ISO 15189

ISO 15189 certification (ISO standard for quality management of medical laboratories)


Benefits of obtaining ISO 15189 certification

  • Observance of quality requirements in medical laboratories
  • Globalization and creating a competitive advantage in exports
  • Receive a valid international certificate with a registration code
  • Create a sense of confidence in customers
  • Reduce the risk of risks due to laboratory errors
  • Creating a dynamic and regular laboratory environment


What is the standard and certification of ISO 15189?

In order to obtain ISO 15189 certification, RoseCal Consulting is ready to provide services to companies and organizations. (Receiving ISO 15189 – Issuing ISO 15189 – Obtaining ISO 15189 – Obtaining ISO 15189). International standard and ISO 15189 certification are a specialized governorate for medical and medical laboratories for quality management and certification of these laboratories. The ISO 15189 standard is based on the two standards ISO 9001 and ISO 17025.


Purpose and scope of application of ISO 15189 certification

The purpose of writing the ISO 15189 standard is to specify specific requirements for the quality and special qualification of medical and medical laboratories.

ISO 15189 is used by medical laboratories to create and develop a quality management system and its competency assessment. It is also used by certification bodies to certify or certify medical laboratories.

ISO 15189 is developed by the Technical Committee of the International Organization for Standardization (ISO) and is used to evaluate medical laboratories and medical diagnostic systems.

This standard, written in accordance with ISO 17025 and ISO 9001, provides requirements for qualification and quality, which are specific to medical and medical laboratories.

Medical laboratory services are essential in-patient care and should therefore be available to meet the needs of all patients and clinical staff responsible for patient care.


Necessity of using and implementing the standard and obtaining ISO 15189 certification

The necessity of ISO 15189 certification becomes apparent when considering the services of medical laboratories in maintaining the satisfaction and health of patients or those who deal with this system in any way is inevitable, so the personnel of each of these departments are responsible. Use these standards professionally to meet the needs of all patients.

These services should be available to all customers. Such services include needs prioritization, patient preparation, patient identification, sample collection, transfer, storage, processing, and testing of clinical specimens, confirmation of report interpretation, and recommendations, as well as safety and ethics in laboratory activities.


Edit ISO 15189 standard

Currently, the latest edition of the ISO 15189 standard was published in 2012, which is expressed as ISO 15189: 2012. Previously, the 2003 and 2007 editions of this standard were published by ISO International Organization and the General Directorate of Standards and Industrial Research of Iran had translated and localized this version.

ISO System with an experienced team and a questionable resume is ready to consult and issue the latest version of ISO 15189 certification for medical and medical laboratories.


ISO 15189 standard and connection with other ISO standards

Obtaining ISO 15189 certification along with basic standards such as ISO 9001 or IMS integrated management system as well as customer-oriented standards such as ISO 10004 and ISO 10002 for medical laboratories is strongly recommended because in addition to positive structural effects, in the minds of customers a favorable image of the organization will create.


Obtaining ISO 15189 – Issuing ISO 15189 – Receiving ISO 15189

To obtain ISO 15189 (Receive ISO 15189 – Issue ISO 15189) you can apply through the RoseCal Consulting.

RoseCal Consulting is the top center for obtaining ISO 15189 (receiving ISO 15189 – issuing ISO 15189) in the country with the official license of the Industry, Mining and Trade Organization.

To obtain ISO 15189 (Receive ISO 15189 – Issue ISO 15189) Apply through the certificate application link on this page. You can also apply for ISO 15189 (Receive ISO 15189 – Issue ISO 15189) through this link to quickly register your application.