Iso 15189 quality manual
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A prerequisite for a medical laboratory to become accredited is to have a documented quality management system. The usual contents of the quality manual follow the outline of the ISO 15189 standard. This is as follows:
4.1 Organization and management
4.2 Quality management system
4.3 Document control
4.4 Review of contracts
4.5 Examination by referral laboratories
4.6 External services and supplies
4.7 Advisory services
4.8 Resolution of complaints
4.9 Identification and control of nonconformities
4.10 Corrective action
4.11 Preventive action
4.12 Continual improvement
4.13 Quality and technical records
4.14 Internal audits
4.15 Management review
5.1 Personnel
5.2 Accommodations and environmental conditions
5.3 Laboratory equipment
5.4 Pre-examination procedures
5.5 Examination procedures
5.6 Assuring the quality of examination procedures
5.7 Post-examination process
5.8 Reporting results
