The Basics of QAing Medical Devices


At STEWART Industries, we are no stranger to quality. From employing rigorous inspection to sorting and comprehensive quality control, we have all your concerns covered. 

There is no room for error when it comes to protecting your staff and the people they serve. A medical device malfunction could result in a critical, or even fatal, error. That’s why we offer high-quality goods and guarantee the utmost accuracy in quality every single time. 

One of the most important steps in ensuring the best possible product is quality assurance and control. Let’s explore some of the basics of the medical device QA process and how we at STEWART work to meet and exceed those expectations.

Quality Assurance vs. Quality Control
Quality assurance is considered to be any proactive measures taken to prevent flaws in the medical device manufacturing process. It’s an ongoing practice where staff members are actively looking for issues in production or materials that might result in a defective product. Once a nonconforming product is found, it is a part of quality assurance to resolve any issues and prevent them from happening again. 

Quality control is a reactive process that works to identify any flaws that may exist in products after production, before they are distributed to the marketplace or client. Products are tested in batches to make sure they conform to strict product specifications. This essential step catches any defective products that may have slipped through quality assurance and prevents them from getting into the end-users’ hands. 

So, what sets our processes above the rest? Read on to find out.

Certifications
Proper QAing of medical devices means ensuring both internal company standards and goals are met, as well as those set forth by medical regulators like the FDA and ISO. 

Stewart Medical Supply is ISO 13485:2016 certified, the standard required of a Quality Management System (QMS) for manufacturing medical supplies. Surprisingly, being certified isn’t a requirement in order to work with medical supplies. However, we went the extra step to give our clients peace of mind and ensure performance at the highest quality.

Visual Inspection & Dimensional Inspection
STEWART Industries reacts quickly after a containment, providing sorting services to ensure defect-free products to your customers. We provide visual inspection sorting and dimensional inspection of production lines. Our comprehensive quality control services help prevent additional defective products from reaching your customer and forcing further containment action.

Multi-Supplier Sorting
If products received from multiple suppliers are in containment, they can all be sent to STEWART for a cost-effective, consolidated sorting operation. With all the pieces going through one sorting company, responsibility and sort integrity can be managed by a single-source—saving valuable time and money while providing higher sort quality.

Up-to-Date Processes 
We use the most current tested quality assurance systems available and employ the following methods to maintain quality and prevent errors:

  • Lean manufacturing systems
  • Continuous improvement system
  • 5s system
  • Error proofing
  • Employee monitoring system (performance/quality)
  • In-process inspection
  • Final audits
  • Dock audits
  • Pareto charting
  • Business operating procedures

The quality of our products and services is key to our competitiveness. Quality is everyone’s responsibility. To put it simply, we go above and beyond to give our clients peace of mind. Contact us today to learn more and receive an estimate for your organization.

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