ISO 13485, Need advice from QE’s!!!

ISO 13485, Need advice from QE’s!!!

TL:DR: Small medical company not ISO 13485 compliant due to bad previous engineer. Need a fix for never releasing any doucmentation that is ISO 13485 approved!

Hi R/Engineering!

I recently began contract designing for a small medical company (ISO 13485 certified) that produces machined components for Orthopedic Instruments. The nature of my employment at the time of my hire was strictly design related. I would be fed design criteria, given a timetable, and submitted concepts with direct customer interaction.

Shortly after I joined the company, it began apparent to the CEO that the only full time Design Engineer/Operations Manager (the company has less than 10 employees) was simply outsourcing all of his work to me. Shortly after, he was fired. As a result, I have been asked to complete several tasks above and beyond the simple designing aspect of the job. I am now responsible for completing the designs, and completing the Engineering Change Orders/New Product Introductions to formally release the designs into the quality system.

I quickly realized that the former Design Engineer/Operations Manager was not formally releasing my designs into the quality system. Instead, he would inform the CNC programmer that the design was ready to manufacture and he would design the CNC program, manufacture, and ship the parts. As a result, over 600 internal part numbers were never formally released by any ISO 13485 compliant method. The company has over 600 parts and have a total of 15 ECO's, 7 of which are actively missing from the completed ECO log.

This company does have a standard ISO 13485 compliant system that was never followed. The likelihood of this company being audited is slim to none since the annual revenue is sub $500k. However, I do want to "fix" the system. I suggested revisiting ever part number that has not been released and ECO'ing before the next manufacturing run. The only problem with this strategy is that it will be apparent to customers that the parts have never released since they began ordering.

To all of the QE's out there, have you ever seen a system like this? What would be the most appropriate way to fix the system? I am not concerned with the amount of work, but also want to protect the company, and most importantly, myself.

Thank you for all that comment!

Submitted May 13, 2017 at 02:13PM by tsudneves
via reddit

ISO 13485, Need advice from QE’s!!!

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