Introduction
ISO 15189 standard has been based upon ISO/IEC 17025 and ISO 9001, specifying requirements for competence and quality that are particular to the operation of Medical Laboratories. Medical Laboratory services are essential to patient care and therefore have to be available to meet the needs of all patients and the clinical personnel responsible for the care of those patients. Such services include arrangements for examination requests, patient preparation, patient identification, collection of samples, transportation, storage, processing and examination of clinical samples, together with subsequent interpretation, reporting and advice, in addition to the considerations of safety and ethics in medical Laboratory work.
This International Standard contains requirements for Medical Laboratories to enable them to demonstrate that they operate competently and are able to generate valid results.Application of ISO 15189
ISO 15189 is applicable for all types of Medical Laboratories regardless of number of personnel, whether they are owned and operated by Public or Private sector or any other Organization.
CSAS has the competence to assist and help Medical Laboratories to operate and become an ISO 15189 Accredited Laboratory for Worldwide recognition.
Intention of ISO 15189 Standard
An International Medical Standard is intended for use throughout the currently recognized disciplines of Medical Laboratory services, those working in other services and disciplines such as clinical physiology, medical imaging and medical physics could also find it useful and appropriate.
ISO 15189 is an indispensable standard to declare that the laboratory meets both the technical competence requirements and the management system requirements which is prerequisite to consistently deliver valid results.
Training and System Development
CSAS has a team of internationally Qualified and Competent Trainers, Assessors and Technical Experts who can assist with your projects, whether they take days or weeks. They have extensive experience working with MRA signatory Accreditation Bodies following international practices, which can help to expand your business.
Training of laboratory personnel, both in management and technical roles, is a crucial requirement of the ISO 15189 Standard. CSAS possesses a wide range of expertise in developing simple and robust Laboratory Quality Management Systems to help you achieve your goals in a competitive environment. CSAS teams are prepared to guide you through all stages of the accreditation process, from the submission of the Application to the awarding of the accreditation Certificate and ensure its sustainability.
Budget
Development of System for operation and achieving accreditation of ISO 15189 Standard requires significant investment and effort. The costs associated with accreditation are influenced by various factors, including the location of the Laboratory, Size and Scope of Accreditation.
When determining the cost of implementing the ISO 15189 Accreditation System, key factors to consider include reviewing the Scope of the Laboratory's Operations, Evaluating its Policies and Procedures, assessing the availability and suitability of equipment and software and ensuring a strong Quality Management System is in place. Interestingly, having a robust Quality Management System can help to reduce the overall budget required for accreditation.
Timeframe for System Development
CSAS claims to be able to assist in preparing your system for ISO 15189 Accreditation within a timeframe of 2.5 months. CSAS utilize modern techniques to enhance the capabilities of your technical and support teams through training. Additionally, CSAS can develop new or update existing system documentation in accordance with the requirements of ISO 15189, ILAC/APAC/EA Guidelines and relevant regulatory requirements applicable to your specific scope.
According to CSAS, implementing an ISO 15189 management system can bring substantial benefits to your organization, including improved performance and a reduction in day-to-day issues and challenges.
CSAS aims to achieve the task efficiently and within a competitive budget.
How CSAS can Help
CSAS emphasizes its ability to assist in developing an effective system for accreditation without causing unnecessary disruption or introducing unwanted changes that could impact regular operations. CSAS aims to implement the necessary improvements in a seamless and transferable manner, ensuring a smooth transition. CSAS prioritize adherence to best practices and standards.
We strongly believe in doing the right things in the right way.
CSAS also offers wide-range of online services.