How Can I Get ISO 13485 Certificate?
ISO 13485 is an internationally recognized quality management system for the design and manufacture of medical devices. It is based on the ISO 9001 standard, but with additional requirements specific to the medical device industry. There are a number of steps involved in get ISO 13485 certification. Understand the requirements The first step to getting an ISO 13485 certificate is to understand the requirements of the standard. You can purchase a copy of the standard from the ISO website or from a number of other sources. Once you have a copy of the standard, take some time to read through it and identify the requirements that are applicable to your organization. Implement the quality management system The next step is to implement a quality management system that meets the requirements of the ISO 13485 standard. This will involve developing policies and procedures, and putting in place the necessary infrastructure to support the quality management system. Choose a certificati...