Welcome to 2 Minutes to Launch.

My names is Terry and today I'll be answering the question, "What are the benefits of an ISO13485 certification for a contract manufacturer or an electronics manufacturing service provider?"

First in answering the question, what is this certification? It really is an overall quality management system that governs the activities inside of the factory. It is the medical device industry's most widely used international standard.

In order to become certified, a manufacturer must go through two major phases. The first is internal: where you're going to establish, document, and implement an entire quality management system. You may go through a few internal audits and may take some corrective actions to get there to ensure that you do in fact meet the requirements set forth in the ISO13485 documentation.

Once you've done that, you move on to phase two, which is where you hire an external third-party regulatory agency to come in and they perform the audit. Again, on documentation, process control, and all the activities to make sure you meet the requirements that they have set forth.

That's how you become certified. Really the most important question to ask from that point on is, What does it mean to you? What does it mean for your product or your business?

Firstly, it really gives you confidence in the manufacturer's ability to control quality and risk. Quality of the product, and the process, and the training of the staff to make that product.

It also, in terms of risk mitigation, making sure that there isn't inconsistencies in the process, making sure they're choosing the right component vendors and material suppliers to make sure you have consistent supply. And, you may need traceability down to the component level, and that's part of the risk mitigation set forth in this documentation.

Secondly, ISO13485 means that the full company has bought into this process. This quality management system has clearly defined roles and responsibilities from everyone through senior management to production line workers. You'll make sure the entire company is bought in to what it means to have this certification.

Lastly, you'll be sure to get continuous improvement in the training and skills development of the personnel and also the cleanliness of the facility, and the organization. Making sure everything from start to finish is properly labeled and properly dispositioned.

That's what it means to have an ISO13485 certification.

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Date first published: 19 Jun 2020