Article Index

Introduction

1. The purpose of the EBME Department is to provide the hospital, clinics and similar departments with a professional and efficient repair and maintenance service on a range of biomedical and associated equipment. When appropriate, the department Manager will offer a consultancy service and advise in the procurement of hospital biomedical and associated equipment.

 

2. The Department Manager runs a team of qualified and competent technologists. The Department also ensures that sub contracted departments which maintain, repair and service biomedical equipment carry out the operations in a timely, efficient and responsible manner

 

A wide range of associated workshop and test equipment is used to provide this service. The Department Manager also maintains a "library" of equipment that can be borrowed on a loan basis.

 

3. In fulfilling the quality management requirements, three separate Quality manuals have been prepared:

  • A POLICY Manual
  • A PROCEDURES Manual
  • WORK INSTRUCTIONS

This document is the POLICY Manual and is available for inspection by any interested third party.
 
The following parts of this document are broken down into these quality management areas:

 

4.0 GUIDE TO QUALITY MANAGEMENT SYSTEM
4.1 General Requirements
4.2 Documentation Requirements

 

5.0 MANAGEMENT RESPONSIBILITY
5.1 MANAGEMENT COMMITMENT
5.2 CUSTOMER FOCUS
5.3 QUALITY POLICY
5.4 PLANNING
5.5 RESPONSIBILITY AUTHORITY AND COMMUNICATION
5.6 MANAGEMENT REVIEW

 

6.0 RESOURCE MANAGEMENT
6.1 PROVISION OF RESOURCES
6.2 HUMAN RESOURCES
6.3 INFRASTRUCTURE
6.4 WORK ENVIRONMENT

 

7.0 SERVICE REALISATION
7.1 PLANNING OF SERVICE REALISATION
7.2 CUSTOMER-RELATED PROCESSES
7.3 DESIGN AND DEVELOPMENT
7.4 PURCHASING
7.5 PRODUCTION AND SERVICE PROVISION
7.6 CONTROL OF MONITORING AND MEASURING DEVICES

 

8 0 MEASUREMENT, ANALYSIS AND IMPROVEMENT
8.1 GENERAL
8.2 MONITORING AND MEASUREMENT
8.3 CONTROL OF NONCONFORMING SERVICE
8.4 ANALYSIS OF DATA
8.5 IMPROVEMENT

 

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