| ISO9001: 2000 indicates records to be controlled by adding "(see 4.2.4)". There are 19 kinds of records with the parenthesis. But there are other records to be recorded with " shall", but without theparenthesis. They are 5. Are they mistakes? |
| Anyway to make clear, the following list is of clearly required records. There are 24 kinds of records to be controlled with "shall". |
| (1) 4.2.1ｅ） |
| (2) 5.6.1 Management review |
| (3) 6.2.2ｅ）Training |
| (4) 7.1ｄ） Recording |
| (5) 7.2.2 Contract review |
| (6) 7.3.2 Design input |
| (7) 7.3.4 Result of design review |
| (8) 7.3.5 Result of design verification |
| (9) 7.3.6 Result of design validation |
| (10) 7.3.7 Design change ( no parenthesis) |
| (11) 7.3.7 Review of design change |
| (12) 7.4.1 Evaluation of suppliers |
| (13) 7.5.2ｄ） Special processes |
| (14) 7.5.3 Tracerability |
| (15) 7.5.4 Customer property |
| (16) 7.6.ａ） Basis used for calibration ( no parenthesis ) |
| (17) 7.6 Record of nonconformance about calibration ( no parenthesis ) |
| (18) 7.6 Record of calibration |
| (19) 8.2.2 Internal audit |
| (20) 8.2.4 Result of inspection ( no parenthesis ) |
| (21) 8.2.4 Records of inspectors |
| (22) 8.3 Nonconformities |
| (23) 8.5.2ｅ） Results of corrective action |
| (24) 8.5.3ｄ) Results of preventive action |