However, it brings changes in the following areas: Since ISO 13485:2016 doesn’t follow Annex SL, it kept most of the requirements from the previous version, so the transition wouldn’t be too dramatic. There are some new requirements, but the most significant are the incorporation of risk-based approaches in the context of the safety and performance of the medical device, and in meeting regulatory requirements and harmonization of the requirements for software validation for different software applications in different clauses of the standard. Comparisonīoth versions have the same number of clauses however, the new version requires additional documents and allows exclusions from clauses 6, 7, and 8. Transition periodĬompanies certified against the 2003 revision of ISO 13485 must transition to the new version by March of 2019. The new version of ISO 13485 is aligned with ISO 9001:2008, which may pose challenges for organizations that need to comply with both ISO 9001 (for which the 2015 version complies with the High Level Structure) and ISO 13845.
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