ISO13485：2022质量手册英文版(修改公司名及程序名就可直接套用).pdfVIP

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ISO13485：2022质量手册英文版(修改公司

名及程序名就可直接套用)

TableofContents

1.PurposeScope(2)

2.ApplicableStandards(2)

3.BusinessProfile(2)

4.AuthorityResponsibility(2)

5.TermsDefinitions(2)

6.PolicyObjectives(3)

7.Application(4)

8.QualityManagementSystem(4)

9.ManagementResponsibility(6)

10.ResourceManagement(8)

11.ProductRealization(8)

12.Purchasing(11)

13.ProductionControl/ProductIdentification

Traceability(12)

14.ControlofInspection,Measuring,andTest

Equipment(13)

15.Measurement,Analysis,Improvement(14)

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1.PurposeScope

ThismanualdescribestheQualityManagement

System(QMS)establishedbyandfor

DongguanXXXAppliancesLimited.

Theprinciplesandpoliciesonwhichthismanual

isbased;alongwithoperatingprocedures,work

instruc-tions,andothersupportingdocuments;govern

allprocessesthataffectqualitythroughoutthe

organiza-tion.

2.ApplicableStandards

2.1TheQMSisstructuredandintendedtobein

compliancewiththefollowingstandards.

ISO13485:2022MedicalDevicesQualityManagement

SystemsRequirementsforRegulatoryPurposes21CFR

Part820QualitySystemRegulation(Exclusionsand

Exceptionsnotedbelow.)

2.2NormativeReferences

ISO9000:2022QualityManagement

Systems·FundamentalsandVocabulary

I