ISO9001：2025质量手册-英文版.docxVIP

QualityManual

[OrganizationName]

*InConformitywithISO9001:2025*

Version:[X.X]

DateofIssue:[MonthYear]

Status:Controlled

TableofContents

1.Introduction

2.Scope

3.NormativeReferences

4.TermsandDefinitions

5.ContextoftheOrganization

6.Leadership

7.Planning

8.Support

9.Operation

10.PerformanceEvaluation

11.Improvement

1.Introduction

2.Scope

2.1Purpose

2.2Application

TheQMS,asdescribedinthismanual,appliestoallcoreandsupportingprocessesof[OrganizationName],including[specificprocesses,e.g.,“designanddevelopment,production,servicedelivery,andsuppliermanagement”].Itcoversallsitesanddepartmentsinvolvedindeliveringproducts/servicestocustomers,aswellasadministrativefunctionsthatsupporttheseactivities.

2.3Exclusions

NoclausesofISO9001:2025havebeenexcludedfromthescopeofthisQMS.Allrequirementsofthestandardareapplicableto[OrganizationName]’soperations,asourprocessesdonotincludeactivitiesthatwouldnecessitatejustifiedexclusionsunderISO9001:2025,Clause4.3.

3.NormativeReferences

ThefollowingdocumentsareintegraltotheapplicationofthisQualityManual:

ISO9001:2025,*Qualitymanagementsystems—Requirements*

ISO9000:2025,*Qualitymanagementsystems—Fundamentalsandvocabulary*

4.TermsandDefinitions

ForthepurposesofthisQualityManual,thetermsanddefinitionsspecifiedinISO9000:2025apply.Additionalorganization-specifictermsaredefinedbelow,wherenecessary,toclarifycontext:

KeyProcess:AprocessidentifiedascriticaltomeetingcustomerrequirementsormaintainingQMSeffectiveness(e.g.,“customerorderprocessing”or“finalproductinspection”).

5.ContextoftheOrganization

5.1UnderstandingtheOrganizationandItsContext

[OrganizationName]regularlyassessesinternalandexternalfactorsthatmayimpactitsabilitytodeliverqualityproducts/services.Internalfactorsinclude