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What are the Requirements to Get ISO 15189 Certification for Medical Laboratory?

To demonstrate the quality and reliability of services, Medical laboratories can seek ISO 15189 Certification, Medical laboratories – Particular requirements for quality and competence, an internationally recognised standard that contains the requirements necessary for diagnostic laboratories to demonstrate their competence to deliver reliable services. ISO 15189 Certification involves the independent assessment of a laboratory to determine competence, impartiality and consistency.

Principles of ISO 15189

  • ISO 15189 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

Requirements for ISO 15189 Certification

Management Requirements

The following are management requirements for ISO 15189 Certification:

  • 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

The following are technical requirements for ISO 15189 Certification:

  • 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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Posted by on November 11, 2017 in ISO 15189


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