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ISO 15189(2007), 임상검사실-질과 능력에 관한 특정요구사항 |
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정비호 |
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2008-08-09 |
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등록된 파일이 없습니다. |
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없음 |
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국제기준에 부합하는 세계적인 임사검사 전문기관으로 인정을 받기 위해서는
국제적인 임상검사 규격 ISO 15189:2007, Medical laboratories - Particular
requirements for quality and competence 에 따라 수립, 실행 및 유지해야 합니다.
관련된 규격으로는,
ISO 15189:2003, ISO/IEC 17025:1999, ISO/IEC 17025:2005, ISO 9001:2000 있습니다.
아래는 참고적으로 문서화된 절차(QOP, SOP, WDI) 입니다.
quality manual
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. General
5.2. Personnel
5.3. Accomodation
5.4. Test methods and validation
5.5. Equipment
5.6. Measurement traceability
5.7. Sampling
5.8. Test items
5.9. Quality control
5.10. Reports / calibration certificates
procedures
- Document control
- Contract review
- Purchasing
- Client complaints
- Control of non-conforming work
- Corrective actions
- Preventive actions
- Control of quality records
- Internal quality audits
- Management review
- Training
- Estimation of uncertainty
- Equipment
- Sampling
- Handling of test items
quality records
- 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
업무에 참고 하시고 궁금한 내용이 있으시면 연락 주시기 바랍니다.
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