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8/19/2019 ISO 15189 - Medical Laboratory Accreditation
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PPT Presentation onISO 15189 Medical
Laboratory Accreditation
- By Punyam Management Services
8/19/2019 ISO 15189 - Medical Laboratory Accreditation
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What is ISO 15189?
ISO 15189 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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Purpose of ISO 15189
• Laboratories accredited to ISO 15189 are formally
recognized to be competent, thus providing a ready means for
customers to identify and select medical testing and clinical
analysis services.
• 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.
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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 to use throughout
recognized disciplines of medical laboratory services. ISO15189 requirements consist of two parts,
• Management Requirements
• Technical Requirements
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• 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), moreover it requires that
laboratories shall participate proficiency testing(s) and
laboratories’ examination results shall have traceability of
measurements and implement uncertainty of measurement.
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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
15189 and 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
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Importance of ISO 15189
AccreditationAccreditation 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’.
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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
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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 resourcesand 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.
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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.
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