Risk can mean many different things depending on the situation. Flying on an airplane, biking on a busy road, driving in a car—all of these involve some level of risk.

Although risk is a variable we encounter in everyday life, it means something uniquely different to the medical device industry. Risk is a critical factor to consider throughout the life cycle of a medical device because it can mean the difference between life and death for patients.

Industry resources like ISO 14971 exist to help medical device professionals define and clarify risk management best practices. According to the internationally recognized standard for medical device risk management, risk is defined as “the combination of the probability of occurrence of harm and the severity of harm.”

There are varying levels of risk factors medical device companies must consider in practicing effective risk management. By following the established processes outlined in ISO 14971 and leveraging the best quality management tools, medical device companies can improve their overall risk management system.

Arguing against globalization is like arguing against the laws of gravity, said former United Nations Secretary General Kofi Annan. Globalization, the international trade in goods and services with minimal barriers between countries, may seem inevitable as the world’s economies become more interdependent.

Properly regulated, globalization can be a powerful force for social good. For wealthy nations, globalization can mean less expensive goods, additional spending, and a higher standard of living. For those who live and work in poorer nations, globalization can lead to greater prosperity with the power to reduce child labor, increase literacy, and enhance the economic and social standing of women.

Effective organizations rely on teamwork, not least because it facilitates problem solving. Many leaders, however, are ambivalent about teams. They fear overt and covert conflict, uneven participation, tunnel vision, lack of accountability, and indifference to the interests of the organization as a whole. Also, more than a few have no idea how to put together well-functioning teams. Their fear of delegating—losing control—reinforces the stereotype of the heroic leader who handles it all.

Although teams can generate a remarkable synergy, a number of them do become mired in endless sessions that generate very high coordination costs and little productivity gain. In some corporations and governments, the formation of teams, task forces, or committees can even be a defensive act that gives the illusion of real work while disguising unproductive attempts to preserve the status quo.

About one in two U.S. adults has a musculoskeletal disorder, costing an estimated $213 billion each year in treatment and lost wages, according to a report from the United States Bone and Joint Initiative. Musculoskeletal disorders (MSD) are injuries and conditions to the bones, muscles, and joints that result in pain and can affect activity (e.g., carpal tunnel syndrome, tendonitis). About 140 million Americans live with an MSD. The total of direct and indirect costs for people who have both musculoskeletal disorders and other conditions such as diabetes, heart disease, or obesity is $874 billion, according to the report.

Millions of Americans are unemployed and looking for work. Hiring continues, but there’s far more demand for jobs than supply.

As scholars of human resources and management, we believe artificial intelligence (AI) could be a boon for job seekers who need an edge in a tight labor market like today’s.

What’s more, our research suggests it can make the whole process of finding and changing jobs much less painful, more effective, and potentially more lucrative.

Make me a match

During the last three years, we’ve intensely studied the role of AI in recruiting. This research shows that job candidates are positively inclined to use AI in the recruiting process and find it more convenient than traditional analog approaches.

Each article in this series presents new tools for increasing return on investment (ROI), enhancing customer satisfaction, creating process excellence, and driving risk from an ISO 9001:2015-based quality management system (QMS). They will help implementers evolve quality management to overall business management. In this article we look at the clauses and subclauses of Section 10 of the standard.

10 Improvement

Define “improvement.” In quality parlance it typically means reducing defects and making processes more efficient and mistake-proof. For the CFO it might be improving the return on investment numbers on the financials. For the marketing director it might be expanding market share. For the CEO it might be exceeding the expectations of the board of directors.

The theme of this series includes “presents new tools for increasing return on investment (ROI), enhancing customer satisfaction, creating process excellence, and driving risk from an ISO 9001:2015-based quality management system (QMS).” To conclude the theme, we will look at Clause 10 from a more holistic perspective.

10.1 General

10.1 and excellence