Open Access

My Quality Story: When Opportunity Knocks

by Fu, Lin

My friends have asked me, “How did you end up as a quality manager?” To be honest, I don’t know—I never planned to be a quality professional in the medical technology industry. What I do know is this: Always be prepared when an opportunity comes along....

In Context

by Miller, William J.; Lowery, Christopher M.; Sumner, Andrew T.; Deane, Richard H.; Randles, Theodore J.

Does quality depend on context? While many of the principles and practices of quality management are universal, there are aspects of quality that are different for diverse organizations, and other variables must be taken into consideration....

Open Access

Try This Today: A Roll of the Dice

by Levinson, William A.

According to ISO 9001:2015, clause 7.5.1, an organization must maintain documented information required by the standard, and any additional documentation the organization deems necessary for the effectiveness of its quality management system (QMS)....

Elevate Your Strategy

by Schonberger, Richard J.

Design for manufacture and assembly (DFMA) has been selling itself short. Its effective method targets operational costs, which, from the vantage point of the executive suite, makes DFMA look like a tactical-level pursuit readily delegated to engineering....

Down With Silos

by Duncan, Linda; Luchs, Sherri

Penn State Health is an academic health system in south central Pennsylvania with more than 10,000 staff members across two hospitals (an adult hospital and a freestanding children’s hospital) and the College of Medicine....

Mobility Matters

by Cowan, Ryan; Norouzzadeh, Shaghayegh; Riebling, Nancy; Joseph, Antz; Doerfler, Martin, M.D.;

The word “mobilization” was first used in a military context by the Russian army during the 1850s. Mobilization, in that context, is the act of assembling and making troops and supplies ready for war....

Field Notes: Bridge the Gaps

by Duffy, Grace L.

While it may seem natural for healthcare professionals to work together to achieve the best patient outcomes, it isn’t always that simple in practice. The silo-nature of modern healthcare can make fluid collaboration a challenge....

Open Access

Career Coach: A Powerful Mechanism for Success

by Kovach, Jamison V.

Successful people never reach their goals alone. We all rely on mentors, whether formal or informal, to support our career development and advancement. For example, professionals often encounter situations where their career path is ill defined....

Standard Comparison

by Wright, Carolyn

I have often heard quality or regulatory colleagues in health industries say they’re familiar with drug regulations but not medical device regulations; or that they know the ISO requirements for medical devices but don’t know the drug risk standard....

Lean Delivery

by Vago, Tony; Bell, Ashley M.; Thompson, Heather;

A hospital improves its labor and birth unit with lean, quality culture....

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