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As a result, the risk-based approach required by the current revision includes safety, performance and compliance risks because all of them are required to be appropriately mitigated to ensure your QMS is effectively implemented and maintained.Īssessment of the risk level, whether high or low, depends on the combination of the severity of the undesired effects and the probability of their occurrence. As another example, CAPA effectiveness may be a regulatory compliance risk, but it may not directly result in any harm or damage. For example, frequent service or maintenance issues may cause inconvenience to the user but not result in any harm to the patient beyond delay in treatment. Therefore, risks related to product performance and regulatory compliance also need to be considered. Keep in mind that the scope of ISO 13485 includes not only safety, but all product and applicable regulatory requirements. This may cause some confusion in terms of the scope as the term harm is usually applicable to safety related issues. The term risk, as defined in ISO 13485, refers to the combination of the probability of occurrence of harm and the severity of that harm.
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Business risks, while important for setting priorities and objectives, are not included in the scope of ISO 13485. It also includes compliance to applicable regulatory requirements on a secondary basis. It is important to understand that the term risk, within the context of ISO 13485, applies primarily to the safety and performance of the medical device.
#Qms iso 13485 how to#
What is the scope of these risks? How to determine the level of risk? The following questions, and the accompanying discussion, are intended to help you evaluate the need for additional improvement actions in your QMS. These newly added requirements can be difficult to interpret and implement.
#Qms iso 13485 verification#
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)).