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All "Quality Systems" articles

Medical Devices
• March 20, 2024

The 13 Essentials of a Quality Plan for Medical Device Companies

A medical device quality plan is not only required by the FDA and the ISO 13485 framework, but it can help you build quality into your product and ...
Medical Devices
• March 20, 2024

14 medical device quality management system requirements for regulatory compliance

Every day, three medical device quality managers open a piece of mail they will never forget. And these letters aren’t unforgettable in a good way. ...
Quality Systems
• January 05, 2024

How to solve the four most common quality management issues in 2024
Quality Systems
• November 22, 2023

The ultimate guide to pharmaceutical quality assurance
Quality Systems
• March 16, 2023

Mastering quality management in laboratory environments: 12 essential techniques for 2024
Medical Devices
• July 05, 2022

Medical device quality management system template: 8 powerful options

Starting a medical device company is an immense task. You have plans to make, employees to hire, funding to obtain, and on top of all that, you have ...
Quality Systems
• September 09, 2021

4 Examples of Continuous Improvement in Quality Management in Life Sciences Companies

We all know that quality management isn't a "set it and forget it system," but how do you actually make continuous improvement in quality management ...
Quality Systems
• October 20, 2020

What Are the Objectives [5 Examples] of Quality Assurance in the Pharmaceutical Industry?

When quality assurance in the pharmaceutical industry isn't prioritized, the results can be disastrous for the manufacturer and consumer. Imagine ...
Quality Systems
• November 27, 2019

6 Signs Your Quality Management Process Is Failing

Is your company vulnerable to recalls, reputational damage, and regulatory issues because of quality management process problems? A single major ...
Quality Systems
• November 12, 2019

The Quality Policy of Pharmaceutical Industry Leaders Includes These 5 Things

Is a pharmaceutical quality policy just the necessary fine print that nobody reads? Not to industry leaders like Anders Vinther. Listen to the audio ...
Quality Systems
• October 31, 2019

How to Pass Every Quality Management Audit Without Breaking a Sweat

Over one million companies around the world have passed ISO certification. So, don't let a quality management audit scare you to death. Many quality ...
Quality Systems
• September 26, 2019

The 4 Worst Supplier Quality Management Procedure Problems for Life Sciences Organizations

Did you know that supplier quality management procedure issues have resulted in 1,111 citations by the FDA since 2008? 142 of those observances ...