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:

• Compliant: Requirement has been met.

• Non-Compliant: Requirement has not been met.

• 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").

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