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Medical devices — Quality management systems —...

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Medical devices — Quality management systems —...

relationship between ISO 13485 and ISO 9004. The key ... introductory subclause are the ones between ISO 13485 and ISO 9001 and ISO/TR 14969.

http://sic.com.ua/wp-content/uploads/2009/11/iso-13485-2003.pdf

Date added: January 26, 2013 - Views: 544

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TECHNICAL ISO/TR REPORT 14969

... and comments related to the content of ISO 13485:2003 and/or ISO/TR 14969:2004. ... of ISO 13485:2003 either by revision of ISO/TR 14969 or the development of a ...

http://www.evs.ee/eelvaade/iso-tr-14969-2004-en.pdf

Date added: May 6, 2013 - Views: 169

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ISO 13485 Registration Guidance Document - NQA

ISO 13485 Registration Guidance Document Introduction This document is written to help you understand your organization’s role and responsibilities in the

http://www.nqa.com/Nqa.com/media/PDF-Download-Documents/Registration%20Guidance%20US/ISO-13485-Registration-Guidance.pdf

Date added: March 27, 2015 - Views: 1

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ISO 13485:2003 ISO 13485:1996 Most significant...

ISO 13485:2003 ISO 13485:1996 Most significant differences ... New, refers to ISO/TS 14969 to guide application of ISO 13485:2003 0.4 Compatibility with other

http://www.qmii.com/content/downloads/Handout%201996%20to%202003%20differences%20to%20ISO%2013485.pdf

Date added: April 17, 2012 - Views: 30

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ISO 13485-9001 All In One Documentation and...

• Comparison between ISO 9001-and-ISO-13485: ... • ISO/TR 14969:—1), Medical devices — Quality management systems — Guidance on the application of ISO

http://13485store.com/downloads/samples/iso-9001-13485-all-in-one.pdf

Date added: June 22, 2013 - Views: 21

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ISO 13485:2003 - An Introduction

ISO 13485:2003 promotes a process approach when developing, implementing, and improving a QMS. Requirements ... ISO/TR 14969. Thank you on behalf of Study Group 3

http://www.qacompass.com/wp-content/uploads/2011/05/iso13485PP.pdf

Date added: June 6, 2013 - Views: 32

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Quality Management System Certification - BSI...

BSI Understanding Quality Management System certification The ISO 13485 standard is an effective solution to meet the comprehensive requirements for

http://www.bsigroup.com/LocalFiles/en-GB/iso-13485/resources/BSI-ISO13485-Product-Guide-UK-EN.pdf

Date added: November 5, 2013 - Views: 41

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ISO 13485:2003 Training - QA/RA Compliance...

9To discuss the differences between ISO 13485 and ISO 9001 ... 14969 ISO 13485 ISO 9001 Q u a lit y Ma na ge m e n t S y st e m s Fu nd am e n t a ls an d Vo c a b u ...

http://www.qaracc.com/PDF/ISO_13485_Training_2_pp_Brochure.pdf

Date added: January 28, 2012 - Views: 118

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What is the relationship between FDA's Quality...

FDA's Quality System Regulation Part 820, is harmonized with ISO 13485:1996 , which is based on ISO 9001:1994 . ISO 13485 :1996 contains requirements for

http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/PostmarketRequirements/QualitySystemsRegulations/UCM134625.pdf

Date added: October 27, 2011 - Views: 49

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MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS -...

systems — Guidance on the application of ISO 13485:2003 ... application of ISO 13485:2003 either by revision of ISO/TR 14969 or the development of a “Frequently ...

http://infostore.saiglobal.com/store/PreviewDoc.aspx?saleItemID=871619

Date added: January 7, 2014 - Views: 1

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Nederlandse praktijkrichtlijn NPR- ISO/TR 14969

Nederlandse praktijkrichtlijn NPR-ISO/TR 14969 (en) Medical devices - Quality management systems - Guidance on the application of ISO 13485:2003

https://www.nen.nl/pdfpreview/preview_98620.pdf

Date added: July 4, 2015 - Views: 1

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IAF Mandatory Document for the Application of ISO...

This document follows the structure of ISO/IEC 17021. IAF specific ... ISO/TR 14969:2004 Medical devices ... ISO 13485 requires the organization to ...

http://www.iaf.nu/upFiles/IAFMD92011ApplicationofISO17021inMDQMSIssue1v2Pub.pdf

Date added: February 12, 2014 - Views: 32

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13485-FDA Internal Audit Checklist -...

ISO 13485:2003/FDA QSR - INTERNAL AUDIT CHECKLIST ... • ISO/TR 14969:—1), Medical devices — Quality management systems — Guidance on the application

http://www.complianceonline.com/images/supportpages/10389/13F-Internal-Audit-Checklist.pdf

Date added: November 16, 2012 - Views: 727

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Introduction to: ISO 13485 - BSI Group

Introduction to: ISO 13485 ... the use of ISO 13485 as the basis for a quality management system implemented by ... Interpret the clauses of ISO 13485 using ISO 14969

http://www.bsigroup.com/Documents/medical-devices/training/BSI-ISO-13485-Medical-Devices-training-course-guide-introduction-UK-EN.pdf

Date added: July 10, 2013 - Views: 22

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ISO 13485-9001 Small Business Package

ISO 13485-9001 Small Business Package ... Here is a list of the standards referenced in ISO 13485 bibliography ... • ISO/TR 14969: ...

http://13485store.com/downloads/samples/iso-9001-13485-small-business-package.pdf

Date added: August 30, 2014 - Views: 6

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INTERNATIONAL ISO STANDARD 13485

ISO 13485:2003(E) 0.3.2 Relationship with ISO/TR 94969 ISO/TR 14969 is a Technical Report intended to provide guidance for the application of ISO

http://www.fbpgroup.org/pages/EffectiveFiles/Standards/ISO%2013485-2003.pdf

Date added: February 5, 2012 - Views: 28

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ISO 13485 Certification - LifeSciences BC

ISO 13485:2003 • ISO 14971:2000 Application of Risk Management to Medical Devices • ISO 14969:2004 Guidance on the Application of ISO 13485:2003.

http://www.lifesciencesbc.ca/files/PDF/ISO_13485_Certificate.pdf

Date added: March 21, 2012 - Views: 19

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13485-9001-Internal Audit Checklist -...

ISO 13485:2003 - INTERNAL AUDIT CHECKLIST ... • ISO/TR 14969:—1), Medical devices — Quality management systems — Guidance on the application of ISO 13485:2003

http://www.complianceonline.com/images/supportpages/10383/139-Internal-Audit-Checklist.pdf

Date added: January 8, 2013 - Views: 281

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TECHNICAL REPORT CEN ISO/TR 14969 RAPPORT...

the application of ISO 13485:2003 ... ISO/TR 14969 has been managed by the CEN/CENELEC Co-ordinating Working Group on quality supplements for medical devices ...

http://www.evs.ee/preview/cen-iso-tr-14969-2005-en.pdf

Date added: October 2, 2012 - Views: 40

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GD210: ISO 13485:2003 Quality Management System...

... ISO 13485:2003 Quality Management System Audits ... ISO/TR 14969:2004 Medical ... Guidance on the content of ISO 13485 and ISO 13488 quality system ...

http://www.emergogroup.com/sites/default/files/file/canada-cmdcas-13485audits-v2.pdf

Date added: October 2, 2014 - Views: 6

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When Recognition Matters

... BASED ON ISO 13485 ... System (QMS) as specified in ISO 13485, as well as ISO 14969 (Medical devices ... ISO 27001 Training Exam Certification

http://pecb.com/pdf/brochures/1/iso-13485-foundation_1p.pdf

Date added: February 27, 2015 - Views: 1

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Checklist for Determining Design and Development...

Checklist for Determining Design and Development Inputs (ISO 14969:2004 (Section 7.3.2.1) and ISO 13485:2003 (7.3.2) Documentation for previous designs Synthes Large ...

http://xa.yimg.com/kq/groups/19251760/564293404/name/APPENDIX+B+-+CHECKLIST+FOR+DETERMINING+DESIGN+AND+DEVELOPMENT+INPUTS.pdf

Date added: June 12, 2013 - Views: 20

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NORMA TÉCNICA NTC COLOMBIANA 947-1

LA NORMA ISO 13485:1996 ... 0.3.2 Relación con el Informe Técnico ISO/TR 14969 El Informe Técnico ISO/TR 14969, ...

http://tienda.icontec.org/brief/NTC-ISO13485.pdf

Date added: August 4, 2015 - Views: 1

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Understanding ISO 13485:2003 for Medical Devices...

Understanding ISO 13485:2003 for Medical Devices (Plexus Curriculum) ... o The purpose of ISO 14971 and ISO/TR 14969 and their relationship with ISO 13485:2003

http://www.asqphilly.org/Site/pdf/SC325_Understanding%20ISO%2013485%202003.pdf

Date added: August 30, 2014 - Views: 1

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TM Summer 2005 Quality Systems and CE Marking —...

to ISO 13485:2003, and some future trends. Words in italics are defined in a glossary at the end of the article. ... and issued as ISO/TR 14969:2004,

http://gmprocedures.com/news_letters/news0605.pdf

Date added: August 4, 2015 - Views: 1

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ISO/TR 14969:2004, Medical Devices - Quality...

ISO/TR 14969 Medical devices - Quality mangement systems - Guidance on the ... Will EN ISO 13485:2012 be revised when ISO 13485 is like ISO/TR 14969:2004 Medical

http://perennial57.isoiec20000qualifications.com/youll/iso-tr-14969-2004-medical-devices-quality-mangement-systems-tdaoijb.pdf

Date added: July 26, 2015 - Views: 1

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CERTIFIED ISO 13485 LEAD IMPLEMENTER

This training is fully compatible with ISO 14969 guidance ... The “Certified ISO 13485 Lead Implementer” exam fully meets the requirements of the PECB Examination ...

http://pecb.com/pdf/brochures/4/iso-13485-lead-implementer_4p.pdf

Date added: August 4, 2015 - Views: 1

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Europe Adopts EN ISO 13485:2001 ( ISO 13485:1996)...

transition to ISO 13485:1996 or ISO 13488:1996 before EN 46001:1996 and EN 46002:1996 are fully withdrawn on 1 March 2004.

http://www.taika.com/files/application-of-risk-management-to-medical-devices.pdf

Date added: May 31, 2012 - Views: 43

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Quality and Medical Devices: ISO 13485:2003 -...

O3 Enterprise s.r.l. Medical Device ISO 13485 Quality Management Systems Quality and Medical Devices: ISO 13485:2003 Quality Management System requirements for

http://www2.units.it/accardo/SPRING-SCHOOL/Poli.pdf

Date added: June 20, 2014 - Views: 10

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Medical Devices Quality Management Systems...

Course Description BSI’s “Lead Auditor: ISO 13485” course teaches the principles and practices ... Explain the relationship with ISO/TR 14969 and the ISO 9000 ...

http://medicaldevices.bsigroup.com/LocalFiles/en-GB/Training/BSI-md-lead-auditor-iso-13485-training-flyer-UK-EN.pdf

Date added: March 19, 2014 - Views: 13

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GUÍA TÉCNICA GTC- ISO/TR COLOMBIANA 14969

guÍa tÉcnica gtc-iso/tr colombiana 14969 2007-08-29 dispositivos mÉdicos. sistemas de gestiÓn de la calidad. guÍa para la aplicaciÓn de la iso 13485:2003

http://tienda.icontec.org/brief/GTC-ISO-TR14969.pdf

Date added: March 31, 2014 - Views: 3

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other industries - Product Development and...

ISO 9001:2008 and ISO 13485:2003 f 14969 August 12, 2013 August 12, 2016 Certificate Number: First Issued: Valid Until: For and on behalf of NQA, USA, 4 Post Office ...

http://www.foliage.com/images/Footer_PDFs/Foliage_Inc-_ISO_13485_Certificate.pdf

Date added: May 21, 2014 - Views: 1

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CERTIFIED ISO 13485 LEAD IMPLEMENTER -...

This training is fully compatible with ISO 14969 guidance ... The “Certified ISO 13485 Lead Implementer” exam fully meets the requirements of the PECB Examination ...

http://www.continuitylink.com/public/brochures/ISO13485-LI-p4-English.pdf

Date added: July 25, 2015 - Views: 1

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ISO/TR 14969:2004-10 (E)

-1 - ISO/TR 14969:2004-10 (E) Medical devices - Quality mangement systems - Guidance on the application of ISO 13485: 2003 Contents Page Foreword ...

http://www.beuth.de/cmd%3Bjsessionid=OK2NECJ5R2DB0SPPV48VV2BM.3?workflowname=infoInstantdownload&docname=9603661&contextid=beuth&servicerefname=beuth&ixos=toc

Date added: August 4, 2015 - Views: 1

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Status Update of ISO 13485 - MEDEC

Status Update of ISO 13485 Linda Lindsay Director, RA USCAN GE Healthcare April 30, 2015

http://www.medec.org/webfm_send/2586

Date added: June 26, 2015 - Views: 1

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K EAC Code - Foliage

ISO 9001:2008 and ISO 13485:2003 f 14969 August 12, 2013 August 12, 2016 Certificate Number: First Issued: Valid Until: For and on behalf of NQA, USA, 4 Post Office ...

http://www.foliage.com/images/Foliage_Inc-_ISO_13485_Certificate.pdf

Date added: April 23, 2014 - Views: 2

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Sub scope provides confidence that conformity...

Sub scope provides confidence that conformity assessment results are equivalent ISO 13485 certificates are equivalent AB conforms to ISO/IEC 17011 + CB conforms to ...

http://www.fda.gov.tw/upload/189/Content/2013011111441681280.pdf

Date added: June 19, 2013 - Views: 2

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Intertek ISO 13485 CMDCAS Software rev 2.1 - FINAL

How to Prepare for ISO 13485:2003 ... • Interpretation document on the application of ISO 13485:2003: ISO/TR 14969. ... Intertek ISO 13485 CMDCAS Software rev 2.1 ...

http://itac.ca/uploads/pdf/Intertek.pdf

Date added: September 25, 2013 - Views: 2

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Medical devices — Quality management systems —...

This edition of ISO 13485 addresses quality assurance of product, ... It is intended to revise ISO/TR 14969 to provide guidance for the application for this version ...

http://infostore.saiglobal.com/store/PreviewDoc.aspx?saleItemID=2679597

Date added: April 2, 2014 - Views: 4

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Waters Quality System Documentation - Home :...

Waters Quality System Documentation ... This manual follows ANSI/ISO/ASQ Q9001:2008 and ISO 13485:2003 Quality Management Systems Requirements ... ISO/TR 14969:2004(E)

http://www.waters.com/webassets/other/corp/about/assets/files/wat000001qm.pdf

Date added: October 28, 2011 - Views: 97

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Iso 13485 Quality Manual

Iso 13485 Quality Manual ... Small Contract Medical Device Manufacturer ISO 13485 and ISO 14969 - Medical Devices - Quality Management Systems

http://pdf500.sildenafilhub.com/iso-13485-quality-manual-rhmbvaa.pdf

Date added: August 4, 2015 - Views: 1

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Setting Up a Quality System - FAKKEL bvba

Setting Up a Quality System for a Medical Device Company ISO 13485 ... - ISO 14969 : Guidance on the application of the ISO13485

http://www.fakkel-bvba.com/downloads/FAKKEL%20Clinical%20research_The%20ISO%2013485%20Qualtiy%20System.pdf

Date added: June 1, 2013 - Views: 4

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Setting the Medical Device Lifetime - Ombu...

Setting the Medical Device Lifetime . ... ISO 13485:2003 . ... ISO/TR 14969:2004 . ISO/TR 14969:2004 Medical devices ...

http://www.ombuenterprises.com/LibraryPDFs/Setting_the_Medical_Device_Lifetime.pdf

Date added: May 20, 2013 - Views: 16

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Willem van den Biggelaar - Process Vision

ISO 13485 Willem van den Biggelaar ... •ISO/TR 14969 Guidance on the application of ISO 13485 •Annex B of ISO 13485: difference between 13485 and 9001

http://www.processvision.nl/Training/KZOB%20ISO13485%20-%20Process%20Vision-V1.0.pdf

Date added: May 17, 2013 - Views: 6

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INTRODUCTION - Medsociate

The requirements of ISO 13485 3. Usage of ISO 14969 as guidance for the organisations ISO 13485 QMS ... perform ISO 13485 auditing with the skills and methodology ...

http://www.medsociate.com/uploads/5/2/6/6/52667897/iso13485_ia_course_brochure_(web).pdf

Date added: August 4, 2015 - Views: 1

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BSI Training Services Lead Auditor for ISO 13485...

Explain the relationship with ISO/TR 14969 and the ISO 9000 series BSI Training Services > Why should I attend? BSI’s “Lead Auditor: ISO 13485” course teaches ...

http://healthcare.org.hk/app_form/BSIISO13485.pdf

Date added: August 10, 2013 - Views: 13

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REGULATORY AUDITING OF QUALITY MANAGEMENT SYSTEMS...

of ISO 13485:2003. The audit strategy can be seen as guidance on how to audit the ... ISO 13485:2003: ... ISO/TR 14969:200X Guidance on the Application of ISO

http://www.mdb.gov.my/mdb/documents/auditing%20qms.pdf

Date added: February 9, 2012 - Views: 76

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IAF Mandatory Document Application of ISO/IEC...

... (ISO 13485) Issue 2 (IAF MD 9:2015) ... ISO/TR 14969:2004 Medical devices — Quality management systems — Guidance on the application of ISO 13485:2003

http://www.iaf.nu/upFiles/IAFMD9App17021MedicalDeviceQMSPublicationVersion.pdf

Date added: February 27, 2015 - Views: 1

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Medical device risk management using ISO 14971 -...

using ISO 14971 This White Paper ... management is however required as part of ISO 13485. ISO 14971 is also directed referenced in IEC 60601-1:2005 Medical Electrical ...

http://pharmout.net/downloads/mkt_wpr225_medical_device_risk_management_using_iso_14971_r01.pdf

Date added: April 17, 2013 - Views: 228