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 ...

Chapter 14: Current Good Manufacturing Practices and Quality System Design Chapter 15: Canadian Good Manufacturing Practices and Establishment Licensing Chapter 25: Components of a REMS: Communication ...

Quality management systems (QMS) have been in place since the beginning of the Industrial Revolution. They were used to manage and curtail defects in products and eventually evolved to become a set of ...

Explore resources and examples that explain how small firms can perform monitoring procedures, document results, and turn SQMS No. 1 into an executable process. Firms will need to learn from mistakes, ...

According to FDA, medical devices are distinguished from other discretely manufactured products because devices are “intended to affect the structure or any function of the body of man.” 1 By contrast ...

Food safety testing company BioControl Systems has been ISO 9001– 2000 certified. The certification attests that BioControl meets internationally accepted standards of quality systems management for ...

A medical device firm posted signs at strategic locations throughout its manufacturing area that stated, “Follow the SOPs and tell other departments about problems; the pacemaker you're working on may ...

The US Food and Drug Administration (FDA) has reissued a final guidance on quality system management considerations for medical device cybersecurity following the agency's transition from the Quality ...

The purpose of the e-learning is to provide guidance to technical monitoring services in radiation safety on developing and implementing a quality management system consistent with the requirements ...

The adoption of a quality management system (QMS) should be a strategic decision of a Nuclear Medicine service. Its design and implementation will be influenced by various factors, for example the ...