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TABLE OF CONTENTS - AUDIT MANUAL


1.0 CHANGE CONTROL 4
2.0 GENERAL 5
2.1 POTENTIAL BENEFITS 5
2.2 POTENTIAL PROBLEMS 5
3.0 INTERNAL AUDIT FREQUENCY 6
3.1 QUALITY SYSTEM AUDIT PLANNING 6
3.1.1 Audit Timetable 6
3.2 SAFETY AUDIT PLANNING 6
3.3 AUDITS DUE TO NON-CONFORMANCE OR COMPLAINTS 7
4.0 THE AUDITOR 7
5.0 PLANNING THE AUDIT 8
6.0 PERFORMING THE AUDIT 9
6.1 General 9
6.2 Types of Audits 9
6.2.1 Horizontal Audit 9
6.2.2 Vertical Audit 10
6.3 Auditing Techniques 10
6.3.1 ‘Show and Tell’ 10
6.3.2 Observing 10
6.4 Audit Hints 10
6.4.1 Keep the Audit Flowing 10
6.4.2 When Things Seem Wrong 11
6.4.3 Dealing with Tension 11
6.5 Audit Checklists 12
6.5.1 Equipment Audit 12
6.5.2 Method Manuals & Test Procedures Audit 12
6.5.3 Training Audit 13
6.5.4 Quality Systems Audit 13
6.5.5 Administration Audit 14
6.5.6 Client Services (including Phlebotomy) Audit 14
6.5.7 Safety Audit 15
7.0 WRITING THE AUDIT REPORT 15
7.1 FORMAT 15
7.1.1 Summary of Findings 15
7.1.2 The Report 16
7.2 RESPONSE TO AUDIT 17
7.3 FOLLOW-UP 17
7.4 RECORDS 17
7.4.1 Record Filing 17
7.4.2 Previous Audits and Responses 18
7.4.3 Audit Timetable Record 18
7.5 GRATITUDE 18
8.0 MANAGEMENT REVIEW 18
9.0 AUDITOR TRAINING 19
9.1 General 19
9.2 Choice of Auditors 19
9.3 Who Performs the Training? 19
9.4 How to Train Auditor Candidates 19
10.0 APPENDIX A - AUDIT TIMETABLE 20
11.0 APPENDIX B – ARCHIVED 2/8/00 21
12.0 APPENDIX C - EQUIPMENT AUDIT 22
13.0 APPENDIX D - METHOD MANUALS & TEST PROCEDURES 23
14.0 APPENDIX E - TRAINING AUDIT CHECKLIST 24
15.0 APPENDIX F - QUALITY SYSTEM AUDIT CHECKLIST 25
16.0 APPENDIX G – ARCHIVED 1/3/2002 26
17.0 APPENDIX H – ARCHIVED 9/5/2002 27
18.0 APPENDIX I - SAFETY AUDIT CHECKLIST 28
19.0 APPENDIX J - ADMINISTRATION AUDIT CHECKLIST 29


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