A quality audit examines your company's quality management system. A quality system auditor closely guards the checklist he uses and can adapt the list to ensure it applies to your business. If you ...

What is a Quality Manual? A Quality Manual is an authorized document created by a business, detailing how its quality management system operates. In other words, it’s a Table of Document Contents and ...

Quality management systems are really just about one thing: quality. But assuring quality in your products and services has a nice ripple effect of increasing customer satisfaction and keeping them ...

Is your medical device company ready for the QMSR shift? Engineer Aldo Vidinha explains why "checkbox compliance" is over and how the FDA’s alignment with ISO 13485 redefines quality as a connected, ...

The TPP Quality team is responsible for the creation and implementation of quality systems in compliance with internal and external quality standards as well as government regulations, as applicable, ...

Firms that perform audits, reviews, or compilations have a little more than four months to implement the new risk-based quality management (QM) standards. The task may feel daunting, but Joe Lynch, ...

Gone are the days when quality is owned by a single department or measured on a distant dashboard. Today, clinical quality is woven into the fabric of nearly every aspect of health system operations, ...

Design is a commonly outsourced process. As with all services, it requires significant quality considerations. The ability to implement a seamless and sound quality management system (QMS) for a ...

Quality engineering must evolve faster than code; otherwise, agentic AI will move quickly, learn rapidly and fail expensively.