ISO 13485 and 21 CFR 820

 

The quality needed of a medical device is perhaps equal to if not more that that required in aerospace. As ISO 13485training will identify, the standard is built upon the framework of ISO 9001. Medical devices need to be precision made taking into account the various potential risks and building controls within the manufacturing process to mitigate these risks. Non-conformities can be fatal resulting in the loss of a human life. ISO 13485:2016 is the most current version of the quality management system specifically for medical devices.

Organizations that manufacture medical devices are required to comply with national legislation as applicable and in addition choose to be certified to ISO 13485, a voluntary standard. Manufacturers, laboratories, hospitals and universities certify to this internationally recognized standard to demonstrate a commitment to quality products/services as also to demonstrate to stakeholders a commitment to continual improvement. Companies use this management system standard to meet regulatory requirements, as well as to employ industry best practices. This standard can be easily integrated with other ISO standards for those companies looking to develop integrated management systems.

ISO 13485 training covers the standard in details and those who opt for lead auditor training will also learn the principles of auditing per ISO 19011 and how to lead an audit to determine conformity and effectiveness of the system. In the United States Medical Device companies are regulated by the FDA under 21 CFR Part 820. This is compliance and law and not voluntary like ISO 13485. The two however are quite aligned when it comes to requirements and FDA is looking to further align the CFR to the internationally accepted standard. Although ISO 13485 and CFR part are quite aligned there are some differences that might not be included explicitly in ISO 13485, for example Device History Record (FDA Part 820.184). FDA regulations do not place as much emphasis on the risk-based approach. However, the FDA does mention risk analysis. ISO 13485 requires users to think about risk during every step of the manufacturing process. Further the risks need to be documented as also the controls that have been integrated into the manufacturing and design process to address there risks.

ISO 13485 training can be delivered in different formats such as online or onsite as also in a lead, internal auditor format and an overview format. It is your responsibility to make sure that your company meets FDA and ISO guidelines for training. You need to be clear on who needs to be trained, what they need to learn, and how often they need training. Contact QMII to address your ISO 13485 training needs.