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  • Kyle Rose

'Tis the Season... for an Internal Audit

Updated: Dec 14, 2021


As the end of the year rapidly approaches, many companies are rushing to get their internal audits completed before 2022. The internal audit process is critical to medical device companies to ensure that their Quality System is effective and compliant for the size and scope of their company. RookQS has a team of 11 certified quality auditors (CQAs) for a variety of regulations, including FDA 21 CFR 820, ISO 13485:2016, MDSAP, and CE Mark under MDR.


The internal audit process is required for each of these regulations, and must be done annually. Companies should maintain an audit schedule that outlines their internal audit timelines, and complete the audits as scheduled. If your company needs additional support to complete your internal audit before the end of 2021, RookQS has capacity to complete a remote audit by end of year.


Internal audits are not only required for established companies; startups that are seeking ISO certification in 2022 should also plan to conduct an audit in 2021. During the ISO certification process, your internal audit records will be reviewed in detail- typically during the stage 1 audit- and need to have all the proper documentation in order to demonstrate compliance.


The internal audit program at your company should be carefully designed to find areas that need improvement, and to catch any potential non-conformities internally: It’s far better to identify any issues or gaps in your QMS during an internal audit than during an FDA or ISO audit.


At RookQS, we recommend a comprehensive internal audit program to include the following documentation and records to show compliance:


  • Internal Audit SOP – This procedure should outline the internal audit program and requirements for auditor selection and qualification, as well as what standards/regulations apply to your quality system.

  • Internal Audit Schedule – This record should outline the timeline for the internal audits. This schedule should be reviewed each year at management review meetings to ensure that the schedule still applies to the following year.

  • Internal Audit Checklist – We use audit checklists to accompany the standard and ensure that all aspects of the QMS are properly reviewed for both compliance in the procedures and in the records.

  • Internal Audit Report – This record is the final report summarizing the outcome of the audit, any findings, and a detailed action plan to correct any issues.

RookQS’ seasoned team of CQAs has completed over 100 remote internal audits and can assist your team in completing your audit in the timeliest and most efficient manner possible. We believe strongly in the effectiveness of the internal audits being a key indicator for the overall status of the QMS. Internal audits are a great tool for consistently improving both your QMS and your compliance.


If you're short on time and bandwidth, we're here to help.


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