ISO 15189 aims at creating a standard measure of quality in medical laboratories,The standard has developed initiatives to promote competence and responsibility in medical laboratory processes, equipment’s and outcomes. ISO 15189 was developed by the International Standards Organizations Technical Committee and has been implemented in over 200 countries
Active Business Solutions is the preferred consulting company for ISO 15189 Medical Test laboratory accreditation across the Middle East. We will get your laboratory accredited quickly. We can provide you with a complete system including a Quality Manual, Procedures, Forms and other documentation along with the training for your staff and support through the accreditation process to get you to the point you need to be – ISO 15189 ACCREDITED. Our consultants have extensive knowledge of working with various accreditation bodies for Medical Test Laboratory
Our Service Offerings and Approach
ABS can help you in the following areas:
- Developing and implementing ISO 15189 Standard.
- Detailed analysis of medical laboratory procedures in a bid to make sure that all weaknesses have been identified.
- Detailed evaluation reports of the existing quality management system as well as other monitoring and evaluation reports.
- Developing and implementing authentic work process for each of the test.
- Identifying and implementing appropriate global method statements for each test.
- Developing technically competent employees.
- Producing records demonstrating conformance with ISO 15189 requirements.
Using the ABS approach to ISO 15189 Accreditation in a Laboratory covers:
- Professional support for accreditation process.
- Define the scope of accreditation.
- Undertake measurement uncertainty analysis.
- Undertake inter-laboratory comparison for your test.
- Guide on Equipment Calibration Program.
- Prepare your staff to face the accreditation board.
- Prepare your lab for accreditation.
- Undertake relevant training for your employees.
- Undertake schedule of internal audits.
- Undertake your annual surveillance audits.
- Act as your third-party professional laboratory/quality advisory board or quality management department.
BENEFITS OF ACCREDITATION
- It improves testing results and efficiency;
- National and international recognition and reputable image of your organization through quality assurance and Management system;
- Public and industry acceptance globally.
- Assurance to clients of good laboratory practice.
- It promotes modern laboratory practices that include professionalism and expertise in conduction of medical activities in the labs.
- Insurer provides lower premium to accredited organizations.
- Provides comparability in measurements.
- Decision makers can rely on test results.
- Ensures better support in the event of legal challenge.
- Saves money by getting it right at first time.