Compliance ISO 9001:2008 to requirement FDA: 21 CFR 820
21 CFR 820: | Brief Description: | ISO 9001:2008 clauses: |
§ 820.1 – Scope. § 820.3 – Definitions. § 820.5 – Quality system. |
General Provisions | Scope: 1, 2, 3 4.1-General Requirement |
§ 820.20 – Management responsibility. § 820.22 – Quality audit. § 820.25 – Personnel. |
Quality System Requirements | clause 5: Management Responsibilityclause 8.2.2: Internal Audit
clause 6.2 Human Resources |
§ 820.30 – Design controls | Design Controls | clause 7.3 Design and Development |
§ 820.40 – Document controls | Document controls | clause 4.2 Documentation Requirements |
§ 820.50 – Purchasing controls. | Purchasing controls. | clause 7.4 Purchasing |
§ 820.60 Identification. § 820.65 – Traceability. |
Identification and Traceability | clause 7.5.3 Identification and Traceability |
§ 820.70 – Production and process controls. § 820.72 – Inspection, measuring, and test equipment. § 820.75 – Process validation. |
Production and Process Controls | clause 7.5 Production and service provision clause 7.6 Control of monitoring and measuring equipment |
§ 820.80 – Receiving, in-process, and finished device acceptance. § 820.86 – Acceptance status. |
Acceptance Activities | clause 7.4.3 Verification of purchased product clause 7.1 Product realization |
§ 820.90 – Nonconforming product. | Nonconforming product. | clause 8.3 Control of noncoforming product |
§ 820.100 – Corrective and preventive action. | Corrective and preventive action. | cluase 8.5.2 Corrective Actionclause 8.5.3 Preventive action |
§ 820.120 – Device labeling. § 820.130 – Device packaging. |
Labeling and Packaging Control | |
§ 820.140 – Handling. |
Handling, Storage, Distribution, and Installation | 7.5.5 Preservation of product |
§ 820.180 – General requirements. § 820.186 – Quality system record. § 820.198 – Complaint files. |
Records | clause 4.3 Control of records |
§ 820.250 – Statistical techniques. | Statistical Techniques | clause 8.4 Analysis of data |