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ISO 15189:2012 Certification

What is ISO 15189:2012 Certification

ISO 15189:2012 is a regulatory standard for medical labs. Its criteria help labs develop quality management systems and assess their own competence. The standard is also used by regulators, accreditation bodies and customers to confirm or recognize a lab’s competence.

Benefits of ISO 15189:2012 Certification:

  • Improves the competence and performance of medical laboratories
  • Increased Customers’ trust in the services.
  • Creates a competitive atmosphere that benefits the nation’s overall socio-economic development.
  • Provides health-care units with the ability to compete with the best.

ISO 15189 remains the ‘gold standard for quality in medical laboratories. The cleaner organization of the 2012 version will allow laboratories to better understand this standard and better meet the standard requirements. In fact, it is an obligation for laboratories to use the ISO standard to move toward accreditation in order to ensure the trust of patients and to gain national and international respect.

ISO 15189:2012

Have a question or need consultation in regards to ISO 15189:2012? Contact a consultant below.

Requirements of ISO 15189:2012 Certification

Based on ISO/IEC 17025, General requirements for the competence of testing and calibration laboratories, and ISO 9001, Quality management systems – Requirements, ISO 15189 includes five additional criteria for medical laboratories

  • Providing advice on the type of sample and testing that may be required.
  • Interacting with clinical staff with the laboratory responsible for the quality of service to clinicians referring patient samples for testing.
  • Providing opinions on results of testing relative to diagnosis and patient care.
  • Collecting samples or providing information on collection procedures, sample containers, and sample volumes.
  • Ethical practice.

Importance of ISO 15189:2012 Certification

  1. Improves the competence and performance of medical laboratories
  2. Customers’ trust in the services provided by Medical Labs is increased.
  3. Creates a competitive atmosphere that benefits the nation’s overall socio-economic development.
  4. Provides health-care units with the ability to compete with the best.

Interested in ISO 15189 Certification?

Feel free to contact one of our representatives.

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Shahrah-e-Faisal, Karachi

+92 300 8270988
+92 300 8218041

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Ace Management System Consultants is an ISO 9001 certified organization that provides customization consulting, training, auditing, and certification services that reduce risks and save time for organizations while educating, empowering, and enabling leadership to implement, improve and integrate management systems and strategic initiatives.

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