4.2.6-2 Audit reporting, audit closure and audit files
Illuminating the Path to ISO 15189 (SLMTA 3) e-Learning Course Download Video
After the audit field work is completed, it is time to analyze and sort the information gathered and determine conformance to the documented system and the effectiveness of that system. The results of the audit are primarily reported in the form of a nonconformity statement.
In this activity, participants learn how to prepare an audit report.
- To initiate a nonconformity, a requirement must first exist.
- Objective evidence must be traceable to the source.
- An auditor should never surprise an auditee by including anything negative in the audit report that has not been discussed with the auditee.
- Compare facts with requirement criteria to determine conformance or not?
- Write a nonconformity statement?
Ms. Scholtz helped redesign the classroom-based SLMTA 3 curriculum for on-line delivery and will serve as an instructor and facilitator of the e-learning course. Ms. Scholtz is a Quality Manager, Regional Western and Northern Cape, at National Health Laboratory Services (NHLS), South Africa. She is a certified auditor for The South African National Accreditation System (SANAS). Ms. Scholtz has a Medical diploma in Biomedical Technology. She is a SLMTA master trainer and has trained numerous laboratorians in the past decade.