A. Quality Assurance (QA) Responsibilities
Ensure compliance with ISO 13485, GMP, and regulatory requirements.
Review and approve Batch Manufacturing Records (BMR) and batch release documentation.
Implement and maintain Standard Operating Procedures (SOPs).
Conduct internal quality audits and ensure closure of audit observations.
Monitor and drive Corrective and Preventive Actions (CAPA).
Handle change control processes.
Manage deviation, non-conformance (NC), and root cause analysis (RCA).
Ensure proper document control and archival systems are maintained.
Support external audits (FDA, notified bodies, customers).
Review completed BMRs for accuracy, completeness, and compliance.
Approve or reject batches based on BMR review and test results.