The International Organization for Standardization (ISO) released a major review of its ISO 13485 standard. This review includes several important changes for both medical device industries that already have this certification and those looking to develop and implement a quality management system (QMS).
With the changes, many questions come up:
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How long will ISO 13485:2003 continue to be recognized and audited to?
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What is the timeline for ISO 13485:2016 implementation?
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How will organizations with ISO 13485:2003 certification be affected by the new standard’s changes?
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What benefits can the organization expect with the new standard?
In this eBook, you will find the answers to these and many other questions and will be better prepared to conduct a smooth transition at your organization. Download it now!
Language: English