首先是生肖虎的朋友们。虎年出生的人敢于接受挑战，他们的创新精神和决断力使他们在商业领域中脱颖而出。他们的勇往直前和不怕困难的性格常常使他们的业务不断扩大。 其次是生肖龙的朋友们。龙年出生的人拥有天生的领导才能和魄力，他们的独特视角和进取心使他们能够带领团队向前，也因此他们往往能够有效地运营业务，使其日益壮大。 然后是生肖鼠的朋友们。鼠年出生的人机敏，有眼光，他们懂得发现和抓住机会，他们在商业领域中往往能预见未来的趋势，这使他们的生意常常能茁壮成长。 最后是生肖蛇的朋友们。蛇年出生的人精明，他们在管理和谈判方面的能力使他们在商业领域中游刃有余。他们善于利用资源并找到最佳的解决方案，使他们的生意越做越大。

一、水瓶女 水瓶女从不随波逐流，具有非常独立的精神特点，喜欢沉迷于自由的天地，而且水平都属于比较理性的，她们会尽心尽力去和自己感兴趣的人相处，而且他们干净利落的态度也非常招人喜欢。接触过他们的人都会觉得，她们特别可爱，特别平易近人，她们也最容易被男生当成暗恋对象。 二、射手女 射手女性格都很爽朗，在和人的相处中也不会咄咄逼人，而且她们总是能够轻易俘获异性的欢心，所以身边总是不乏追求者，而且射手女的颜值也非常高，她们在和男生相处的时候，非常洒脱，所以，射手女也经常被男生当做暗恋对象。 三、双鱼女 双鱼女的性格都比较和善，特别喜欢助人为乐，而且大多数双鱼女都属于通情达理的类型，她们不会整天因为一点小事就愁眉苦脸，影响到身边人的心情，所以这样的双鱼女最能激起男生的保护欲，她们也经常被男生当作爱恋对象。

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