Audit Checklist for Medical Device Facility

Prepared by:

[YOUR NAME]

Date:

September 4, 2055

Company Name:

[YOUR COMPANY NAME]

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.

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.

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.

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.

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.

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.

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.