In part one of this series, I said that I want to help my colleagues use their ISO 9001 implementation as a profit center and to turn risk-based thi

In 1989, I was handed a copy of ISO 9001:1987 by my employer with the direction to find out what it was all about. Our company was headquartered in Europe, and we would be compelled to implement the standard straightaway.

As today’s industries and operations become increasingly more global, an effective management system is rapidly becoming an essential part of a sustainable business strategy.

The Automotive Industry Action Group’s (AIAG’s) and German Association of the Automotive Industry’s (VDA’s) new Failure Mode and Effects Analysis Handbook (AIA

After the first crash, of Lion Air in Indonesia in October 2018, people blamed poor maintenance and insufficient pilot training. When a second airliner, an Ethiopian Air aircraft, crashed in March 2019, similarities quickly transpired.

If you are wondering whether your organization could benefit from formal root cause analysis (RCA) and corrective action training, read on to see if any of these issues are present in your day-to-day operations.

As usual with Quality Digest’s diverse audience, this year’s top stories covered a wide range of topics applicable to quality professionals. From hardware to software, from standards to risk management, from China trade to FDA regulations.

Weekly CGMP Quiz 1: Part 210 & 211 Subpart A General Provisions. Use with your team for training credit!

Software as a medical device (SaMD) is a growing sector in medical device technology.

As artificial intelligence (AI) becomes increasingly ubiquitous in various industry sectors, establishing a common terminology for AI and examining its various applications is more important than ever.