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

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