ISO 15189 Certification in Australia

About ISO 15189

The ISO 15189 international standard was created specifically for the implementation of a quality management system in medical labs. The standards for establishing, monitoring, maintaining, and constantly improving the quality and competency of medical labs are outlined in ISO 15189. In addition, ISO 15189 assists organizations and governing agencies in evaluating the performance of medical labs. In addition, the ISO 15189 certification standard assists accrediting organizations and governing agencies in evaluating the performance of medical laboratories.

ISO 15189 Certification

Which Organizations Can Obtain ISO 15189 Certification?

The ISO 15189 standard is designed to address the needs of hospitals and other healthcare institutions that conduct medical laboratory testing. As a result, the standard is primarily aimed at large-scale healthcare institutions with sufficient resources and personnel. Smaller laboratories, such as those in doctors’ offices and clinics, are also covered. As a result, any medical laboratory, regardless of size, kind, or location, may get ISO 15189 accreditation.

The Process of ISO 15189 Certification

A medical laboratory organization must meet the standards of ISO 15189 in order to become ISO 15189 accredited. All guidelines of ISO 15189 must be applied and documented by lab management to ensure that the lab is competent. Furthermore, they must guarantee that the process properly handles program implementation risks.

A certification agency, such as IAS, will assess the organization’s paperwork and perform external audits to ensure that the medical laboratory is complying with ISO 15189 requirements after the quality management system is in place. IAS will provide ISO 15189 certification once any non-conformities discovered during the external audit are addressed and remedied.

Online ISO 15189 Certification Audits by IAS

IAS also conducts ISO 15189 certification audits through the use of online web testing tools. Going through the online test scenarios for your system documentation, as well as testing all policies and other essential processes, are among the tasks. After the audit is completed successfully, IAS issues a certificate saying that your company is ISO 15189 certified in compliance with a number of standards.

Why Choose IAS to Obtain ISO 15189 Certification?

The International Organization for Standardization (ISO) develops and publishes ISO 15189 standards; however, they do not provide ISO 15189 certification. As a result, companies rely on third-party certification bodies like IAS to get ISO 15189 accreditation. IAS is a prominent ISO 15189 Certification body in Australia, assisting businesses in assuring the effectiveness of their ISO 15189 quality management system for medical laboratories by performing conformity assessments with qualified specialists and experienced auditors. IAS examines your activities against the criteria of the standard to guarantee that you receive ISO 15189 certification in a timely process.

Advantages of ISO 15189 Certification

ISO 15189 accreditation allows medical laboratories to strengthen their quality management systems. Some of the numerous advantages of ISO 15189 certification are as follows:

  • ISO 15189 accreditation gives medical laboratories a competitive advantage in the market by improving their operations and increasing their reputation.
  • It establishes a foundation for future growth, better services, and, ultimately, more delighted consumers.
  • ISO 15189 certification establishes a shared understanding of medical laboratory quality management systems across regulatory agencies and certifying organizations.
  • It allows stakeholders to identify the components of the quality management system for their own use and reference, as well as comply with rules and other applicable obligations.
  • ISO 15189 certification assures that all firms in the supply chain follow the same set of international standards.

For more information on ISO 15189 certification and ISO 15189 certification Process, please contact us or ISO 15189 certification frequently asked questions page to learn more.

Also check out our blog on how to get ISO 15189 Certification!