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21 CFR 820
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ISO 13485
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| § 820.1 – Scope. |
1 Scope
2 Normative References |
| § 820.3 – Definitions. |
3 Terms and Definitions |
| § 820.5 – Quality system. |
4 Quality Management System
4.1 General Requirements
4.2 Documentation Requirements |
| Subpart B–Quality System Requirements |
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§ 820.20 – Management responsibility.
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5.0 Management Responsibility |
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§ 820.22 – Quality audit.
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8.2.4 Internal Quality Audits |
| § 820.25 – Personnel. |
6 Resource Management |
| Subpart C–Design Controls |
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| § 820.30 – Design controls. |
7.1 Planning of Product Realization
7.2.1 Customer Related Processes
7.2.2 Review of Requirements Related to Product 7.3 Design and Development |
| Subpart D–Document Controls |
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| § 820.40 – Document controls. |
4.2.4 Control of Documents |
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Subpart E–Purchasing Controls
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| § 820.50 – Purchasing controls. |
7.4.1 Purchasing Process
7.4.2 Purchasing Information
7.4.3 Verification of Purchased Product |
| Subpart F–Identification and Traceability |
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| § 820.60 – Identification |
7.5.8 Identification |
| § 820.65 – Traceability. |
7.5.9 Traceability |
| Subpart G–Production and Process Controls |
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| § 820.70 – Production and process controls. |
6.2 Human Resources
6.3 Infrastructure
6.4 Work Environment and Contamination Control
7.5.1 Control of Production and Service Provision 7.5.6 Validation of Processes for Production and Service Provision |
| § 820.72 – Inspection, measuring, and test equipment. |
7.6 Control of Monitoring and Measurement Equipment |
| § 820.75 – Process validation. |
7.5.6 Validation of Production and Service Provision |
| Subpart H–Acceptance Activities |
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| § 820.80 – Receiving, in-process, and finished device acceptance. |
7.1 Planning of Product Realization
7.4.3 Verification of Purchased Product
7.5.1 Control of Production and Service Provision |
| § 820.86 – Acceptance status. |
7.5.8 Identification |
| Subpart I–Nonconforming Product |
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| § 820.90 – Nonconforming product. |
8.3 Control of Nonconforming Product |
| Subpart J–Corrective and Preventive Action |
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| § 820.100 – Corrective and preventive action. |
8.5.2 Corrective Action
8.5.3 Preventative Action |
| Subpart K–Labelling and Packaging Control |
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| § 820.120 – Device labelling. |
4.2.3 Medical Device File
7.5.8 Identification
7.5.11 Preservation of Product |
| § 820.130 – Device packaging. |
4.2.3 Medical Device File
7.5.8 Identification
7.5.11 Preservation of Product |
| Subpart L–Handling, Storage, Distribution, and Installation |
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| § 820.140 – Handling. |
4.2.3 Medical Device File
7.1 Planning of Product Realization
7.5.8 Identification
7.5.11 Preservation of Product |
| § 820.150 – Storage. |
4.2.3 Medical Device File
7.1 Planning of Product Realization
7.5.8 Identification
7.5.11 Preservation of Product |
| § 820.160 – Distribution. |
4.2.3 Medical Device File
7.1 Planning of Product Realization
7.5.8 Identification
7.5.11 Preservation of Product |
| § 820.170 – Installation |
4.2.3 Medical Device File
7.5.3 Installation Activities
7.5.8 Identification
7.5.11 Preservation of Product |
| Subpart M–Records |
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| § 820.180 – General requirements. |
4.2 Documentation Requirements
4.2.3 Medical Device File
7.1 Planning of Product Realization |
| § 820.181 – Device master record. |
4.2.3 Medical Device File |
| § 820.184 – Device history record. |
4.2.5 Control Records
7.1 Planning of Product Realization
7.5.8 Identification |
| § 820.186 – Quality system record. |
4.2 Documentation Requirements
7.1 Planning of Product Realization |
| § 820.198 – Complaint files |
7.2.3 Communication
8.2.1 Feedback
8.2.2 Complaint Handling
8.2.3 Reporting to Regulatory Authorities |
| Subpart N–Servicing |
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| § 820.200 – Servicing |
4.2.3 Medical Device File
7.1 Planning of Product Realization
7.5.4 Servicing
7.5.8 Identification |
| Subpart O–Statistical Techniques |
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| § 820.250 – Statistical techniques. |
8.1 General
8.4 Analysis of Data |
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