When Matrix Tooling, Inc. 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 were good at designing and building precision plastic injection molds and molding custom parts. The quality of our work and our responsiveness to customers had earned us a good reputation over the previous two decades. Our existing customers were pleased with our performance and were not requiring us to be ISO 9001 certified. But we decided to pursue it anyway on our own terms – and on our own timeline – to stay ahead of our competition.

We quickly realized the internal benefits of modeling our quality management system (“QMS”) on the ISO 9001 standard. The consistency that ISO 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 the virtual disappearance of vendor returns. Formal management review meetings took place at regular intervals, bearing targeted plans of continual improvement.

In short, ISO 9001 made us better while giving our sales force increased credibility with potential customers. Today, ISO 9001 certification is almost expected; a prerequisite for doing business in almost any industry.

Over the years, Matrix has increased our focus on medical device applications where our detailed micro-tooling, close-tolerance molding and advanced inspection capabilities provide a natural fit. We added a class 100,000 clean room and cross-sectional scanning (“CSS”) technology.

But we also discovered that the quality standard specific to the medical device industry is ISO 13485, not ISO 9001. Though its structure is based on 9001, 13485 contains additional requirements for risk management, regulatory compliance, traceability, contamination control, and device history documentation.

Our medical customers come to Matrix with device design concepts and requirements for how their devices must function. Our design engineers are often involved in the development stage from a production perspective and make recommendations for resolving part geometry, material selection and other manufacturability issues. While we are technically a second-tier supplier, not the “specifications developer,” we are certainly invested and involved in the success of these products and consider ourselves a critical link in the supply chain. If a customer gets audited by the FDA, we want to be well equipped to fully support them and provide all the documentation and traceability they may need.

To date, our customers have not required us to become ISO 13485 certified. However, we have decided to pursue it anyway. We feel that aligning our QMS with our customers’ requirements will make us an even more reliable supplier. It will also differentiate us from our competition. We like that idea.

As we adapt our ISO 9001 QMS to comply with ISO 13485, we plan to implement risk analysis, process validation, and product recall procedures as well as incorporate device master records & device history records into our quality control plans. The end result will be a more robust, hybrid QMS that will enable us to apply for dual certification (we were pleased to learn that our current registrar handles both).

Why maintain dual certification? For one thing, ISO 13485 doesn’t mean anything to our non-medical customers. Secondly, we find it interesting to note that ISO 13485 does not require an organization to demonstrate continuous improvement or monitor customer satisfaction. These are key components in ISO 9001 – components we certainly would not want to dismiss in a competitive environment where things like customer satisfaction and continuous improvement are just a couple of the reasons why our customers keep coming back to Matrix.

Written By:

Anne Ziegenhorn
Document Control Coordinator