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1、XXX LimitedDocume nt NameISO13485:2021 Quality Con trol ManualPage Code1/16Versio nADocume ntCodeQM-A-01Edited/Revised Date2021.10.24Issued Date2021.10.24Table of Contents1. Purpose & Scope22. Applicable Stan dards23. Busin ess Profile24. Authority & Resp on sibility25. Terms & Defin iti ons26. Poli
2、cy & Objectives37. Applicati on48. Quality Man ageme nt System49. Man ageme nt Resp on sibility610. Resource Man ageme nt811. Product Realizati on812. Purchas ing1113. Production Control / Product Identification & Traceability1214. Con trol of In specti on, Measuri ng, and Test Equipme nt1315. Measu
3、reme nt, An alysis, Improveme nt14If this man ual is prin ted, it is an UNCONTROLLED copy.Docume nt NameISO13485:2021 Quality Control ManualPage Code2/16Versio nADocume ntCodeQM-A-01Edited/Revised Date2021.10.24Issued Date2021.10.241. Purpose & ScopeThis man ual describes the Quality Man ageme nt Sy
4、stem (QMS) established by and forDon ggua n XXX Applia nces Limited.The principles and policies on which this manual is based; along with operating procedures, workin struc-ti ons, and other support ing docume nts; gover n all processes that affect quality throughout the orga ni za-ti on.2. Applicab
5、le Stan dards2.1 The QMS is structured and intended to be in compliance with the following standards.ISO 13485:2021 Medical Devices Quality Ma nageme nt Systems Requireme nts for Regulatory Purposes21 CFR Part 820 Quality System Regulation (Exclusio ns and Excepti ons no ted below.)2.2 Normative Ref
6、ere ncesISO 9000:2021 Quality Man ageme nt SystemsFun damentals and VocabularyISO 13485:2021 Medical devices Quality Ma nageme nt SystemsGuida nce on the Applicati on of ISO13485:20213. Bus in ess Profile3.1 Missi on Stateme ntTo deliver zero defects to our in ter nal and external suppliers and cust
7、omers.3.2 XXX, with one facility located at xxx, Dongguan City, Guangdong Province, China.3.3 The organizational structure is described by Dongguan XXX Appliances Limited Organization Chart.4. Authority & Respo nsibility4.1 This man ual is issued un der the authority of the Preside nt.4.2 It is the
8、responsibility of the Director of Quality, who is the designated Management Representative, to en sure that the pri nciples of this man ual, the Quality Policy, quality objectives, customer requireme nts, applicable regulatory requireme nts, and quality man ageme nt system requireme nts are promoted
9、, com-mu ni cated to and un derstood by all XXX employees.5. Terms & Defin iti ons5.1 Corrective Acti onA process improveme nt methodology aimed at ide ntify ing and elim in at ing the causes of known non-con formities to preve nt their recurre nce. A problem solvi ng process.Docume nt NameISO13485:
10、2021 Quality Con trol ManualPage Code3/16Versio nADocume ntCodeQM-A-01Edited/Revised Date2021.10.24Issued Date2021.10.245.2 Customer1. A bus in ess en tity and the in dividuals represe nting it that specify and purchase products produced byXXX.2. A bus in ess en tity con sideri ng XXX as a pote ntia
11、l supplier.5.3 Customer Complai ntA commu ni cati on from a customer express ing dissatisfacti on with product or service or a concern based on observations or perceptions of XXX ; classified as Formal Complaint, Informal Complaint, or Customer Return.5.4 Customer FeedbackCustomer assessme nt of XXX
12、s performa nee as it relates to meet ing customer requireme nts an d/or expectati ons.5.5 ProcessA set of in terrelated resources and activities; i.e. people, materials, equipme nt, en vir onment, methods;used to tran sform specific in puts into specific outputs.5.6 Product1. The end result of activ
13、ities performed and resources applied by XXX; a process output.2. Purchased goods and services.5.7 Preve ntive Acti onA process improveme nt methodology aimed at ide ntify ing and elim in at ing pote ntial causes of noncon-formities before they occur.A risk man ageme nt process.5.8 QualifiedHaving a
14、ttained the knowledge, skills, or other attributes necessary to perform a particular activity or task in accorda nee with specified requireme nts.6. Policy & Objectives6.1 Quality PolicyOur goal, at XXX, is to provide products and services that comply with applicable requireme nts and exceed our cus
15、tomers expectati ons. This will be accompfed through employee in volveme nt andongoing educati on to en sure contin uous improveme nt of our processes.This quality policy is commu ni cated to all employees as part of their trai ning, with the intent of provid-i ng a clear, com mon un dersta nding, directly applicable to their work. The quality policy is reviewed at least once per year for con ti nuing suitability and adequacy.6.2 Quality Objectives? Only Defect -Free Product and Services shipped/provided to customers/suppliersDocume nt NameISO13485:2
