers out to methodologies such as FMECA. Atlantic Bridge can provide suitable methods to conduct Risk Management to EN ISO 14971:2012 (N.B. This is the 2010 version of the standard with appendices to help show the relationship between the standard and the medical devices directives).

 

RISK ASSESSMENT OF EXISTING MACHINERY UNDER THE UK HEALTH AND SAFETY REGULATIONS

Provision and Use of Work Equipment Regulations. (PUWER) 1998

Assessment is carried out in a similar fashion to that required for "CE" Marking but additional emphasis is put onto the operational side of the equipment and the assessment must include the position and environment selected for the equipment when in use.