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NPX is excited to announce we have received ISO 13485:2016 certification. Obtaining ISO 13485:2016 certification is something we have planned since the beginning of NPX, and we’re excited to have this certification not only for ourselves but for our customers.

What Is ISO 13485?

ISO 13485 is an internationally recognized standard for organizations involved in the medical device industry. The standard specifies requirements for a quality management system.

Obtaining ISO 13485:2016 certification for NPX means we have demonstrated compliance with the standard and provides our customers with the confidence that we have established and maintained effective processes.

What Are the Requirements for Getting the ISO 13485 Certification?

Step one is to implement a strong quality management system that is compliant with the requirements of ISO 13485:2016.

Once that is in place, a company is evaluated, through a series of audits, by an accredited certification body. Based upon the auditor’s recommendations and the certifier’s approval, the certificate will be issued.

How Long Did It Take for NPX to Receive the Certification?

We formally began the certification process in January (2020), but we have been implementing the system since the very beginning of NPX. We wanted to take our time and make sure the systems were appropriate for our company and our customers.

Aside from logistical issues due to the Covid-19 pandemic, the certification process went very well with no non-conformances identified during the certification audit.

What Does This Certification Make Possible for NPX?

It’s additional reassurance to us too that our system is working, and it demonstrates to others that we’re doing things the right way.

Having ISO 13485:2016 certification benefits our current and future customers. They can have confidence in knowing we are committed to providing high-quality medical devices and services through an effective quality management system.

Plus, having this certification opens the door up for us to serve even more companies with medical device manufacturing, as ISO 13485 certification is a supplier requirement for them.

The future is bright at NPX!