PPT Presentation ISO 15189 for Medical Laboratory Accreditation - PowerPoint PPT Presentation

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PPT Presentation ISO 15189 for Medical Laboratory Accreditation

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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. – PowerPoint PPT presentation

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Updated: 14 March 2016
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Title: PPT Presentation ISO 15189 for Medical Laboratory Accreditation


1
PPT Presentation on ISO 15189 Medical Laboratory
Accreditation
- By Punyam Management Services
2
What is ISO 15189?
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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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3
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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4
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. ISO
    15189 requirements consist of two parts,
  • Management Requirements
  • Technical Requirements
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5
  • 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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6
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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7
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.
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8
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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9
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.
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10
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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