Ghtf sg4 Auditing of qms of Medical Device Manufacturers-Part 2 Audit Strategies

GHTF/SG4/N30R20:2006

FINAL DOCUMENT

Title: Guidelines for Regulatory Auditing of Quality Management

Systems of Medical Device Manufacturers –

Part 2: Regulatory Auditing Strategy
Authoring Group: Study Group 4
Endorsed by: The Global Harmonization Task Force
Date: 28 June 2006

Georgette Lalis, GHTF Chair

The 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 medical 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 English, 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 Contents

Preface
1.0 Introduction

2.0 Scope

3.0 Rationale

4.0 References

5.0 Definitions

0. 
   General Remarks on Regulatory Auditing Strategy
   

0. 
   Objectives
   
1. 
   Auditing Quality Management Systems
   
2. 
   Auditing Approaches
   
3. 
   Process Based Auditing
   
4. 
   Sampling
   
5. 
   Audit Planning
   
6. 
   Guidance for Logistics During an Audit
   
7. 
   Links
   

0. 
   Auditing Subsystems
   

0. 
   Management Subsystem
   
1. 
   Design and Development Subsystem
   
2. 
   Product Documentation Subsystem
   
3. 
   Production and Process Controls Subsystem
   
4. 
   Corrective and Preventive Actions (CAPA) Subsystem
   
5. 
   Purchasing Controls Subsystem
   
6. 
   Documentation and Records Subsystem
   
7. 
   Customer Related Processes Subsystem
   
   
   

Appendices
Appendix 1: Binominal Staged Sampling Plans
Appendix 2: Factors Used to Determine Audit Duration

Appendix 3: Cross-reference between ISO 13485:2003 and 21 CFR Part 820

Appendix 4: Sterilization Process

Preface

The document herein was produced by the Global Harmonization Task Force, a voluntary group of representatives from medical device regulatory agencies and the regulated industry. The guideline is intended to provide nonbinding guidance for use in the regulation of medical devices, and has been subject to consultation throughout its development.

There are no restrictions on the reproduction, distribution or use of this guideline; however, incorporation of this guideline, in part or in whole, into any other document, or its translation into languages other than English, does not convey or represent an endorsement of any kind by the Global Harmonization Task Force.

Introduction

This document gives guidance to regulators and auditing organizations conducting audits of quality management systems of medical device manufacturers based on the process approach to quality management system requirements (e.g., ISO 13485:2003 and 21 CFR Part 820).

Note: For the purpose of these guidelines, “audit” means a regulatory audit.

Potential benefits for the regulators or auditing organizations include:

• 
  improved auditing, leading to improved quality management systems and product quality
  
• 
  achievement of greater consistency in audits both among auditors within an auditing organization and between auditing organizations
  
• 
  promotion of greater collaboration between regulators in regard to audits
  
• 
  increased confidence in audits performed by an auditing organization and acceptance of those audits by other regulators
  
• 
  more efficient use of auditing resources
  
• 
  guidance for countries intending to develop a strategy for auditing quality management systems
  

Potential benefits for the manufacturer of medical devices include:

• 
  improved auditing, leading to improved quality management systems and product quality
  
• 
  greater consistency in audit practices and feedback provided to manufacturers about their quality management system saving resources through easier preparation for audits
  

• 
  reducing the number of times a single manufacturer undergoes audits by different regulatory bodies
  
• 
  increased confidence in and acceptance of audits by different regulators
  

Beneficiaries also include patients and users of medical devices, who will have a higher degree of assurance that medical devices placed on the market are safe and effective.
This guideline has been prepared by GHTF Study Group 4 “Regulatory Auditing”. Comments or questions about the use of this guideline should be directed to the Chair of SG 4 whose contact details may be found on the GHTF web page (www.ghtf.org).

Scope

This guideline is intended to be used by regulators and auditing organizations conducting quality management system audits of medical device manufacturers based on the process approach to quality management system requirements (e.g., ISO 13485:2003 and 21 CFR Part 820). Where auditing organizations are bound by regulatory or accreditation requirements the audit strategy given in this document should be considered as supplementary to these regulatory or accreditation requirements as appropriate.

Although an audit of a medical device manufacturer can incorporate regulatory requirements not related specifically to quality management, this guideline will limit its coverage to quality management system requirements. Where additional regulatory requirements apply and are part of the scope of the audit, the auditor will need to consider these by identifying and documenting them in the audit objective and criteria.

This guideline applies to initial and surveillance audits and can apply to other audits as they are defined in “Guidelines for Regulatory Auditing of Quality Systems of Medical Device Manufacturers – Part 1: General Requirements” (SG4/N28) – including any supplements – developed by GHTF Study Group 4 as a guide for auditing organizations. The purpose of the other audits will determine the subsystem elements selected for the audit.