We completed our first annual ISO 13485 Continuing Assessment Audit

[Doug Tropf]

We just completed our first annual 13485 Continuing Assessment Audit. We had one minor nonconformity in that the annual re-training records for one of our staff members was not available for audit (this individual seems to feel he's above some of the annual training requirements).

We also had two "opportunities for improvement" relating to some of the forms we use.

[SteelMaiden]

there is always one, isn't there? Is this a member of management?

anyway, good job.

[GStough]

Indeed, congratulations on a job well done!

[Doug Tropf]

Thanks for the congratulations!

The individual is our staff engineer who manages the validation / calibration side of the business.

Not that it applies to this person - but the auditor stated that we might want to include a statement in our training procedures to the effect that individuals that write procedures or conduct the actual training will be considered trained due to the research / preparation for such activities.

[Gert Sorensen]

Congratulations. It is always nice to "survive" an audit with this few NC´s. I hope that it reflects the state of your QMS