Laboratory Accreditation Patcharee Jearanaikoon ISO 15189 patjeakku ac
การพฒนาหองปฏบตการสมาตรฐา น Laboratory Accreditation Patcharee Jearanaikoon & ISO 15189 patjea@kku. ac. th ������� AMS 2007
Objectives l Gain general familiarity with the professional standard in Thailand l Understand the difference between ISO 15189 and other standards l Road map to achieve accreditation
Certification versus Accreditation • Accreditation – Third party organization (or agency) with authority formally recognizes competence to perform a task (s) • Third party – An external competent agency – Totally independent and unbiased
ทำไมตองขอการรบรอง • ������������ 1. ������������ lab 2. (A tool to assess capability of laboratory) 2. ����������� )Help us to do thing better & Encourage cont improvement) 3. ������������ )learning not copy from other’s experiences)
Lab accreditation involves four major steps • Application or implementation • On-site Assessment • Correction of deficiencies • Accreditation granting and renewal
Laboratory Accreditation scene - now 2 Standards : SIMILAR or DIFFERENT – accreditation processes – team composition – assessment coverage
ISO 15189: 2003. Medical Laboratories - Particular requirements for quality and competence (Based on ISO 9001: 2000) • was introduced on 1 April 2003 • was intended to harmonize quality management procedures and regulations for medical labs • emphasis on competence requirement • is basically the application of the ISO 17025 and ISO 9001 standards to a medical lab
Conclusion for Lab Accreditation under ISO 17025 or ISO 15189 ISO 17025 – Good for research and industrial labs – Formal recognition of technical competency of lab testing ISO 15189 – Specific for medical/clinical lab – Formal recognition of technical competency of lab testing and appropriate medical competency is also required
ISO 15189 (Con’t) 4. Management requirement 4. 1 Organization and management 4. 2 Quality management system 4. 3 Document control 4. 4 Review of requests and contracts 4. 5 Examination by referral laboratories 4. 6 External services and supplies 4. 7 Advisory services
ISO 15189 (Con’t) 4. 8 Resolution of complaints 4. 9 Identification and control of nonconformities 4. 10 Corrective action 4. 11 Preventive action 4. 12 Continual improvement 4. 13 Quality and technical records 4. 14 Internal audits 4. 15 Management review
ISO 15189 (Con’t) 5. Technical requirements 5. 1 Personnel 5. 2 Accommodation and environmental conditions 5. 3 Laboratory equipment 5. 4 Pre-examination procedures 5. 5 Examination procedures 5. 6 Assuring the quality of examination procedures 5. 7 Post-examination process 5. 8 Reporting of results
������� 2544 ��������� • Professional standard • Based on - ISO/FDIS 15189: 2000 – ISO 9001: 2000 – HA standard (2543) • Accrediting body ��������� �� • Quality system essentials 10 elements • Accredited labs - 13 (in process 2)
��������� 2547 ��������� • Improved professional standard 2544 • Based on – ISO 15189: 2003 – ��������� 2544 • Issued: April 2004 • Accredited lab =
The checklist / questionnaires for accreditation • provide a point of reference • provide inspectors with a guide through the critical points
Laboratory Accreditation scene - now 2 Standards : SIMILAR or DIFFERENT – accreditation processes – team composition – assessment coverage
Similarity&Difference? : assessment coverage LA ISO l Checklist 243100 l ����� 23(15+8) l Accreditation ����� part l Team 10 ���� LAB 1 -2 >2
Similarity&Difference? : assessment coverage ISO LA l 4. 8 ������ 4 3 (��� 10( l 4. 9���������� 8 2 (” 7( l 4. 10���� 5 6 (” 9( l 4. 11����� 5 3 (” 10( l 4. 12 CQI 6 7 (” 9) l 4. 13����� 7 6 (” 6( l 4. 14 IQC 8 4 (” 8) l 4. 15 ������ 6 3 (” 10(
Similarity&Difference? : assessment coverage ISO l l l l 5. 1 ���� 13 5. 2 ENV 12 7 5. 3 EQUIPMENT 19 5. 4 PRE 25 5. 5 Analytical 13 5. 6 QC 17 5. 7 POST 5 5. 8 Report (5. 6/5. 7 ”) 5 LA 11(2 ”) (” 5. 1( 10 (” 3( 8 (” 5. 3( 7 (” 5. 4) 7 (” 5. 2( 3 (” 5. 5) 24
Road map to achieve accreditation l�������. 3 ������� (On-site assessment) l�������� l�����
Road map to achieve accreditation l������� 4 �������������� (Correction of deficiency) l ����������������� On-site
Key Success Factor l������� core value ������� l Teamwork l Patient focus l evidence base management , l continuous improvement ������ l
Thank you for your attention
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