May 5, 2017


  • Audit reports to medical device companies should be generated and delivered typically within one week following a quality system audit.
  • Formal audit reports should provide more than just “audit checklists” in order to support management decisions.

Common medical device quality system audit problems: preparing audit reportsIn the final installment of Emergo's blog series on medical device quality management system audit problems, we examine the audit report publication process and related challenges.

(Our previous posts on audit problems cover lack of management support, poor audit preparation and dealing with difficult auditees.)

One of an auditor’s final and often least-liked tasks is generating an audit report, which typically takes more time to complete than initially planned and is delivered later than expected. Usually, auditees expect these reports within one week after undergoing an audit.

Companies that include their audit checklists in final audit reports find it easier to meet this one-week deadline; for external or frequent supplier audits, however, formal reports—not just checklists—are often expected. Managers require audit reports to clearly communicate findings in order to support ensuing decisions.

In order to produce formal audit reports in a timely manner, three key techniques can assist audit staff:

  • Creating standardized audit report forms to be used by all auditing staff. These forms can be “fill in the blank” to allow staff to efficiently and easily enter any observations or nonconformities.
  • Refraining from publishing checklists as substitutes for actual audit reports. Checklists do not properly convey audit information. If checklists are included as part of an audit report, staff should also ensure that nonconformities, observations and opportunities for improvement are clearly identified.
  • Scheduling ample time to prepare and complete an audit report. In some cases, submitting an audit report more than a week after an audit results in information being forgotten by the auditee, and thus the organization realizes no benefit.

Audit reports provide the most value to organizations when they identify issues or nonconformities before someone else does, or before these issues become major problems: regulatory actions by agencies, added expenses or even device recalls.

Emergo resources and services for quality management system audits:

  • Audits for gap, internal, pre-certification and supplier quality systems
  • Internal auditor training for ISO 13485 and FDA Quality System Regulations (QSR)


  • Stewart Eisenhart