1. Dr. Adel Younis
Quality consultant
Quality Tip
The main concern: ISO 15189.
Manual Content:
1. Introduction
2. Scope
3. Definitions and terminology
4. Mangement requirements
4.1. Organization
4.2. Quality system
4.3. Document control
4.4. Review of contracts
4.5. Subcontracting
4.6. Purchasing
4.7. Service to the client
4.8. Complaints
4.9. Control of non-conforming work
4.10. Corrective actions
4.11. Preventive actions
4.12. Control of quality records
4.13. Internal audits
4.14. Mangement review
5. Technical requirements
5.1. Personnel
5.2. Accomodation and environmental conditions
5.3. Laboratory equipment
5.4. Pre-examination procedures
5.5. Examination procedures
5.6. Assuring quality of examination procedures
5.7. Post-examination procedures
5.8. Reporting of results
5.9. Release of results
5.10. Information management
System Procedures :
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Document control
Contract review
Purchasing
Client complaints
Control of non-conforming work
2. Dr. Adel Younis
Quality consultant
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Corrective actions
Preventive actions
Control of quality records
Internal quality audits
Management review
Training
Estimation of uncertainty
Equipment
Sampling
Handling of test items
Reporting of results
Release of results
Confidentiality
System Records
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Definitions and terminology
Quality policy and quality objectives
Organization scheme
Personal cards
Function descriptions
Responsibilities
Training
Maintenance cards
Maintenance schedule
Maintenance survey
Tests and specifications
Client complaints
Supplier cards
Supplier problems
Supplier review
Approved suppliers
Measuring equipment
Calibration schedule
Calibration survey
Audit schedule
Audit reports
Internal problems
Projects
