ISO 15189 Certification

What is ISO 15189 standard and why is it important?

ISO 15189, a specifically developed standard for the Quality Management system of medical laboratories. This standard helps fulfill the requirements in medical laboratory testing and competency in providing the test results, sample collection procedures, emergency handling in the laboratory effectively. ISO 15189 focuses on the effective implementation of the medical laboratory management system in all their operations and lead them to continual improvement.

The standard ISO 15189 follows the best practices for the examination of samples, customer’s privacy, storage of samples, handling customer complaints, and competency of lab personnel that certainly improves the laboratory work environment effectively.

Getting certified to ISO 15189 is a good way to convey the competency of the laboratory and enables all their business process are standardized, continually monitored, evaluated, and documented in an effective manner to avoid any regulatory complaints.

What are the benefits of obtaining the ISO 15189 Certification?

  • Meets statutory and regulatory requirements
  • Increase customer satisfaction
  • Effective quality management system
  • improvement in productivity and quality
  • Global recognition to the laboratory

IAS – the top-searching ISO certification body in Germany

Integrated Assessment Services (IAS) is a leading globally recognized ISO 15189 Certification Body operating in Germany and other major EU countries, which is accredited by Universal Quality Accreditation Services (UQAS). IAS is predominant in auditing the client companies for their business growth and development since 2006.

IAS is incorporated in 7 major countries and operating its associates in 14 more countries under the guidance of IAS-INDIA.

We offer ISO 15189 Certification throughout the EU countries with the help of qualified auditors and technical expertise. We also act as a consultant for the organizations to implement ISO certification procedures to successfully get certified.

IAS also offers ISO management system certifications against ISO 14001, 27001, 45001, 50001, 22301, 22000, etc. Furthermore, we provide product certifications such as CE Marking, GOST-R, Green, GOST-R, Kosher, Halal, BRC, cGMP, etc.

 What are the procedures to achieve ISO 15189 Certification?

  • At first, Make an Enquiry in our website or contact us by telephone based on your country/region.
  • Download and fill the application form and email
  • After reviewing your application, the certification audit process will begin.
  • IAS will come out with the audit plan based on the scope submitted by your organization to conduct audits.
  • Stage 1 audit includes the document review and site visit
  • After the completion of the audit, IAS will provide audit reports with a deviation report (if found any deviation).
  • Stage 2 audit verifies the effective implementation of ISO 15189
  • The time duration for NC closure between 60-90 days.
  • After successfully implementing the non-conformities, IAS will issue the ISO 15189 certificate which is valid for 3 years.
  • IAS also conducts a surveillance audit every 12 months from the date of initial certification and as well as the re-certification audit after the validity of the initial certification is over.

Further, to know more details regarding ISO 15189 Certification and also about our audit procedure, feel free to contact us: