医疗器械质量管理体系IShangsha.pdf

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1、ISO13485:2003ॱ⯍ಞỦ--䍞䠅㇗⨼։㌱--⭞ӄ⌋㿺Ⲻ㾷≸ḽ߼䇨䀙TÜVSÜD04/09/2013Slide1䇨ᐾԁ㔃⧁䐥RandyWang¾TÜVSÜDPSॱ⯍фڛᓭᵃࣗ䜞঍ѣള॰ᇗṮ㔅⨼¾ISO13485/ISO9001/MDD/J-GMP儎㓝ᇗṮ઎¾ᴿⓆॱ⯍ಞỦӝ૷щᇬTEL:075533323226Email:randy.wang@tuv-sud.cnTÜVSÜDGreaterTÜVSÜDChina13-09-04Slide2ISO13485:2003lj५⯇ಘỠ䍘䟿㇑⨶փ㌫⭘Ҿ⌅㿴Ⲵ

2、㾱≲NJഭ䱵ḷ߶ӻ㓽TÜVSÜDTÜVSÜDCorporatePresentation04/09/20131ISO13485ḷ߶ㆰӻӰѸᱟISOISO˛InternationalOrganizationforStandardizationഭ䱵ḷ߶ॆ㓴㓷५⯇ಘỠ-䍘䟿㇑⨶փ㌫-⭘Ҿ⌅㿴Ⲵ㾱≲⌅㿴㾱≲˖⌋ᗁ⌋㿺㾷≸ӻ䲆ᇐ൞ॱ⯍ಞỦⲺᆿޞૂᙝ㜳р˄ISO134855.1ISO134855.1⌘˅TÜVSÜDISO13485ḷ߶ㆰӻࡦᇊ˖ISO/TC210Qualitymanagementandcorrespo

3、ndinggeneralaspectsformedicaldevices˄ഭ޵ㅹ਼ḷ߶⭡SAC/TC221५⯇ಘỠ䍘䟿㇑⨶઼䙊⭘㾱≲ḷ߶ॆᢰᵟငઈՊࡦᇊ˅⭘䙄˖ᇎᯭ㓿ॿ䈳Ⲵ䍘䟿㇑⨶փ㌫Ⲵ⌅㿴㾱≲DŽ㓴㓷ਟ׍↔㾱≲䘋㹼५⯇ಘỠⲴ䇮䇑઼ᔰਁǃ⭏ӗǃᆹ㻵઼ᴽ࣑ԕ৺⴨ޣᴽ࣑Ⲵ䇮䇑ǃᔰਁ઼ᨀ׋DŽҏਟ⭘Ҿ޵䜘઼ཆ䜘˄वᤜ䇔䇱ᵪᶴ˅䇴ᇊ㓴㓷┑䏣亮ᇒ઼⌅㿴㾱≲Ⲵ㜭࣋DŽTÜVSÜDISO13485ḷ߶ㆰӻISO13485ᱟу䰘䪸ሩ५⯇ಘỠⲴ䍘䟿㇑⨶փ㌫ʽᡰ䉃¯५⯇ಘỠāᱟᤷ˖ࡦ䙐୶Ⲵ亴ᵏ⭘䙄ᱟѪлࡇањᡆཊњ⢩ᇊⴞⲴ⭘Ҿ

4、Ӫ㊫Ⲵˈн䇪অ⤜⭘ᡆ㓴ਸ⭘ⲴԚಘǃ䇮༷ǃಘާǃᵪಘǃ⭘ާǃἽޕ⢙ǃփཆ䈅ࡲᡆṑ߶ಘǃ䖟Ԧǃᶀᯉᡆ㘵ަԆ⴨լᡆ⴨ޣ⢙૱DŽ䘉ӋⴞⲴᱟ˖ʊʊ⯮⯵Ⲵ䇺ᯝǃ亴䱢ǃⴁᣔǃ⋫⯇ᡆ㘵㕃䀓˗ʊʊᦏՔⲴ䇺ᯝǃⴁᣔǃ⋫⯇ǃ㕃䀓ᡆ㘵㺕گ˗ʊʊ䀓ࢆᡆ⭏⨶䗷〻Ⲵ⹄ウǃᴯԓǃ䈳㢲ᡆ㘵᭟ᤱ˗ʊʊ᭟ᤱᡆ㔤ᤱ⭏ભ˗ʊʊྺၐ᧗ࡦ˗——५⯇ಘỠⲴ⎸∂˗——䙊䗷ሩਆ㠚ӪփⲴṧᵜ䘋㹼փཆỰḕⲴᯩᔿᶕᨀ׋५⯇ؑ᚟DŽަ֌⭘ҾӪփփ㺘ᡆփ޵Ⲵѫ㾱䇮䇑֌⭘нᱟ⭘㦟⨶ᆖǃ⯛ᆖᡆԓ䉒Ⲵ᡻⇥㧧ᗇˈնਟ㜭ᴹ䘉Ӌ᡻⇥৲оᒦ䎧аᇊ䖵ࣙ֌⭘DŽTÜVSÜDTÜVSÜD

5、CorporatePresentation04/09/20132ISO13485ḷ߶ㆰӻਁኅ䗷〻˖˖1996ᒤ䎧ᔰ࿻ਁᐳㅜа⡸ˈवᤜISO13485˖˖1996“1996“QualitysystemsQualitysystems--MedicaldevicesMedicaldevices--ParticularParticularrequirementsfortheapplicationrequirementsfortheapplicationofISO9001ofISO9001””ISO13488˖

6、˖1996“1996“QualitysystemsQualitysystems--MedicaldevicesMedicaldevices--ParticularParticularrequirementsfortheapplicationrequirementsfortheapplicationofISO900ofISO90022””ISO14969˖˖19992003ᒤ䎧ᔰ࿻ਁᐳㅜҼ⡸ˈवᤜISO13485˖˖2003“Medicaldevices2003“Medicaldevices——Qual

7、itymanagementQualitymanagementsystemssystems——Requirementsforregulatorypurposes”Requirementsforregulatorypurposes”ISO/TR14969˖˖2004“Medicaldevices2004“Medicaldevices——QualitymanagementQualitymanagementsystemssystems——GuidanceontheapplicationofISO13485:2

8、003”GuidanceontheapplicationofISO13485:2003”TÜVSÜDISO13485ḷ߶ㆰӻѫ㾱᧘㹼ഭᇦ——⅗⅗⍢˖2000ᒤ亱ᐳENISO13485˖˖2000઼઼ENISO13488˖˖2000ˈˈ2003ᒤ亱ᐳENISO13485˖˖2003ˈ൘५⯇ಘỠ㹼ъѝޘ䶒᧘㹼㹼ISO13485᯿ḷ߶ˈਆԓ৏ᴹⲴEN4600x㌫ࡇḷ߶ˈᱟCE䇔䇔䇱ѝ䍘䟿փ㌫㾱≲Ⲵ᰾⺞㿴ᇊDŽ㖾㖾ഭ˖QSR820ѝ㾱≲оISO13485˖˖200