Internal audit of quality management systems (QMS) in accredited laboratories

Overview

ABSTRACT

Audit practices have globally remained the same regardless of the context or the conditions in which they are conducted. The rigorous implementation of audits is what makes them strong, enabling objectives to be achieved, namely to obtain undisputable findings in a limited period of time, which is in the best interest of all parties involved. Audit, inspection and diagnosis approaches share this definition. This article deals with aspects linked to the management of auditing activities within the laboratory as well as the modalities of audit implementation.

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AUTHOR

Cédric TROUVÉ: Production and Quality Manager – QUALYSE Champdeniers – France

INTRODUCTION

This article is intended for anyone wishing to find out more about auditing in the broadest sense of the term, and its methodology and practice. It is primarily aimed at the quality departments of accredited laboratories. However, any entity recognized under any standard will find a suitable methodology here. Audit practice, and in particular the method to be used, is always the same, whatever the conditions under which the audit takes place. This is all the more true as it is the respectful application of this method that must guarantee the success of this activity, i.e. the achievement of indisputable findings within a limited timeframe, in the best interests of all parties.

Audit, diagnosis and inspection are not or no longer to be seen as opposites. Auditing must be the reference method for carrying out this same activity under different implementation conditions, with different output elements and different consequences.

In this article, the aspects relating to the management of auditing activities within a laboratory, and then the procedures for carrying out audits, are directly inspired by the standard NF EN ISO 19011 of July 2018. If not in the success of the audit, then at least in the feeling left after it.