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Audits and MDR - Internal Audit Requirements

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Guest user Created:   Jan 19, 2023 Last commented:   Jan 19, 2023

Audits and MDR - Internal Audit Requirements

Hi, my question is the requirements for internal audit. Can we conduct it in house using your internal audit package? Or does the internal auditor have to be a professional/approved auditor. Currently we are using an external consultant but if we can do it ourselves, that would be great. Thank you!

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ISO 9001 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 9001 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

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Carlos Pereira da Cruz Jan 19, 2023

Yes, you can conduct in-house audits using our internal audit package.

The only requirement is that your internal auditor(s) comply with competence requirements established by your organization. Normally, those requirements are:

  • Auditor(s) know the audit criteria (the management standard)
  • Auditor(s) know good auditing practices
  • Auditor(s) should not audit their own work to ensure independence (please check ISO 9000:2015 definition 3.13.1 where one can read that an audit is “ a systematic, independent, and documented process.) 

Usually, organizations translate these requirements into something that can be evidenced like doing an internal audit course and passing an exam.

Internal auditors don’t need to be professionals approved by a third party, they just have to comply with competence requirements. Of course, if your company requirements say that internal auditors must be approved by a third party, and must have at least 100 hours of audit experience, then that is the benchmark to abide by.

The following material will provide you with information about audits:

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Jan 19, 2023

Jan 19, 2023