GD210- ISO 13485-2003

GD210- ISO 13485-2003 Quality Management System Audits Performed by Health Canada Recognized Registrars

February 8, 2007

Notice

Our file number: 07-103218-349

Re: GD210: ISO 13485:2003 Quality Management System Audits Performed by HealthCanada Recognized Registrars

Health Canada is pleased to announce the release of the revised guidance document GD210: ISO 13485:2003 Quality Management System Audits Performed by Health Canada RecognizedRegistrars. This guidance document supersedes the December 16, 2002 version of the samedocument.

GD210 provides guidance to registrars recognized by Health Canada on how to perform ISO13485:2003 quality management system (QMS) audits under the Canadian Medical DevicesConformity Assessment System (CMDCAS). This guidance document has been revised toreflect CAN/CSA-ISO 13485:03, Medical devices – Quality management systems –

Requirements for regulatory purposes, and other new international standards. Specifically, themost significant changes that have been made to the document:

References to ISO 13485:2003 have been added and references to 13485:1996/8 havebeen removed.

Under the document’s Purpose, a paragraph has been added to describe how medicaldevice manufacturers can use the document.

The text, “Control over Audits performed by CMDCAS recognized registrars” has beenremoved.

The terms “Exclusion” & “Non-applicability” have been reinforced.

An explanation has been added as to how an applicable Medical Devices Regulations(MDR) requirement can be incorporated into the quality management system (QMS)documentation.

The distinction between an inspection and a QMS audit has been explained.The information to gather prior to an on-site audit has been listed.The role of the Regulatory Correspondent has been explained.

The need for the manufacturer to inform the registrar of QMS changes has beenreiterated.

Licence Amendment and Obligation to Inform have been reinforced.

The auditing of virtual manufacturers and regulatory correspondents has been clarified.Annex A has been revised to show linkages between MDR and ISO 13485:2003.

The table in Annex B describes which section of the MDR is applicable to what party.A new Annex lists MDR amendments.

.../2

GD210- ISO 13485-2003 Quality Management System Audits Performed by Health Canada Recognized Registrars

-2-Please direct any questions or comments regarding the content of this guidance document to thefollowing:

Quality Systems SectionMedical Devices Bureau

150 Tunney’s Pasture Driveway

Main Statistics Canada Building, Room 1605Address Locator: 0301H1Ottawa, Ontario K1A 0K9

Phone: (613) 952-8250Fax: (613) 946-6758

E-mail: ISO13485_CMDCAS_SCECIM@hc-sc.gc.ca

GD210- ISO 13485-2003 Quality Management System Audits Performed by Health Canada Recognized Registrars

GUIDANCE DOCUMENT

GD210: ISO 13485:2003 Quality Management SystemAudits Performed by Health Canada Recognized Registrars

Published by authority of the

Minister of Health

Date AdoptedEffective Date

2002/12/162007/01/31

Health Products and Food Branch

GD210- ISO 13485-2003 Quality Management System Audits Performed by Health Canada Recognized Registrars

Our mission is to help the people of Canadamaintain and improve their health.

Health Canada

The Health Products and Food Branch’s mandate is to takean integrated approach to the management of the risks andbenefits to health related products and food by: minimizing health risk factors to Canadians while

maximizing the safety provided by the regulatorysystem for health products and food; and,

promoting conditions that enable Canadians to

make healthy choices and providing informationso that they can make informed decisions abouttheir health.

Health Products and Food Branch

© Minister of Public Works and Government Services Canada 2007

Également disponible en français sous le titre : GD210 - Audits des systèmes de managementde la qualité ISO 13485:2003 menés par les registraires reconnus par Santé Canada

GD210- ISO 13485-2003 Quality Management System Audits Performed by Health Canada Recognized Registrars

Guidance DocumentPerformed by Health Canada Recognized Registrars

Foreword

Guidance documents are meant to provide assistance to industry and health care professionals onhow to comply with governing statutes and regulations. Guidance documents also provideassistance to staff on how Health Canada mandates and objectives should be implemented in amanner that is fair, consistent and effective.

Guidance documents are administrative instruments not having force of law and, as such, allowfor flexibility in approach. Alternate approaches to the principles and practices described in thisdocument may be acceptable provided they are supported by adequate justification. Alternateapproaches should be discussed in advance with the relevant program area to avoid the possiblefinding that applicable statutory or regulatory requirements have not been met.

As a corollary to the above, it is equally important to note that Health Canada reserves the rightto request information or material, or define conditions not specifically described in this

document, in order to allow the Department to adequately assess the safety, efficacy or quality ofa therapeutic product. Health Canada is committed to ensuring that such requests are justifiableand that decisions are clearly documented.

This document should be read in conjunction with the accompanying notice and the relevantsections of other applicable guidance documents.

Date Adopted: 2002/12/16; Effective Date: 2007/01/31i

GD210- ISO 13485-2003 Quality Manage …… 此处隐藏：25674字，全部文档内容请下载后查看。喜欢就下载吧 ……