What records are required to show compliance to ISO 13485:2016?

SGquality

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#1
We have a well established QMS to ISO 13485:2003 and are getting ready for 2016 certification audit next month. The quality manual and all procedures are revised to include the new requirements but on going through the standard, I did not find any examples where the records would be impacted.

Does any one have a ready cheat sheet to show which types of records would be impacted from a ISO 13485:2016 standard perspective?

Thank you!
 
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yodon

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#2
A few thoughts (quite possible I missed some). Definitely a case of "the devil is in the details."

Management review inputs have changed and there's a new requirement to include the inputs reviewed so that record is likely impacted (5.6).

Records of the actions taken to ensure competence (could be training) might possibly need more information to demonstrate that the effectiveness assessment was proportionate to the risk (6.2).

(Non-product) Software validation records are required to include conclusions about the validation (throughout).

Added requirement to include the ID of the design under review and participants in Design Review records (probably already doing it) (7.3.5).

Rationale for choice of product used in validation is now required to be recorded (7.3.7).

Conclusions from product verification and validation are now required (7.3.6 & 7.3.7).

The design transfer record is new... unless you were already under FDA regulations. Specific requirements to document results and conclusions of the design transfer (7.3.8).

New requirement to record adjustments or re-adjustments for calibrated equipment (7.6).

New requirement to maintain records of reporting to regulatory authorities (8.2.3) (almost certainly already doing).

A bit more explicit content required for internal audit results (8.2.4).

New requirement to include test equipment used in monitoring and measurement of product records (8.2.6).

NC records now must have the rationale for actions / disposition decisions documented (8.3.1).

Explicit requirement for keeping records of actions related to issuance of advisory notices (8.3.3).

Explicit requirement for records of rework (8.3.4).
 
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