Always moving forward
Protomatic has nearly completed the process of becoming ISO13485:2003 certified for medical component manufacturing. We have had an ISO9001 certification since 1998, which has ensured you of getting high quality products delivered on schedule.
While the ISO13485 auditors were scrutinizing our current quality system this month for the Phase 1 Audit, opportunities were found for further improvement (since audits of any company result in findings of one kind or another, that’s hardly surprising).
These recent audits have verified that our machine and shop practices are excellent with only a few changes called for. Since non-manufacturing functions are where most companies come up short for ISO-13485, they were intensely targeted by the auditors.
One of those areas is record keeping. To achieve medical certification, accurate record keeping is critical. Our current approach meets or exceeds all standards for ISO9000. With the heightened security and retrieval requirements for ISO13485, we are now also using secure cloud resources for storing some records. This revamp has made our record and retrieval system even more efficient.
Protomatic has always had a very close relationship with suppliers, especially those who perform the coating and surface treatments of final machined parts. We know how critical they are to the quality of our products, so any problems are always handled quickly and smoothly. The recordkeeping required for our new certification will result in an even higher level of accountability and quality.
Protomatic is always looking for new ways to improve the quality of our products and the service we provide. We’re looking forward to being certified in April 2014 with the Phase 2 Audit.