3/21/2021 0 Comments What Is Iso 13485
You may already have a system for risk evaluation within your ISO 14971 risk management framework.Here are some questions to consider and guidance for implementation.Developing and deploying a QMS that meets the requirements of this standard is necessary to commercialize your medical device in several important global markets.
ISO 13485 was revised in 2016 with a heavy emphasis on risk and planning. The term risk appears twice as many times in this revision compared to the prior 2003 version Risk and Risk Management are now explicitly defined and a risk-based approach is required for control of appropriate processes in the QMS. A good understanding of these requirements is needed to ensure your QMS continues to be in compliance. It is important to note that the requirement for a risk-based approach now appears very early in the standard, starting at the top-level general requirements for a QMS. The organization shall apply a risk-based approach to the control of appropriate processes needed for the quality management system. 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)). Control of these processes to achieve their desired results is now expected to be based on risk. In simple terms, high risk processes are expected to have a higher level of control compared to lower risk processes. What Is 13485 Verification Of ExternallyThis high-level requirement then flows down to specific requirements under different clauses related to personnel, suppliers, verification of externally provided productsservices and validationre-validation of software. These newly added requirements can be difficult to interpret and implement. The following questions, and the accompanying discussion, are intended to help you evaluate the need for additional improvement actions in your QMS. What is the scope of these risks How to determine the level of risk 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. It also includes compliance to applicable regulatory requirements on a secondary basis. Business risks, while important for setting priorities and objectives, are not included in the scope of ISO 13485. 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. This may cause some confusion in terms of the scope as the term harm is usually applicable to safety related issues. ![]() Therefore, risks related to product performance and regulatory compliance also need to be considered. 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. As another example, CAPA effectiveness may be a regulatory compliance risk, but it may not directly result in any harm or damage. 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. Assessment 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. You need to analyze each process of the QMS and identify various scenarios which may lead to these undesired effects on safety, performance and compliance. Next, you have to develop a system of rating each scenario for their probability and severity. While it is always preferred to have a numerical, quantitative scale for both probability and severity, it is not uncommon to use a qualitative scale if each level is clearly defined. In practice, everyone feels different about risk that is why it is important to establish a well-defined rating system and criteria for risk level.
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