ISO 13485 Clause 4: Quality Management System

ISO 13485 Clause 4 state the general requirements for a Quality Management System. Clause 4 is divided into two main Subclauses:

4.1 General Requirements  

Subclause 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

Subclause 4.1 documentation requirements states that organizations are required to document all statements regarding 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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