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, ...

Firms that offer audit and accounting services still have time to successfully implement the new quality management standards, but they should start now to be ready when the standards take effect Dec.

Following the launch of its initiative, "Pharmaceutical cGMPs for the 21st Century: A Risk-Based Approach," FDA has been looking to process analytical technology (PAT) for improvements in process ...

Editor’s note: This article is the second in a series to help practitioners learn about the AICPA’s new quality management standards and prepare to implement them. The interrelated final standards on ...

A quality management system is a formal process used to review a company's operations, products and services to identify areas of potential quality improvement. Effective quality management is a ...

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 ...

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 ...

Due to the emerging need of quality management system implementation in banking industry now is the time for us to move about "paradigm shift." Our commercial banks must pay attention to this shift ...