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    MS Iso 15189

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    Abu Abbas Aiyub
    The document discusses medical laboratory accreditation based on international standards MS ISO 15189 and the Malaysian Laboratory Accreditation Scheme (SAMM). Accreditation ensures laboratories are competent and provide quality testing through an impartial evaluation of the management system, facilities, staff qualifications, test procedures, safety, and continuous quality improvement. Accreditation benefits both laboratories and the public by improving healthcare quality, recognizing competence, and gaining credibility for accurate test results.

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    MS Iso 15189

    Uploaded by

    Abu Abbas Aiyub
    1K views3 pages
    The document discusses medical laboratory accreditation based on international standards MS ISO 15189 and the Malaysian Laboratory Accreditation Scheme (SAMM). Accreditation ensures laboratories are competent and provide quality testing through an impartial evaluation of the management system, facilities, staff qualifications, test procedures, safety, and continuous quality improvement. Accreditation benefits both laboratories and the public by improving healthcare quality, recognizing competence, and gaining credibility for accurate test results.

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    MS ISO 15189

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    The document discusses medical laboratory accreditation based on international standards MS ISO 15189 and the Malaysian Laboratory Accreditation Scheme (SAMM). Accreditation ensures laboratories are competent and provide quality testing through an impartial evaluation of the management system, facilities, staff qualifications, test procedures, safety, and continuous quality improvement. Accreditation benefits both laboratories and the public by improving healthcare quality, recognizing competence, and gaining credibility for accurate test results.

    Copyright:

    © All Rights Reserved
    Download as DOCX, PDF, TXT or read online from Scribd
    Download as docx, pdf, or txt
    1K views3 pages

    MS Iso 15189

    Uploaded by

    Abu Abbas Aiyub
    The document discusses medical laboratory accreditation based on international standards MS ISO 15189 and the Malaysian Laboratory Accreditation Scheme (SAMM). Accreditation ensures laboratories are competent and provide quality testing through an impartial evaluation of the management system, facilities, staff qualifications, test procedures, safety, and continuous quality improvement. Accreditation benefits both laboratories and the public by improving healthcare quality, recognizing competence, and gaining credibility for accurate test results.

    Copyright:

    © All Rights Reserved
    Download as DOCX, PDF, TXT or read online from Scribd
    Download as docx, pdf, or txt
    of 3

    MS ISO 15189: ASSESSMENT FOR COMPETENCE & QUALITY

    What is Accreditation? Procedure by which an authoritative body (STANDARDS MALAYSIA) gives formal
    recognition that a body (laboratory) or person (signatory) is competent to carry out specific tasks (scope)
    Procedure assesses conformity to required levels of competence National criteria / standards
    International criteria / standards Impartial evaluation Ensures quality

    MS ISO 15189 : PENILAIAN BAGI KOMPETENSI DAN KUALITI

    Apakah Akreditasi ? Tatacara yang sebuah badan yang berwibawa (STANDARDS MALAYSIA)
    memberi pengiktirafan rasmi bahawa sesuatu badan ( makmal) atau orang
    ( penandatangan) adalah kompeten untuk menjalankan tugas-tugas tertentu ( skop)

    Prosedur menilai pematuhan kepada tahap yang diperlukan kecekapan


    - Negara kriteria / Piawaian
    - antarabangsa kriteria / standard
    penilaian berat sebelah
    Memastikan kualiti

    Medical Laboratory Accreditation - what does it mean? The laboratory is competent & has quality
    Optimal medical testing Has suitable organizational set-up, management & facilities Work performed by
    qualified & trained staff Work performed according to approved procedures Work place is safe for staff

    Akreditasi Makmal Perubatan –


    Makmal ini adalah berwibawa & mempunyai kualiti ujian perubatan Optimal Adakah sesuai
    organisasi set -up , pengurusan & kemudahan Kerja yang dilakukan oleh kakitangan yang
    berkelayakan & dilatih Kerja dilaksanakan menurut prosedur yang telah diluluskan Bekerja
    tempat yang selamat untuk kakitangan

    Accreditation - benefits to the laboratory Improvement to lab management & performance Competitive
    advantage Mark of quality & competence Credibility & recognition Reimbursement of fees in healthcare
    financing/insurance schemes Increase prospects for international market (AFTA & WTO)

    akreditasi - manfaat kepada makmal Penambahbaikan kepada pengurusan makmal &


    prestasi kelebihan daya saing
    Tanda kualiti & kecekapan Kredibiliti dan pengiktirafan Pampasan caj yang dalam penjagaan
    kesihatan skim pembiayaan / insurans Meningkatkan prospek bagi pasaran antarabangsa
    ( AFTA &WTO)

    Accreditation - benefits to the Public Getting your money’s worth Better medical care International
    standards Don’t mess around with substandard laboratories • Inaccurate results = wrong diagnosis,
    inappropriate treatment, prolonged illness (even death).

    Akreditasi - faedah kepada Public Mendapatkan bernilai rawatan perubatan Piawaian


    antarabangsa wang anda lebih baik tidak kucar-kacir di sekitar dengan makmal substandard
    • Keputusan yang tidak tepat = diagnosis salah, rawatan yang tidak sesuai, penyakit
    berpanjangan ( kematian ).

    Skim Akreditasi Makmal Malaysia (SAMM)

    Standards used in SAMM nMS ISO/IEC 17025 “General Requirements for the Competence of Calibration
    and Testing Laboratories” nMS ISO 15189 “Medical Laboratories – Particular Requirements for Quality
    and Competence”

    Akreditasi

    Criteria - MS ISO / IEC17025 ; MS ISO 15189


    1. Memberi Jaminan kepada pelanggan bahawa prosedur yang dilakukan adalah sah
    2. Mengiktiraf kecekapan kakitangan makmal
    3. Menyokong sistem pengurusan kualiti
    4. Memberi jaminan kepada pelanggan bahawa keputusan ujian adalah sah

    Mengapa MS ISO 15189


    Dalam cara apakah makmal ujian perubatan berbeza daripada makmal penentukuran &
    makmal pengujian ?

    An international standard for the development of quality systems and accreditation for medical / clinical
    laboratories Takes into account contribution of medical laboratory service to patient care Not only
    testing, also advisory, interpretative and educational services A

    ISO 15189
    Standard antarabangsa bagi pembangunan sistem kualiti dan akreditasi untuk makmal-
    makmal perubatan dan klinikal
    Mengambil sumbangan akaun perkhidmatan perubatan makmal untuk penjagaan pesakit
    Bukan sahaja ujian , juga nasihat, tafsiran dan perkhidmatan pendidikan

    SAMM documents produced for MS ISO 15189


    SC2 -Specific Criteria for Accreditation in the field of Medical Testing
    Specific Technical Requirements Anatomical Pathology (Cytopathology) – STR 2.1
    Anatomical Pathology (Histopathology)
    STR 2.2 Chemical Pathology
    STR 2.3 Haematology
    STR 2.4 Medical Microbiology
    STR 2.5 Medical Microbiology (Virology)
    STR 2.6 Assisted Reproductive Technology
    STR 2.7 Cytogenetics – STR 2.8

    How to achieve Quality? Have a quality management system Have a monitoring


    system Prevent things from going wrong Improve as you go along Assessment
    for quality: Is there a quality culture? Commitment to quality by the highest
    level of management Clearly defined organisational structure including clear
    assignment of responsibilities and authorities Participation and cooperation
    by all staff working as a team Focus on people processes as well as system
    content Focus on prevention rather than correction Does Quality concern
    everyone? Is there an appraisal system? Checking to confirm that testing was
    right Monitoring Internal and external QC/QA Internal and external audits
    Feedback & complaints Controlling and monitoring every step in a production
    process leads to a quality product Is there preventive action? Prevent things
    from going wrong Planning the system Documenting the plan Training staff
    Equipment management Reviewing the system Is there Quality Improvement?
    Quality assurance Vs Quality improvement Focusing on quality improvement
    leads to better outcomes than focus on quality assurance activities alone
    Quality improvement is like a race without a finish line Quality & competence
    issues: EQA and Continuing Professional Development Subscription just to
    fulfill requirements of standards? Need to develop culture of professional
    development and continuous improvement Quality & competence issues: Who is in
    charge of the laboratory? Administrative vs professional leadership Clinical
    role of the laboratory Pathologists not assuming sufficient clinical
    responsibilities Deficient forum for clinico-pathological / patient care
    discussion

    Bagaimana untuk mencapai Kualiti?

    1. Mempunyai sistem pengurusan kualiti


    2. Mempunyai sistem pemantauan
    3. Mencegah perkara dari berlaku salah
    4. Meningkatkan sebagai anda pergi bersama-sama

    Penilaian untuk kualiti: Adakah budaya kualiti?

    1. Komitmen kepada kualiti oleh peringkat tertinggi pengurusan


    2. ditakrif dengan jelas struktur organisasi termasuk tugasan tanggungjawab yang jelas
    dan pihak berkuasa
    3. Penyertaan dan kerjasama oleh semua kakitangan yang bekerja sebagai Focus
    pasukan pada orang proses serta Focus kandungan sistem pencegahan dan
    bukannya pembetulan Adakah kebimbangan Kualiti semua orang? Adakah terdapat
    sistem penilaian? Semakan untuk mengesahkan ujian yang tepat Pemantauan
    Dalaman dan QC luar / QA dalaman dan audit luaran Maklum balas & aduan
    Mengawal dan memantau setiap langkah dalam proses pengeluaran membawa
    kepada produk yang berkualiti Adakah terdapat tindakan pencegahan? Mengelakkan
    perkara-perkara dari yang salah Ada sistem Mendokumentasikan pelan kakitangan
    Latihan pengurusan Peralatan Mengkaji sistem Adakah Peningkatan Kualiti? Jaminan
    kualiti Vs peningkatan kualiti Dengan memberi tumpuan kepada peningkatan kualiti
    membawa kepada hasil yang lebih baik daripada memberi tumpuan kepada aktiviti
    jaminan kualiti peningkatan kualiti sahaja seperti bangsa yang tidak mempunyai
    garisan penamat Quality & kecekapan isu: EQA dan Langganan Pembangunan
    Profesional Berterusan hanya untuk memenuhi keperluan piawaian? Perlu
    membangunkan budaya pembangunan profesional dan isu-isu Quality & kecekapan
    penambahbaikan yang berterusan: Siapakah yang bertanggungjawab dalam
    makmal? Pentadbiran vs peranan Klinikal kepimpinan profesional yang Pathologists
    makmal tidak menganggap cukup tanggungjawab klinikal forum Kekurangan untuk /
    perbincangan penjagaan pesakit clinico-patologi

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