HOW TO GET ISO CERTIFICATION FOR MEDICAL LABORATORY?
ISO 15189 Certification is a laboratory accreditation standard. IAS coordinates with UQAS to deliver the laboratory accreditation. It is a comprehensive standard specifically meant for MEDICAL LABORATORIES.
ISO 15189 PRINCIPLES
ISO Certification For Laboratory Management has a responsibility to manage
The laboratory must know who are its users (customers) and meet their requirement
The physical laboratory should not interfere with laboratory workers or laboratory samples
The requirements of this standard cover the following aspects:
Management, staff, customers, physical lab, error prevention and management towards achieving laboratory quality.
MANAGEMENT REQUIREMENTS
Organization and management responsibility
Quality management system
Document control Service agreements
Examination by referral laboratories
External services and supplies
Advisory services
Resolution of complaints
Identification and control of nonconformities
Corrective action Preventive action
Continual improvement Control of records Evaluation and Audits Management review.
TECHNICAL REQUIREMENTS
Personnel
Accommodation and environmental conditions
Laboratory equipment,
reagents, and consumables
Pre-examination processes
Examination processes
Ensuring quality of examination results
Post-examination processes
Reporting of results Release of results
NEED MORE INFORMATION About ISO Certification & Training?
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