ISO 13485 and ISO 9001 Certification
Creating a Hybrid Quality Management System
ISO 13485:2012 Certificate (PDF Download)
ISO 9001:2015 Certificate (PDF Download)
Our Quality Policy:
Matrix Plastic Products combines traditional craftsmanship, technical expertise, state-of-the-art technology, and GMPs to manufacture high-precision plastic injection molded components and mold tooling. We will continue to meet our customers' expectations and support their compliance with regulatory requirements by continually improving our processes, procedures, and employee training, thereby ensuring consistent quality in our products and services.
ISO 9001 Since 1999 to Stay Ahead
When Matrix Plastic Products, then Matrix Tooling, first acquired ISO 9001 certification in February 1999, our primary motivation was to increase our sales potential with a larger number of OEM’s. We knew we were good at designing and building precision plastic injection molds and molding custom parts.
Over the previous two decades, the quality of our work and our responsiveness to customers had earned us an excellent reputation. Although not required by our customers at the time, we decided to pursue it on our own terms – and on our own timeline – to stay ahead of our competition.
The Goal of our Quality Management System (QMS)
The goal of any QMS system is to create a formal system that documents processes, procedures, and responsibilities for achieving quality policies and objectives.
We quickly realized the internal benefits of modeling our QMS on the ISO 9001 standard. The consistency that ISO 9001 brought to all areas of the company yielded obvious improvements. We became more consistent in how our jobs were quoted, documented, designed, processed and inspected; this led to a greater degree of control and confidence throughout the company.
Consistency in our purchasing methods and receiving inspections led to a significant reduction in vendor returns.
Formal management review meetings took place at regular intervals, bearing targeted plans for continual improvement.
In short, ISO 9001 made us better while giving our sales force increased credibility with potential customers.
Today, ISO 9001 certification is expected; a prerequisite for doing business in almost any industry.
Why ISO 13485? To Stay Ahead And Grow…
Over the years, it became clear that our precision micro-tooling, close-tolerance molding and advanced inspection capabilities made us a natural fit for medical device applications. As we began to acquire an increasing number of medical device customers, we made the important decision to focus our growth on that market. We invested in a Class 100,000 / ISO 8 clean room and cross-sectional scanning (“CSS”) technology to accommodate our medical device clients' requests.
We also made the decision to pursue certification to the quality standard specific to the medical device industry: ISO 13485. The structure of ISO 13485 was based on 9001 at that time, so we worked to incorporate the additional requirements for risk management, regulatory compliance, traceability, contamination control, and device history documentation into our existing QMS.
Our medical device customers typically approach Matrix Plastic Products with device design concepts and requirements for how the devices must function.
Our design engineers are actively involved throughout product development, including part design, mold design and production planning. We make recommendations for part geometry, material options and other manufacturability issues.
While we are technically a first-tier supplier to the OEM, not the “specifications developer,” we are certainly invested and actively involved in maintaining the quality and compliance required for our medical customers' programs. We realize that we are a critical link in their supply chain. If a customer gets audited by the FDA, we want to be fully equipped to support them. We are capable of providing all the documentation and traceability they may need.
Aligning our QMS with our customers’ requirements has made us an even more reliable supplier.
As we adapted our ISO 9001 QMS to comply with ISO 13485, we implemented risk analysis, process validation, and product recall procedures. We also incorporated device master records and device history records into our quality control plans. The end result was a more robust, hybrid QMS that is certified to both standards.
Why Maintain Dual Certification?
Today, ISO 13485 certification is required by most of our medical device customers, and ISO 9001 certification is required by most of our non-medical device customers. While the largest segment of our business is medical, we do want to continue serving other key industries requiring a similar degree of quality and precision. We find that by incorporating the best of both standards, we get the benefit of having a more comprehensive QMS that focuses on meeting both customer and regulatory requirements, risk-based thinking, customer satisfaction, and continual improvement - components we feel are just some of the reasons why our customers keep coming back to Matrix.