目 錄... 11-1... 11-1... 11-3... 11-4 4.1... 11-4 4.2... 11-8 4.3... 11-11... 11-13... 11-14... 11-14
PDCA 11-1
The American Society of Mechanical Engineers, ASME Quality Inspection, QI ( Quality Control, QC ) (Hold Point) Quality Assurance, QA 11-2
ISO 9000 CNS 12680 CNS 12680 2.8.2 2.82 CNS 12680 2.8.2 / 11-3
CNS 12680 4.1 4.1.1 11-4
master audit plan audit schedule 1. 2. 11-5
3. 4.1.2 4.1.3 1. a b c d e 2. a b 3. 11-6
4. 4.1.4 checklist 1. a. b. c. d. e. 2. a. b. c. 11-7
4.2 4.2.1 4.2.2 11-8
-- 4.2.3 11-9
11-10
4.2.4 corrective action request a) b) c) d) a) investigative b) remedial c) corrective 4.3 4.3.1 11-11
4.3.2 4.3.3 11-12
fact fault 11-13
(1) 1.Allan J. Sayle, Management Audit, 2nd edition, ASQC, 1988. 2. 1990. 3. 1990. 4. 1988. (2) 1. CNS 12680. 2. ISO 10011-1, Guidelines for auditing quality systems, Part 1~ Part3, 1990. 3. ISO 9000-2000, Quality Management Systems Fundamental & Vocabulary. 11-14
Form No. QA0102 11-15
11-16 Form No. QA0103
11-17 Form No. QA0202
1.CAR 2. 3. 11. 1 4. 5. 6. 7. 8. 9. 10. 12. 13. 14. 15. 11-18
16. 17. QA-03 1. 1) 2) 11-19
3) 2. 3. 4. 5. 6. 11-20
1) 2) (1) (2) (3) (4) 3) 7. 1) (1) (2) (3) 11-21
(4) 2) 8. 9. 1) 2) 3) 4) 10. 11-22
11. 12. (1) (2) (3) 1. 2. 13. 14. 15. 11-23
16. 17. 18. 19. 1. 2. 11-24
3. 4. 5. 6. ( ) 7. 8. 9. 10. 11. 11-25
12. 13. 14. 15. 16. 17. 18. 19. 11-26
70% 40% 7% 20% 11-27