ISO 13485 and ISO 9001 Certification
Creating a Hybrid Quality Management System
ISO 9001 and 13485 Dual Certificate (PDF Download)
ISO 9001 & 13485 Dual Certificate (PDF Download)
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 existing customers, 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 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.
Why ISO 13485? To Stay Ahead…
Driven by customer demand over the years, Matrix Plastic Products has found it increasingly important to focus on medical device applications. Our precision micro-tooling, close-tolerance molding, and advanced inspection capabilities are a natural fit. We invested in a class 100,000 clean room and cross-sectional scanning (“CSS”) technology to accommodate the requests of our medical device client's requests.
We also discovered that the quality standard specific to the medical device industry is ISO 13485, not ISO 9001. The structure of ISO 13485 is based on 9001, but 13485 contains additional requirements for risk management, regulatory compliance, traceability, contamination control, and device history documentation.
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 design. We make recommendations for 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 actively involved in the success of these products. We consider ourselves a critical link in the 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 will make us an even more reliable supplier. It will also differentiate us from our competition.
As we adapt our ISO 9001 QMS to comply with ISO 13485, we plan to implement risk analysis, process validation, and product recall procedures. We will also incorporate device master records and 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.
Why Maintain Dual Certification?
ISO 13485 is not required by our non-medical customers and, conversely, ISO 9001 is not required by our medical device customers, but it has become critically important for our medical device customers. It is interesting to note that ISO 13485 does not require an organization to demonstrate continuous improvement or monitor customer satisfaction. Yet 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.