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We are an ISO 13485 registered company, approaching our surveillance audit in early September. We are completing the internal audits and have just completed our Management meeting.
One of our objectives is to make on time shipments 95% of the time. This did not happen last year and we gave ourselves a Corrective Action (which is still open). This year our audits have revealed that we still have not made that 95%, however we are greatly improved over last year.
My question is, can our registrar remove our status if we consistently do not meet our objectives? Do we close the Corrective Action and open a new one for the same issue, or just continue to work with the Corrective Action that was opened last year??
Your guidance is totally appreciated!!
First off, let me comment you on setting the target. In so doing, you are completely on the right track.
One important question is whether or not your management review / corrective action procedures reflect the idea that any decision taken at Management review is a preventive action? If so, you did not need to raise the corrective action. Recording the condition in the management review minutes is sufficient.
You have shown progress over the last year. Based on that progress, I would close the corrective action, citing the discussion in management review. Hopefully, this will include an action plan to achieve the 95% target.
A registrar cannot rescind your registration due to non-achievement of a target. The fact that you are managing your system & actions to attempt to achieve that target is, in fact, what they are looking for in a successful system.
Good to hear you are making progress. Carry on!
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