| ISO 9001 | FDA QSR | ||
| Section | Title | Section | Title -- Section |
| 1 | Scope | 820.1 | A. General Provisions -- Scope |
| 2 | Normative Reference | ||
| 3 | Definitions | 820.3 | A. General Provisions -- Definitions |
| 4.1 | Management responsibility | 820.20 & 820.25 | B. Quality System Requirements -- Management responsibility and Personnel |
| 4.2 | Quality system | 802.5, 20 & 186 | A. General Provisions -- Quality system, B. Quality System Requirements -- Management responsibility and M. Records -- Quality system record |
| 4.3 | Contract review | ||
| 4.4 | Design control | 820.30 | C. Design Controls -- Design controls |
| 4.5 | Document and data control | 820.40 | D. Document Controls -- Document controls |
| 4.6 | Purchasing | 820.50 | E. Purchasing Controls -- Purchasing Controls |
| 4.7 | Control of customer supplied product | ||
| 4.8 | Product identification and traceability | 820.60 & 65 | F. Identification and Traceability -- Identification and Traceability |
| 4.9 | Process control | 820.70 & 75 | G. Production and Process Controls -- Production and process controls and Process validation |
| 4.10 | Inspection and testing | 820.80 | H. Acceptance Activities -- Receiving, in-process and finished device acceptance |
| 4.11 | Control of measuring, inspection and test equipment | 820.72 | G. Production and Process Controls -- Inspection, measuring and test equipment |
| 4.12 | Inspection and test status | 820.86 | H. Acceptance Activities -- Acceptance Status |
| 4.13 | Control of nonconforming product | 820.90 | I. Nonconforming Product -- Nonconforming product |
| 4.14 | Corrective and preventive action | 820.100 | J. Corrective and Prevent Action -- Corrective and prevent action |
| 4.15 | Handling, storage, packaging, preservation and delivery | 820.140, 150 & 160 | L. Handling, Storage, Distribution and Installation -- Handling, Storage and Distribution |
| 4.16 | Control of quality records | 820.180 | M. Records -- General requirements |
| 4.17 | Internal quality audits | 820.22 | B. Quality System Requirements -- Quality audit |
| 4.18 | Training | 820.25 | B. Quality System Requirements -- Personnel |
| 4.19 | Servicing | 820.200 | N. Servicing -- Servicing |
| 4.20 | Statistical techniques | 820.250 | O. Statistical Techniques -- Statistical techniques |
The QSR is generally somewhat more stringent and detailed (particularly in regard to documentation and record keeping requirements) than the ISO 9001 model. Areas covered by the QSR that are not in the ISO 9001 model are Labeling and Packaging Control ( Subpart K -- Sections 820.120 & 130), Installation (Subpart L -- Section 820.170), Device master record (Subpart M -- Section 820.181), Device history record (Subpart M -- Section 820.184) and Complaint files (Subpart M -- Section 820.198) Two areas not covered by the QSR that are in the ISO 9001 model are Contract review (element 4.3) and Control of customer supplied product (element 4.7).
AAMI/ISO 13485:1997 which in conjunction with ISO 9001 specifies quality system requirements for medical devices includes additional requirements for Documentation, Development and design, Product identification and traceability, Process control (including Maintenance, Installation and Software), Inspection and test, Control of nonconforming product, Corrective an preventive action, Handling, storage, packaging, preservation and delivery and Control of quality records.