I would like to commend the AXEON Staff again for the (4) day Lead Auditor course I took during August
2019, specifically for ISO 13485-2016 certification. The course length, study materials and instructor pacing
provided high quality understanding and practical application.
I took the course to be better prepared with our overall Quality Management System.
Our company recently completed the (3) year ISO 13485-2016 re-certification process.
We were informed of the auditor’s recommendation for certificate issuance. All audited evaluation categories in
the conclusion report met applicable requirements for certification.
Our company manufactures x-ray medical device components and has less than 15 employees.
The AXEON course helped us to improve our overall QMS preparedness to meet the documentation, traceability and corrective action requirements necessary for engineering and manufacturing high quality safe products, providing employee training and insuring customer satisfaction.
This was a very beneficial experience for our company. Our thanks for a great program.
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