Auditing plays a critical role in ensuring quality, valid test results and compliant laboratory operations and provides valuable information about how well the laboratory’s management system is performing. Audits also help identify whether the laboratory is meeting regulatory requirements and accreditation standards such as ISO 15189 and ISO/IEC 17025.
Great auditors need highly specialised knowledge and skills to be able to conduct and lead effective audits. Mastering audits in the laboratory is a combination of excellent planning and competent auditors conducting and leading audits using best-practice principles and practices.
So how do you develop the right person in your organisation?
NATA conducts a comprehensive Mastering Audits in the Laboratory course as part of its suite of education training courses.
For objectivity on course value, we approached Integrated Quality Laboratory Service (IQLS), an organisation that helps strength the laboratory response in low/middle income countries. As an organisation, they are committed to improving the access to quality diagnostics in medical laboratories in these countries.
We spoke with Joanne Letchford, IQLS’ Monitoring and Evaluation Specialist about her course experience and why a great auditor is so important in the laboratory setting.
“The Mastering Audits in the Laboratory course helped to refine my approach and offered me the chance to develop my own skills in understanding what the requirements are at an ISO level.
Importantly, the course really helped me understand and teach others about the value of doing the audits. The course focused on taking the time to appreciate the unique culture of your workplace and how to recognise the challenging pressures of an audit while offering empathy.
We also looked at how to implement continuous improvement in laboratory processes and demonstrate the ongoing value of auditing. Sometimes encouragement is required to start the audit program and understanding its value amongst the laboratory staff, and sharing how other participants approached this, offered a different perspective.
Would you recommend the course to an organisation looking to undertake successful audits?
“Categorically, yes. Mastering Audits in the Laboratory has given me an understanding of the specific ISO 19011 guidelines and a framework. I now have a systematic approach to audits which is very helpful. It also helped me see the interconnected relationship between the ISO 19011 guideline and conducting audits based on my medical laboratory standard ISO 15189.
The practical aspect was also invaluable. We did simulated meetings where it helped raise awareness for all how people would feel during an audit (where there’s often an atmosphere of fear and blame). It helped to create a newfound sense of empathy which is especially important for me within the context of working with laboratories in low resource settings.
I now feel better equipped and confident when conducting, or providing advice on preparing, conducting, and reporting on audits for labs in Cambodia. I can take the knowledge from the training and apply it in the specific lab setting.”
Can you recommend who might benefit from the course?
“Anyone keen to improve their laboratory as it gives them a clear systematic framework to follow. For me personally, I was enthusiastic to also find out NATA took on volunteers, and I’ve recently been accepted as a Technical Assessor. I love to contribute in that way, and it wasn’t something I knew about before.”
If your organisation needs to a great auditor, learn more about NATA’S Mastering Audits in the Laboratory