Internal audits MUST be completed for all organizations that are ISO 9001/13485/22716 certified. It is a process that an auditor will review whether at surveillance or re-certification. If you don’t perform internal audits in your organization the probability of striking a MAJOR NC against you is extremely high.

The objective of the audit program is to ensure continuing compliance to the requirements of ISO 13485, ISO 9001 and ISO 22716.

A first party audit (aka internal audit) schedule should always be used.

Audits will only be conducted by appropriately trained and competent personnel:

• trained by a recognized body or successful completion of at least three audits as a trainee auditor
• completion of training in an organization’s QMS
• previous experience

For more guidance on Internal audits refer to ISO19011 and ISO17021. If your organization is not equipped with an internal auditor, contact Compliance Management Solutions to sort your internal audit needs. 

About CMS:

Compliance Management Solutions is a Melbourne based consultancy assisting organizations in obtaining and maintaining TGA (medicinal products and medical devices ISO 13485) | ISO 9001 (Quality) | Cosmetics GMP ISO 22716 | AS/NZS 4801 (OH&S) | ISO 14001 (Environmental) certification and registration.