GMP Quality Manual质量手册Word文件下载.docx

GMP Quality Manual质量手册Word文件下载.docx

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POLICY方针

QUALITYSYSTEMDESCRIPTION质量系统描述

QUALITYDEFINITIONS质量定义

QUALITYACHIEVEMENT质量目标

QUALITYVERIFICATION质量确认

QUALITYIMPROVEMENT质量改进

ADMINISTRATIVECONTROLS行政控制

ComparisonMatrix比对矩阵

OrganizationalMatrixforQualitySystemFunctionalResponsibilities质量系统功能图

QualitySystemsOrganizationalChart质量系统组织机构图

ParentCategory上级分类

QualityManuals质量手册

QualityPolicy质量方针

Wearededicatedtoachievingcustomersatisfactionthroughanuncompromisingcommitmenttoquality.我们致力于让客户满意，承诺对质量永不妥协。

（保证产品质量，让用户满意）

Thesehighstandardsarerealizedthroughthefollowingpractices:

通过下列实践达到高标准

1.Anopendoorpolicythatenablesallpersonneltobringtomanagement'

sattentionanyconcernsregardingqualityachievementandcustomersatisfaction.

保证产品质量，让用户满意应成为每一员工的工作关注点。

2.Personnelperformingtheirworkinamannerthatensuresproductsandservicesmeetallqualityrequirements.

员工的操作方式、行为规范要以满足所有质量要求为基本准则。

3.Enablingpersonneltocarryouttheirresponsibilitiesbyprovidingthenecessarytraining,resources,andworkenvironment.

为员工提供必要的培训、资源及工作环境以保证员工履行其职责。

4.Thedevelopmentofamulti-disciplinarycollaborativeteamstructurethroughoutallactivitiesofthecompany.

构建多种学科协作的专业团队和组织架构。

5.Theapplicationofhighstandardstobusinessconduct,includingcontactswithcustomers,co-workers,andcollaborators.

建立和实施较高的企业营运（包括与与客户、合作商及合作人的联系与合作）操作标准。

References:

▪ISO9001,4.1.1,QualityPolicy

ManualObjectives质量目标

Wehaveestablishedaqualitysystemthatisdesignedtomeetdomesticandworldwideregulatorystandardsforitsproductsinthemarketplace.Thekeyapplicableregulatorystandardsinclude:

▪21CFRPart820,QualitySystemRegulationsforMedicalDevices

▪93/42/EEC,EuropeanMedicalDeviceDirective

▪ISO9001,ISOQualityManagementSystemsRequirements

▪ENISO13485:

2001,ISOQualitySystemsforMedicalDevices

Thequalitysystemaddressestheelementsnecessaryforimplementingqualitymanagementincludingtheorganizationalstructure,responsibilities,procedures,processesandresources.

TheQualityManualdescribesourqualitysystem.ThecentralobjectiveoftheQualityManualistohelpemployeesmeetallapplicableregulatoryrequirementsandtounderstandthequalitycommitments.InAppendixA,therequirementsof21CFR820,ISO9001andtheMedicalDeviceDirective93/42/EEChavebeencross-referencedtothesectionsofthisQualityManual.

Themanualdescribesanoverallprocessapproachofplanningforquality,applicationtoactivities,verification,andimprovement（Deming'

sPDCAcycle）.Whereapplicable,StandardOperatingProcedures（SOPs）applicabletoeachsectionarecited.TheQualityManualisupdated,reviewedandapprovedevery2years.ThecurrentversionoftheQualityManualisdistributedtoallpersonnel.

▪12-0048-SOP,ControlledExternalDocumentFile

▪ISO9001,4.2.1,DevelopQualitySystemDocuments

QUALITYSYSTEMDESCRIPTION

Scope

Thequalitysystemappliestoallourproductsandservices.Wehaveasingle,globalqualitysystemapplicabletoallworldwidelocations.

Commitment

Ourcommitmenttoqualityisdemonstratedwithacomprehensivesystemthatsatisfiesallapplicableregulatoryrequirements.Assuranceofqualityanditscontinuousimprovementrequiresthesupportoftheentireorganization.Qualityisassuredbyworkinginasystematicmannertoeliminatedefects,errors,andnonconformancethroughproperproductandprocessdesignandimplementation,andfollowingformalizedproceduresandworkinstructions.

Employeesareencouragedtobringtomanagement'

Weenablesallemployeesbyprovidingthefollowingsupport:

▪Specificjobskilltraining,

▪QualitySystemtraining,

▪Thenecessarytoolsandequipment,

▪Anenvironmentandtheresourcesthatpromotecontinuousimprovement.

QualityPlanning

Thequalityplanningprocessdefinesproductspecifications,meetsthespecificrequirementsforprojectsandcontracts,andensurescustomerneedsandexpectationsaremetorexceeded.Qualityplanningisachievedthroughacombinationofbusinessandproductplanning,projectteams,qualityimprovementplans,reviewofDeviceMasterRecorddocuments,internalandsupplieraudits,andemployeetraining.Thequalitysystemisfullydocumentedtoensurethatqualityplanningisconsistentwithallotherrequirements.

▪12-0050-SOP,DesignControlGuideline

▪12-0072-SOP,InspectionandTestRequirements

▪12-0073-SOP,ProcessControlGeneralRequirements

▪ISO9001,4.2.3,ControlQualitySystemDo