ISO 9001 Revision Puts Risk and Quality Management Closely TogetherISO 9001 Revision Puts Risk and Quality Management Closely Together

The International Organization for Standardization is rolling out ISO 9001:2015, its first revision to the universally practiced quality management standard in seven years. The new revision to ISO 9001 places a pervasive influence on risk management in an organization's quality management system (QMS).

The value of risk management in product design has garnered heightened attention as products become more complex and companies accelerate development time frames. In industries like medical device manufacturing, defects can cause physical harm or even loss of life, exposing a company to devastating financial losses and regulatory penalties.

“Risk management and quality management are closely aligned,” wrote Ron Makar in a paper presented at the 2014 World Conference on Quality and Improvement, organized by the American Society for Quality (ASQ). “In fact,” Makar continued, “if you take a good look at all of the elements of a typical quality management system, you will find that most of them are subject to some degree of risk, that is, something can go wrong, if left uncontrolled.”

Makar, who now runs a quality consultancy for medical device and biotech companies, was global quality manager for industrial biosciences at DuPont, helping identify high-priority risks up front in development efforts.

ISO 9001 sets out the requirements for a company to fulfill ISO 9000. The organization reviews its standards every five years and produces revisions if needed.

Among the higher-level changes in ISO 9001:2015, there is heightened importance to risk-based thinking, although the revised standard does not require formal risk assessments. ISO defines “risk” as “the effect of uncertainty,” whether it is positive or negative. An organization should seek ways to assess its quality-related risk by understanding the likelihood and consequences of a given event.

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