Good leadership is necessary for any successful company, no matter what circumstances surround your business. But in times of crisis it becomes even more important. How your company weathers this crisis may have lasting effects for years to come. 

With great uncertainty comes great reward. If you’ve planned for the unknown, when something unexpected happens you’ll be that much more prepared. 

If ever there was a time for risk-based thinking, it would be now. During this strange season, the entire world seems to be shutting down as the pandemic disrupts lives and businesses.

Anyone involved in medical device manufacturing knows that their industry is highly regulated. Almost every medical device manufacturer or pharmaceutical supplier uses materials testing systems in their quality control and research laboratories or outsources their testing to approved third-party laboratories. 

NASA. Volkswagen. BP. It’s not hard to find examples of quality gone awry. The consequences of the Challenger disaster, VW’s Dieselgate, and the Deepwater Horizon were tragic and far-reaching. While these are some of the most well-known incidents, stories of quality failures are numerous and almost constant.

The requirements of ISO 9001:2015 are viewed and implemented very differently by organizations, depending upon such variables as their size, resources, business sector, maturity, and external requirements.

The scope of the ISO/IEC 17025:2005 accreditation includes several SAE AS6171 test methods for suspect/counterfeit electrical, electronic and electromechanical (EEE) parts. 

Executives are facing challenges to identify the most important risks in their operations and lack adequate systems in their companies to address risk.

Rivo Software is a global provider of cloud-based environmental, health, safety and risk management software.

New changes to ISO 13485, published this spring as EN ISO 13485:2016, mean U.S. medical device companies that sell in Europe will need to integrate risk-based approaches throughout their quality management systems. The emphasis on risk management is the biggest of several changes in the third version  of ISO 13485.