GM Nameplate's Seattle division recently met the quality standard for ISO 13485: 2003. Following the exciting milestone, I took the opportunity to sit down with the division's director of quality, Michael Wodrich.
Congratulations on achieving ISO 13485:2003. For those that don’t know, can you explain what it is?
ISO 13485:2003 is the international quality management system standard for the design and manufacturing of medical devices, subassemblies and their components. Many aspects of the 13485 standard align very well to requirements of the Quality System Regulations (QSRs per 21CFR820) for FDA-regulated products, often referred to as current Good Manufacturing Practices (“cGMPs”). Companies certified to the 13485 standard can ensure their medical device market and customers that they have a strong business system with procedures in place to demonstrate consistent controls exist to consistently meet applicable specifications and quality requirements.
It is important to recognize that while GM Nameplate is prepared to manage a quality system that maps closely to those QSRs, we deliver only subassemblies and components to FDA-regulated customers. GM Nameplate is not currently producing regulated medical device products and therefore we’re exempt from those federal QSRs, but we still use them as guidance.
Why did GM Nameplate pursue ISO 13485?
We sought ISO 13485 to pursue even better alignment with our customers and their quality systems, which are driven by federal requirements. The 13485 standard is generally harmonized with ISO 9001 but promotes greater awareness and emphasis on cGMPs to ensure there is a system in place to consistently produce safe and consistently reliable products for the medical devices market.
As a supplier to the medical industry, we are exempt from the QSR requirements which drive many of our customers. However, it is important to us that we support our customers, understand their requirements, and align with their needs. By meeting the standards set for ISO 13485 we are better positioned to serve our customers across the medical device industry.
This also sets us apart from our peers in the industry. Few competitors have the same level of quality systems in place.
How is it different from other quality standards that GM Nameplate already meets?
ISO 13485 is specific to the quality management system requirements for medical device manufacturers (sub-assembly and component manufacturing, as far as GM Nameplate is concerned). ISO 13485 builds upon the ISO 9001 framework with higher expectations for risk management and design control activities when we develop sub-assemblies and product components together with our customers. There is no margin for error in any regulated industry, and this ISO 13485 standard promotes the effectiveness of meeting a comprehensive set of requirements. Achieving certification to the ISO 13485 standards helps ensure that the medical device components and parts we produce meet or exceed thoroughly planned quality specifications every time, without exception.
All GM Nameplate facilities already meet ISO 9001, a quality management standard that applies to general quality and management oversight principals, regardless of the industry. In general, ISO 13485 compliments ISO 9001 and can be seen as broadening our quality system to better align to cGMPs.
In addition to ISO 9001 and 13485, two GMN divisions are also certified to AS 9100C, an aerospace quality system standard. All are examples of GMN’s commitment to stringent quality management systems. GM Nameplate’s pursuit of so many stringent quality systems is a testament to the company’s commitment to quality.
To learn more on the difference between our quality systems, visit my blog Quality Systems 101.
What was the greatest challenge in achieving this milestone?
The first step was to revise our procedures to better align procedure language with our intent. In the end, we developed a stand-alone quality manual to meet ISO 13485.
Once that step was completed, our biggest challenge was transition and education to the additional requirements and supporting procedures. Our staff needed to understand the new procedures – what they mean, what they don’t, how they apply to core business functions, and how to comply. With quality, compliance is paramount.
What’s next on the horizon for GM Nameplate’s quality group?
A lot of hard work went into achieving this milestone and an equal amount of work will go into maintaining it. It is important to keep staff trained and vigilant about protocols through education and development efforts. Quality is always an ongoing process.
In addition, we will be looking to align our quality systems across our facilities. Quality standard are applied on a facility by facility basis. We will be taking what we have learned while rolling out ISO 13485 in Seattle to further improve our processes at other locations.