7.3设计与开发的理解要点和审核思路

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1、7.3设计与开发的理解要点和审核思路Understandthemainpointsandideasofaudit2009-10-1609:40:13,classification7.3designanddevelopmentofthesystem:

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3、nameandsubscription.7.3.1DesignanddevelopmentplanningTheorganizationshallplanandcontrolthedesignanddevelopmentoftheproduct・Theorganizationshalldeterminewhendesigningand

4、developingtheplan:A)designanddevelopmentphase;(b)forreview,validation,andvalidationactivitiesateachdesignanddevelopmentphase;C)responsibilitiesandauthorityfordesignanddevelopmentTheorganizationshallmanagetheinterfacesbetweenthedifferentdepartmentsinvolvedinthedesignanddevelopmenttoensureeffectiveco

5、mmunicationandcleardivisionofresponsibilitiesAsplannedanddeveloped,theplannedoutputshallbeupdatedasappropriate7.3.1PlanningandDesign一一Understanding1)designanddevelopment:asetofprocessesthattranslaterequirementsintoproducts,processes,orsystemsthatspecifycharacteristicsorspecifications2)theobjectofde

6、signanddevelopmentcanbe"productprocesssystem";3)thetermreferstothedesignanddevelopmentoftheproduct;4)toensurethedesignanddevelopmentofanyproduct,threeitemsshouldbeguaranteed:A)designanddevelopmentphase;(b)forreview,validation,andvalidationactivitiesateachdesignanddevelopmentphase;C)responsibiliti

7、esandauthorityfordesignanddevelopment5)managetheinterfacesbetweenthevariousdepartmentsinvolvedinthedesignanddevelopment,anddefinethedivisionofresponsibilities;6)plannedoutputs(suchasdesignplans)willbeupdatedasnecessaryinaccordancewiththeprogressofdesignanddevelopment7.3.1Designanddevelopmentplannin

8、greviewideas1)doestheorganizationhaveproductdesignanddevelopmentactivities?1)whichproductshavedesignanddevelopmentactivities?2)doyouhaveataskplanorplanforproductdesignanddevelopment?3)doesitincludethreerequirementsinthestandard?4)doestheinterfacebetweenthedepartmentsinvolvedinthedesignbeclearandist

9、hedivisionofresponsibilitiesclear?5)isthereanychangeintheplannedoutputandisthechangesuitable?7.3.2DesignanddevelopmentinputInputsrelatedtoproductrequirementsshallbedeterminedandrecordsmaintained(see4.2.1)sh