Paradigm Compliance Management Software Helps Medical Laboratories Maintain ISO 15189 Quality Standards

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Paradigm 3 software, distributed by the Interax Group Inc. is providing medical laboratories with the tools to achieve and maintain accreditation to ISO 15189.

The Interax Group is pleased to announce more US and Canadian Laboratories have joined their Paradigm Compliance Management Software users group to enable them to electronically manage their ISO 15189 standard. Paradigm software provides the systems and tools required for managing compliance standards. The rigorous attention required by laboratories to detail their actions necessitates a powerful EMS.

Our laboratory customers are impressed with the ease of using Paradigm software, "Paradigm 3 enables me to complete the work associated with managing my compliance system many times faster than before." Kevin Condon, Wyoming Forensic Laboratory.

ISO 15189:2007 is for use by medical laboratories to develop their quality management systems and for use by accreditation bodies to confirm or recognize the competence of medical laboratories. ISO 15189 is available to all US-based medical laboratories and accreditation can be achieved through CAP (The College of American Pathologists). Clinical Laboratories applying to CAP 15189 must be CAP accredited through the CAP Laboratory Accreditation Program. ISO 15189 accreditation is voluntary in the United States but gaining ground as a necessary standard. ISO 15189 was created to be used by medical laboratories and was written by medical laboratory professionals.

In Canada the OLA Program (Ontario Laboratory Accreditation) developed in September 2000, was based on ISO 15189 and has helped a large number of laboratories within Ontario and Newfoundland reach ISO accreditation.

Quality in medical laboratories is essential as a large percentage of clinical decision making comes from any number of medical testing procedures. How can this be ensured? It can be ensured through recognized standards. More and more medical laboratories are earning ISO 15189 accreditation as the recognized standard and many countries are now requiring ISO 15189 accreditation for their medical laboratories

Through the requirements of ISO 15189 the documentation and development of policies, procedures, work instructions, forms and audits become the foundation for corrective and preventative action, continuous improvement and customer satisfaction.

The efficient control of documentation is also a growing concern for medical laboratories. Utilizing an electronic quality management system helps laboratories maintain the large number of required documents and other essential information.

Since 1991, the Interax Group and Paradigm software has aided an extensive group of hospitals and laboratories achieve whatever certification is essential for the electronic management of their quality system. For more information and advice on ISO 15189, please contact us at 1 800 884 3160 or visit our website

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Gary Halford
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