Simplifying Quality Control for Medical Manufacturers


For medical device, equipment and supplies manufacturers, quality control needs to be in the forefront of developing business processes. Subpar quality control leads to noncompliance, wasted materials and production time, recalls, and can destroy a brand’s reputation. For operations to run smoothly and to navigate inspections, medical manufacturers must simplify their quality control systems by taking advantage of their ERP.

Establish a quality management plan

To be compliant with ISO 13485, it is necessary for manufacturers to have a documented plan that defines the “quality practices, resources, and activities relevant to devices that are designed and manufactured” (International Organization for Standardization). By collaborating with your design and other teams, you can come up with a comprehensive plan containing exact specifications for acceptance criteria. This plan becomes a resource for your employees and can be integrated into your business processes through your ERP.  If you are unsure how to apply your quality management plan to your ERP, talk to an ERP consultant like Datix for support. With our business-first approach, our team will take the time to learn the competitive advantage of your business to guide you in maximizing it and your ERP system.

Acceptance criteria

Once your quality management plan is outlined, it is simple to set up your acceptance criteria in your ERP. With your system, you can make steps in the production process required and set fixed parameters to match your acceptance criteria. Quality control staff can also record acceptance rates for products or batches in the ERP. Having these records is essential for inspections and audits, in addition to helping your business become more productive by showcasing the strengths and failure points in your systems.

Product testing

For product testing, the FDA gives manufacturers the ability to design their own quality control tests if they can provide detailed documentation of its effectiveness. By tracking product testing with your ERP, you can quickly generate this documentation as reports for demonstrating the efficacy of your verification systems. During an inspection, investigators will be able to see your quality control testing in action and how it is recorded in your systems.

CAPA Management

Corrective Action/Preventive Action (CAPA) processes needs to be planned out and incorporated into your larger quality management plan. With your ERP, identifying, analyzing, and resolving quality issues with closed-loop CAPA processes can be integrated into your business processes from the start. Many of these processes can be automated, saving your team time and safeguarding their accuracy. In the event of an issue, your ERP’s tracking features are invaluable for recognizing the issue and finding the source of the problem.

Wrap Up

Quality control is an integral part of your business processes, so it should be a part of your software. Taking advantage of an ERP is essential for medical device, equipment and supplies manufacturers who want to get ahead by streamlining their quality control systems. However, implementing a new quality control methodology through an ERP requires a software expert to offer support during the process. At Datix, we recognize that every medical manufacturer has specific needs that must be addressed in quality control and ERP management. Our team will partner with you every step of the way to bring your organization to the next level.

Read our Ultimate ERP for Ophthalmic Goods Manufacturing or our Ultimate ERP for Dental Manufacturing

About Datix

Datix is the ERP consultant of choice for medical manufacturers. Our consultants understand the medical device, equipment and supply industries and dedicate themselves to analyzing each of our clients so that we can develop the best software solutions to maximize their investments to the fullest.

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