ISO 15189 Certification

What is ISO 15189 Certifcation?

ISO 15189 is an international standard that specifies the requirements necessary for a medical laboratory to demonstrate competence in conducting tests and providing reliable results. The standard is designed to promote the harmonization of quality assurance practices among medical laboratories around the world, as well as enable clients to identify qualified testing services quickly and easily. ISO 15189 Certification is granted to organizations after they have successfully met all of the requirements specified in the standard.

Importance of ISO 15189 Certification

ISO 15189 plays an important role in ensuring the accuracy and reliability of medical laboratory tests. By meeting the requirements laid out in the standard, organizations can improve their quality assurance processes and provide better patient care. Additionally, ISO 15189 certification is often required for laboratories to be eligible for accreditation from regulatory bodies or credentialing from hospitals and other healthcare organizations. ISO 15189 also helps organizations differentiate themselves in the competitive medical laboratory industry.

Which Organizations Can Apply for ISO 15189 Certification?

Organizations that provide medical laboratory services, such as clinical testing laboratories (including those in hospitals), research and development laboratories, and commercial diagnostics laboratories, can all apply for ISO 15189 Certification. The certification is applicable to any medical laboratory, including large international companies and small local businesses.

Once you successfully achieve ISO 15189 Certification, you can check the status of your certificate by visiting our ISO 15189 Certification search Page!

ISO 15189 Certification

What Are The Benefits of Achieving ISO 15189 Certification?

ISO 15189 Certification is a must-have for organizations that provide medical testing services. It helps healthcare providers demonstrate their commitment to quality and patient safety while providing assurance to customers and stakeholders that laboratory tests are being conducted with accuracy and reliability. It also gives your organization a competitive edge in the medical industry by helping you attract more customers, increase market share, and reduce potential legal liability.

ISO 15189 Certification Process Through IAS

The process to obtain ISO 15189 certification through IAS is quite simple and effective.

  • Fill out an ISO 15189 Certification Application Form.
  • Our team of experts will review your application and provide a quotation.
  • Upon approval of the quotation, IAS will schedule a series of audits to review your organization’s processes and procedures.
    • Stage 1 Audit: This audit evaluates the readiness of your organization for certification, including an assessment of your current quality management system.
    • Stage 2 Audit: This audit verifies the compliance of your organization to all requirements specified in the standard.
  • Upon successful completion of both stages, IAS will issue a certificate indicating that your organization has met all applicable requirements for ISO 15189 Certification.

Why Choose IAS for ISO 15189 Certification? 

Integrated Assessment Services is a leader in the certification industry, with more than 20 years of experience providing quality assurance solutions to organizations around the world. We provide specialized services for ISO 15189 Certification including on-site assessments, gap analysis, and training programs. Our team of experts can help ensure that your organization meets all the requirements specified by the standard and obtain the certification you need to stay competitive in the medical testing industry. With a track record of success and a commitment to customer satisfaction, IAS is your partner for ISO 15189 Certification.

Contact us today to learn more about the ISO 15189 certification process and ISO 15189 Certification Procedure!  Also visit our ISO 15189 certification frequently asked questions page to learn more.

Also check out our blog on how to get ISO Certification!