In the contract manufacturing world, Quality Management System (QMS) certifications are one of the first items a prospective customer should have on their checklist. Why is this? Quality Management System certifications provide a standard of documentation, quality, and controls that assures the customer that the manufacturer can produce consistent, quality product. There are hundreds of different standards for almost any industry you can imagine. Let’s talk a little bit about the three QMS certifications that REDCOM EMS has achieved thus far, and the purpose of each one.
This certification is essentially the “baseline” certification that prospective customers should look for. It provides a framework for a system of, “say what you do, and do what you say.” This standard can be used within any industry, whether it’s manufacturing, or human resources, or accounting. It focuses on processes, customer satisfaction, and involvement of top management in the overall system. The primary purpose of this certification is to provide business with a standardized method of producing high-quality and consistent products and services. REDCOM EMS achieved this certification in March 2017, opening the doors to the general commercial market.
This certification builds upon ISO 9001:2015, and the standard uses the text from ISO 9001:2015 and inserts additional requirements in bold, italicized font. This certification provides the requirements for the Defense, Aviation, and Space industries. It holds the organization to a higher level of quality and control that’s necessary for mission-critical products and services. Risk management is heavily emphasized, as is tight control of the supply chain to prevent counterfeit parts.
As you can imagine, the consequences of an in-flight failure of a critical component in a commercial airline carrying 300 people would be catastrophic. Pilots, astronauts, and military personnel need to be able to do their jobs without worrying whether the equipment that their lives depend on is going to work. That criticality of high-quality products and services flows down the supply chain. REDCOM EMS achieved this certification in July 2019, providing opportunities to delve a little deeper into the aerospace and defense markets.
This certification outlines the conditions for the QMS as it relates to regulatory requirements associated with medical devices. This standard also focuses heavily on risk management and regulatory compliance. Many medical device manufacturers are subject to FDA regulations, and these controls must be implemented throughout the supply chain. This standard and certification process can be a bit complex for designers of medical products; however, because REDCOM EMS only manufacturers to print (i.e. to a customer’s design and requirements), some of the complexity was removed from the equation. REDCOM EMS secured ISO 13485:2016 certification in May 2020, indicating its Quality Management System meets all the requirements for medical device manufacturing.
Why Require QMS Certifications of Your Contract Manufacturers?
QMS certifications assure an industry-standard level of quality and control over processes and documentation and are continuously being monitored through internal audits, annual surveillance audits by the certification body, and re-certification audits by the certification body every three years.
At REDCOM EMS, we pride ourselves on the commitment to quality throughout the entire organization that is required to obtain and maintain these certifications. Each new certification and each internal and external audit give us opportunities to improve our processes and make our QMS more robust as we continuously strive to meet and exceed customer expectations.