ISO13485：2016文件控制程序-英文版.pdfVIP

QOP-42-01ControlofDocuments(fulltext)

Issuedby:AQACo.Inc.EffectiveDate:7/30/2017Rev.#Pg.1of9

Thisprocedureprovidesgeneralrulesforcontrollingdifferentcategoriesofdocuments,and

documentsindifferentmedia.

TheproceduresisbasedontheassumptionthattheIMSXpresssystemisusedfor

controllingmostofthedocuments,butthattherealsoaresomepaperdocuments(legacy

drawings,customerdocuments,etc.).

IMSXpressDocumentControlsystemissuitableforcontrollinganycategoryandtypeof

documents,includingengineeringdrawings,specifications,reports,etc.

IPURPOSE

Thepurposeofthisprocedureistoprovideforasystemandinstructions,andtoassign

responsibilitiesfortheestablishment,review,authorization,issue,distribution,andrevision

ofcontrolleddocuments.

IIAPPLICATION

Thisprocedureappliestothefollowingcategoriesofdocuments:

MakesuretocoordinatethislistwithQualityManualSection4.2wherethesedocuments

arealsolistedanddefined.Editthelisttobeappropriateforyourcompany,forexample,if

youdontinstallorserviceyourdevices,deleteanyreferencestoinstallationandservicing.

Qualitymanual;

Operationalprocedures;

Workinstructions;

Forms;

Device,labelingandpackagingspecifications;

Manufacturing,installationandservicingspecifications;

Qualityassuranceproceduresandspecifications;and

Standardsandcodes.

IIIPROCEDURE

1IMSXpresselectronicdocumentcont