Internal audits (IA) provide a measure of current performance and benchmarks the level of quality currently being achieved.

In Part II, participants learn how to implement a practical internal audit program that meets ISO15189 requirements while adding significant, measurable value to the laboratory’s continual improvement activities.

QMS 4.2 References

American Association for Laboratory Accreditation (A2LA). (2012). Internal Auditor Course Handbook.

Arter, D. R., Cianfrani, C. A., & West, J. E. (2003). How to Audit the Process-Based QMS. Milwaukee: American Society for Quality, Quality Press.

Arter, D. (n.d.). The How and Why of Auditing. American Society of Quality TV Library. Retrieved June 29, 2016, from http://videos.asq.org/product/the-how-and-why-of-auditing

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

Clinical and Laboratory Standards Institute (CLSI). (2006). Laboratory Documents: Development and Control; Approved Guideline GP2-A5 (5 ed., Vol. 26). Wayne, PA: Clinical and Laboratory Standards Institute.

Clinical and Laboratory Standards Institute (CLSI). (2010). Development and Use of Quality Indicators for Process Improvement and Monitoring of Laboratory Quality: Approved Guideline (QM12-A). 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). (2013). Assssments: Laboratory Internal Audit Program; Approved Guideline (QMS15-A). Wayne, PA: Clinical and Laboratory Standards Institute .

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

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

Dawson, J. (2016). Cultivating a Culture of Quality. Retrieved May 1, 2016, from https://www.aacc.org/store/thought-leadership/10600/cultivating--a-culture-of-quality-in-the-laboratory

Dhatt, G. S., Sahni, S., & Damir, H. A. (2008). Aspects of Auditing in Clinical Laboratories. Accreditation and Quality Assurance Journal, 13, 505-509.

European Cooperation for Accreditation of Laboratories. (n.d.). Internal Audits and Management Review for Laboratories (EAL-G3).

Fulks, G. (2018, May 14). The Art of Active Listening. Retrieved January 20, 2019, from LinkedIn: https://www.linkedin.com/pulse/art-active-listening-glenna-fulks/

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

Institute for Quality Management in Healthcare (IQMH). (2014). Decoding ISO 15189 Interactive Online Education Series: Module 9 - Quality Indicators.

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

National Accreditation Board for Testing and Calibration Laboratories (NABL). (2012). Guide for Internal Audit and Management Review for Laboratories.

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

Olea, S. (2016, April 5). Tracer Methodology and Performing Mock Tracers. Retrieved from Point of Care Group Webinars : https://www.whitehatcom.com/POC_Group_Webinars_2016.htm

Phillips, A. W. (2009). ISO 9001:2008 Internal Audits Made Easy. Milwaukee: American Society for Quality, Quality Press .

Quinley, E. D. (n.d.). Quality, It’s More than Compliance. Retrieved July 10, 2016, from Ortho On Demand: https://vts.inxpo.com/scripts/Server.nxp?LASCmd=AI:1;F:SF!40000&BoothKey=239788

Robitaille, D. (2009). The Corrective Action Handbook (2 ed.). Chico, CA: Paton Press LLC.

Russell, J. (2007). The Internal Auditing Pocket Guide (2 ed.). Milwaukee: American Socieity for Quality, Quality Press.

Russell, J. (2010). The Process Auditing and Techniques Guide (2 ed.). Milwaukee: American Socieity for Quality, Quality Press.

Schiffgens, J. (2014, January 30). Laboratory Internal Audit Program: Tips for Developing and Implementing an Internal Audit Process. Retrieved from Clinical and Laboratory Institute.

Venner, M. (2019, April 4). AS9100 for Smart People-Internal Audit Planning. Retrieved from https://www.linkedin.com/pulse/as9100-smart-people-internal-auditplanning-michael-venner-beng/

Venner, M. (2019, March 26). ISO Auditor Questioning Techniques. Retrieved from https://www.linkedin.com/pulse/iso-auditor-questioning-techniques-michael-venner-beng/

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).