This high-level requirement then flows down to specific requirements under different clauses related to personnel, suppliers, verification of externally provided products/services and validation/re-validation of software. ![]() In simple terms, high risk processes are expected to have a higher level of control compared to lower risk processes. ![]() Control of these processes to achieve their desired results is now expected to be based on risk. ![]() It all starts with the role your organization (clause 4.1.1) plays in the lifecycle of the medical device, and the processes you have identified and implemented in your QMS (4.1.2(a)).
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