ISO 15189 CERTIFICATION

ISO 15189 is a laboratory accreditation standard. GAS coordinates with UKQAAS to deliver the laboratory accreditation. It is a comprehensive standard specifically meant for MEDICAL LABORATORIES.

ISO 15189 PRINCIPLES

• 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

To know more about obtaining this accreditation standard, kindly contact GAS office about the due procedure. Write a mail to info@iasiso.com