The ISO 13485:2016 transition must occur in conjunction with a regularly scheduled assessment either as a surveillance or recertification assessment: Besides the increased emphasis on regulatory and risk management, there is additional clarity regarding validation, verification, and design activities, strengthening of supplier control processes and increased focus regarding feedback mechanisms.
Risk management is now applied to all processes including outsourced processes such as process control, purchasing, and software validation risk-based approaches are now expanded beyond product realization. In 2003 version, the words “regulatory requirements” appear 9 times in clauses 4 to 8 while in the 2016 version, they appear 37 times the word “risk” appears 5 times in the 2003 version, however it appears 14 times in the 2016 version. It is important to note the significant emphasis on regulatory requirements and risk management, which should be translated into your updated quality system. ISO 13485:2016 still retains the same 8 clause structure and main clause numbering, however due to the addition of several new clauses, sub-clauses have been renumbered. Moreover, there is now a strong departure between ISO 13485:2016 and ISO 9001:2015. ISO 13485:2016 has an increased emphasis on regulatory requirements, risk management, validation/verification & design transfer, outsourced processes & supplier control, and feedback. Currently, ISO 13485:20 will coexist which allows time for everyone to transition to the new standard.
There are many differences between the versions but the changes are easily implemented with AlvaMed’s help and support.
ISO 13485:2003 becomes obsolete on Mabut companies should begin the transition process as soon as possible.
ISO 13485 CHANGES UPDATE
In early 2016, the International Organization for Standardization (ISO) released the update to the ISO 13485 standard which replaces the version from 2003.
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