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| Procedure Title | Purpose | Comments |
| Risk Management Policy | The
purpose of the risk management policy is to define risk principles
and establish a policy for the formal management of risk. |
This policy is the basic corporate policy for the management of risk associated with products (under development and in the market), manufacturing processes, equipment, computer systems, product distribution, etc. |
| Risk Management Procedure | This procedure defines a method for risk management that is applicable to formal risk management efforts. | This procedure has been crafted to follow ISO14971, "Medical devices – Application of Risk Management to Medical Devices." |
| Failure Mode and Effect Analysis | This procedure defines a process for conducting a Failure Mode and Effect Analysis (FMEA). | FMEA is a structured method for evaluating the risks associated with potential failures of a system or piece of equipment. |
| Fault-tree Analysis | This procedure defines a process for conducting a Fault-tree analysis. | Fault-tree analysis is a structured method for evaluating the risks associated with potential failures of a system or piece of equipment. |
| Hazard Analysis and Critical Control Point Assessment | This procedure defines a process for conducting a Hazard Analysis and Critical Control Point assessment (HACCP). | HACCP is a risk analysis tool used to identify the risk associated with process control points by determining if variability, difference or failure could affect process reliability or effectiveness. |