As a medical device contract manufacturer, Marshall is committed to delivering the best and most cost-effective machining solutions possible. That means meeting and surpassing industry standards across our manufacturing capabilities. Today, we’d like to explore one of the important standards we meet for our medical customers: ISO 13485.
What Is ISO?
“ISO” stands for the “International Organization for Standardization.” This group develops and publishes worldwide commercial and industrial standards. According to the organization’s website, “ISO creates documents that provide requirements, specifications, guidelines or characteristics that can be used consistently to ensure that materials, products, processes and services are fit for their purpose.”
What Is ISO 13485:2016?
The ISO 13485 standard applies to medical devices. Per the ISO website, “ISO 13485:2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.”
The Importance of Being ISO 13485:2016 Certified
Since Marshall Manufacturing Company was founded in 1951, we have provided contract manufacturing services for numerous types of original equipment manufacturers (OEMs). In the spring of 1996, Marshall’s owner and management team sought to improve and upgrade their quality management system. Seeing that many of our customers were implementing ISO for their quality management systems, it was evident that this was a standard that would elevate our company. The decision was made by our company president to work toward becoming ISO 9001 certified, which was later achieved in 1997.
Because of Marshall’s ISO 9001 certification and the improvements it provided to both Marshall and our customers, we were awarded numerous new projects, many of them by medical customers. A decade later, our medical device contract manufacturing business entered a period of heavy growth. The Marshall management team again began to examine its quality management system, seeking a system that would be more helpful and specific to medical device contract manufacturing. This brought Marshall to another level of competence in 2010, with the objective to obtain ISO 13485 certification—which is specifically directed toward the medical device industry.
Where Would Marshall Be Without ISO?
Manufacturing medical devices and components for medical OEMs is extremely demanding. Being ISO 13485 Certified over the last ten years has guided Marshall to improvements in many areas. Consistency is critical in every step of the manufacturing process, for every customers’ product. The documentation and storage of all medical device records provides verification of material, processes and quality of product.
Prior to accepting a new or recurring order with a medical company, Marshall’s management team reviews the proposed contract. Within the contract review process, the management team confirms that materials, dimensions and other specifications are clearly defined, and that Marshall is fully capable of manufacturing and measuring all required aspects of the customer’s product.
Material Certification and Traceability
When raw material arrives at Marshall, it is inspected and measured to verify it is within the specifications of the purchase order issued to Marshall’s approved vendor. After passing incoming inspection and documentation, the material is labeled accordingly, recorded into inventory and delivered to a storage tray on the production floor—or to the specific machine where the machine operator can easily access it.
Throughout the manufacturing process, the machine operators and the quality department work hand-in-hand to ensure the product is being built to print specifications. If it is a first-time project, the customer often requires a “First Article Inspection Report” (FAIR), in which the customer clearly explains the inspection process and parameters.
Marshall requires a “First Piece Inspection” on a daily basis, in which the machine operator inspects their first part off the machine, and then confirms with the quality department that all inspection dimensions of the part are within spec. The operator continues to inspect the parts throughout their shift per instructions specific to the “Control Plan,” which in some cases can include “statistical process control (SPC).” Control plans are developed by a combination of people, including engineering, quality and the customer. Depending upon the complexity of the part, the intended use of the part and what could go wrong with critical manufacturing processes, control plans can greatly vary from one type of part to another.
A final inspection and inspection sign-off is required upon the completion of a production order. Marshall has developed a standard final inspection process; however additional criteria are often dictated by the customer—and may involve a random quality check on a specific percentage of parts or specific dimensions that were run within a particular order. All inspection data gathered is documented in the customer files.
An ISO Audit
To become certified, an initial certification audit to the ISO 13485 standard must be performed by an independently certified registrar. Upon passing the certification audit, an ISO certificate is awarded by the auditing registrar. A certification is valid for three years with the condition that surveillance audits are passed without any major un-corrected findings following the 1st and 2nd years. At the end of the 3rd year, a recertification audit is required. Successfully achieving and maintaining ISO 13485 certification demonstrates that Marshall is effectively maintaining our quality management system.
Contact Marshall Today
Marshall Manufacturing Company looks forward to an opportunity to work with new medical customers. Please let us know if you would like to talk with us. You can contact us by phone at 612-788-9621—or connect online through our website.