SG4N28R4Word文档格式.docx

1、 Dr. Roland Rotter, GHTF ChairThe document herein was produced by the Global Harmonization Task Force, which is comprised of representatives from medical device regulatory agencies and the regulated industry. The document is intended to provide non-binding guidance for use in the regulation of medic

2、al devices, and has been subject to consultation throughout its development. There are no restrictions on the reproduction, distribution or use of this document; however, incorporation of this document, in part or in whole, into any other document, or its translation into languages other than Englis

3、h, does not convey or represent an endorsement of any kind by the Global Harmonization Task Force.Copyright 2000 by the Global Harmonization Task Force Table of ContentsPreface 41.0 Introduction 52.0 Scope 53.0 Purpose 54.0 Rationale 65.0 References 66.0 Definitions 67.0 General requirements for aud

4、iting organizations 107.1 Legal responsibility 107.2 Independence and impartiality 107.2.1 Management of impartiality 117.3 Confidentiality, due professional care and code of ethics 117.3.1 Management of confidentiality 117.4 Liability and financing 118.0 Management 128.1 Structural requirements 128

5、.2 Quality management system 128.3 Consistency 129.0 Resources 129.1 Resources 129.2 Audit team competence 139.2.1 Audit team competence criteria 139.2.2 Audit team competence records 149.2.3 Auditor qualifications, training and experience 149.3 Outsourcing 1510.0 Audit Process 1510.1 Audit objectiv

6、es and scope 1510.1.1 Audit objectives 1510.1.2 Audit scope 1610.2 Types of audits 1610.2.1 Full audit 1610.2.2 Partial audit 1610.2.3 Surveillance audit 1710.2.4 Special audit 1710.2.5 Combined audit 1910.2.6 Joint audit 1910.3 Flow Chart 1910.4 Roles, responsibilities and authorities 2110.4.1 Audi

7、ting organization 2110.4.2 Auditors 2210.4.3 Lead auditor 2310.4.4 Auditees 2410.4.5 Observers 2510.4.6 Language requirements 2510.5 Audit team composition 2610.6 Audit activities 2610.6.1 Notification 2610.6.2 Preparation 2710.6.3 Audit execution 2910.6.4 Audit report 3410.6.5 Audit completion 3510

8、.6.6 Retention of audit records 3510.7 Adequacy of audit documentation 3510.8 Follow-up activities 36PrefaceThis document was produced by the Global Harmonization Task Force, a voluntary group of representatives from medical device regulatory agencies and the regulated industry. The document is inte

9、nded to provide nonbinding guidance for use in the regulation of medical devices, and has been subject to consultation throughout its development.1.0 IntroductionThis document gives guidance to regulators and auditing organizations conducting audits of quality management systems of medical device ma

10、nufacturers based on the process approach to quality management system requirements （e.g., ISO 13485:2003 and 21 CFR Part 820）.The incorporation of quality management system requirements, based on ISO 13485, into regulations applicable to manufacturers of medical devices, provides the opportunity fo

11、r developing mechanisms that would lead to global harmonization. Regulators can use these guidelines when introducing regulatory systems for medical devices.Note: For the purpose of these guidelines, “audit” means a regulatory audit.Potential benefits for the patients/users, regulators, auditing org

12、anizations or auditees include: a high degree of assurance （along with technical evaluation, where required in addition） that safe and effective devices will be available independent, reliable, objective evaluation of compliance with regulatory requirements of the manufacturers quality management sy

13、stem if satisfactory, results are evidence （or part thereof） of compliance with regulatory requirements necessary to market devicesIn this document the terms “compliance” and “conformity” are used interchangeably whereas in some jurisdictions they may have distinct and different meanings.The auditin

14、g of a medical device manufacturers quality management system may represent only one part of the conformity assessment procedure required by the applicable regulations.2.0 ScopeThis document provides guidance for auditing organizations responsible for establishing, planning, carrying out, and docume

15、nting audits of medical device manufacturers quality management systems. The document also covers related requirements on the follow-up of corrections, corrective, preventive, or improvement actions, as applicable. In addition, it describes the competence criteria that the audit team should meet.3.0

16、 PurposeThe purposes of this document are: To harmonize and to provide guidance on auditing quality management systems of medical device manufacturers To help the auditing organization develop their auditing procedures To assist auditors and auditees in preparing for, facilitating and responding to

17、audits4.0 RationaleThis guideline promotes consistency in auditing of medical device manufacturers quality management systems which is important in harmonization and mutual acceptance of audit results.5.0 ReferencesGHTF/SG4/N30R20:2006 Guidelines for Regulatory Auditing of Quality Management Systems

18、 of Medical Device Manufacturers Part 2: Regulatory Auditing StrategyGHTF/SG4/N33R14:2007 Guidelines for Regulatory Auditing of Quality Management Systems of Medical Device Manufacturers Part 3: Regulatory Audit ReportsGHTF/SG4 （00） 3 Training Requirements for AuditorsISO 13485:2003 Medical devices

19、- Quality management systems Requirements for regulatory purposesISO 17000:2004 Conformity assessment - Vocabulary and general principlesISO/IEC 17021:2006 Conformity assessment Requirements for bodies providing audit and certification of management systemsISO 19011:2002 Guidelines for quality and/o

20、r environmental management systems auditingISO 9000:2005 Quality management systems Fundamentals and vocabulary6.0 Definitions6.1 AuditSystematic, independent, documented process for obtaining records, statements of fact or other relevant information and assessing them objectively to determine the e

21、xtent to which specified requirements are fulfilled.2004 4.4For the purpose of these guidelines, audit means audit of the auditees quality management system to determine compliance with the relevant regulatory requirements.6.2 Audit CriteriaSet of policies, procedures, or requirements. Audit criteri

22、a are used as a reference against which audit evidence （3.9.4） is compared.2005 3.9.36.3 Audit EvidenceRecords, statements of fact or other information, which are relevant to the audit criteria and verifiable. Audit evidence may be qualitative and/or quantitative and is used to substantiate audit ob

23、servations.2005 3.9.46.4 Audit findingsResults of the evaluation of the collected audit evidence against audit criteria. Audit findings can indicate either conformity or nonconformity with audit criteria or opportunities for improvement.2005 3.9.56.5 Audit languageThe language（s） routinely used for

24、the communication or exchange of information between auditees personnel and auditors.6.6 Audit programSet of one or more audits planned for a specific time frame and directed towards a specific purpose. An audit program includes all activities necessary for planning, organizing and conducting the au

25、dits.2005 3.9.26.7 AuditeeAny organization whose quality management system is to be audited for compliance with relevant medical device regulatory requirements. The organization may be the manufacturer and/or their supplier（s）. ISO 9000:2005 3.9.8 defines auditee as “organization being audited”.6.8

26、Auditing organizationA body designated, on the basis of specific regulations, to carry out audits according to assigned tasks. ISO 17000:2004 2.5 defines the term conformity assessment body as “body that performs conformity assessment services”.6.9 AuditorA person with relevant qualifications and co

27、mpetence to perform audits or specified parts of such audits and who belongs to, or is authorized by, the auditing organization.2005 3.9.9 defines auditor as “person with the demonstrated personal attributes and competence to conduct an audit”.6.10 ComplianceOverall conformity to regulatory requirem

28、ents.6.11 ConformityFulfillment of a requirement.2005 3.6.16.12 EstablishEstablish means define, document （in writing or electronically）, and implement. This definition differs from the usage of the word “establish” in ISO 13485:2003 in that the ISO 13485:2003 term is not defined and is less prescri

29、ptive.6.13 Lead auditorAn auditor appointed to manage an audit See ISO 9000:2005 3.9.10 Note 16.14 ManufacturerAny natural or legal person who designs and/or manufactures a medical device with the intention of making the finished medical device available for use, under his name; whether or not such a medical device is designed and/or manufactured by that person himself or on his behalf by a third party（ies）. SG1（PD）/N055R6 In some internationally recognized Standards and Guidelines on auditing, specific responsibilitie