Title Page
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Conducted on
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Location
Section I: Information
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Document number
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Audit type
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Conducted by
Section II: Compliance with Requirements
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Are all processes documented properly?
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Are all documents easily accessible?
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Are technical documents easily understandable and accessible?
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Is there a safety plan in place? And has it been communicated effectively to workers?
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Is the existing quality management system still applicable to the organization's current needs?
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Are there existing risk management and mitigation systems in place? And have they been communicated effectively to workers?
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Are the parts for the medical devices sourced from credible providers?
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Is there a clinical evaluation and management plan in place? And has it been communicated effectively to workers?
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Is there a post-market surveillance system in place? And has it been communicated effectively to workers?
Section III: Auditing
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Perform an audit on specific parts of your medical device production, sale, and distribution as needed with this section. Reproduce the next section for each audit.
Audit
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Item, process, or activity to audit
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Is this item, process, or activity working or performing as intended?
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Failure investigation (reference all potential root causes, records, and evidence; including tools and period for the investigation)
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Corrective actions to be taken (ensure actions are aligned with investigation results)
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Preventive actions to be taken (ensure actions are aligned with investigation results)
Section IV: Signature
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Other notes and suggestions
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Lead Auditor Name
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Signature
