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"ISO 13485 - Change? Do I Have to??"

ISO has published the final draft of the latest ISO 13485 quality management standard for medical devices.

Once a standard has reached the Final Draft International Standard (FDIS) stage, comments and objections have been addressed. Each technical reason is addressed in a comments resolution meeting, so that the parties resolve issues before the standard is published. So in effect, the standard has been approved at this point, and only very technical issues would be addressed before its publication.

Accordingly, many companies have a conundrum if they want to maintain both ISO 9001 and ISO 13485 certification: How to comply with the varied requirements within only one quality system. The array of opportunity may not be as broad in terms of rationalizing how to do business as an outlier. In other words this standard is now at a new level of application based on these three points:

1. Any actions taken by a business must be measures for controlling risk
2. Critical factors must be evaluated as Risk and Opportunistic (R&O) driven outcomes
3. As a result of 1&2 it is explicitly imperative to make planning a tangible and documented activity with appropriate review and actions at executive-level decision-making

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