ISO 13485

Key Word Search

Filter by Category

Popular tags

Bob Coyne GM Nameplate
By Bob Coyne | Sep 19, 2017
GMN will help guide the design and manufacturability of your product.

GM Nameplate’s (GMN) design support capabilities spread across a variety of technologies to meet the needs of a variety of industries. As a custom manufacturer, GMN has to be ready to accommodate a vast array of needs a customer has. Our specialties lie in graphic, industrial, mechanical, and electrical design support, providing design considerations for manufacturability, and managing projects in a coordinated and efficient manner to meet the agreed requirements of a project.

When supporting a customer’s design, GMN brings forth many departments to help provide input. These in-house experts make up our product development team which includes product line managers, the rapid prototyping group, graphic designers, design engineers, and the process engineering group. GMN can provide design support for all customers, and the extent of that support varies based on the customer’s specific requirements and information given to GMN on the project. 

In addition to developing a product, we construct the manufacturing process for the product as well. To produce a custom part, there must be a manufacturing process in place that is efficient, reliable, and repeatable and in alignment with the project requirements. The process begins by obtaining requirements from the customer with sufficient detail and specification (thermal management, moisture ingress, UV, chemical, or corrosion resistance, etc.). Then a development plan is created with assigned roles and timelines. Next, validation parts are built, parts are tested, revisions are made and updated, and then the production process for that specific part begins. Once that process is developed, it is tested and validated before starting production.

GMN is a vertically integrated manufacturer that offers a wide range of value-added capabilities and services under one roof. To continue to simplify the supply chain, GMN sources high quality materials from its extensive network of strategic partners and suppliers to ensure that we provide our customers with the best product possible.

Quality is key in manufacturing, and GMN is compliant to internationally recognized quality standards across several industries including aerospace and medical. Although quality standards are specific to each GMN facility, a few certifications maintained by GMN include: ISO 9001, ISO 13485, AS 9100, ISO 14001, China ISO/TS 16949, China ISO 14001, and OHSAS 18001. To learn more about our certifications, check out our quality and compliance page.

Our company has several facilities throughout the US and Asia. We are headquartered at our Seattle, WA Division, and other GMN divisions include: Monroe, NC Division, San Jose, CA Division, Beaverton, OR Division, China Division, and Singapore Division. Although many of our facilities share similar capabilities, each one also possesses unique capabilities specific to that plant.

If you would like more information about our processes and development capabilities for your company’s next product, please click here to request a consultation with one of our in-house technical experts.

Chris Passanante, GMN
By Chris Passanante | Jun 23, 2017
ISO 13485

Due to our ongoing commitment to the medical device industry and growing demand, GM Nameplate’s (GMN) Beaverton, OR Division attained ISO 13485:2003 certification. The Beaverton, OR Division, GMN’s dedicated plastics facility, received this certification after auditing and approval by the Orion Registrar on May 9, 2017. This ISO standard is in regard to the quality management system requirements specific to medical device manufacturers. GMN’s Beaverton, OR Division is the third GMN division to obtain this quality certification.

What does this standard mean for GMN customers?

Meeting the strict standards of ISO 13485 assures that GMN can continue to support existing and future customers in the medical industry. ISO 13485 demonstrates that GMN meets regulatory standards and legal requirements to operate in the medical device industry, reduces risk effectively, and has systems in place to consistently yield safe and effective medical device components.

With little room for error in the medical industry, GMN has continually worked to uphold a quality system that meets the highest quality standards in order to produce best-in-class solutions. This certification validates the strength and sustainability of our processes which differentiates us from competitors.

Dedication to quality

For decades, GMN has shown commitment to the medical device industry and a dedication to creating quality products. Compliance with ISO 13485 ensures that the medical device components and sub-assemblies produced by GMN will meet or exceed thoroughly planned specifications every time, without exception.

As a company that supports multiple regulated industries, such as medical, we are committed to ensuring that our Quality Management System is robust and flexible enough to meet the variety of challenges presented by our wide range of customers and industries. With this new recognition, GMN’s Beaverton, OR Division shows its ability to handle increasingly stringent and diverse customer requirements. In addition, the ISO 13485 compliments ISO 9001, another quality standard that GMN has long been in compliance with, which reflects our continual efforts to broaden our quality system to better align with the current Good Manufacturing Practices.

Cynthia Schulte, GMN
By Cynthia Schulte | Jan 3, 2014

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.