Quality Management System (QMS) Requirements

Overview of the parts, tasks and purpose of the quality management system (QMS) requirements.

A quality management system (QMS) is essential to ensure that health care products are high quality, safe and effective. This page details the key QMS elements required for compliance. 

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Required Functions of a QMS

A quality system needs to include tools, processes and resources that enable a company to fulfill quality management requirements. The following are key functions of a QMS:

  • Document Control:

    Ensure that only current documents are used. Changes must be reviewed and approved. Documents and records must be kept for the required length of time.

  • Corrective and Preventive Action (CAPA) Management:

    Actions to identify, resolve and prevent product compliance issues.

  • Training Control:

    Processes for identifying training needs. Includes ensuring that all required staff training is up to date and recorded.

  • Audit Management:

    Processes for conducting quality audits. Required to ensure the QMS is effective in the manufacture of safe and compliant products.

  • Risk Management:

    A proactive means to identify and control quality issues. Must be part of new product development, design change, manufacturing, CAPA and postmarket oversight.

Ensure Quality Across the Value Chain

QMS compliance is easier and more effective when quality is part of the business culture. Visit these free resources to learn how to ingrain quality in the value chain.

Achieve QMS Compliance With Closed-Loop Quality Management

Closed-loop quality management elevates the company’s quality efforts. The concept involves effectively connecting people, processes and data up and down the supply chain. The end goal is ensuring process and product quality as early as possible and throughout the product life cycle.

How MasterControl Meets All the QMS Requirements

MasterControl’s QMS is designed according to regulatory QMS guidelines. It seamlessly integrates with all other enterprise systems for more unified quality efforts. As a result, you achieve compliance faster and get to market sooner. 

MasterControl QMS Requirements


MasterControl Documents™:


MasterControl CAPA™:


MasterControl Training™:


MasterControl Audit™:


MasterControl Risk™:

Simplify compliance with QMS requirements.

Ensure QMS compliance by integrating and automating quality processes.

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