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The auditor’s approach in the world: GMP and culture

Written by Emanuele Volpe | Jun 1, 2023 7:00:00 AM

Introduction 

According to ISO 19011:2018, “Guidelines for auditing management systems” definition, an audit is a “systematic, independent and documented process for obtaining audit evidence and evaluating it objectively to determine the extent to which the audit criteria are fulfilled.” As such, essentially an audit is a verification tool used to: 

  • Check something; 
  • Allow the auditor to understand how the auditee is working and, therefore, to verify if the concerned activities are carried out as per current regulations and applicable internal rules and requirements. 

In fact, the term “audit” comes from the Latin word “audire” meaning “listening.The major purpose of the auditor is indeed to carefully listen directly and indirectly to the auditee’s SMEs in order to understand their way of working. For that purpose, a good relationship needs to be created between the auditor and the auditee and it is fundamental that the auditor fully understands and respects the culture of the auditee’s personnel, as this reflects each person’s way of working.