Detailed Documentation and Research Can Streamline ISO 13485 Audits

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February 17, 2011

As an auditor for the ISO 13485:2003 standard for the design, manufacturing and distribution of Medical Devices, I can attest to the benefits of preparing for and documenting audit information in detail. Through the implementation of ISO 13485, companies increase the probability of making safe and effective medical devices, meeting regulatory requirements, and ultimately meeting customer expectations. Many times a client may not realize that a comprehensive internal audit needs to be conducted before a registrar like Smithers can perform an official audit.


An internal audit involves a management review and the use of workbooks and materials to build an internal audit schedule. Each of the identified processes should also contain associated objectives.

Detailed documentation of objective evidence during an internal audit also is helpful. For example, if you are reviewing a medical device Purchase Order, record the specific Order Number.

View the steps to ISO 13485:2003 certification here. If these basics were followed, most of our noncompliance findings could be avoided. In addition, the FDA website offers detailed information to help with a 13485:2003 audit such as:
- How to determine the class of a device and what type of controls must be in place.
- Past problems others encountered with the device (if not new) and how they were addressed.
- Requirements for everything from pest control to record storage.

Related Tags:ISO 13485