There are numerous benefits from the implementation of ISO 15189:2012 management system for the quality and competence requirements in a medical laboratory in accordance to the standard.
The international standard ISO 15189:2012 contains all requirements for the quality of the services provided and the competence of the employees required for a certified medical laboratory.
The basic requirements for the development, implementation and accreditation of such a management system in any medical laboratory include:
- Well documented operating procedures
- A procedure for planning, implementation and assessment of a training program for the laboratory personnel on all levels
- Efficient analysis of the procedures for locating weak links and potential risks which can affect the results from the medical tests
- Performance of planned audits – vertical and horizontal, as well as analyzing their results
- Regular Management reviews for thorough analysis of the results, the nonconformities and the possibilities for improvement of the management system and the results
The main advantages of implementing an ISO 15189:2012 management system in a medical laboratory are:
- A certificate for compliance with the standard is a recognized testimony for the excellent reputation of your laboratory on a national and on an international level.
- Guarantees continuous compliance to the national and international laws, regulations and standards for medical laboratories.
- Decreases the risk of nonconformities during the pre-analytic, analytic and post analytic procedures, as well as the risk of incorrect results from the medical examinations done by the laboratory.
- Acts as a guarantee for the reliability and high quality of the services provided for all your customers, partners and patients.
The 12 core components of the management system for the quality and competence requirements in the medical laboratory are:
- The organization
- Documents and records
- Medical equipment and equipment, purchase, maintenance and calibration
- Buying and inventory of basic materials and reagents
- Process management – from the pre-analytical ones: sampling, storage, transportation and pre-analytical preparation, to the analysis itself, as well as the follow-up processes for verification, validation and transmission of results)
- The Laboratory Information System
- Managing discrepancies and risks
- Improving laboratory processes.
- Evaluating the efficiency and effectiveness of processes.
- Relations with clients and patients
- The security of staff, patients and the environment.
The certificate of compliance will guarantee you a leading position in any tenders and will have a huge impact on the choice of patients as well as your potential partners when choosing a referential medical laboratory. The ISO 15189 compliance certificate will help ensure the best reputation for your laboratory among patients, hospitals, colleagues, both nationally and internationally.
Our consultants will help you develop, implement and accredit a quality management system in line with the requirements of ISO 15189: 2012 in your medical laboratory. We will work with all members at all levels of your staff to senior management to train everyone, and to ensure that all processes in the laboratory comply with national regulations and global standards.
We offer support for the management system, help with auditing, as well as preparing and passing accreditation, auditing and re-certification. For more information, contact us.