Creating a QMS that is ISO 13485 is a major undertaking and can be very complicated for people who are new to the medical device industry. To help you get started, I’m breaking down the five key elements of ISO 13485 and explaining the importance of the standard. Element 1: Management Responsibility The single most … Read more
You’ve qualified your suppliers and purchased their products, but what should a company do once the products arrive? ISO 13485 section 7.4.3 is all about the verification of purchased products to ensure they meet the company’s and supplier’s specifications. What are the requirements for verification of purchased product? The variety in purchased product verification can … Read more
When it comes to Medical Device companies’ purchasing processes, managing suppliers takes the bulk of the attention. This makes sense, as having a great supplier management system will make the other parts of the system run much smoother. That being said, Medical Device companies that want to conform to standards and regulations should still record … Read more
All medical devices start from somewhere, and that somewhere is usually supplied by an outside organization. Supplier management is critical for medical device companies as the quality and safety of their devices is determined by the products and services coming in their door. Many medical device companies have difficulty with supplier management, and for good … Read more
While medical device companies can get caught up with processes and regulations, they are still businesses. And since they are businesses, they will have customers who purchase their products or services. In fact, ISO 13485 has an entire clause (7.2) dedicated to customer-related processes to ensure this aspect is incorporated into a company’s QMS. Like … Read more
Change is essential and necessary for any organization, especially medical device manufacturers. Organizations need to be constantly aware of changes to materials, suppliers, processes, specifications, and other items related to their products. Not only are medical device companies required to be mindful of changes, but they must implement change control to maintain the function of … Read more
Controlling medical device monitoring and measuring equipment is an essential element of an ISO 13485 QMS. Monitoring and measuring equipment verifies that a medical device is safe to put on the market, so any issues with the equipment’s accuracy can put patients at risk. This article will provide a guide for understanding and implementing the … Read more
It’s impossible to have a well-running ISO 13485 QMS without a good document control procedure. Not only will it leave your QMS open to undesired changes and gaps, but it can also lead to confusion and costly mistakes. Document control is also the area of a QMS where it is easiest to get findings during … Read more
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