製品設計管理規定（第1版）
Contents
1. ID 1 gt gt amp SFL s25 RR Ba QDC01033 FMEA CERE FERA pcons4 ZE QDC06005 did QDC06008 QDCO7003 NN da QDC06016 6 4 32. ID 4 QDC08001 lens QDC08002 Il e EEEREN dis QDCO8003 QDC08004 m sma LHH Rm mi QDCO8005 n Spese p RT QDC08006 UPM Copyright 2014 UPMC All Rights Reserved J HD zuzLAS ID QDA0600 01 ah RE T E PRSE ndn Product design and development control standard
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5. ID i QDC01023 ju FETH n Ji 2 Copyright C 2014 UPMC All Rights Reserved E UPM ID QDA0600 01 Jj Product design and development control standard 27 36 8 4 5 SEU Z S e
6. 6 4 9 Vx TRAVES LE EIN p7 y P ID QDCO1024 6 4 10 PQR2 Lih Seo rp IE ERE A E uua ERT Y NES ID Ja n O ES pone 008 UPM Copyright C 2014 UPMC All Rights Reserved EH uas n ID QDA0600 01 Product design and development control standard 18 36 7 Design and development phase TA
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9. ID QDC06008 LL 6 QDC06009 A i EL d QDC06010 QDC06014 QDC07001 QDCO7003 QDC07004 QDC07005 QDC07016 T A F ES 6 4 7
10. J HD zuzLAS ID QDA0600 01 a Product design and development control standard 8 2 Start trigger trigger ID E ID trigger input document Template ID 1 QDC01008 PQR3 BX tabe VE 8 3 Exit trigger trigger ID ID trigger output document Template ID 1 QDC01008 PQR4 2 QDC01008 PQR4 8 4 Process 8 4 1 E
11. hn QDC01008 F S QDC01022 UPM Copyright C 2014 UPMC All Rights Reserved 12 36 Product design and development control standard ID QDA0600 01 6 Requirements specification phase 6 1 Flowchart FMEA emX DR1 FMEA DR2 PQR2
12. ELA hE ERT ER eS PE ID lul I QDC06042 6 4 8 DR2 UPM Copyright C 2014 UPMC All Rights Reserved ID QDA0600 01 E ux HH EX H Product design and development control standard 17 36 E ID 1QDC01023 PHA
13. p doit UPM Copyright C 2014 UPMC All Rights Reserved I D QDA0600 01 Jj noua Product design and development control standard 22 36 i SOUP SOUP 23J v8 E 23J vB E EI x 4 ul uil ATY RAISES
14. Copyright C 2014 UPMC gt w UPM TY All Rights Reserved ID QDA0600 01 amp Product design and development control standard 35 36 e ID QDB0613 3 QMS e ID QDA0700 e ID QDBO701 e ID QDBO702 e ID QDBO703 e ID QDBO704 e ID QDB0705 e SOUP ID QDBO706 e ID QDB0707 e ID QDB0708 e ID QDA0800 e ID QDBOSOL e ID QDBO802 e ID QDBO803 e CSV ID QDB0804 e ID QDA0900 e ID QDB0901 e
15. 12 2 Distribution Interested paty s QA 12 3 Relational documents QMS QMS 1 QMS e ID QDS0100 2 QMS ID QDB0601 ID QDB0602 ID QDBO603 ID QDB0604 ID QDB0605 ID QDB0606 HE ID QDB0607 ID QDB0608 ID QDB0609 ID QDB0610 ID QDB0611 ID QDB0612 l Wi mu zw zw ND ii X F PORE LEM zm mE H ATEEEE
16. 2 1 3 Normative reference 2 1 4 Informative reference e ISO TR14969 First edition 13485 2003 e Design Control Guidance For Medical Device Manufacturers UPM Copyright C 2014 UPMC All Rights Reserved ID QDA0600 01 6 39 Product design and development control standard 3 Application control of Product design and development control standard 3 1 Responsibility and authority responsibility authority 3 2 Start trigger and exit trigger 3 2 1 Start trigger trigger ID AAT E ID trigger input document
17. 32 SEMEL s T M 32 10 4 2 PQR6 i 32 11 i 33 Copyright C 2014 UPMC All Rights Reserved ID QDA0600 01 amp Product design and development control standard 12 ICES TIE 2 pdApu 2 MNMMMRMMRMKEKHHFRRSoHooaKKEKRKKRRNNRNNNNNMM 34 CAE VIS E E A A A E A E E 34 AA a 34 2 34 13 ani EIE 36 UPM Copyright C 2014 UPMC All Rights Reserved ID QDA0600 01 amp Product design and development control standard 5 36 1 Objective and scope 1 1 Objective 1 2 Scope A a d 2 Regulations and standards 2 1 1 Applicable regulations 2 1 2 Applicable standards
18. 1 ji E MERR ID QDC06003 QDC06004 5 4 2 FI S F S F S UPM DRO Copyright C 2014 UPMC All Rights Reserved
19. ID trigger output document Template ID QDCO1008 1 PQR5 Z zz 9 4 Process 9 4 1 DMR DHR e DMR DHR DMR DHR ii 9 4 2 2 o 9 4 3 ID DMR QDC03018 UPM Copyright C 2014 UPMC All Rights Reserved ID QDA060
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21. PQR5 ID O EH bid 008 UPM Copyright C 2014 UPMC All Rights Reserved EH aual gt 31 36 ID QDAO600 01 Product design and development control standard 10 Production closing phase 10 1 Flowchart PQR6 Copyright C 2014 UPMC gt Ww id Viu E All Rights Reserved ID QDA0600 01 amp Product design and development control standard 32 36 10 2 Start trigger trigger
22. Copyright C 2014 UPMC A UPM did MEE All Rights Reserved
23. e DB5 e DR6 e DR7 SE UPM Copyright C 2014 UPMC All Rights Reserved EH aual gt 9 36 ID QDAO600 01 Product design and development control standard 5 User reduirements analysis phase 5 1 Flowchart PQR1 F S F S DRO PQR1 2m Copyright C 2014 UPMC A UPM did MEE All Rights Reserved ID
24. 28 36 ID QDA0600 01 Product design and development control standard 9 Production phase 9 1 Flowchart DR7 PQR5 n n Copyright C 2014 UPMC UPM PE All Rights Reserved ID QDA0600 01 E ux HH EX H Product design and development control standard 29 36 9 2 Start trigger tigger ID d x y PE ID trigger input document Template ID 1 QDCO1008 PQR4 9 3 Exit trigger trigger ID
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29. Process 6 4 1 1 amp ID QDC01023
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31. A PHA UPM Copyright C 2014 UPMC All Rights Reserved E Per ID QDA0600 01 Product design and development control standard 16 36 FMEA 6 wu cup qul N MB MB Xa uu up mul F Dun
32. ID 4T PNE ID trigger input document Template ID 1 QDCO1008 PQR5 10 3 Exit trigger tigge ID ID trigger output document Template ID 1 QDCO1008 PQR6 10 4 Process 10 4 1 ID DMR LAE QDC03018 10 4 2 PQR6 ID nco1oos
33. RR UE ID gt gt F E Y gt z S ES Mr c AVC lopco1oos Copyright C 2014 UPMC UPM Ad 9 All Rights Reserved J EH aual gt 24 36 ID QDA0600 01 Product design and development control standard 8 Design transfer phase T 8 1 Flowchart DR5 DR6 PQR4 CHIERE Copyright C 2014 UPMC gt Ww id Viu E All Rights Reserved
34. ID QDC06015 7 4 6 Ka aul uil HR DR4 Bl ERTI MZ ID QDC01023 PQRS3 UPM Copyright C 2014 UPMC All Rights Reserved 23 36 ETES ID QDA0600 01 Binn HUE BERAE Product design and development control standard FR IE 7 4 7 Bx n SE ID QDCOI024 7 4 8 PQR3
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40. e e e Copyright C 2014 UPMC gt Ww EUM a dct All Rights Reserved ID QDA0600 01 Product design and development control standard 8 36 4 3 Product quality review PQR1 e PQR2 e PQR3 e PQR4 e PQR5 e PQR6 4 4 Design and development review 4 IK 8 6 DRO e DR1 e DR2 Lv LA bo e DRS3 e DR4
41. H UPM Copyright C 2014 UPMC All Rights Reserved ETE ID QDA0600 01 amp 33 36 Product design and development control standard 11 Definition of terms terms explanation Copyright C 2014 UPMC UPM Ad 9 All Rights Reserved 34 36 ID QDA0600 01 Product design and development control standard 12 Document control of Product design and development control standard 12 1 Responsibility and authority responsibility authority QMS QA QMS QA QA
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44. D trigger output document Template ID 1 QDCO1008 PQRS3 2 QDC01008 PQR3 7 4 Process 7 4 1 x
45. Template ID 1 3 2 2 Exit trigger trigger ID ID trigger output document Template ID 1 QDC01008 UPM Copyright C 2014 UPMC All Rights Reserved J EH aual gt 7 36 ID QDA0600 01 Product design and development control standard 4 Product life cycle 4 1 Flowchart A P Er LE z ge P P 4 2 Phase 6 e e e
46. o7023 QDCO6031 QDCO06032 ax 2 EA lt EX H ni EX n opco803 ETT ET e a a O PIPERIS DOOBIE ETE QDCO6036 UPM Copyright C 2014 UPMC All Rights Reserved ID QDA0600 01 Jj noua Product design and development control standard 21 36 FE zJua QDC06037 opcoe038 7 4 2 UR ET EE NS ID
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