Maintaining Two ISO Certifications: 13485 and 9001

By: Anne Ziegenhorn

October 2, 2019

When Matrix 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.  So we became one of the first mold shops in the Chicago area to become ISO 9001 certified.

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 expected; a prerequisite for doing business in almost any industry.

Over the years,  Matrix continued to focus more heavily on medical device applications where our detailed micro-tooling, close-tolerance molding and advanced inspection capabilities provide a natural fit. We added an ISO Class 8 clean room and more advanced inspection technology.

But we also discovered that the quality standard specific to the medical device industry is ISO 13485, not ISO 9001. Though its structure was originally based on 9001, 13485 contained 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.

So in 2010, we decided to pursue ISO 13485 certification as well because we felt that aligning our QMS with our customers’ requirements would make us an even more reliable supplier. We also liked the idea that having the additional certification would further differentiate us from our competition. 

As we adapted our ISO 9001 QMS to comply with ISO 13485, we implemented risk analysis, process validation, and product recall procedures, as well as incorporated device master records & device history records into our quality control plans. The end result yielded a more robust, hybrid QMS that enabled to achieve our dual certification.

Today, of course, ISO 9001:2015 and ISO 13485:2016 are no longer structured in sync, so we now maintain two separate certifications. Why?  Because 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.