“A formal system that documents the structure, processes, roles, responsibilities and procedures required to achieve effective quality management.”

A QMS is comprised of the core set of business policies, procedures, forms, and work instructions, along with their sequence, interactions, and resources required to conduct business within a medical device company. Quality records are documentation that demonstrate the QMS is being executed and followed.

Example of QMS Hierarchy:

Level 1: Quality Manual

Level 2: Device Master Record (DMR), Quality Procedures

Level 3: Work Instructions, Forms, Specifications and Drawings

Level 4: Quality Records, Design History Files (DHF), Device History Records (DHR)

The QMS should address the specific, applicable requirements of the standard, as well as the specific, applicable regulatory requirements based on markets where you plan to manufacture and market medical devices.

A valuable best practice for managing a QMS is to continually monitor its effectiveness and ensure that the QMS is adjusted as necessary. One means to do so is to establish key performance indicators for the processes within the QMS.

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