Managing Medical Device Records for ISO 13485 (4.2.5)

Managing medical device records for ISO 13485

Do you want to know what medical device companies produce the most? You might think it’s medical devices, but that’s not the case. It’s actually records.  Each manufacturing batch, audit, complaint, training session, and more creates records. The output of nearly every process is at least one, sometimes many, records. And there are specific requirements … Read more

The 5 Key Elements of ISO 13485

The 5 key elements of ISO 13485 1.Management Responsibility 2.Customer Focus 3. Risk-based decision making 4. Document Everything 5. Improvement is essential

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

Exploring Careers in Quality Management

Exploring careers in quality management.

“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

What’s the right number of SOPs for your QMS?

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

Verifying Purchased Product According to ISO 13485 7.4.3

Verification of purchased product for ISO 13485

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

Retraining Is Not The Solution

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

There are No Good Manufacturing Practices

A Cartier Watch

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

Effective Supplier Management for Medical Devices (ISO 13485 7.4.1)

How to create an effective medical device supplier management process to meet ISO 13485 7.4.1

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