ISO 15189, Medical Laboratories — Requirements for Quality And Competence Consultancy & Training
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.
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. Our consultants have extensive knowledge of working with various accreditation bodies for Medical Test Laboratory Management System Accreditations.
Using the ABS approach to ISO 15189 Accreditation in a Laboratory covers:
- 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 & relevant training for your employees.
- Producing records demonstrating conformance with ISO 15189 requirements.
- Define the scope of accreditation.
- Undertake measurement uncertainty analysis & Guide on Equipment Calibration Program.
- Prepare your staff to face the accreditation board.
- Undertake schedule of internal audits & surveillance audits.
- Act as your third-party professional laboratory/quality advisory board or quality management department.
- 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.
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We are proud to serve diverse markets and business sectors with a wide range of accredited ISO certifications, and training solutions around the world.
Simplified Process to Achieve the ISO Certification
· ISO 9001 : Quality Management System
· ISO 14001 : Environmental Management System
· ISO 45001 : Occupational health and safety Management System
· ISO 27001 : Information security Management System
· ISO 22301 : Business Continuity Management System
· ISO 13485 : Medical Devices Quality Management System
· ISO 22000 : Food Safety Management System
· ISO 20000 : Information Technology Service Management System
· ISO 20121 : Event Sustainability Management System
· ISO 28000 : Supply Chain Security Management System
· ISO 37001 : Anti-Bribery Management System
· ISO 39001 : Road Traffic Safety Management System
· ISO 50001 : Energy Management System
· ISO 55001 : Asset Management System
· SA 8000 : Social Accountability Management System
· ISO/TS 16949 : Quality Management System for Automotive Production
· BRC : British Retail Consortium
· GMP : Good Manufacturing Practice
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