ISO 15189:2012 specifies requirements for quality and competence in medical laboratories.
ISO 15189:2012 standard can be used by medical laboratories in developing their quality management systems and assessing their own competence. It can also be used for confirming or recognizing the competence of medical laboratories by laboratory customers, regulating authorities and accreditation bodies.
ACCREDITATION WILL HAVE DEMONSTRATED:
• competency to perform specific testing procedures • its quality system is documented, is fully operational, and addresses and conforms to all elements of ISO 15189:2012 • it is operating in accordance with the required quality system
Basic Requirements for ISO 15189 Accreditation
• A well documented procedure analysis by the laboratories. • Training manual provided by the laboratories. • ISO 15189 requires an effective detailed analysis of medical laboratory procedures in a bid to make sure that all weaknesses have been identified. • Detailed evaluation reports of the existing quality management system as well as other monitoring and evaluation reports. • A detail audit of management reviews
BENEFITS OF ACCREDITATION
ISO 15189 accreditation promotes development of an international reputable image for your organization through Quality Assurance and Management Systems.
Promotes a strong degree of consistency in compliance to medical laboratory laws and legislation both from an international and national perspective.
Fundamentally critical in promoting laboratory efficiency and responsibility for better results and service delivery.
The accreditation program also has been very critical in promoting modern laboratory practices that include professionalism and expertise in conduction of medical activities in the labs.
Ultimately promoted the growth of customer satisfaction in organizations involved in medical laboratory testing.
HOW WE CAN HELP YOU ?
New Chem Vision provides expert consulting, training and auditing services for ISO 15189 medical laboratory management system standard. Our focus is on providing timely and cost-effective solutions for your system development, implementation, training and auditing needs Contact US NOW.
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