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FDA 21 CFR Part 820 vs. ISO 13485:2016Comparison Table created by Greenlight GuruFDA QSR (21 CFR PART 820)ISO 13485:2016820.1 Scope1 Scope2 Normative References820.3 Definitions3 Terms and Definitions820.5 Quality System4 Quality Management System4.1 General Requirements4.2 Documentation Requirements820.20 Management Responsibility5.0 Management Responsibility820.20(a) Quality Policy5.3 Quality Policy820.20(b) Organization4.1 Management Responsibility – General820.20(b)(1) Responsibility & Authority5.5 Responsibility & Authority820.20(b)(2) Resources5.1e Management Commitment820.20(b)(3) Management Representative5.5.2 Management Representative820.20(c) Management Review5.6 Management Review820.20(d) Quality Planning5.4 Quality Planning820.20(e) Quality System Procedures4.2.1 General4.2.2 Quality Manual820.22 Quality Audit8.2.4 Internal Quality Audits820.25 Personnel6 Resource Management 2018 Greenlight GuruQuality Management Software Exclusively for Medical Device Companies
820.25(a) General6.1 Provision of Resources6.2 Human Resources820.25(b) Training6.2 Human Resources820.30 Design Controls7.3 Design and Development820.30(a) General7.3 Design and Development820.30(b) Design and DevelopmentPlanning7.1 Planning of Product Realization7.3.2 Design and Development Planning820.30(c) Design Input7.2.1 Customer Related Processes7.2.2 Review of Requirements Related toProduct7.3.3 Design and Development Inputs820.30(d) Design Output7.3.4 Design and Development Outputs820.30(e) Design Review7.3.5 Design and Development Review820.30(f) Design Verification7.3.6 Design and DevelopmentVerification820.30(g) Design Validation7.3.7 Design and Development Validation820.30(h) Design Transfer7.3.8 Design and Development Transfer820.30(i) Design Changes7.3.9 Control of Design and DevelopmentChanges820.30(j) Design History File7.3.10 Design and Development Files820.40 Document Controls4.2.4 Control of Documents820.40(a) Document Approval andDistribution4.2.4 Control of Documents 2018 Greenlight GuruQuality Management Software Exclusively for Medical Device Companies
820.40(b) Document Changes4.2.4 Control of Documents820.50 Purchasing Controls7.4.1 Purchasing Process820.50(a) Evaluation of Suppliers,Contractors, and Consultants7.4.1 Purchasing Process820.50(b) Purchasing Data7.4.2 Purchasing Information7.4.3 Verification of Purchased Product820.60 Identification7.5.8 Identification820.65 Traceability7.5.9 Traceability820.70(a) Production and ProcessControls7.5.1 Control of Production and ServiceProvision7.5.6 Validation of Processes forProduction and Service Provision820.70(a)(b) Production and ProcessControlsChanges6.3 Infrastructure6.4 Work Environment and ContaminationControl7.5.1 Control of Production and ServiceProvision7.5.6 Validation of Processes forProduction and Service Provision820.70(c) Environmental Control6.4 Work Environment and ContaminationControl820.70(d) Personnel6.2 Human Resources820.70(e) Contamination Control6.4.2 Contamination Control820.70(f) Buildings6.3 Infrastructure 2018 Greenlight GuruQuality Management Software Exclusively for Medical Device Companies
820.70(g) Equipment6.3 Infrastructure7.5.1 Control of Production and ServiceProvision7.5.6 Validation of Production andService Provision820.70(h) Manufacturing Material7.5.11 Preservation of Product820.70(i) Automated Processes6.3.b Infrastructure7.5.6 Validation of Production and ServiceProvision820.72 Inspection, Measuring, and TestEquipment7.6 Control of Monitoring andMeasurement Equipment820.75 Process Validation7.5.6 Validation of Production and ServiceProvision820.80(a) Receiving, In-process, andFinished Device Acceptance – General7.1 Planning of Product Realization7.4.3 Verification of Purchased Product7.5.1 Control of Production and ServiceProvision820.80(b) Receiving Acceptance7.4.3 Verification of Purchased Product820.80(c) In-Process Acceptance7.1 Planning of Product Realization820.80(d) Final Acceptance Activities7.1 Planning of Product Realization820.80(e) Final Acceptance Records7.1 Planning of Product Realization820.86 Acceptance Status7.5.8 Identification820.90(a) Non-Conforming Product8.3 Control of Nonconforming Product820.90(b) Nonconformity Review andDisposition8.3 Control of Nonconforming Product 2018 Greenlight GuruQuality Management Software Exclusively for Medical Device Companies
820.100 Corrective and PreventativePreventiveAction8.5.2 Corrective Action8.5.3 PreventativePreventive Action820.120 Device Labeling4.2.3 Medical Device File7.5.8 Identification7.5.11 Preservation of Product820.130 Device Packaging4.2.3 Medical Device File7.5.8 Identification7.5.11 Preservation of Product820.140 Handling4.2.3 Medical Device File7.1 Planning of Product Realization7.5.8 Identification7.5.11 Preservation of Product820.150 Storage4.2.3 Medical Device File7.1 Planning of Product Realization7.5.8 Identification7.5.11 Preservation of Product820.160 Distribution4.2.3 Medical Device File7.1 Planning of Product Realization7.5.8 Identification7.5.11 Preservation of Product820.170 Installation4.2.3 Medical Device File7.5.3 Installation Activities7.5.8 Identification7.5.11 Preservation of Product820.180 Records4.2 Documentation Requirements4.2.3 Medical Device File7.1 Planning of Product Realization820.181 Device Master Record4.2.3 Medical Device File 2018 Greenlight GuruQuality Management Software Exclusively for Medical Device Companies
FDA QSR !21 CFR PART 820 " ISO 13485:2016 1 Scope 2 Normative References 4.2.1 General 4.2.2 Quality Manual 4.1 Management Responsibility Ð General 5.5.2 Management Representative 5.4 Quality Planning 6 Resource Manage
