Invitro Diagnostics Medical Laboratory is proud to announce that it has obtained the certificate of accreditation, which guarantees that the medical establishment meets requirements of the standard SM SR EN ISO 15189:2014. Thus, the accredited fields of hematology, biochemistry, molecular biology and immunology have been confirmed to operate according to requirements of the international standard, and the quality management and continuous improvement system has been implemented in all departments.

ISO 15189 is a standard specific to medical laboratories that can objectively assess the activity of a laboratory carrying out medical tests and the quality of services provided.

Services provided by a medical laboratory are essential in diagnosing diseases and managing the patients' behavior and, therefore, must comply with the requirements, according to all standard criteria and expectations of patients or clients as well as of the health personnel responsible for their care.

The most important elements of implementing this strict standard are: ensuring sample traceability, internal control and participation in external quality assessment scheme (RIQAS).

The application of the standard SM SR EN ISO 15189:2014 enables the laboratory to participate in various scientific research projects and recognize the laboratory test results.

In addition, in the accredited laboratories the Quality Management System covers all activities of the organization. It integrates the activities of management, sales, marketing, finance, courier, logistics, and IT with effective testing of patient samples. This means that each department of the organization uses QMS to solve problems, reduce or eliminate the source of system errors, and to recognize and pursue opportunities to provide greater value for clients.

“Our priority is to give patients and doctors full confidence that laboratory tests are performed with the utmost precision and efficiency, are accurate and go through a number of stages of verification for final validation. Being certified to ISO 15189:2014, we have committed ourselves to our beneficiaries, constantly improving the quality management system of Invitro Diagnostics Medical Laboratory. Thus, we offer our beneficiaries, patients and doctors the support of Invitro Diagnostics Medical Laboratory, guaranteeing quality, speed, convenience, safety and professionalism!”, Sergiu Armasu, Director of Invitro Diagnostics Laboratory says.

In particular, the standard includes management requirements for:

• Quality Management System,
• document control,
• external services and supplies,
• advisory services,
• resolution of complaints.

The standard also includes technical requirements for:

• accommodation and environmental conditions,
• laboratory equipment, reagents and consumables,
• pre-examination processes,
• examination processes,
• ensuring quality of examination results,
• post-examination processes.