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ISO 15189:2012

Overview

ISO 15189:2012 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.

Benefits of ISO 15189

The benefits of ISO 15189:

  • An ISO 15189 certification 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. Ultimately promoted the growth of customer satisfaction in organizations involved in medical laboratory testing

Who Needs ISO 15189?

This International Standard specifies requirements for a quality management system that can be used by an organization for the design and development, production, installation and servicing of medical devices, and the design, development, and provision of related services

It can also be used by internal and external parties, including certification bodies, to assess the organization’s ability to meet customer and regulatory requirements.

How Kayzed Helps to Get Certified?

Kayzed Consultants is one of the largest & leading business management consulting organizations offering business management consulting services to organizations of all nature and size.

Our services are essential for businesses of all types whether it is to get products to market, meet contractual and regulatory requirements or improve quality, safety, efficiency and sustainability.

The core of our business is our people whose depth of knowledge and experience means they understand the issues that are important to your business and to meeting your goals.

Our ISO certification services cover training, gap analysis, documentation, implementation assistance, internal audit, pre-assessment audit, assistance in selection of the ISO certification body and ensuring successful completion of the ISO certification audit.

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