Essential Criteria for Quality Control Systems for Medical Laboratories

Essential Criteria for Quality Systems of Medical Laboratories

1. Introduction and scope
2. General information
3. Quality policy and strategy
4. Organization and management
5. Personnel
6. Premises and environment
7. Equipment, materials and reagents
8. Pre-analytical phase
9. Analytical phase
10. Post-analytical phase
11. Evaluation of the quality system

Additional Essential Criteria for Quality Systems of Medical Laboratories

1. General Information
2. Quality Policy and Strategy
3. Organisation and Management
4. Personnel
5. Premises and Environment
6. Equipment, Materials and Reagents
7. Pre-Analytical Phase
8. Analytical Phase
9. Post-Analytical Phase
10. Evaluation of the Quality System

Additional Criteria on Point of care (POC) Testing

1. General Information
2. Quality Policy and Strategy
3. Organisation and Management
4. Personnel
5. Premises and Environment
6. Equipment, Materials and Reagents
7. Pre-Analytical Phase
8. Analytical Phase
9. Post-Analytical Phase
10. Evaluation of the Quality System

EC4 Quality Manual Model

Here you can download the EC4 Quality Manual Model in complete form (pdf 7.7 MB) or in parts.
For the pdf files you need the Adobe Acrobat Reader.

01 General Information

1.1 Introduction (88kB)
1.2 Definition and Abbreviations (127kB)
1.3 Legal Identity (84kB)
1.4 Clinical Advisory Services (86kB)
1.5 Research and Development (80kB)
1.6 Teaching (85kB)
1.7 Subcontractors (74kB)

02 Quality, Policy and Strategy

2.1 Quality Policy of the Parent Organization (59kB)
2.2 Quality Policy of the Laboratory (59kB)
2.3 Quality Strategy of the Laboratory (68kB)
2.4 Confidentiality (58kB)
2.5 Ethics: Managing Improper Influence (55kB)

03 Organization and Management

3.1 External Relationship (77kB)
3.2 Internal Organisation Structure (88kB)
3.3 Budget Management (61kB)
3.4 Laboratory Director (74kB)
3.5 Professional Staff (90kB)

04 Personnel

4.1 Job Descriptions, Duties and Responsabilities (81kB)
4.2 Service and Leave Planning; Sickness Substitution (74kB)
4.3 Education, Training and Development of Staff (86kB)
4.4 Staff Appraisal System (103kB)

05 Premises and Environment

5.1 Laboratory Space(73kB)
5.2 Office Space (59kB)
5.3 Facilities for Personnel (100kB)
5.4 Facilities for Patients (68kB)
5.5 Safety Facilities (86 kB)
5.6 Provisions for working Environment (65kB)
5.7 Storage Facilities (61kB)

06 Equipment Materials Reagents

6.1 Administration of Equipment (74kB)
6.2 Purchasing of Equipment (71kB)
6.3 Calibration (64kB)
6.4 Instructions for use and Maintenance (69kB)
6.5 Computer Facilities (88kB)
6.6 Administration of Materials and Reagents (79 kB)
6.7 Safety and Environment (240 kB)

07 Preanalytical Phase

7.1 User Information (103 kB)
7.2 Consultation and Efficacy (88 kB)
7.3 Repertoire (102 kB)
7.4 Request Procedures (104 kB)
7.5 Information and Preparation of Patients (93 kB)
7.6 Specimen Collection (104 kB)
7.7 Specimen Transport and Handling (102 kB)
7.8 Experimental Testing (106 kB)
7.9 Confidentiality and Safety (98 kB)

08 Analytical Phase

8.1 Validation (136 kB)
8.2 Calibration and Traceability of Methods (126 kB)
8.3 Working Procedures (147 kB)
8.4 Quality Control and Assessement (133 kB)
8.5 Authorization (117 kB)
8.6 Archiving (125 kB)
8.7 Disposal of Specimens and waste Material (116 kB)

09 Post Analytical Phase

9.1 Reporting Procedures (110 kB)
9.2 Amendment Procedures (95 kB)
9.3 Turnaround Time (108 kB)
9.4 Reference Values (105 kB)
9.5 Interpretation and Consultation (116 kB)
9.6 Archiving (127 kB)
9.7 Confidentiality (98 kB)

10 Evaluation of the Quality System

10.1 Internal Audit (100 kB)
10.2 Internal and External Complains (85 kB)
10.3 External Audit (75 kB)