Free Audit Checklist for Medical Device Facility Template
Audit Checklist for Medical Device Facility
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Prepared by: |
[YOUR NAME] |
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Date: |
September 4, 2055 |
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Company Name: |
[YOUR COMPANY NAME] |
I. Regulatory Compliance
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Checklist |
Status |
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Verify facility licensing and registration with applicable regulatory bodies. |
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Ensure all staff qualifications meet regulatory standards. |
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Review adherence to FDA and other relevant medical device regulations. |
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Confirm labeling and promotional materials comply with regulations. |
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II. Quality Management System (QMS)
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Checklist |
Status |
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Assess the implementation of the facility's quality management system. |
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Examine document control processes for effectiveness and compliance. |
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Inspect internal audit records and corrective action procedures. |
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Verify regular quality management reviews and updates. |
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III. Production and Process Controls
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Checklist |
Status |
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Evaluate cleanliness and maintenance of production equipment. |
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Review validation and control of manufacturing processes. |
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Check the traceability of raw materials and components. |
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Ensure process documentation is accurate and up-to-date. |
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IV. Risk Management
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Checklist |
Status |
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Audit risk management plans and activities. |
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Ensure risk assessments are conducted and documented. |
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Verify implementation and monitoring of risk control measures. |
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Review emergency preparedness and response plans. |
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V. Training and Competency
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Checklist |
Status |
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Evaluate training programs and materials. |
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Verify staff competency and certification records. |
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Ensure training is conducted regularly and covers relevant updates. |
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Check the effectiveness of training programs through assessments. |
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VI. Facility and Environmental Controls
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Checklist |
Status |
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Inspect facility layout for compliance with safety standards. |
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Review environmental monitoring results and controls. |
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Assess maintenance schedules for facility equipment. |
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Verify that waste management procedures are in place and followed. |
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VII. Customer Complaints and Product Quality
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Checklist |
Status |
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Review customer feedback and complaint-handling procedures. |
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Audit records of product quality issues and resolutions. |
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Ensure there is a systematic approach to product recalls. |
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Verify improvements are made based on customer feedback. |
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