质量手册

  Wujiang Cloud & Dragon Medical Device Co.,Ltd

                      Quality Manual

In view of YY/T0287-2017 Idt EN ISO13485-2016, MHLW MO169 (from Japan), CFR 820 (From USA), Australian TGA & Canadian CMDR Quality System Standard, Chinese “Manufacturing Quality Management Specifications of Medical Device” as well as MDSAP & MDD 93/42/EEC and MDR 2017/745 EU, article 120 of “Transitional period clause”.  

 

                      (YL/QM001)

 

                   Version No   E/5       

                   Controlled status  Controlled   

                   Controlled No     02         

 

Prepared by : Lv Kanting Nov 22 of 2022  Checked by: Wang Yanwen Nov 22 of 2022 

Approved by: Chen Yueting  Nov 22 of 2022

 

Issurance date: Nov 22 of 2022   Implementation date: Nov 22 of 2022

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

                    Document Modification Record

Modification No.	Date	Modification clause	Modified by	Approved by
A/0	March 25 of 1998	First issuance		Chen Shunyong
B/0	March 25 of 2004	The standard was upgraded to ISO13485:2003.	Ni Aimei	Chen Shunyong
C/0	March 25 of 2005	The original version (B) of the standard was upgraded to Version C.	Ni Aimei	Chen Shunyong
D/0	Dec 25 of 2009	The original version (C) of the standard was upgraded to Version D.	Ni Aimei	Chen Yueting
D/1	June 25 of 2010	The standard of EN ISO13485:2003 was upgraded to EN ISO13485:2003+AC:2009.	Chen Liang	Chen Yueting
D/2	Nov 25 of 2012	Added the requirements of “Manufacturing Quality Management Specifications of Medical Device (trial)” ; The standard of EN ISO13485:2003 was upgraded to EN ISO13485:2012.	Ding Yichun	Chen Yueting
D/3	June 28 of 2014	Added program documents in accordance with the law of 2013/473/EU.	Ding Yichun	Chen Yueting
D/4	Dec 28 of 2014	Changed executive representative from Ding Yichun to Wang Yanwen.	Wang Yanwen.	Chen Yueting
E/0	Sep 1 of 2017	The standard of EN ISO13485:2012 was upgraded to EN ISO13485:2016, and the version D of quality system was upgraded to Version E.	Wang Yanwen.	Chen Yueting
E/1	March 1 of 2018	Added the requirements of MDSAP.	Wang Yanwen.	Chen Yueting
E/2	July 25 of 2020	Added the production site as follows: West building FS-02, No 807, Ganquan West Road, Wujiang Economic-Technological Development Area, Suzhou city, Jiangsu province.	Wang Yanwen.	Chen Yueting
E/3	Feb 22 of 2021	Added the law of MDR 2017/745 EU, and the article 120 of “Transitional period clause”.	Wang Yanwen.	Chen Yueting
E/4	March 1 of 2022	Added facial acupuncture, Elongated Needle etc special needling instruments, round-sharp needle, blade needle.	Wang Yanwen.	Chen Yueting
E/5	Nov 18 of 2022	Because of modifications of Canadian laws & Japanese laws	Wang Yanwen.	Chen Yueting

                          

 

Table of Contents

 Document Modification Record ..........................................................................1

 Table of Contents .................................................................................................2

Approval page ....................................................................................................3

Scope, quoted standards, reduction note.................................................................4

Management of quality manual ..............................................................................5

Quality management system....................................................................................6

General requirements...............................................................................................6

Main process identification chart of quality management system...........................7

Document requirements............................................................................................8

Management responsibilities....................................................................................10

Management commitment........................................................................................10

Focus on customers...................................................................................................10

Quality direction........................................................................................................10

Planning.....................................................................................................................11

Responsibility, authority, communication..................................................................12

Organization Chart.....................................................................................................17

Element Allocation Table of quality management system.........................................18

Management audit...................................................................................................19

Resource management...............................................................................................20

Provision of Resources..............................................................................................20

Human resources........................................................................................................21

Infrastructure..............................................................................................................21

Work environment & pollution control......................................................................22

Product realization......................................................................................................22

Planning of product realization...................................................................................22

Process related to customer.........................................................................................23

Design & Development ..............................................................................................24

Sourcing.......................................................................................................................28

Manufacturing & provision of service.........................................................................29

Control of supervision & measuring equipment..........................................................32

Measuring, analysis & improvement............................................................................33

General rule...................................................................................................................33

Supervision & measuring..............................................................................................33

Control of unqualified products.....................................................................................36

Data analysis ..................................................................................................................37

Improvement...................................................................................................................38

Requirements of related laws..........................................................................................40

Appendix 1 Implementation Rules Comparison Chart of ISO 13485:2016 & GMP......42

Appendix 2 Program documents index ...........................................................................45