DIAGNOSTIC AUDIT

What is a diagnostic audit?

A diagnostic audit is a general rehearsal for a real audit, preceding Certification in various management systems or passing the procedure for assessing compliance with the Technical Regulations.
At this stage, the IMPROVE MEDICAL auditors will analyse the operation of the enterprise and the submitted documentation for compliance with the requirements of the standard or TR “diagnosable”.
During a diagnostic audit, it is possible to identify and quickly correct the shortcomings and discrepancies found in a particular management system with the requirements of the relevant standards. As a result, the probability of passing the official procedure according to the predicted scenario increases.

 Who needs a diagnostic audit?

A diagnostic audit performed with the involvement of independent auditors makes sense for those companies that are preparing for Certification for compliance with various quality management systems or for the procedure for assessing compliance with the Technical Regulations.
A diagnostic audit is especially important for “newcomers” who are preparing to receive a Certificate of Conformity for the first time. Internal audits, which such companies are usually satisfied with, as a rule, do not reveal non-compliance with standards. They are identified by professional auditors of the conformity assessment body during the certification of the enterprise – as a result of which the procedure cannot be successfully completed.

 Benefits of a diagnostic audit

Some of the most obvious benefits of conducting a diagnostic audit include:

– analysis and elimination of possible inconsistencies before certification of the enterprise for quality management systems (in particular, ISO 9001 and ISO 13485);

– Analysis and elimination of possible inconsistencies before passing the procedure for assessing compliance with the Technical Regulations (in particular, N 753 “On the approval of the Technical Regulations for medical devices”, N 754 “On the approval of the Technical Regulations for medical devices for in vitro diagnostics”, N 755 “On the approval of the Technical Regulations active implantable medical devices).

But the main advantage of conducting a diagnostic audit is the absence of negative consequences in the form of a denial of certification or a failed conformity assessment when non-compliance with the standards or requirements of the TR is identified.

 How do I complete a diagnostic audit?

For a diagnostic audit, please contact the Improve Medical Certification Body.

For more information about our opportunities and cooperation organizations, please contact

 tel. +38 044 355 50 30