Accreditation of Medical Testing Laboratories to ISO 15189:2007

($795 non-members/$745 members)

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Driving towards excellence:
 A “GPS” guide for applying the ISO 15189 standard:

This is a practical course designed to provide:

  • Knowledge of the ISO 15189 Standard and
  • Tools that you can use to address and incorporate the quality principles of medical laboratory services.

 

Using the ISO 15189 Standard as your “map” you will learn:

  • How to design a total laboratory process that addresses the principles of quality medical laboratory services and
  • Implementation of the pre-examination, examination and post examination processes that are essential to patient care and that you have designed specific for your laboratory. 

The course combines review of the standards, case studies, and group exercises to introduce concepts for:

  • Applying the ISO 15189 standard and Medical Laboratory Quality Management Systems
  • Document System design, control and implementation
  • Managing arrangements with Clients, referral laboratories and consultants, Suppliers and Advisory services
  • Identifying, managing, monitoring learning from complaints and non-conformances
  • Effective use of the corrective and preventive action process, internal audits, management reviews and continuous improvement.
  • Involving your personnel in the entire quality process from job descriptions, credentialing, training, responsibilities, competency assessment, performance
  • Pre-examination (preanalytic) considerations for test selection, patient preparation, sample collection, sample transport and communication with the clinicians.
  • Processes that impact the examination (analytic) processes to include the laboratory facility, equipment, test methods, supplies, the quality of the results and the records.
  • Post examination processes for reviews and approval and result reporting.

 

When you effectively apply this knowledge you will:

  • Focus on ensuring that your laboratory successfully meets the patient care needs
  • Reduce use of precious resources on efforts that don’t add value to your laboratory services.
  • Stop “gearing up” for a third party inspection, assessment or audit.

 

You will be travelling on the road to excellence:
Staying in compliance and effectively supporting your clients will be your norm.

 

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