Compliance Matrix Format
Compliance Matrix Format
1. Regulation/Standard
Name the specific regulation or industry standard applicable to your organization (e.g., FDA Regulations, ISO Standards).
2. Section/Clause
Identify the specific section or clause of the regulation that outlines the requirement (e.g., 21 CFR Part 820.30).
3. Requirement Description
Provide a detailed description of the requirement or obligation that needs to be fulfilled (e.g., "Establish and maintain a quality management system for medical devices").
4. Responsible Party
Specify the individual or department responsible for ensuring compliance with each requirement (e.g., Quality Assurance Team).
5. Compliance Status
Indicate the current status of compliance for each requirement. Common statuses include:
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Compliant: Requirement has been met.
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Non-Compliant: Requirement has not been met.
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In Progress: Efforts to achieve compliance are underway.
6. Evidence of Compliance
Document the evidence that supports the compliance status, such as completed audits, certifications, training records, or policy documents (e.g., "Quality Manual, Audit Reports").
7. Due Date
Set a due date by which compliance must be achieved or maintained (e.g., "2054-12-01").
8. Comments
Provide any additional notes, observations, or context that may be helpful for understanding the compliance status or requirements (e.g., "Annual review scheduled").
