Free Audit Checklist for Medical Device Facility

Audit Checklist for Medical Device Facility

Prepared by:	[YOUR NAME]
Date:	September 4, 2055
Company Name:	[YOUR COMPANY NAME]

I. Regulatory Compliance

Checklist	Status
Verify facility licensing and registration with applicable regulatory bodies.
Ensure all staff qualifications meet regulatory standards.
Review adherence to FDA and other relevant medical device regulations.
Confirm labeling and promotional materials comply with regulations.

II. Quality Management System (QMS)

Checklist	Status
Assess the implementation of the facility's quality management system.
Examine document control processes for effectiveness and compliance.
Inspect internal audit records and corrective action procedures.
Verify regular quality management reviews and updates.

III. Production and Process Controls

Checklist	Status
Evaluate cleanliness and maintenance of production equipment.
Review validation and control of manufacturing processes.
Check the traceability of raw materials and components.
Ensure process documentation is accurate and up-to-date.

IV. Risk Management

Checklist	Status
Audit risk management plans and activities.
Ensure risk assessments are conducted and documented.
Verify implementation and monitoring of risk control measures.
Review emergency preparedness and response plans.

V. Training and Competency

Checklist	Status
Evaluate training programs and materials.
Verify staff competency and certification records.
Ensure training is conducted regularly and covers relevant updates.
Check the effectiveness of training programs through assessments.

VI. Facility and Environmental Controls

Checklist	Status
Inspect facility layout for compliance with safety standards.
Review environmental monitoring results and controls.
Assess maintenance schedules for facility equipment.
Verify that waste management procedures are in place and followed.

VII. Customer Complaints and Product Quality

Checklist	Status
Review customer feedback and complaint-handling procedures.
Audit records of product quality issues and resolutions.
Ensure there is a systematic approach to product recalls.
Verify improvements are made based on customer feedback.

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