Our Quality commitment
Rolenn Manufacturing’s Quality Team has extensive experience with the demanding requirements for the Aerospace and Medical Device industries and uses a range of methods and tools to support elements of the Quality System such as Process Development, Product Realization, Risk Management and mitigation strategies.
Rolenn Manufacturing has established, documented, and implemented a quality management system which is continuously reviewed and evaluated for effectiveness in accordance with ISO 9001, ISO 13485, FDA QSR 21 CFR part 820.
cGMP and QSR compliant globally
ISO 9001 certification
ISO 13485 certification
ISO Class 7 & 8 Cleanrooms
Climate-controlled inspection laboratory
Test method development, first article inspections, Gauge R&R
Process Validations (IQ, OQ, PQ)
Electronic Record Keeping
We perform post-production testing following the
ASTM D2240 standards.
This test method covers twelve types of rubber hardness measurement devices known as durometers: Types A, B, C, D,DO, E, M, O, OO, OOO, OOO-S, and R.
We want to give you the peace of mind of being delivered with fully operational products.
We have a high degree of assurance in our manufacturing process and with our experience we are able to provide qualifications for a new product line very shortly.
IQ : Installation Qualification
We make proper installation and configuration of our machinery. We ensure that the environment is adequate, the procedures have been approved and that our employees are fully trained.
OQ : Operational Qualification
From the amount of power needed to operate to the right amount of pressure or rotation per minute rate delivered, we verify that our equipment works with its specific operational requirements.
PQ : Performance Qualification
Now that our machines have succeeded the operational qualifications, we repeat our process on load and authenticate that we still meet our expectations.
Certified Clean Rooms
Class 7 and 8 Clean Rooms
When contamination is a risk, our clean rooms can fulfill your needs for safe molded products