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ISO 15189 Certification standard provided a generic framework for a laboratory quality management system; essential elements relative to clinical laboratories were missing. Consequently, the laboratory community approached to create a standard specifically for the unique requirements of clinical laboratory practice.
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PPT Presentation on ISO 15189 Medical Laboratory Accreditation - By Punyam Management Services
What is ISO 15189? • Make Effective Presentations • Using Awesome Backgrounds • Engage your Audience • Capture Audience Attention were missing. Consequently, the laboratory community approached to create a standard specifically for the unique requirements of clinical laboratory practice. ISO 15189 standard provided a generic framework for a laboratory quality management system, essential elements relative to clinical laboratories www.Punyam.com sales@punyam.com
Purpose of ISO 15189 • Laboratories recognized to be competent, thus providing a ready means for customers to identify and select medical testing and clinical analysis services. accredited to ISO 15189 are formally • Compliance to ISO 15189 aids the laboratories to determine whether they are performing their work correctly and to appropriate standards, and provides them with a benchmark for maintaining that competence. • Compliance to ISO 15189 is an effective marketing tool for medical and clinical laboratories and a passport to submit tenders to contractors that require independently verified laboratories. www.Punyam.com sales@punyam.com
ISO - 15189: A Two-Part Standard ISO 15189 International Standard, based upon ISO 17025 and ISO 9001, provides requirements for competence and quality that are particular to medical laboratories. While this International Standard is intended recognized disciplines of medical laboratory services. ISO 15189requirements consist of two parts, to use throughout • Management Requirements • Technical Requirements www.Punyam.com sales@punyam.com
• Management Requirement: This includes the requirements of all parts of ISO 9001, moreover it includes the requirement of conformity assessment body, for example, impartiality and independence from any other party. • Technical Requirements: This includes the requirements of laboratory competence (e.g. personnel, facility, instrument, and examination methods), laboratories shall participate laboratories’ examination results shall have traceability of measurements and implement uncertainty of measurement. moreover proficiency it requires testing(s) that and www.Punyam.com sales@punyam.com
Implementation of ISO 15189 • Gaining support for the program from higher management • Baseline assessment of the laboratories against ISO 15189 standard • Gap analysis, recommendations for improvement • Development of action plan and agreed upon timeline • Formation of a Laboratory Management Committee to oversee implementation and practice of quality standards • Training of laboratory staff, laboratory management on ISO 15189and its implementation • Support with generic quality documents (management and technical) and its adaptation into document control system • Periodic monitoring of the implementation, mentoring and off site and onsite technical support • Pre accreditation assessment •Support in submission of the application for accreditation www.Punyam.com sales@punyam.com
Importance of ISO 15189 Accreditation Accreditation to ISO 15189 places five additional critical criteria on medical laboratories which include: • Providing advice on the type of sample, and testing that may be required • Interacting with clinical staff by placing a responsibility on the laboratory to liaise with clinician who refer patient samples for testing about the quality of their services. • Providing on the opinions on results of testing in relation to diagnosis and patient care • Collecting samples or if not, providing information on collection procedures, sample containers and sample volumes; and • Ethical practice – first duty is to the patient, not to the ‘customer’. www.Punyam.com sales@punyam.com
Features of ISO 15189 • Streamlined process for committee reviews • Visualized flowcharts of document approvals • Control of document creation and templates • Automatic notifications of new/revised documents • Advanced search capability • Record of user review • Administrator dashboard with upcoming document reviews • Automatic versioning and archival of documents • Regulatory alerts www.Punyam.com sales@punyam.com
Conclusion Implementation ISO 15189 standards improved the overall quality of laboratories, not only for tests under the scope of accreditation, but all tests performed in the laboratory. Furthermore, accreditation has spurred an interest in other laboratories to improve their quality. With adequate resources and support from management, ISO 15189 compliance is an achievable and sustainable goal for medical laboratories in developing countries, where national standards might not be developed. www.Punyam.com sales@punyam.com
Punyam Management Services Pvt Ltd is leading a market as well known ISO Certification Consultant in India offering consultancy services for all ISO standards. As leading ISO consultant in India, Punyam's portfolio includes wide range of certification services. Punyam management is working in field of ISO and management consulting practices since 1991 and our group of companies has developed ISO systems in more than 900 organizations in India. Catch us On…. Catch us On….
