A Quality Policy is the highest-level document for a medical device company. It is the star on the top of the Christmas tree, and the guiding light for a medical device QMS. So how does a company make one? If you are wondering how to make an excellent Quality Policy for your company, you’re in … Read more
Management’s commitment to the Quality Management System is one of the key principles of ISO 13485. One of the ways management’s commitment is demonstrated is through management reviews (ISO Clause 5.6). While management review is frequently seen as a box to check to meet ISO 13485 requirements, if properly executed, it can be a powerful … Read more
This article will cover all the ins and outs of the Human Resources section (6.2) of ISO 13485:2016, and provide a complete guide to creating a compliant training procedure. Training is one of the most important things for a company to get right if it wants to be successful. While many companies can train their … Read more
Have you implemented an ISO 13485 compliant training system, but are still struggling to determine how to evaluate the effectiveness of training actions? You’re not alone. The effectiveness aspect of ISO 13485 clause 6.2 is something that causes the most difficulties when implementing a medical device QMS. You know your employees are trained and management … Read more
A medical device company’s complaint handling system is one of the most essential elements of its Quality Management System. A bad process will leave the company with an increased likelihood of audit findings, and present the company with possible legal and regulatory consequences. A good ISO 13485 complaint handling process can lead to increased customer … Read more