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TECHNICAL ISO/TR REPORT 14969 - Vĩnh Long Province

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TECHNICAL ISO/TR REPORT 14969 - Vĩnh Long Province

application of ISO 13485:2003 either by revision of ISO/TR 14969 or the development of a ... This first edition of ISO/TR 14969 cancels and replaces ISO 14969 ...

http://thuvienkhcn.vinhlong.gov.vn/tailieukhcn/data/TieuChuantoanvan/ISO/ISO_TR_14969_2004.pdf

Date added: July 18, 2013 - Views: 30

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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: 528

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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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ANSI/AAMI/ ISO TIR14969:2004, Medical devices -...

Technical Information Report ANSI/AAMI/ISO TIR14969:2004 Medical devices—Quality management systems— Guidance on the application of ISO 13485:2003

http://marketplace.aami.org/eseries/scriptcontent/docs/Preview%20Files/149690412preview.pdf

Date added: March 13, 2012 - Views: 396

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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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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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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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Introduction to: ISO 13485 - British Standards

Introduction to: ISO 13485 ... Interpret the clauses of ISO 13485 using ISO 14969 Recognize the role and responsibilities of management in ISO 13485

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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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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News on the ISO 13485 revision - 2011 - 2012 (now...

Is the intent to bring out a revised version of ISO 14969 at around the same ... ISO 13485 cannot be used as a substitute for criteria that is laid down in the ...

http://elsmar.com/quality_assurance_pdf/The%20ISO%2013485%20revision%20-%202012.pdf

Date added: November 18, 2014 - Views: 1

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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: 716

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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: 13

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Post-Market Surveillance required by the EU’s MDD...

- ISO 13485 and ISO 14969 - Medical Devices - Quality Management Systems ... Post-Market Surveillance required by the EU’s MDD vs. ISO 13485 Requirements

http://elsmar.com/pdf_files/quality_assurance_pdf/Post-Market%20Surveillance%20required%20by%20the%20EU%E2%80%99s%20MDD%20vs.%20ISO%2013485%20Requirements.pdf

Date added: July 23, 2013 - Views: 6

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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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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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ISO 13485 Medical Device Management Systems Lead...

ISO 13485 Medical Device Management Systems ... This course teaches auditing principles using ISO 13485, ... Explain the relationship with ISO/TR 14969 and the ...

http://www.bsigroup.com/LocalFiles/en-SG/ISO%2013485%20SG/ISO%2013485%20Lead%20Auditor%20Training%20Medical%20Devices%20SG.pdf

Date added: March 11, 2014 - Views: 1

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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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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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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: 116

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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=5MAMEP6W6ZAIVUEZB1VEBVRM.2?workflowname=infoInstantdownload&docname=9603661&contextid=beuth&servicerefname=beuth&ixos=toc

Date added: April 26, 2015 - Views: 1

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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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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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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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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://www.gmplabeling.com/news_letters/news0605.pdf

Date added: February 1, 2012 - Views: 31

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ISO 9001 to ISO 13485:2003 QMS Upgrade...

ISO 13485:2003 = ISO 9001:2008 with some added + some deleted requirements. Here is more information ... • ISO/TR 14969:—1), ...

http://13485store.com/downloads/samples/iso-9001-13485-qms-upgrade.pdf

Date added: August 2, 2013 - Views: 20

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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: 12

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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: 96

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Medical devices — Quality management systems —...

ISO 13485:2003(E) PDF disclaimer ... ISO/TR 14969 is a Technical Report intended to provide guidance for the application of ISO 13485.

http://www.saiglobal.com/PDFTemp/Previews/OSH/iso/updates2003/07/ISO_13485_2003%28E%29-Character.pdf

Date added: August 30, 2014 - Views: 3

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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: 274

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ISO 13485:2003 / Cor 1:2009 - NIBSC - Home

ISO 13485:2003 / Cor 1:2009 EN ISO 13485:2012*, CAN/CSA ISO 13485-03 (R2008)* and ANSI/AAMI/ISO 13485:2003 (R2009)* The design and manufacture of liquid and freeze- ...

http://nibsc.org/pdf/ISO%2013485%202003%20Cor%201%202009.pdf

Date added: April 10, 2014 - Views: 1

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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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13485:2003 Internal Audit

basic understanding of ISO 13485:2003 requirements and ISO/TR 14969:2004 which is ... • ISO 13485:2003 Requirements, ...

http://www.entismanagement.com/upload/course/ISO13485-Internal-Audit-2-days.pdf

Date added: December 21, 2014 - Views: 1

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GHTF SG4 Guidelines for Regulatory Auditing of...

ISO 13485:2003: Medical devices - Quality management systems – Requirements for ... ISO/TR 14969:2004: Medical devices - Quality management systems ...

http://www.imdrf.org/docs/ghtf/final/sg4/technical-docs/ghtf-sg4-n30r20-guidance-regulatory-auditing-060628.pdf

Date added: March 11, 2013 - Views: 8

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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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CERTIFIED ISO 13485

This training is fully compatible with ISO 14969 guidance’s ... The “Certified ISO 13485 Lead Implementer” exam is available in different languages, ...

http://nebula.wsimg.com/92879c8ec519fa8356ee2e6bc821379c?AccessKeyId=E5403EAE8EC07D18AB33&disposition=0&alloworigin=1

Date added: July 4, 2015 - Views: 1

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INTERNATIONAL ISO STANDARD 13485

ISO 13485 was prepared by Technical Committee ISO/TC 210, Quality management and corresponding general aspects for medical devices. This second edition cancels and ...

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

Date added: February 5, 2012 - Views: 28

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Management System Certification for Medical Device...

ISO 13485:2003 Special Points and System/Process Requirements The ISO 13485:2003 standard has eight sections. Three sections are general information for manufacturers ...

http://www.sriregistrar.com/A55AEB/sricorporateweb.nsf/0/D1E1DC087A3B2A3D8625729900752FC1/$FILE/ISO+13485+V6.pdf

Date added: August 30, 2014 - Views: 1

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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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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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Process Validation for Medical Devices - Ombu...

Process Validation for Medical Devices 2 Ombu Enterprises ... – ISO/TR 14969:2004 Guidance on ISO 13485:2003 – ISO 14971:2007 Medical device risk management.

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

Date added: August 18, 2011 - Views: 67

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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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ANSI/AAMI/ ISO 13485:2003, Medical devices—Quality...

ANSI/AAMI/ISO 13485:2003 AAMI Association for the ... ISO/TR 14969 is a Technical Report intended to provide guidance for the implementation of ISO 13485.

http://marketplace.aami.org/eseries/scriptcontent/docs/Preview%20Files/134850306preview.pdf

Date added: September 20, 2012 - Views: 12

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Setting Up a Quality System - FAKKEL - clinical...

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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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: 1

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ISO/TC 210 N206 ISO/TC 210/WG 1 N61

ISO/TC 210 and WG 1 for comment after ... Review of the Second Working Draft Revision of ISO 14969:1999 ... text of ISO 13485:200X will undergo the unique ...

http://www.imdrf.org/docs/ghtf/final/sg3/meetings/ghtf-sg3-n61-meeting-minutes-020909-germany-berlin.pdf

Date added: August 24, 2013 - 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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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: 74

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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