With this certification, you can ensure that your customers receive the best possible product while reducing liability risk.Īn ISO 13485 audit checklist is a tool used by auditors to assess whether an organization’s QMS meets the standard’s requirements. In other words, an ISO 13485:2016 certification is a badge of quality that lets your customers know that you’re serious about product safety and quality. Organizations with ISO 13485:2016 certification are recognized for producing medical devices on par with current industry standards. ISO 13485:2016 standardizes the Quality Management System (QMS) for organizations involved in every stage of medical device production-from distribution to servicing and disposal. In this article, we will discuss an ISO 13485 audit checklist and how to make one using a digital format. ![]() A well-documented QMS ensures that your products comply with ISO 13485 and meet the safety and regulatory requirements of the medical device industry. ![]() ISO 13485 is an internationally recognized standard that specifies requirements for a quality management system (QMS) when manufacturing medical devices.
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