Three Approaches to Defining a QMS: Elements

To fully understand how Cloud Computing is changing the world of Quality Management System validation, it’s important to define just what a QMS is. There are three common ways to do so. In this post, we’ll look at the first: QMS Elements.

In this definition, we can think of a QMS as the relationship between roles within an organization and a set of procedures. One set of roles falls under the Executive element. These business decision-makers can hold various titles, including CEO, chief quality officer, a division president or vice-president of quality. Ideally, leaders will be part of a Quality steering committee and participate in audits of their own company’s supply chain and those of their customers,

A second set of roles is encompassed by a company’s Quality and Compliance arm. Different functions have a hand in ensuring product quality, some more directly that others. The typical players are Systems, Validation, Training, Compliance and Information Security.

A third set of roles under a company’s Quality umbrella focuses on Operations. Departments in this area work to ensure the functions of production are carried out with maximum efficiency. Two specific departments – Infrastructure (physical assets such as machinery) and Technical Operations (IT) – have many elements that require detailed Quality testing.

In most companies, there is a tug-of-war between Operations and Quality, where the former group is driven to meet production targets, and the latter, which concentrates on quality, sometimes counterbalancing the Operations group’s desire to get wares off the line and into buyers’ hands.

Tomorrow, we’ll look at the other two common ways to define a QMS.

To learn more about this QMS definition and the concept of QMS Validation in the Cloud, download our free Definitive Guide on the subject today.


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