The words “risk” or “risks” have been sprinkled throughout the 2015 revision of ISO 9001, the quality management system standard from the International Organization for Standardization (ISO).

Editor’s note: This is the second in a five-part series exploring issues that affect management’s ability to detect the warning signals of current good manufacturing practice (cGMP) compliance problems in the pharmaceutical industry.

American manufacturing is at a noteworthy and exciting convergence of three powerful trends that can provide an opportunity for growth in industry.