ISO 15189 Certification

What is ISO 15189?

ISO 15189 is an international standard that specifies the requirements for quality and competence in medical laboratories. It is designed to be used by medical laboratories in developing their quality management systems and assessing their own competence. The standard was first published in 2003 and was last revised in 2012.

Why is ISO 15189 Important?

Medical laboratories play a vital role in the diagnosis, treatment, and prevention of disease. They generate reliable results that are used to make decisions about patient care. The quality of laboratory results is therefore essential, and laboratories must be able to demonstrate their competence in order to earn the trust of patients, healthcare providers, and regulators. ISO 15189 provides a framework for laboratories to do this.

How can My Medical Laboratory Become ISO 15189 Certified?

To become ISO 15189 certified, laboratories must undergo an assessment by a third-party certification body. Certification bodies are organizations that have been accredited by an authoritative body to provide certification services. The assessment process includes a review of the laboratory’s quality management system and a demonstration of technical competence. Once the certification body is satisfied that the laboratory meets all the requirements of ISO 15189, it will issue a certificate.

What are the Benefits of ISO 15189 Certification?

There are many benefits to ISO 15189 certification, for both laboratories and their clients. Certification can help laboratories to:

  • Demonstrate their competence and commitment to quality
  • Win new business and tenders
  • Increase efficiency and reduce costs
  • Improve communication and coordination with other laboratories
  • Enhance their reputation
  • Reduce the risk of errors and improve patient safety

ISO 15189 Certification Through IAS

Integrated Assessment Services (IAS) is a globally recognized leader in ISO 15189 certification. We are one of the largest providers of ISO 15189 certification audits, and we have a team of experienced assessors who are experts in the standard. We offer both on-site and remote assessments, and we can tailor our services to meet the specific needs of your laboratory. Companies can achieve ISO 15189 certification through IAS by following these simple steps:

  • Contact IAS to receive and fill out the application form
  • Our experts will analyze the information that you provide to give you an accurate and cost-effective quotation
  • If you decide to proceed, we will assign an audit team to your project
  • Pass the Stage 1 and Stage 2 audits for ISO 15189 certification
  • Correct any nonconformities (deviations from the standard) if required.
  • Issuance of the ISO 15189 certificate by IAS
  • Receive your certificate and display it with pride!

Why Choose IAS for ISO 15189 Certification?

When you choose IAS for ISO 15189 certification, you can be confident that you are working with a reputable and experienced organization. We have a proven track record of success, and we are dedicated to providing our clients with the highest level of service. If you would like to learn more about ISO 15189 certification through IAS, or if you have any questions about the process, we would be happy to help. Contact us today!


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Want to help your organization prepare for ISO 15189 certification? Become an ISO 15189 internal auditor by enrolling in ISO 15189 Internal Auditor Training provided by IAS! We provide both virtual and self-learning options to clients across the globe!

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