An analysis of U.S.

In the healthcare sector, precision isn’t just a requirement. It’s a necessity where the margins for error are perilously thin, and the consequences of inaccuracy can be grave.

The Center for Organ Recovery & Education (CORE),

Trust makes the world go ’round. Without it, democracies crumble and relationships suffer. The same goes for organizations and businesses: Without the trust of their customer base, they simply can’t succeed.

In less than two months we will celebrate the 100th anniversary of the invention of the control chart, a tool most often associated with statistical process control (SPC). Considering SPC from our modern perspective made us ask, “Is SPC still relevant?”

The buzz has begun. ISO 9001 is being revised. There hasn’t been a revision in about 10 years, so it’s due—if not overdue. Still, there are individuals who don’t understand the justification or the purpose of the revision. After all, it’s a perfectly good standard.

In his Quality Digest article published in February 2023, Michael Mills¹ reported that the next version of ISO 9001 will add to clause 4.1, “Understanding the organization and its context” the words, “the organization shall determine whether clima

ISO 9001 has begun its revision process. In the next few months, all eyes will be riveted on that arena as everyone seeks to anticipate the changes and what they’ll augur for their own quality management systems. The attention is not undeserved.

The FMEA (failure modes and effects analysis) turned 75 years old in 2024. However, a look at the literature may paint a different picture. Both the origin year of FMEAs and the name of the organization that developed FMEAs seem to vary among authors.

At Qualio, our mission is to help life science companies embed robust digitized quality to get their critical products to market at rapid speed and keep them there.