ISO 13485 for Small Manufacturing Businesses

Due to the differences in the ISO 9001:2015 and ISO 13485:2016 standards, small machining and fabrication facilities may find it difficult to blend the requirements of the ISO 13485 standard into their existing ISO 9001QMS.

The Key to a successful integration is understanding the correct method of blending the two sets of requirements. This can be done in a way that is not disruptive to the daily activities of an ISO 9001 manufacturing facility, while still meeting the requirements of the ISO 13485 standard. If implemented properly, the facility will find value in the QMS changes.

If you own a small manufacturing business and are looking to upgrade your QMS to support medical device machining and/or fabrication, contact us for a free consultation call.