ISO 13485 Medical Device Quality Management Workflow
Ensures adherence to ISO 13485 standards for medical device quality management through a structured process of planning, execution, monitoring, and review of all activities related to design, development, production, and servicing.
Plan Medical Device Quality Management System
Define Scope of Operations
Establish Quality Policy Statement
Designate Quality Management Representatives
Conduct Training on ISO 13485 Requirements
Develop Quality Manual and Procedures
Establish Document Control Process
Identify, Assess, and Mitigate Risks
Develop Corrective Action Procedure
Implement Internal Audits
Document Nonconformities and Corrective Actions
Conduct Management Review Meetings
Plan Medical Device Quality Management System
Type: Fill Checklist
Plan Medical Device Quality Management System This critical step involves defining and documenting the overall quality management system for medical devices. The process starts with identifying regulatory requirements and industry standards that must be adhered to. Next, a thorough analysis of the company's current systems, processes, and personnel is conducted to determine their effectiveness in ensuring product quality. A detailed plan outlining the organization's quality policy, objectives, and procedures is then developed. This includes establishing a quality manual, defining roles and responsibilities, and creating a system for documenting and controlling records. The goal is to create a robust quality management framework that ensures consistency and adherence to regulatory requirements throughout all stages of product development, manufacturing, testing, and distribution. Effective planning lays the foundation for efficient quality control processes.
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