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| ISO/DIS 15189: 2022 | |||||
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| Table of contents | |||||||||
1.0. General 1.1. Index and revision status 1.2. Purpose 2.0. Background of the laboratory 2.1. Activities 2.2. History 3.0. Definitions and conventions 3.1. Definitions and terminology 3.2. Abbreviations 4.0. General requirements 4.1. Impartiality 4.2. Confidentiality 4.3. Requirements regarding patients 5.0. Structural and governance requirements 5.1. Legal entity 5.2. Laboratory director 5.3. Laboratory activities 5.4. Structure and authority 5.5. Objectives and policies 5.6. Risk management 6.0. Resource requirements 6.1. General 6.2. Personnel Management 6.3. Facilities and environmental conditions 6.4. Equipment 6.5. Equipment calibration and metrological tracebility 6.6. Reagents and consumables 6.7. Service agreements 6.8. Externally provided products and services 7.0. Process requirements 7.1. General 7.2. Pre-examination processes 7.3. Examination processes 7.4. Post-examination processes 7.5. Nonconforming work 7.6. Control of data and information management 7.7. Complaints 7.8. Continuity and emergency preparedness planning 8.0. Management system requirements 8.1. General requirements 8.2. Management system documentation 8.3. Control of management system documents 8.4. Control of records 8.5. Actions to address risks and opportunities for improvement 8.6. Improvement 8.7. Nonconformites and corrective action 8.8. Evaluations 8.9. Mangement reviews | |||||||||
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