Both QMS Certifications audited at Protomatic
Annual Internal Audits (First-Party Audit)
Protomatic manufactures precision CNC parts for the aerospace and medical industries. To help ensure that every part meets optimum quality standards, we perform regular independent inspections of the Quality Management System. These inspections are conducted with trained in-house staff, as well as with independent certified quality auditors.
Additionally, on a monthly basis, corporate Key Process Indicators (KPI’s) are monitored and reacted to improve corporate performance. This takes place within the company to prepare for a registration independent auditor. The time, work, and extra effort put forth by our employees on this task is definitely appreciated.
Customer Audits (Second Party)
Protomatic welcomes customer audits. This type of an audit is an important way to discuss improvements to systematically address company relationships and focus on customer needs. This gives us the opportunity to look at the whole system and focus on product improvements specific to the customer needs. “This is one of my favorite type of audits, because customer audits are productively focused on product improvements,” stated Doug Wetzel, VP/ General Manager.
QMS Renewal with the Registration Auditor (Third-Party Audit)
The Quality Management System that most people are familiar with is the Registration Audit, also called the Third-Party Audit. In this Quality System review, inspections are contracted by a qualified independent auditor. Inspections are conducted annually, typically with a three-year contract. In this audit the entire QMS is analyzed. Findings are reported and corrected to maintain registration.
Protomatic conducts this review twice annually. Once for AS9100/ISO-9001 for Aerospace requirements, then again for ISO-13485 covering Medical requirements. In February of this year (2023), both of these audits have been completed. Although, the quality systems for both industries are very similar, and the products we manufacture are of similar size and quality requirements, the process covers all interactions of policies, procedures, instruction, forms, and records.
This year, QMS registrations are in the annual “maintenance phase” for AS9100 and a complete audit was conducted on ISO13485. So the AS9100D Registration certifications will not change for Protomatic, and the ISO-13485 will be updated, with an estimated update by March 31st, 2023.
The Protomatic Status
Protomatic has currently completed the Annual Audit, Management Review, and the AS9100/ISO-9001 and ISO-13485 audit.
Supporting the Quality Management System (QMS)
“Protomatic is focused on improvement in understanding the needs of our customers. That is the principal reason for supporting QMS at Protomatic” stated Doug Wetzel, Vice President and General Manager. “The team’s acceptance of QMS helps all of our customers and enables us to continue to provide them with Life-saving Precision throughout every CNC part we manufacture.”
About the author: Doug Wetzel is Vice President and General Manager of Protomatic. Protomatic is a CNC precision machining shop specializing in prototype and short-run production components for the medical, aerospace and other technical industries. Because of the critical nature of the parts they design and manufacture, the emphasis is always on Life-Saving Precision.