Protomatic Renews QMS Certification
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.
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. 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, both QMS registrations are in the annual “maintenance phase” of the three-year cycle, so the Registration certifications will not change for Protomatic.
Dealing with Industry Stress
As we are all aware, Covid-19 has created some supply strains and stresses. In meetings with our supplier and auditors, they brought up a new situation; “There has been an increase in the number of companies that have lapsed their ISO/AS, NADCAP registrations”.
This means that customers of the auditors simply dropped the registration for financial reasons, or the auditors have found systemic failures due to changes. In this case, the registration status is typically changed to “Suspended.”
The Protomatic Status
Protomatic has currently completed the Annual Audit, Management Review, and the AS9100/ISO-9001 audit. In March 2022 we will conduct the ISO-13485 audit.
If you would like copies of our current certifications, they are available online at Protomatic.com
Why Support QMS
“Protomatic is focused on continual 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.”
You reviewed first-party and third-party audits. What is a second-party audit?
Answer: A second-party audit is a customer’s audit on site or remote, or a QMS Survey.
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.