ISO 13485:2016. Kimberly A. Trautman. Executive Vice President, Medical Device International Services
|
|
- Dustin Day
- 7 years ago
- Views:
Transcription
1 ISO 13485:2016 Kimberly A. Trautman Executive Vice President, Medical Device International Services
2 This document is intended to facilitate an oral briefing. It is not intended for use as a stand-alone report. 2
3 Background ISO International Organization Standardization (ISO) standard published first in 1996, revised in 2003, and now in 2016 Sector specific standard based off ISO 9001 Represents the requirements for a comprehensive quality management system (QMS) for the design and manufacture of medical devices and in vitro diagnostic devices, as well as their related processes and services 3
4 Why was ISO revised? Since 2003, new medical device regulatory activities emerged in South American nations, Asian Pacific nations, and more recently in African nations Global Harmonization Task Force (GHTF) in 2011 requested TC210 to consider revisions in light of the ISO Technical Management Board s decision on the QMS High Level Structure and requirements Sweden challenged the EU designation of EN ISO 13485:2003 as a harmonized standard in a formal process within the EU 4
5 Why was ISO revised? In 2011, ISO/TC 201 Working Group 1 conducted a web-based user survey to determine need for revision of the standard Responses from every global region Responses from a range of size and types of organizations Responses from a range of medical device manufacturers of different regulatory classification 5
6 Results of User Survey 83% surveyed stated the standard was highly effective or effective, while only 1% stated it was ineffective 60% surveyed supported revision to improve effectiveness 30% cautioned on problems integrating with other QMS standards 6
7 New Work Item In 2012, a New Work Item Proposal was drafted and submitted for ballot 23 of 24 voting members voted affirmatively on the New Work Item Proposal to revise ISO with the original goal of publication in
8 Objectives Improve clarity of the requirements Increase confidence that the requirements are consistent with cgmps or current Quality System regulatory requirements/objectives Increase harmonization of QMS regulatory requirements Increase medical device manufacturers ability to meet customer requirements 8
9 Intended Benefit To serve as a harmonized model to be used by national and regulatory bodies in charge of QMS regulatory requirements 9
10 Design Specifications for 13485:
11 Purpose and Scope Purpose: to enhance the clarity of ISO 13485:2003 and to enhance its compatibility with the latest regulatory requirements and expectations Scope: intention to maintain the general scope of ISO while taking into consideration the latest QMS regulatory requirements and the need to avoid: Hindering the application of new technologies for meeting QMS requirements Including requirements outside those of the QMS, and Including QMS requirements that are not appropriate as regulatory requirements 11
12 Compatibility Common elements of the standard can be implemented by organizations without unnecessary duplication or imposing conflicting requirements compatibility related activities include efforts: To converge its requirements further with those in the US FDA 21 CFR Part 820, the Japanese MHLW Ministerial Ordinance No. 169: 2004, and the conformity assessment requirements of the European medical device legislation To address developments in regulatory requirements for QMS in other jurisdictions To maintain requirements compatibility with ISO 9001:2008 and ISO 9000:
13 Consistency Consistent with other documents currently existing within the ISO family May refer to, but does not include duplication of requirements from other horizontal or vertical ISO standards (e.g., software, risk management, usability, sterilization) Consistency maintained between the requirements contained in the revised ISO standard and any guidance contained in the revision of the ISO/TR technical report 13
14 Subjects to Be Addressed Scope Management Responsibilities Corrective and Preventive Actions Software Validation Supply Chain Outsourcing Risk Management Post-Market Information Gathering Adverse Event Reporting Design Verification & Validation Complaint Handling Handling of Returned Product Environment Controls Process Validation Records Management Process Approach Annex Z to EN ISO13485:2012 Alignment with ISO 9001:2008 Product Lifecycle Management Emerging Markets 14
15 General Guidelines on Drafting Original intent is to be maintained Outputs of justification study and translated into requirements Free from cultural bias Written in a clear style and can be understood by persons who have a working knowledge of quality systems Written to be unambiguous, to give a common understanding that prevents multiple interpretations Sentences are kept short to reduce excessive wordiness without becoming ambiguous 15
16 General Guidelines on Drafting (cont.) Consistent use of terminology is maintained, and that terminology issues are resolved by reference to ISO 9000:2005 Effect of any proposed change on the other requirements of ISO 13485:2003 is considered before it is implemented Requirements written in such a manner as to enable them to be audited Account taken of comments received through the process Can be translated into other languages Due consideration given to the issue of compatibility and consistency with other management system standards and ISO/CASCO standards and guidelines 16
17 Questions? 17
Medical Devices. Notified Bodies and the CE certification Process for Medical Devices. European Surgical Robotics Demonstration Day
Medical Devices Notified Bodies and the CE certification Process for Medical Devices European Surgical Robotics Demonstration Day 27 th March 2014, Leuven, Belgium 1 Bart Mersseman Product Manager Medical
More informationISO 13485:201x What is in the new standard?
ISO 13485:201x What is in the new standard? Eric Finegan, Quality Mgr, BTE Technologies, Inc. 2015-09-10 1 Presentation Slides This slide deck is the presentation performed on 2015-09-10. A more detailed
More informationCharles Corrie, Belo Horizonte, 2013-03 2
ISO Management System Standards, ISO 9001 and the Future Charles Corrie Secretary ISO/TC 176/SC 2 Established Management (system) standards ISO 9000 Quality ISO 14000 Environment IEC 60300 Dependability
More informationISO 9000 Series Standards. ISO 10000 Series Standards. Other Supporting Documents
Current Standards & Future Development: ISO 9000 Series Standards ISO 10000 Series Standards Other Supporting Documents The ISO 9000 family of standards includes: 16 published standards Internet based
More informationInternal Quality Management System Audit Checklist (ISO9001:2015) Q# ISO 9001:2015 Clause Audit Question Audit Evidence 4 Context of the Organization
Internal Quality Management System Audit Checklist (ISO9001:2015) Q# ISO 9001:2015 Clause Audit Question Audit Evidence 4 Context of the Organization 4.1 Understanding the organization and its context
More informationPROPOSED DOCUMENT. Quality management system Medical devices Nonconformity Grading System for Regulatory Purposes and Information Ex-change
AHWP/WG3/P001:2013 PROPOSED DOCUMENT Title: Quality management system Medical devices Nonconformity Grading System for Regulatory Purposes and Information Ex-change Author: AHWP Work Group 3 Date: 13 November
More informationUpdate on ISO 9001:2008
Update on ISO 900:008 Current status Following a recent meeting of ISO s Technical Committee TC76 in Helsinki, Finland, from June th 5 th 007, publication of the new version of ISO 900 has been brought
More informationWHITEPAPER: SOFTWARE APPS AS MEDICAL DEVICES THE REGULATORY LANDSCAPE
WHITEPAPER: SOFTWARE APPS AS MEDICAL DEVICES THE REGULATORY LANDSCAPE White paper produced by Maetrics For more information, please contact global sales +1 610 458 9312 +1 877 623 8742 globalsales@maetrics.com
More informationMedical Device Software Standards for Safety and Regulatory Compliance
Medical Device Software Standards for Safety and Regulatory Compliance Sherman Eagles +1 612-865-0107 seagles@softwarecpr.com www.softwarecpr.com Assuring safe software SAFE All hazards have been addressed
More informationRegulatory Considerations for Medical Device Software. Medical Device Software
Medtec Ireland 2015 Wireless Medical Devices Regulatory Considerations for Medical Device Software Kenneth L. Block, RAC October 7, 2015 Galway, Ireland Offices: Dallas, Texas (12 employees) Tokyo, Japan
More informationISO Revisions Whitepaper
ISO Revisions ISO Revisions Whitepaper What is the difference between a procedures and a process approach? Approaching change Process vs procedures: What does this mean? The concept of process management
More informationFINAL DOCUMENT. Global Harmonization Task Force
FINAL DOCUMENT Global Harmonization Task Force Title: Quality management system Medical Devices Guidance on corrective action and preventive action and related QMS processes Authoring Group: Study Group
More informationDNV GL Assessment Checklist ISO 9001:2015
DNV GL Assessment Checklist ISO 9001:2015 Rev 0 - December 2015 4 Context of the Organization No. Question Proc. Ref. Comments 4.1 Understanding the Organization and its context 1 Has the organization
More informationISO 9001: 2015 EXPECTATIONS OVERVIEW & Presenter Name Paul J. Kunder. Former US Representative to ISO 20 Yrs. Voting Member USTAG - TC 176
OVERVIEW & EXPECTATIONS Presenter Name Paul J. Kunder Former US Representative to ISO 20 Yrs. Voting Member USTAG - TC 176 Purpose Of Presentation To provide an overview 9000:2015 9001:2015 Estimated Release
More informationISO 9001 & ISO 14001 Revisions what will change, and why?
ISO 9001 & ISO 14001 Revisions what will change, and why? Hong Kong November / December 2014 Dr Nigel H Croft Chairman, ISO/TC 176/SC 2 (Quality Systems) Member, ISO Joint Technical Coordination Group
More informationFINAL DOCUMENT. Title: Quality Management System Medical Devices Guidance on the Control of Products and Services Obtained from Suppliers
GHTF/SG3/N17:2008 FINAL DOCUMENT Title: Quality Management System Medical Devices Guidance on the Control of Products and Services Obtained from Suppliers Authoring Group: GHTF Study Group 3 Endorsed by:
More informationRevision of ISO 9001 Quality Management Systems Requirements
Revision of ISO 9001 Quality Management Systems Requirements Frequently Asked Questions When will the new ISO 9001 be published? The international standard ISO 9001:2008 Quality management systems Requirements
More informationINTRODUCTION TO ISO 9001 REVISION - COMMITTEE DRAFT
INTRODUCTION TO ISO 9001 REVISION - COMMITTEE DRAFT AGENDA Introduction Annex SL Changes to ISO 9001 Future Development How SGS can support you 2 INTRODUCTION ISO 9001 Revision Committee Draft Issued 2013
More informationICH Public Meeting. Joseph C. Famulare. October 2, 2006. Acting Deputy Director Office of Compliance CDER / FDA Office of Compliance
ICH Public Meeting October 2, 2006 Joseph C. Famulare Acting Deputy Director Office of Compliance CDER / FDA Office of Compliance The Current State of Pharmaceutical Manufacturing Inability to predict
More informationTable of Contents. Preface 1.0 Introduction 2.0 Scope 3.0 Purpose 4.0 Rationale 5.0 References 6.0 Definitions
Table of Contents Preface 1.0 Introduction 2.0 Scope 3.0 Purpose 4.0 Rationale 5.0 References 6.0 Definitions 7.0 Objectives and User Needs of a Regulatory Audit Report 7.1 Audit report objectives 7.2
More informationQUALITY MANUAL ISO 9001:2015
Page 1 of 22 QUALITY MANUAL ISO 9001:2015 Quality Management System Page 1 of 22 Page 2 of 22 Sean Duclos Owner Revision History Date Change Notice Change Description 11/02/2015 1001 Original Release to
More informationISO 9001 : 2008 QUALITY MANAGEMENT SYSTEM AUDIT CHECK LIST INTRODUCTION
INTRODUCTION What auditors should look for: the items listed in these headings that the ISO requirement is met that the requirement is met in the manner described in the organization's documentation Page
More informationISO 9001:2008 Quality Management System Requirements (Third Revision)
ISO 9001:2008 Quality Management System Requirements (Third Revision) Contents Page 1 Scope 1 1.1 General. 1 1.2 Application.. 1 2 Normative references.. 1 3 Terms and definitions. 1 4 Quality management
More informationISO 9001: 2008 Boosting quality to differentiate yourself from the competition. xxxx November 2008
ISO 9001: 2008 Boosting quality to differentiate yourself from the competition xxxx November 2008 ISO 9001 - Periodic Review ISO 9001:2008 Periodic Review ISO 9001, like all standards is subject to periodic
More informationThe purpose of this Supplier Quality Standard is to communicate the expectations and requirements of Baxter Healthcare Corporation to its suppliers.
Supplier Quality Standard 1.0 Purpose The purpose of this Supplier Quality Standard is to communicate the expectations and requirements of Baxter Healthcare Corporation to its suppliers. These expectations
More informationxxxxx Conformity assessment Requirements for third party certification auditing of environmental management systems - competence requirements
NEW WORK ITEM PROPOSAL Date of presentation 2011-02-25 Reference number (to be given by the Secretariat) Proposer ISO/TC 207/SC 2 ISO/TC 207 / SC 2 N 251 Secretariat NEN A proposal for a new work item
More informationISO 9001:2015 Revision overview
ISO 9001:2015 Revision overview December 2013 ISO/TC 176/SC 2/WG23 N063 1 Purpose of presentation To provide an overview of the revision of ISO 9001 which will be published in 2015 2 Background to this
More informationImplementation Guidance for ISO 9001:2015
International Organization for Standardization BIBC II, Chemin de Blandonnet 8, CP 401, 1214 Vernier, Geneva, Switzerland Tel: +41 22 749 01 11, Web: www.iso.org Implementation Guidance for ISO 9001:2015
More informationFinal Document. Software as a Medical Device (SaMD): Key Definitions. Date: 9 December 2013. Despina Spanou, IMDRF Chair. IMDRF/SaMD WG/N10FINAL:2013
Final Document Title: Authoring Group: Software as a Medical Device (SaMD): Key Definitions IMDRF SaMD Working Group Date: 9 December 2013 Despina Spanou, IMDRF Chair This document was produced by the
More informationISO/IEC Directives, Part 1 Consolidated ISO Supplement Procedures specific to ISO
ISO/IEC Directives, Part 1 Consolidated ISO Supplement Procedures specific to ISO Directives ISO/IEC, Partie 1 Supplément ISO consolidé Procédures spécifiques à l ISO Sixth edition, 2015 [Based on the
More informationUNDERSTANDING THE EC DIRECTIVE 98/79/EC ON IN VITRO DIAGNOSTIC MEDICAL DEVICES
UNDERSTANDING THE EC DIRECTIVE 98/79/EC ON IN VITRO DIAGNOSTIC MEDICAL DEVICES A WHITE PAPER ON THE REQUIREMENTS, REGULATIONS AND OPPORTUNITIES CONTAINED IN EC DIRECTIVE 98/79/EC AND A BRIEF COMPARISON
More informationGUIDELINES ON MEDICAL DEVICES
EUROPEAN COMMISSION DIRECTORATE GENERAL for HEALTH and CONSUMERS Consumer Affairs Health technology and Cosmetics MEDDEV 2.12/2 rev2 January 2012 GUIDELINES ON MEDICAL DEVICES POST MARKET CLINICAL FOLLOW-UP
More informationDiagnostic Tests. Brad Spring Director, Regulatory Affairs
Regulatory Challenges in the Development of Diagnostic Tests Industry Perspective Brad Spring Director, Regulatory Affairs September 28, 2011 Balancing Evidence of Safety & Effectiveness and Time to Market
More informationEmerging ISO Standards on Facilities Management. Questions? May 7, 2014. Administrative Office of the U.S. Courts
Emerging ISO Standards on Facilities Management Questions? May 7, 2014 2 What Interests You About Facilities Management Standards and Good Practices? Forum registrants interests, ranked in priority order:
More informationISO 9001:2015 Internal Audit Checklist
Page 1 of 14 Client: Date: Client ID: Auditor Audit Report Key - SAT: Satisfactory; OBS: Observation; NC: Nonconformance; N/A: Not Applicable at this time Clause Requirement Comply Auditor Notes / Evidence
More informationAnnex SL (normative) Proposals for management system standards
Annex SL (normative) Proposals for management system standards SL.1 General Whenever a proposal is made to prepare a new management system standard (MSS), or to revise an existing one, including sectoral
More informationThe New Paradigm for Medical Device Safety. Addressing the Requirements of IEC 60601-1 Edition 3.1
The New Paradigm for Medical Device Safety Addressing the Requirements of IEC 60601-1 Edition 3.1 Medical devices play a vital role in the diagnosis and treatment of most health-related conditions, and
More informationISO 9001 and the Supply Chain
ISO 9001 and the Supply Chain John DiMaria; CSSBB, HISP, MHISP, AMBCI Sr. Product Manager, Systems Certification - Americas Provide insight into understanding of Clause 4. Context of the Organization Discuss
More informationISO 9001. What to do. for Small Businesses. Advice from ISO/TC 176
ISO 9001 for Small Businesses What to do Advice from ISO/TC 176 ISO 9001 for Small Businesses What to do Advice from ISO/TC 176 ISO Central Secretariat 1, chemin de la Voie-Creuse Case postale 56 CH -
More informationUnderstanding, Knowledge, and Awareness of ISO 9001:2015. Dr Nigel H Croft Chair, ISO/TC176/SC2 (Quality Systems) June 23, 2014
Understanding, Knowledge, and Awareness of ISO 9001:2015 Dr Nigel H Croft Chair, ISO/TC176/SC2 (Quality Systems) June 23, 2014 TÜV SÜD Presenter Dr Nigel H Croft Chair, ISO/TC176/SC2 (Quality Systems)
More informationUS & CANADA: REGULATION AND GUIDELINES ON MEDICAL SOFTWARE AND APPS OR
US & CANADA: REGULATION AND GUIDELINES ON MEDICAL SOFTWARE AND APPS OR A MEDICAL DEVICE IS A MEDICAL DEVICE IS A MEDICAL DEVICE AHWP Medical SW Workshop Taipei, Taiwan November 3, 2012 John G. Abbott,
More informationComparing GCP Requirements for Medical Device Clinical Trials in the US and Japan
REGULATORY MANAGER Comparing GCP Requirements for Medical Device Clinical Trials in the US and Japan By Harmonization-by-Doing Working Group 4 Introduction The convergence of US and Japanese medical device
More informationHow to Use the Design Process to Manage Risk: Elements of Design Controls and Why It Matters
environmental failure analysis & prevention health technology development How to Use the Design Process to Manage Risk: Elements of Design Controls and Why It Matters Kevin L. Ong, Ph.D., P.E. Managing
More informationTHE QUALITY MANAGEMENT PRINCIPLES AND PRODUCT DESIGN REALIZATION REQUIREMENTS
3. Naučno stručni skup sa međunarodnim učešćem KVALITET 2003, Zenica, B&H, 13. i 14 Novembar 2003. THE QUALITY MANAGEMENT PRINCIPLES AND PRODUCT DESIGN REALIZATION REQUIREMENTS Prof.dr. Nedžad Repčić,
More informationRegistration of Class B Medical Devices
Registration of Class B Medical Devices 1 INTRODUCTION Medical devices are classified based on a rule based risk classification system into four risk classes Class A to D with Class A being the lowest
More informationFINAL DOCUMENT. Guidelines for Regulatory Auditing of Quality Management Systems of Medical Device Manufacturers Part 1: General Requirements
GHTF/SG4/N28R4:2008 FINAL DOCUMENT Title: Guidelines for Regulatory Auditing of Quality Management Systems of Medical Device Manufacturers Authoring Group: GHTF Study Group 4 Endorsed by: The Global Harmonization
More informationAn Introduction to ISO 22000: Food Safety Management Systems
: Food Safety Management Systems Stefan Nygren What is ISO 22000? ISO 22000, Food safety management systems - Requirements for any organization in the food chain, was first published in 2005. The standard
More informationQuality Manual TABLE OF CONTENTS APPROVAL SIGNATURE PAGE 1.1 1 AMENDMENT RECORD 1.2 2 SCOPE 2.0 3 EXCLUSIONS 2.1 3
TABLE OF CONTENTS DESCRIPTION SECTION PAGE INTRODUCTION 1.0 1 APPROVAL SIGNATURE PAGE 1.1 1 AMENDMENT RECORD 1.2 2 SCOPE 2.0 3 EXCLUSIONS 2.1 3 CORPORATE POLICY 3.0 3 QUALITY MANAGEMENT SYSTEM 4.0 4 GENERAL
More informationCAPA Common Pitfalls. Sue Jacobs. 1 847 359 4456 sue@qmsconsultant.com. Presented by: QMS Consulting, Inc.
CAPA Common Pitfalls Presented by: Sue Jacobs QMS Consulting, Inc. 1 847 359 4456 sue@qmsconsultant.com 1 Topics CAPA Process Flow Elements of an Effective CAPA System Common Pitfalls 2 CAPA Process Flow
More informationHow To Write Software
1 Medical Device Software - Software Life Cycle Processes IEC 62304 2 Credits John F. Murray Software Compliance Expert U.S. Food and Drug Administration Marcie R. Williams Medical Device Fellow Ph.D.
More informationDevelopment of a Process Assessment Model for Medical Device Software Development
Development of a Process Assessment Model for Medical Device Software Development Marion Lepmets, Paul Clarke, Fergal McCaffery, Anita Finnegan, Alec Dorling Regulated Software Research Centre, Dundalk
More informationIntroduction to AS 9100
Introduction to AS 9100 Rev. C 1 Questions we will cover today: What is AS9100? What does a company need to do to Register to AS9100 Rev C? What are the requirements? Section 4 General Requirements Section
More informationDRAFT SAINT LUCIA NATIONAL STANDARD DNS/ISO 9001 QUALITY MANAGEMENT SYSTEMS REQUIREMENTS [ISO 9001: 2015, IDT]
DRAFT SAINT LUCIA NATIONAL STANDARD DNS/ISO 9001 QUALITY MANAGEMENT SYSTEMS REQUIREMENTS [ISO 9001: 2015, IDT] Copyright SLBS Saint Lucia Bureau of Standards, 2015 No part of this standard may be reproduced
More informationReview and Revision of ISO/IEC 17021
Review and Revision of ISO/IEC 17021 History - September 2000 to present ISO/IEC 17021:2006 ISO/IEC 17021:2011 Revision of ISO/IEC 17021 NWIP Discussion of progress History Developed by ISO/CASCO Working
More informationComparison between FDA QSR and ISO 13485
Comparison between FDA QSR and ISO 13485 Most countries in the world including the Europe, for the conformity assessment of medical devices to be used by their countrymen, assess not only whether the product
More informationThe Gap Analysis Checklist
The Gap Analysis Checklist This table outlines the changes to align your organization with the 21CFR820 requirements. The applicable parts of the regulation that result in additions for the QSR are highlighted
More informationTS/P 247: Proposal to transform ISO/PC 251 Asset management into a TC
ISO/TMB/TS/P 247 2014-10-30 TS/P 247: Proposal to transform ISO/PC 251 Asset management into a TC Dear ISO Members, Please find attached a proposal for a new field of technical activity on Asset management,
More informationQuality Management System MANUAL. SDIX, LLC Headquarters: 111 Pencader Drive Newark, Delaware 19702
Quality Management System MANUAL SDIX, LLC Headquarters: 111 Pencader Drive Newark, Delaware 19702 Doc. No. G5500 Rev. 9.2 Status : APPROVED Effective: 9/25/2015 Page 2 of 23 Quality Manual Table of Contents
More informationWHAT MAKES YOUR OCCUPATIONAL HEALTH AND SAFETY SYSTEMS STANDARD BEST-IN-CLASS?
EMPLOYEE SATISFACTION COMPLIANCE REDUCED RISK REDUCED INCIDENTS FURTHER EXCELLENCE LABOUR CONDITIONS SAFETY HEALTH COMPETITIVE ADVANTAGE WHAT MAKES YOUR OCCUPATIONAL HEALTH AND SAFETY SYSTEMS STANDARD
More informationPreparing for Unannounced Inspections from Notified Bodies
Preparing for Unannounced Inspections from Notified Bodies Europe has introduced further measures for unannounced audits of manufacturers by notified bodies. With this in mind, James Pink, VP Europe-Health
More informationGuidance for manufacturers and Notified Bodies on reporting of Design Changes and Changes of the Quality System
NBOG s Best Practice Guide applicable for AIMDD, MDD, and IVDD 2014-3 Guidance for manufacturers and Notified Bodies on reporting of Design Changes and Changes of the Quality System 1 Introduction The
More informationSelection and use of the ISO 9000 family of standards
Selection and use of the ISO 9000 family of standards ISO and international standardization ISO/TC 176, Quality management and quality assurance ISO is the International Organization for Standardization.
More informationInternational Workshop Agreement 2 Quality Management Systems Guidelines for the application of ISO 9001:2000 on education.
ISO 2002 All rights reserved ISO / IWA 2 / WD1 N5 Date: 2002-10-25 Secretariat: SEP-MÉXICO International Workshop Agreement 2 Quality Management Systems Guidelines for the application of ISO 9001:2000
More informationForm 1: Proposal for a new field of technical activity
Form 1: Proposal for a new field of technical activity Circulation date: Click here to enter text. Closing date for voting: Click here to enter text. Proposer: ESMA Reference number (to be given by Central
More informationOUTSOURCING STRATEGIES & RISKS FROM AN ISO 9001-2000 PERSPECTIVE. Amera-Veritas. Amera-Veritas. Experts in in Quality, Safety & Supply Chain Assurance
OUTSOURCING STRATEGIES & RISKS FROM AN ISO 9001-2000 PERSPECTIVE Amera-Veritas Amera-Veritas Experts in in Quality, Safety & Supply Chain Assurance TOPICS 1. Outsourcing - Requirements of ISO 9001:2000
More informationAsset Management Systems Scheme (AMS Scheme)
Joint Accreditation System of Australia and New Zealand Scheme (AMS Scheme) Requirements for bodies providing audit and certification of 13 April 2015 Authority to Issue Dr James Galloway Chief Executive
More informationQuality Management System Certification. Understanding Quality Management System (QMS) certification
Quality Management System Certification Understanding Quality Management System (QMS) certification The medical device manufacturing sector is one of the most regulated sectors in which significant quality
More informationQuality Management Principles and Guidelines on their Application
Document: ISO/TC 176/SC 2/N 376 Secretariat of ISO/TC 176/SC 2 Our ref: 97/402545 Date: 30 June 1997 To the Members of ISO/TC 176/SC 2 - Quality Management and Quality Assurance/ Quality Systems (TC176/SC2/WG15/N133)
More informationAGREEMENT ON TECHNICAL BARRIERS TO TRADE. Having regard to the Uruguay Round of Multilateral Trade Negotiations;
Page 117 AGREEMENT ON TECHNICAL BARRIERS TO TRADE Members, Having regard to the Uruguay Round of Multilateral Trade Negotiations; Desiring to further the objectives of GATT 1994; Recognizing the important
More informationClinical evaluation Latest development in expectations EU and USA
Clinical evaluation Latest development in expectations EU and USA Medical Devices: staying ahead of regulatory developments Gert Bos BSI Israel 22 April - Herzliya Copyright 2012 BSI. All rights reserved.
More informationISO 14001:2015: Key Changes
ISO 14001:2015: Key Changes Susan LK Briggs Convenor, ISO TC207/SC1/WG5 TC207 Workshop, 9/8/15 Topics for Discussion Background on ISO 14001 Revision Highlight of key changes in ISO 14001:2015 Top Management
More informationQuality Management Systems Manual
Washington Division Quality Management Systems Manual ISO 13485:2003 DOCUMENT NUMBER 01-QM-MED REVISION LEVEL 01 PAGE 1 of 40 This manual describes the quality management systems structure at GM Nameplate
More informationISO 9001:2015. A look at the Revised Standard 9/23/2015 1
ISO 9001:2015 A look at the Revised Standard 9/23/2015 1 Quotes Quality management is a journey, not just a destination. Emily Rhinehart If you can t explain it simply, you don t understand it well enough.
More informationQW Enterprises, LLP. Quality Manual
QW Enterprises, LLP Quality Manual ISO 9001:2008 Quality Manual 9001 2008 D1 Quality Manual 9001 2008 D1 Page 2 of 34 0 Table of contents 0 Table of contents 2 1 General 5 1.1 Purpose and scope 5 1.2 Application
More informationEnvironmental management. The ISO 14000 family of International Standards
The ISO 14000 family of International Standards ISO in brief ISO and the environment ISO is the International Organization for Standardization. It has a membership of 160 national standards institutes
More informationAuditing Process-based Quality Management Systems. Charlie Cianfrani and Jack West
Auditing Process-based Quality Management Systems Charlie Cianfrani and Jack West Agenda Course objectives What is an audit? How to prepare for and plan an audit How to conduct an audit How to report
More informationISO 9001:2000 Gap Analysis Checklist
ISO 9001:2000 Gap Analysis Checklist Type: Assessor: ISO 9001 REQUIREMENTS STATUS ACTION/COMMENTS 4 Quality Management System 4.1 General Requirements Processes needed for the quality management system
More informationFINAL DOCUMENT. Global Harmonization Task Force. Title: Label and Instructions for Use for Medical Devices
GHTF/SG1/N70:2011 FINAL DOCUMENT Global Harmonization Task Force Title: Label and Instructions for Use for Medical Devices Authoring Group: Study Group 1 of the Global Harmonization Task Force Endorsed
More informationSC7-ISO20000 Alignment issues Aligning ITIL to existing ISO JTC1- SC7 Software Engineering Standards
SC7-ISO20000 Alignment issues Aligning ITIL to existing ISO JTC1- SC7 Software Engineering Standards Dr. A.April ETS University Table of Contents Objectives Audience Current clash An ITIL overview ISO
More information9100:2016 Series of Standards Frequently Asked Questions (FAQs)
Frequently Asked Questions (FAQs) In developing this list of Frequently Asked Questions (FAQ's) for the 9100:2016 Series revisions, input has been obtained from experts and users of the standard from around
More informationWhat changes will ISO 9001:2015 bring?
What changes will ISO 9001:2015 bring? 1 Introduction This presentation will cover the following topics: The ISO 9001 Revision Process Key Inputs to ISO 9001:2015 The High Level Structure Key Changes in
More informationCOMMUNIQUE September 27, 1999
IAF ISO/TC 176 ISO/CASCO Joint Working Group COMMUNIQUE September 27, 1999 Results of the IAF ISO/TC 176 ISO/CASCO joint session on Transition Planning for the Year 2000 ISO 9000 Standards IAF-PL-99-019
More informationQuality Management System MANUAL. SDIX, LLC Headquarters: 111 Pencader Drive Newark, Delaware 19702
Quality Management System MANUAL SDIX, LLC Headquarters: 111 Pencader Drive Newark, Delaware 19702 Doc. No. G5500 Rev. 9.1 Status : APPROVED Effective: 12/11/2014 Page 2 of 23 Quality Manual Table of Contents
More informationBUSINESS PLAN CEN/TC 218 RUBBER AND PLASTIC HOSES AND HOSE ASSEMBLIES EXECUTIVE SUMMARY
Page: 1 BUSINESS PLAN CEN/TC 218 RUBBER AND PLASTIC HOSES AND HOSE ASSEMBLIES EXECUTIVE SUMMARY Business environment Rubber and plastics hoses and hose assemblies are used as flexible connections for the
More informationCirculation date: Closing date for voting: Proposer
Proposer ISO/TS/P Institute of Standard and Industrial Research of Iran A proposal for a new field of technical activity shall be (ISIRI) submitted to the Central Secretariat, which will assign it a reference
More informationAuditing as a Component of a Pharmaceutical Quality System
Auditing as a Component of a Pharmaceutical Quality System Tim Fields Conducting internal audits (or self inspections) and external audits of suppliers and outsourcing operations are key elements of a
More informationQuality Management Present and Future
Quality Management Present and Future Nigel H Croft Chairman, ISO/TC176/SC2 Quality Systems Member, ISO/TC176 Chairman s Strategic Advisory Group Member, ISO/CASCO Chairman s Policy Committee Member, IAF/ILAC/ISO
More informationEvaluation de la conformité Exigences pour l'audit tierce partie en vue de la certification de systèmes de management
COMMITTEE DRAFT ISO/IEC CD 17021-2 Date 2008-02-11 Supersedes document Reference number CASCO 03/2008 WARNING: This document is not an International Standard. It is distributed for review and comment.
More informationCorrespondence between ISO 13485:2003 and the US Quality System Regulation
Correspondence between ISO 13485:2003 and the US Quality System Regulation Correspondence between ISO 13485:2003 and the US Quality System Regulation 1 Scope 1.1 General This International Standard specifies
More informationMaking SOP Training More Effective
By David Peterson, Director, GMP and Quality Systems, UL EduNeering SOPs are critical to efficient operations, quality control and regulatory compliance. This paper reviews best practices for the Life
More informationISO 9001:2000 AUDIT CHECKLIST
ISO 9001:2000 AUDIT CHECKLIST No. Question Proc. Ref. Comments 4 Quality Management System 4.1 General Requirements 1 Has the organization established, documented, implemented and maintained a quality
More informationISO 50001 Energy Management System
ISO 50001 Energy Management System DETAILED GUIDE ISO 50001 Background It has been estimated that the ISO 50001 Energy Management Standard could have a positive impact on some 60% of the world s energy
More informationProcedure PS-TNI-001 Information Security Management System Certification
Table of Contents 1. Purpose 2. Scope 3. Definitions 4. Responsibilities 4.1 Head of the Certification Body 4.2 QM Manager / Management Representative 4.3 Auditors 4.4 Order Service 4.5 Certification Service
More informationClient information note Assessment process Management systems service outline
Client information note Assessment process Management systems service outline Overview The accreditation requirements define that there are four elements to the assessment process: assessment of the system
More informationSafety Assurance Cases: What the medical device industry is doing
Safety Assurance Cases: What the medical device industry is doing Sherman Eagles SoftwareCPR seagles@softwarecpr.com BECOMING AWARE 3 Early steps to awareness 2005 EWICS TC7 medical device group begins
More informationMEDICAL DEVICES INTERIM REGULATION
Issued by the Saudi Food and Drug Authority Board of Directors decree number 1-8-1429 and dated 27 December 2008 The Interim was published in Umm Al-QURA Journal year 86 Issue No:4249 dated in 17 April
More informationISO 9001:2015 Overview of the Revised International Standard
ISO 9001:2015 Overview of the Revised International Standard Introduction This document provides: a summary of the new ISO 9001:2015 structure. an overview of the new and revised ISO 9001:2015 requirements
More information