22 April 2019
Comments 0
22 April 2019, Comments 0


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

  1. Laboratory Management has a responsibility to manage
  2. The laboratory must know who are its users (customers) and meet their requirement
  3. 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

  1. Organization and management responsibility
  2. Quality management system
  3. Document control Service agreements
  4. Examination by referral laboratories
  5. External services and supplies
  6. Advisory services
  7. Resolution of complaints
  8. Identification and control of nonconformities
  9. Corrective action Preventive action
  10. Continual improvement Control of records Evaluation and Audits Management review.

Technical Requirements

  1. Personnel
  2. Accommodation and environmental conditions
  3. Laboratory equipment,
  4. reagents, and consumables
  5. Pre-examination processes
  6. Examination processes
  7. Ensuring quality of examination results

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