United Surgical

United Surgical had a potential client that was looking to move their manufacturing to an offshore facility to cut manufacturing costs. As part of the qualification process of United Surgical manufacturing processes the potential client required that United Surgical implement an ISO 13485 quality management system. By implementing a quality management system United Surgical provided the potential client the confidence that had well defined and implemented process. ISO 13485 was implemented within 3-4 months and the contract was won by United Surgical.

ISOReady was able to work with the management staff and process owners to document and map out their current processes and implement the ISO 13485 principles allowing the company to have better defined processes. ISOReady, working with the Executive Team, was able to identify measurable quality objectives to allow the employees to be able to measure their processes and identify if the processes were operating in an effective and efficient manner. As part of implementing the ISO principals the company was able to increase production efficiencies by 30%

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Updating ISO Documentation

Document or not to document During many of our initial assessments of client’s current quality systems we find that the...

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