DOI QR코드

DOI QR Code

International Organization for Standardization (ISO) 15189

  • Schneider, Frank (College of American Pathologists 15189 Committee) ;
  • Maurer, Caroline (College of American Pathologists 15189 Program) ;
  • Friedberg, Richard C. (College of American Pathologists)
  • Received : 2017.03.06
  • Accepted : 2017.06.08
  • Published : 2017.09.01

Abstract

The College of American Pathologists (CAP) offers a suite of laboratory accreditation programs, including one specific to accreditation to the international organization for standardization (ISO) 15189 standard for quality management specific to medical laboratories. CAP leaders offer an overview of ISO 15189 including its components, internal audits, occurrence management, document control, and risk management. The authors provide a comparison of its own ISO 15189 program, CAP 15189, to the CAP Laboratory Accreditation Program. The authors conclude with why laboratories should use ISO 15189.

Keywords

References

  1. Schneider F and Maurer C. ISO 15189. In: Qihui Z, Siegal GP, eds. Quality management in anatomic pathology: Strategies for assessment, improvement, and assurance. Northfield, IL: College of American Pathologists, 2017:185-93.
  2. ISO 15189. Medical laboratories - Requirements for quality and competence. Geneva, Switzerland: International Organization for Standardization; 2012.
  3. Clinical and Laboratory Standards Institute. Quality management system: A model for laboratory services; Approved guideline. 4th ed. QMS01-A4. Wayne, PA: Clinical and Laboratory Standards Institute, 2011.
  4. Okes D. Root cause analysis: The core of problem solving and corrective action. Milwaukee, WI: ASQ Quality Press, 2009.
  5. Ford A. At Henry Ford, 36 lab sites now under ISO umbrella. CAP Today November 13, 2013:50. http://www.captodayonline.com/at-henry-ford-36-lab-sites-now-under-iso-umbrella-111350/
  6. Hamza A, Ahmed-Abakur E, Abugroun E, Bakhit S, Holi M. Cost effectiveness of adopted quality requirements in hospital laboratories. Iran J Public Health 2013;42:552-8.
  7. Carlson RO, Amirahmadi F, Hernandez JS. A primer on the cost of quality for improvement of laboratory and pathology specimen processes. Am J Clin Pathol 2012;138:347-54. https://doi.org/10.1309/AJCPSMQYAF6X1HUT
  8. Wildermuth C, Wood D. When your hospital CFO asks: How we should show our lab's gains from ISO 15189 and QMS programs. Presented at: Lab Quality Confab 2014; October 21, 2014; New Orleans, LA. http://www.labqualityconfab.com/wp-content/uploads/WILDERMUTH-WOOD.tue_.3pm.FINAL_.pdf

Cited by

  1. External Quality Assessment Scheme for HIV-1 Drug-Resistance Genotyping in Thailand vol.34, pp.12, 2018, https://doi.org/10.1089/aid.2017.0299
  2. The College of American Pathologists Biorepository Accreditation Program: Results from the First 5 Years vol.16, pp.1, 2017, https://doi.org/10.1089/bio.2017.0108
  3. Quality assurance of genetic laboratories and the EBTNA practice certification, a simple standardization assurance system for a laboratory network vol.2, pp.4, 2017, https://doi.org/10.2478/ebtj-2018-0052
  4. Evidence for the positive impact of ISO 9001 and ISO 15189 quality systems on laboratory performance - evaluation of immunohaematology external quality assessment results during 19 years in Austria vol.56, pp.12, 2018, https://doi.org/10.1515/cclm-2018-0482
  5. Evidence for the positive impact of ISO 9001 and ISO 15189 quality systems on laboratory performance - evaluation of immunohaematology external quality assessment results during 19 years in Austria vol.56, pp.12, 2018, https://doi.org/10.1515/cclm-2018-0482
  6. Regulation of Laboratory-Developed Tests vol.152, pp.2, 2017, https://doi.org/10.1093/ajcp/aqz096
  7. The pathway for introducing novel examination procedures in routine practice in accordance with ISO 15189:2012: 17-Hydroxy progesterone, dehydroepiandrosterone sulphate and vitamin D as examples vol.56, pp.5, 2017, https://doi.org/10.1177/0004563219835582
  8. The Monitoring and Evaluation of a Multicountry Surveillance Study, the Severe Typhoid Fever in Africa Program vol.69, pp.suppl6, 2017, https://doi.org/10.1093/cid/ciz597
  9. Quantification of total and unbound cefuroxime in plasma by ultra‐performance liquid chromatography tandem mass spectrometry in a cohort of critically ill patients with hypoalbuminemia and renal vol.34, pp.3, 2020, https://doi.org/10.1002/jcla.23100
  10. Maternal obesity and dyslipidemia associated with gestational diabetes mellitus (GDM) vol.246, pp.None, 2017, https://doi.org/10.1016/j.ejogrb.2020.01.007
  11. Quality Indicators for the Performance Evaluation at a Biochemistry Laboratory : QIs for a Biochemistry Laboratory vol.9, pp.2, 2020, https://doi.org/10.4018/ijrqeh.2020040102
  12. Investigation of the long-term yield of auditing for conformity with the ISO 15189:2012 quality standard in a hospital pathology laboratory vol.20, pp.None, 2017, https://doi.org/10.1016/j.plabm.2020.e00159
  13. Development of a genomic DNA reference material panel for thalassemia genetic testing vol.42, pp.5, 2017, https://doi.org/10.1111/ijlh.13213
  14. Strengthening the clinical laboratory workforce in Cambodia: a case study of a mixed-method in-service training program to improve laboratory quality management system oversight vol.18, pp.1, 2017, https://doi.org/10.1186/s12960-020-00521-8
  15. Remote Mentorship Using Video Conferencing as an Effective Tool to Strengthen Laboratory Quality Management in Clinical Laboratories: Lessons From Cambodia vol.8, pp.4, 2017, https://doi.org/10.9745/ghsp-d-20-00128
  16. The International Collaboration for Cancer Classification and Research vol.148, pp.3, 2021, https://doi.org/10.1002/ijc.33260
  17. Temperature-Alternated Electrochemical Aptamer-Based Biosensor for Calibration-Free and Sensitive Molecular Measurements in an Unprocessed Actual Sample vol.93, pp.22, 2021, https://doi.org/10.1021/acs.analchem.1c00289
  18. Laboratory professionals’ attitudes towards ISO 15189:2012 accreditation: an anonymous survey of three Croatian accredited medical laboratories vol.31, pp.2, 2017, https://doi.org/10.11613/bm.2021.020712
  19. Laboratory professionals’ attitudes towards ISO 15189:2012 accreditation: an anonymous survey of three Croatian accredited medical laboratories vol.31, pp.2, 2017, https://doi.org/10.11613/bm.2021.020712
  20. Metabolomics-Based Screening of Inborn Errors of Metabolism: Enhancing Clinical Application with a Robust Computational Pipeline vol.11, pp.9, 2017, https://doi.org/10.3390/metabo11090568
  21. Strengthening Medical Laboratory Systems in Kenya: An Innovative Biosafety Training Model vol.26, pp.suppl1, 2017, https://doi.org/10.1089/apb.20.0072
  22. Design and Control of an Inflatable Spherical Robotic Arm for Pick and Place Applications vol.10, pp.11, 2017, https://doi.org/10.3390/act10110299
  23. Tumor BRCA testing in ovarian cancer and EQA scheme: our experience of a critical evaluation vol.48, pp.12, 2021, https://doi.org/10.1007/s11033-021-06812-0
  24. What factors are associated with improvements in productivity in clinical laboratories in the Asia Pacific Region? vol.99, pp.None, 2017, https://doi.org/10.1016/j.clinbiochem.2021.10.008