Have you ever heard of Goodhart’s Law? Developed by British economist Charles Goodhart, the simple version is: “When a measure becomes a target, it ceases to be a good measure.” On its own, it’s a beneficial concept for Quality Management. For example, if you record the time it takes good, well-trained inspectors to measure a … Read more
Part of maintaining good quality is accountability. You have to understand which people are in charge of which processes so that there are clear lines of responsibility. Without that, tasks are left fuzzy, and no one knows who is supposed to perform certain actions. Section 5.5 of ISO 13485 (Responsibility, authority, and communication) may not … Read more
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
“So what do you do for work?” If you’re in the Quality Management field, you might not be looking forward to this question. There are a couple of different approaches. You can mention that you work in “Quality” in the “enter specific field here”. There’s a good chance they will look at you kind of … Read more
Spoiler Alert: This article isn’t going to tell you how many SOPs to create. Instead, I want to provide a framework for thinking about SOPs and other documents, and what the benefits are to different approaches. Each company will handle this question differently, depending on the specific tools and shortcomings of that company. However, it’s … 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
It’s the third day of an audit. While you’ve been enjoying the provided lunches and getting away from checking email, you’re no longer entertained by the auditors’ elaborate stories and anxiety that a haywire Teams message will appear on the screen you’re sharing. For the last hour, he’s been locked in on one form that … 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