Germany


This past year Thern passed the ISO 9001:2015 standard!

What is the ISO 9001:2015?

In order to be certified, an organization must follow the requirements set forth in the ISO 9001 standard.  The standard is used by organizations to demonstrate their ability to consistently provide products and services that meet customer and regulatory requirements that demonstrate continuous improvement.

In order to continually keep our certification, we were required to have yearly surveillance audits where several critical processes were audited. In addition, every five years an organization has to pass a recertification audit where every critical process is again audited to a more in-depth extent.

How has COVID-19 affected this process?

Due to the Covid-19 pandemic, there has been a significant change in how organizations are audited by their registrars. Instead of external auditors visiting facilities to conduct their compliance audits, virtual auditing is now required in most cases to limit the risk of a COVID-19 spread. Thern has embraced this new approach and the new tools that have been implemented to make a virtual audit successful.  Some of these tools are as follows:

  • Restructuring of Thern’s policies, procedures, forms, and work instructions to make them easily available in an electronic format.
  • Employee interviews conducted using Facetime.
  • A rolling cart with a mounted laptop was created to provide a virtual tour of the facility.
  • Enhanced social distancing precautions
  • New personal headphones with mics provided to everyone interviewed which were distributed in sanitized packaging.

How did Thern do?

The lead ISO auditor complimented Thern on the amount of preparation that was done to ensure an effective virtual audit.  Thern was praised for the creative and improved approach to the typical way virtual tours were conducted by creating a rolling cart with a mounted laptop. This avoided the typical “bouncing video feed” from a guide walking through a facility with a cell phone. However, the highest compliment received from the external auditor was that Thern employees demonstrated superior integrity, not found at all organizations. Instead of finding ways to simply pass an audit we view it as an opportunity to truly improve upon our processes and set our bar higher. Our auditor felt that all the employees she interacted with could be trusted as they spoke very candidly with her about how they perform their work.

Trust is a key element of a virtual audit and we proved that Thern is committed to doing the right thing.