Question: Implementing new systems in a company will always have certain risks. A company that decides to start a formal QMS program may have more risks

Implementing new systems in a company will always have certain risks. A company that decides to start
a formal QMS program may have more risks to success than an ISO 9001: 2015 certified company that
wants to integrate the digitization of quality with Quality 4.0.
Take a risk based thinking approach and determine 3 risk areas for a ISO 9001:2015 certified company to
implement Quality 4.0. Indicate the industry along with the product or service that the company is
involved in and other characteristics of the company that may be relevant for your approach to this
exercise. For each of the 3 risks, determine the severity and likelihood of its occurrence, choose at least
one with your reason why, then determine countermeasures to mitigate this (these) risk(s).

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