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 ...

As we have previously covered on this blog, the primary purpose of Lean Six Sigma (LSS) methodology is to eliminate waste and reduce variation in manufacturing, service and design processes, thus ...

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 ...

Opinions expressed by Digital Journal contributors are their own. In today’s environment, the need for a quality management system is not merely a luxury. Still, instead, it is an essential ...

Quality system objectives were originally introduced as part of the ISO 9001:2000 quality management system. ISO 9001:2000 mandated the use of quality objectives at every important area of a company's ...

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 ...