FDA 21 CFR Part 820 vs. ISO 13485:2016 Comparison Table created by greenlight.guru
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1 FDA 21 CFR Part 820 vs. ISO 13485:2016 Comparison Table created by greenlight.guru FDA QSR (21 CFR Part 820) ISO 13485: Scope 1 Scope 2 Normative References Definitions 3 Terms and Definitions Quality System 4 Quality Management System 4.1 General Requirements 4.2 Documentation Requirements Management Responsibility 5.0 Management Responsibility (a) Quality Policy 5.3 Quality Policy (b) Organization 4.1 Management Responsibility General (b)(1) Responsibility & Authority (b)(2) Resources (b)(3) Management Representative (c) Management Review (d) Quality Planning (e) Quality System Procedures 5.5 Responsibility & Authority 5.1e Management Commitment Management Representative 5.6 Management Review 5.4 Quality Planning General Quality Manual Quality Audit Internal Quality Audits Personnel 6 Resource Management (a) General (b) Training 6.1 Provision of Resources Design Controls 7.3 Design and Development (a) General (b) Design and Development Planning 7.3 Design and Development Design and Development Planning
2 820.30(c) Design Input (d) Design Output (e) Design Review (f) Design Verification (g) Design Validation (h) Design Transfer (i) Design Changes (j) Design History File Customer Related Processes Review of Requirements Related to Design and Development Inputs Design and Development Outputs Design and Development Review Design and Development Verification Design and Development Validation Design and Development Transfer Control of Design and Development Changes Design and Development Files Document Controls Control of Documents (a) Document Approval and Distribution (b) Document Changes Control of Documents Control of Documents Purchasing Controls Purchasing Process (a) Evaluation of Suppliers, Contractors, and Consultants (b) Purchasing Data Purchasing Process Purchasing Information Identification Traceability Traceability (a) ion and Process Controls Control of ion and Validation of Processes for ion and
3 820.70(b) ion and Process Changes (c) Environmental Control (d) Personnel (e) Contamination Control (f) Buildings (g) Equipment (h) Manufacturing Material (i) Automated Processes Inspection, Measuring, and Test Equipment 6.4 Work Environment and Contamination Control Control of ion and Validation of Processes for ion and 6.4 Work Environment and Contamination Control Contamination Control Control of ion and Validation of ion and 6.3.b Infrastructure Validation of ion and 7.6 Control of Monitoring and Measurement Equipment Process Validation Validation of ion and (a) Receiving, In- process, and Finished Device Acceptance General (b) Receiving Acceptance (c) In- Process Acceptance (d) Final Acceptance Activities (e) Final Acceptance Records Control of ion and
4 Acceptance Status (a) Non- Conforming (b) Nonconformity Review and Disposition Corrective and Preventative Action 8.3 Control of Nonconforming 8.3 Control of Nonconforming Corrective Action Preventative Action Device Labeling Medical Device File Device Packaging Medical Device File Handling Medical Device File Storage Medical Device File Distribution Medical Device File Installation Medical Device File Installation Activities Records 4.2 Documentation Requirements Medical Device File Device Master Record Medical Device File Device History Record Control Records
5 Quality System Record 4.2 Documentation Requirements Complaint Files Communication Feedback Complaint Handling Reporting to Regulatory Authorities Servicing Medical Device File Servicing Statistical Techniques 8.1 General 8.4 Analysis of Data greenlight.guru s eqms solution is being used by some of the world s most innovative medical device companies all over the globe to help ensure their compliance to ISO 13485:2016 and FDA 21 CFR Part 820. Visit to learn more about our software + services and see how we might be able to help your company.
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