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ISO 15189 CERTIFICATION

ISO 15189 CERTIFICATION

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

  • 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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