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The principal difference between the two is that ISO 9001 requires continual improvement.
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ISO 13485 corresponds with ISO 9001, a previously implemented standard, yet there are specific differences. This process includes minimizing waste during testing and development as well as improving risk management. ISO 13485 also requires developers to look closely at every decision made during the process of design and development. So, if you’re looking to get your project funded, choose a company that already has proven it can meet and maintain quality standards. When banks or investors want to know if a company is reliable, they will be looking for one registered with ISO 13485. While this standard will ensure safe and reliable products, the newest version also has a financial advantage for both customer and company. With the implementation of ISO 13485: 2016, a standard that according to the International Organization for Standardization (ISO) “ensure(s) the establishment of QMS practices that consistently yield safe and effective medical devices”, clients and partners can feel reassured that the product designed is meeting the highest standards possible in the global market. These clauses help guarantee that medical devices developed will not be compromised by by external biological variables.
EN ISO 13485:2016 UPDATE
The ISO 13485 update also includes guidelines for safety when manufacturing and testing medical devices, specifically those concerning contamination and cleanliness in the work environment. The new standard requires a higher level of responsibility to be in the hands of management by laying out detailed guidelines to create a stronger quality management system (QMS). ISO 13485: 2016 specifically addresses the way companies implement management strategy that focuses on products that are safe and effective. Introducing and updating international standards has proved key in pushing companies to raise the bar in product development over the last fifty years.