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?