Quality Management Systems

The Quality Management System (QMS) is the foundational structure and processes which define how your organization maintains quality, with the Quality Manual as the overarching document.

 

Elements of the Quality Manual include:

• Quality Policy

• Management Responsibility

• Quality Assurance Independence

• Organizational oversight of internal and external regulatory components

• Quality Procedures (e.g., SOPs and Document Control, Training, CAPA, Vendor/Supplier Quality Oversight, Audits and Regulatory Inspection).

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Let us help you with the initial implementation or evaluation of your existing QMS.