What is ISO 15189 Certification?

ISO 15189 is an international quality standard for clinical laboratories. It sets out requirements for quality management and technical competence in order to ensure that laboratory results are reliable and can be used to support healthcare decision-making. The ISO 15189 certification is a seal of approval that proves that a laboratory has met the ISO 15189 criteria.

Why Get ISO 15189 Certification in Iraq?

Clinical laboratories are an important part of the healthcare system, providing essential services to patients, physicians, and other healthcare providers. The quality of laboratory services is crucial to ensuring accurate diagnosis and treatment of disease. To help ensure the quality of clinical laboratory services, many countries have adopted the international quality standard ISO 15189.

Laboratories that are certified to ISO 15189 can demonstrate that they provide high-quality services that meet the needs of their customers. Certification to ISO 15189 also provides a laboratory with international recognition, which can be helpful in obtaining contracts with other laboratories and healthcare providers.

Benefits of ISO 15189 Certification in Iraq

  • It ensures that a medical laboratory meets international quality standards for operation and management.
  • The certification process provides an independent, unbiased assessment of a medical laboratory’s quality system.
  • It provides recognition of a medical laboratory’s commitment to quality and continuous improvement.
  • It can help a medical laboratory to win business and tenders.
  • It can help a medical laboratory to attract and retain high-quality staff.
  • It can lead to improved communication and collaboration with other medical laboratories, healthcare providers, and regulatory authorities.
  • It can give a medical laboratory a competitive edge in the marketplace.

Which Organizations Can Apply?

Any organization that provides clinical laboratory services can apply for ISO 15189 certification. This includes

  • Hospitals
  • Private clinics
  • Independent laboratories.

Audit Procedure for ISO 15189 Certification in Iraq Through IAS

The certification process has 2 auditing stages, which include:

  • Stage 1 Audit (Preliminary audit) – The first stage of an audit is the preliminary audit, which will be conducted to get an understanding of the organization’s business operations, its internal controls, and the overall financial picture. Our auditor will assess and examine the necessary documents and risks associated with the ISO 15189 standard and develop a plan for conducting the audit.
  • Stage 2 Audit (Certification Audit) – In this stage, an organization’s entire management system is assessed and audited to ensure that it meets the ISO 15189 standard. The time it takes a firm to go through the second stage of an audit is determined by a variety of variables, including its size, the number of facilities it has, and the services it provides. The ISO 15189 certificate will be issued after the successful completion of both audits.

Get ISO 15189 Certification in Iraq Through IAS

Integrated Assessment Services Pvt. Ltd. (IAS) is a leading ISO 15189 certification body in Iraq. We offer a wide range of services to help organizations improve their quality management systems and meet the requirements of the ISO 15189 standard. We are accredited by the Universal Quality Accreditation Services (UQAS) and our certifications are globally recognized.

Kindly contact us to have a free discussion about ISO 15189 certification in Iraq for your organization! Request a quote now!