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ISO 13485 - Система Международной ...

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ISO 13485 - Система Международной ...

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: 509

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ISO 13485 Guidance Document - NQA, USA

ISO 13485 Registration Guidance Document . ... • ISO 14969:2004 Medical Devices ... Guidance on the Application of ISO 13485:2003 • ISO 14971:2007 Medical Devices ...

http://www.nqa-usa.com/pdf/ISO_13485_Guidance_Document.pdf

Date added: April 23, 2014 - Views: 18

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

ISO 13485:2003 PREVIEW COPY This is ... ISO 10993-17:2002 ANSI/AAMI/ISO 10993-17:2002 Identical ISO 11134:1994 ... This edition of ISO/TR 14969 is based on ISO 13485 ...

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

Date added: March 13, 2012 - Views: 390

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MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - GUIDANCE ON ...

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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Introduction to: ISO 13485 - Standards, Training, Testing ...

participants will also gain an awareness of the relationship between ISO 13485 and ISO 14971, ... 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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TECHNICAL REPORT CEN ISO/TR 14969 RAPPORT TECHNIQUE ...

CEN ISO/TR 14969 June 2005 ICS 11.040.01; ... the application of ISO 13485:2003 Dispositifs médicaux ... ISO/TR 14969:2005, ...

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

Date added: October 2, 2012 - Views: 40

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IAF Mandatory Document for the Application of ISO/IEC 17021 ...

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: 20

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13485-FDA Internal Audit Checklist - Online Regulatory ...

ISO 13485:2003/FDA QSR ... (and missing a few ISO 9001 requirements.) • This checklist adds US FDA QSR ... • ISO/TR 14969:—1), ...

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

Date added: November 16, 2012 - Views: 687

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News on the ISO 13485 revision - 2011 - 2012 (now 2014?)

Is the intent to bring out a revised version of ISO 14969 at around the same time, or is that a completely unrelated task? Marcelo Antunes 23rd January 2012 08:37 PM

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

Date added: November 18, 2014 - Views: 1

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ISO 13485 Guidance Document ISO 13485 - NQA, USA

ISO 14969:2004 Medical Devices ... NQA, USA quotations for ISO 13485 registration do not include CMDCAS or CE Marking conformance. Scope and Exclusions

http://www.nqa-usa.com/pdf/Guidance%20Document%20ISO%2013485.pdf

Date added: November 8, 2013 - Views: 5

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TECHNICAL ISO/TR REPORT 14969 - Esileht - Eesti Standardikeskus

ISO/TR 14969:2004(E) © ISO 2004 TECHNICAL REPORT ISO/TR ... application of ISO 13485:2003 either by revision of ISO/TR 14969 or the development of a “Frequently ...

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

Date added: May 6, 2013 - Views: 169

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

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: 27

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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

http://www.nen.nl/web/preview.pdf?recordNumber=98620

Date added: March 18, 2014 - Views: 2

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Setting the Medical Device Lifetime - Ombu Enterprises LLC

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

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

Date added: May 20, 2013 - Views: 11

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ISO 13485-9001 All In One Documentation and Training Package

ISO 13485 Internal Auditor Training Materials* ... • 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: 16

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

- 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: 5

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Checklist for Determining Design and Development Inputs (ISO ...

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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Medical Devices Quality Management Systems Auditor/Lead ...

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: 6

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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: 26

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ISO 13485:2003 ISO 13485:1996 Most significant differences

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: 24

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ISO 9001 to ISO 13485:2003 QMS Upgrade Instructions

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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ISO 13485 Medical Device Management Systems Internal Auditor

Conduct an internal audit ISO 13485 of the Management System Who Should Attend : ... • Apply Principles of ISO/TR 14969:2003-WD2 and ISO 14971:2001

http://www.bsigroup.com/LocalFiles/en-SG/ISO%2013485%20SG/ISO%2013485%20Internal%20Quality%20Systems%20Auditor%20SG.pdf

Date added: March 18, 2014 - Views: 3

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ISO 13485:2003 Training - QA/RA Compliance Connection, Inc.

ISO 13485:2003 Training ... 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 l ar y Qua l i t y M a n a m n t S ...

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

Date added: January 28, 2012 - Views: 108

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13485-9001-Internal Audit Checklist - Online Regulatory ...

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: 266

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Introduction to ISO 13485 Medical Device Quality Management ...

Introduction to ISO 13485 Medical Device Quality Management System . ... Introduction to ISO 13485 and guidance document ISO/TR 14969. ISO 13485 Clause 4 ...

http://www.bsigroup.co.uk/LocalFiles/en-MY/medical%20device/Introduction%20to%20ISO%2013485%20Medical%20Device%20Quality.pdf

Date added: February 1, 2015 - Views: 1

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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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Waters Quality System Documentation

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: 89

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ISO 13485: Foundation and Basic Principles

ISO 13485: Foundation and Basic Principles ... ISO 13485 is the reference ... overcome any reserves before moving on to studying the applicable guidance documents of ...

http://www.wmdo.org/course-catalogue.aspx?pdf=1&course_id=73

Date added: August 30, 2014 - Views: 7

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Understanding ISO 13485:2003 for Medical Devices (Plexus ...

Understanding ISO 13485:2003 for Medical Devices (Plexus ... 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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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: 6

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Medical devices — Quality management systems ...

ISO 13485 was prepared by Technical Committee ISO/TC 210, Quality management and corresponding ... 0.3.2 Relationship with ISO/TR 14969

http://infostore.saiglobal.com/store/PreviewDoc.aspx?saleItemID=247540

Date added: February 10, 2014 - Views: 3

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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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BSI Training Services Lead Auditor for ISO 13485:2003

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: 10

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

- ISO 13485 : Requirements of Quality Sysstem for Regulatory Purposes - ISO 14969 : ...

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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REGULATORY AUDITING OF QUALITY MANAGEMENT SYSTEMS (QMS) AND ...

of ISO 13485:2003. The audit strategy can be seen as guidance on how to audit the ... auditing ISO/TC 210/WG1 N62: 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: 70

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GHTF SG4 Guidelines for Regulatory Auditing of Quality ...

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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Process Validation for Medical Devices - Ombu Enterprises

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: 62

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ISO/TC 210 N206 ISO/TC 210/WG 1 N61 - International Medical ...

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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CeRTIfIeD ISO 13485 LEAD IMPLEMENTER

ISO 14969 guidance’s (Medical devices ... The “Certified ISO 13485 Lead Implementer” exam fully meets the r equirements of the AVS Examination and

http://avs.co.ke/downloads/iso/ISO-13485/ISO-13485%20Lead%20Implementer%202.pdf

Date added: February 1, 2015 - Views: 1

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Management System Certification for Medical Device Manufacturers

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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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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ANSI/AAMI/ISO 15223:2000, Medical devices-Symbols to be used ...

ISO 13485:1996 ANSI/AAMI/ISO 13485:1996 Identical ... ISO 14937:200x 1 ANSI/AAMI/ISO 14937:2000 Identical ISO 14969:1999 ANSI/AAMI/ISO 14969:1999 Identical

http://marketplace.aami.org/eseries/scriptcontent/docs/Preview%20Files/15223_A0404preview.pdf

Date added: February 1, 2012 - Views: 60

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IAF MD 9:2015 Application of ISO/IEC 17021 in the Field of ...

IAF MD 9:2015 International Accreditation Forum, Inc. Issue 2 Application of ISO/IEC 17021 in the Field of Page 4 of 30 Medical Device Quality Management Systems (ISO ...

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

Date added: February 27, 2015 - Views: 1

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Sub scope provides confidence that conformity assessment ...

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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Source (2007): www.iso - Adria Kon - Poslovno i informatičko ...

ISO/TR 10017:2003 Guidance on statistical techniques for ISO 9001:2000 ISO/TR 14969:2004 ... ISO 13485:2003 Medical devices ... Requirements and guidelines ISO/IEC ...

http://www.adriakon.hr/Docs/ISO_9001_14001_standards_guidelines.pdf

Date added: October 19, 2011 - Views: 233

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PLANE WORLD CONSULTING GROUP

introductory subclause are the ones between ISO 13485 and ISO 9001 and ISO/TR 14969. 0.4 Compatibility with other management systems

http://www.giaiphapiso.com/images/tieu%20chuan/ISO13485_2003.pdf

Date added: January 10, 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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The Empirical Value of Risk Management

on the implementation of ISO 13485 (ISO/TR 14969) indicates that risk management activities draw fr om, and ... ISO 13485 and ISO 14971. Specifically, ...

http://www.transperfect.com/download/113/975/TheEmpiricalValueOfRiskManagement_csn7.pdf

Date added: September 9, 2014 - Views: 1

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Willem van den Biggelaar

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