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Sequence and interaction of qms processes
This document outlines the key quality management system processes and requirements for medical device manufacturers as defined in ISO 13485, including design and development, production and process controls, monitoring and measurement, customer feedback and complaints, regulatory reporting, management responsibility, resource management, and quality improvement. It covers all stages of product realization from design to distribution and includes requirements for documentation, document control, records management, internal auditing, and management review.
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Sequence and interaction of qms processes
- 1. Design Control (Planning, Inputs, Outputs,Review, V&V) Material Control including Customer Property (Purchasing) Production and Process Control including Process Validation Product Control (Monitoring and Measuring of Product) Distribution Control Customer Feedback including Complaint Handling Process Reporting to Regulatory Authorities Design Transfer Design Change Control Control of Monitoring and Measuring Equipment Preservation of Product Work environment and contamination control Infrastructure (including maintenance) Medical Device File Design and Development Files Planning of Product Realization, including Risk Management Control of Nonconforming Product Internal Audit; Monitoring and Measurement of Processes; Analysis of Data; Improvement (CAPA) Management Commitment; Customer Focus; Quality Policy; Quality Objectives; QMS Planning (including Change Control); Responsibility, Authority and Communication; Management Review ProvisionofResources;HumanResources(Training) QMSDocumentation;QualityManual; ControlofDocuments;ControlofRecords Sequence and Interaction of QMS Processes 4 Quality Management System 5 Management Responsibility 6 Resource Management 7 Product Realization 8 Measurement, Analysis and Improvement QMS Clause Customer Related Processes Servicing Activities Identification and Traceability