Quality Management Systems

MRPC’s overall goal is to create and sustain a Quality Culture.

Per our Mission Statement and Quality Policy, MRPC’s staff completely understands that the manufacturing process creates products that affect patients’ lives. We produce each component and device knowing that patient safety and manufacturer integrity are critical.

In addition to the above, MRPC maintains a single Quality Management System (QMS) for all locations, where the key performance indicators align and support the MRPC Quality Objectives.

MRPC is an ISO 13485 certified company and has held this certification since 2009.

MRPC was one of the first manufacturing companies in the state of Wisconsin to gain ISO 13485 certification. With our longevity in utilizing our QMS, MRPC has a strong procedural foundation that has allowed our quality approach to be second to none.

MRPC received MedAccred® Injection Molding accreditation for demonstrating an ongoing commitment to quality by satisfying customer requirements and industry specifications.

MedAccred® is an industry managed supply chain oversight program that reduces risk to patient safety, assures quality products and compliance with requirements as they apply to critical processes used in the production of medical devices. The program is administered by the not-for-profit Performance Review Institute®.

Beyond our ISO and MedAccred certification, MRPC offers FDA Registration (as a contract manufacturer), and maintains a system for Device Master Records (DMR) and Device History Records (DHR).

MRPC’s Quality and Engineering teams employ a cross-functional approach with a complete understanding for the development and completion of validations utilizing specific IQ OQ PQ protocols for individual components and assembled finished medical devices.

• Installation Qualification (IQ) verifies that tooling and equipment being qualified has been installed and configured according to the manufacturer’s specifications or installation checklist.  The IQ process integrates factory and site acceptance testing (FAT / SAT) and includes sub-system and ancillary equipment.
• Operational Qualification (OQ) involves challenging process parameters to assure the process will result in product that meets requirements.
• Performance Qualification (PQ) is the final step and demonstrates that the process will consistently produce an acceptable product under normal operating conditions. In this phase, the qualification and validation team verifies and documents that the requirements are verified as being met.

MRPC utilizes Minitab® for all capability analysis provided in our validations. In addition to testing data and detailed lot tree traceability records, MRPC also provides detailed Certificate of Conformance packages.

The staff at MRPC has hundreds of years of combined experience that spans across multiple industries. This experience has enabled MRPC to integrate multiple standards and best practices into a single business management system.

1. ISO 13485: Medical Devices
2. MedAccred Accreditation
3. 21 CFR Part 820: Quality System Regulations (including cGMP)

Other References:

1. ISO 14001: Environmental Management Systems
2. ISO 45001: Occupation Health and Safety Management System
3. ISO / IEC 27001: Information Security Management System
4. ISO 9001: Quality Management Requirements

MRPC sterilization consultation and management team assists in identifying an ideal sterilization method for products and manages the process with contract sterilization providers. We are there to support the initial sterilization validation, as well as the ongoing processing activities for our clients. Where appropriate MRPC has the defined microbial and surface testing to support sterilization processes.