QMS 4 - EVALUATION & CONTINUAL IMPROVEMENT

PURPOSE:

The purpose of the review is for management to assess its level of commitment to the quality system at regular intervals, evaluate the effectiveness of the system, and recommend changes as necessary. Findings and actions taken by laboratory management as a result of the review are documented and become a quality record.

 QMS 4.3 References

Burnett, D. (2013). A Practical Guide to ISO 15189 in Laboratory Medicine. London: ACB Venture Publications.

Clinical and Laboratory Standards Institute (CLSI). (2004). Application of a Quality Management System Model for Laboratory Services: Approved Guideline (GP26-A3) (3 ed., Vol. 24). Wayne, PA: Clinical and Laboratory Standards Institute.

Clinical and Laboratory Standards Institute (CLSI). (2004). Continuous Quality Improvement: Integrating Five Key Quality System Components; Approved Guideline - Second Edition (GP22-A2) (2 ed., Vol. 24). Wayne, PA: Clinical and Laboratory Standards Institute.

Clinical and Laboratory Standards Institute (CLSI). (2011). Quality Management System: A Model for Laboratory Services: Approved Guideline (GP26-A4) (4 ed.). Wayne, PA: Clinical and Laboratory Standards Institute.

Clinical and Laboratory Standards Institute (CLSI). (2012). Quality Management System: Leadership and Management Roles and Responsibilities; Approved Guideline (QMS14-A). Wayne, PA: Clinical and Laboratory Standards Institute .

Clinical and Laboratory Standards Institute (CLSI). (2013). Laboratory QMS Certificate Program Module: QSE Organization. CLSI U.

Cochran, C. (2003). The Continual Improvement Process: From Strategy to the Bottom Line. Chico, CA: Paton Press LLC.

Dawson, J. (2015, July-August). Navigating ISO 15189. Retrieved from MedicalLab Management:https://www.medlabmag.com/article/1201/?search=navigating%20ISO%2015189

Dawson, J. (2017, February 9). Do No Harm: Diagnostic Errors and the Lab. Retrieved from http://www.labtestingmatters.org/do-no-harm-diagnostic-errors-and-the-lab/

Dawson, J. (2017, August 29). Lean Six Sigma is Not Quality. Retrieved from G2 Intelligence: https://www.g2intelligence.com/lean-six-sigma-is-not-quality/

Institute for Quality Management in Healthcare (IQMH). (2014). Decoding ISO 15189 Interactive Online Education Series: Module 8 - Internal Audit and Management Review.

International Organization for Standardization (ISO). (2012). ISO 15189: 2012 Medical laboratories -- Requirements for quality and competence.

LabCoP ECHO Session Resource. (2018, June). LARC 2.0 Quality improvement Collaborative Workbook. Retrieved from here

McKinney, B. C. (n.d.). Quality Improvement: Applications for the Viral Load Cascade.

New York State Department of Health, Wadsworth Center. (2010). Guidance for Implementing a Laboratory Quality Management System.

Plebani, M. (2017). Quality in laboratory medicine: an unfinished journey. Journal of laboratory and Precison Medicine, 2(63).

            Robitaille, D. (2002). The Management Review Handbook. Chico, CA: Paton Press.

Theodorou, D. G., & Anastasakis, P. C. (2009). Management Review Checklist for ISO/IEC 17025 and ISO 15189 Quality-management Systems. Accreditation and Quality Assurance, 14, 107-110.

Westgard, J. O., & Westgard, S. A. (2014). Basic Quality Management Systems. Madison: Westgard QC, Inc.

World Health Organization, Regional Office for Africa. (2015). Stepwise Laboratory Quality Improvement Process Towards Accreditation (SLIPTA) Cheklist (ver. 2:2015).