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ISO 13485 Section 4: Quality Management System

Clause 4 is divided into two main categories or subclauses:

4.1 General Requirements

States that organizations are required to document their QMS, and to maintain its effectiveness by following the requirements of the International Standard.  ISO standards states that all businesses are required to create, enact, and continue with all requirements, procedures, activities or arrangements. Additionally, all businesses must document any role undertaken under the regulatory requirements. You should also be familiar with the FDA’s quality management system- Current Good Manufacturing Practices

4.2 Documentation Requirements

Organizations are required to document all statements regarding to the QMS including: policy and objectives, a quality manual, procedures and records, and any documents that are deemed necessary for planning, operation and control of the organization’s process. 

Document Requirements Includes:

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