Quality management system

A quality management system (QMS) is a collection of business processes focused on consistently meeting customer requirements and enhancing their satisfaction.

In the 21st century, QMS has tended to converge with sustainability and transparency initiatives, as both investor and customer satisfaction and perceived quality are increasingly tied to these factors.

Other QMS, e.g. Natural Step, focus on sustainability issues and assume that other quality problems will be reduced as result of the systematic thinking, transparency, documentation and diagnostic discipline.

Previously goods had been made from start to finish by the same person or team of people, with handcrafting and tweaking the product to meet 'quality criteria'.

In the late 19th century pioneers such as Frederick Winslow Taylor and Henry Ford recognized the limitations of the methods being used in mass production at the time and the subsequent varying quality of output.

[3] The two primary, state of the art, guidelines for medical device manufacturer QMS and related services today are the ISO 13485 standards and the US FDA 21 CFR 820 regulations.

[4] The U.S. Food and Drug Administration (FDA) had documented design defects in medical devices that contributed to recalls from 1983 to 1989 that would have been prevented if Quality Systems had been in place.

[5] According to current Good Manufacturing Practice (GMP), medical device manufacturers have the responsibility to use good judgment when developing their quality system and apply those sections of the FDA Quality System (QS) Regulation that are applicable to their specific products and operations, in Part 820 of the QS regulation.

Because the QS regulation covers a broad spectrum of devices and production processes, it allows some leeway in the details of quality system elements.

It is left to manufacturers to determine the necessity for, or extent of, some quality elements and to develop and implement procedures tailored to their particular processes and devices.

Helps manufacturers to monitor, control, and document quality processes electronically to guarantee that goods are made within tolerance, meet all necessary requirements, and are defect-free.

A MES is a complete, dynamic software system for monitoring, tracking, documenting, and controlling the manufacturing process from raw materials to final products.