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A quality management system (QMS) is a collection of business processes focused on consistently meeting customer requirements and enhancing their satisfaction. It is aligned with an organization's purpose and strategic direction (ISO 9001:2015). It is expressed as the organizational goals and … See more
1. Quality objectives
2. Quality manual
3. Organizational structure and responsibilities
4. Data management See moreThe International Organization for Standardization's ISO 9001:2015 series describes standards for a QMS addressing the principles and … See more
A QMS process is an element of an organizational QMS. The ISO 9001 standard requires organizations seeking compliance See more
The concept of a quality as we think of it now first emerged from the Industrial Revolution. Previously goods had been made from start to … See more
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. The two have a great deal of similarity, and many manufacturers adopt … See more
Wikipedia text under CC-BY-SA license ISO 9001 Explained: A Comprehensive Guide to Quality …
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