Standards Features

Ryan E. Day's picture
Ryan E. Day
BioBridge Global (BBG) is a parent organization for four subsidiary organizations, three of which are involved in production activities, and they’re all around regenerative medicine, including blood...
Taran March @ Quality Digest's picture
Taran March @ Quality Digest
These days, even regulatory agencies must innovate if they expect to keep pace with the speed of doing business. The U.S. Food and Drug Administration is no exception, and this year especially it has...
Dirk Dusharme @ Quality Digest's picture
Dirk Dusharme @ Quality Digest
The Dec. 31, 2018 deadline looms for medical device companies that sell their devices in Canada. On that day, any company that sells medical devices to Canada will either need to hold an MDSAP...
Mike Richman's picture
Mike Richman
The future is the ultimate abstraction; anyone who has ever attempted to discern the nature of tomorrow by looking at the yesterdays leading up to today knows that prediction is a fool’s errand. That...
Ryan E. Day's picture
Ryan E. Day
One of the unique aspects of Finch Therapeutics is that although its product does not fall easily into any regulated category and thus is not FDA-approved, the company has been working closely with...
Matthew M. Lowe's picture
Matthew M. Lowe
Life science companies play a major role in the global economy, with revenues expected to reach a staggering $1.5 trillion by 2020.1 Such a rosy forecast is likely to attract innovators and encourage...
William A. Levinson's picture
William A. Levinson
Chad Kymal1 gave an excellent overview of the ISO 45001 occupational health and safety (OHS) standard that was released in March 2018. I purchased a copy of the standard, and it provides an excellent...
Anthony Chirico's picture
Anthony Chirico
In my first article, the merits and cautions of AS9138 c=0 sampling plans were discussed and a simple formula was provided to determine the required sample size to detect nonconforming units. In the...
Andreas Engelhardt's picture
Andreas Engelhardt
An international standard that specifies requirements for an occupational health and safety (OH&S) management system, ISO 45001:2018—“Occupational health and safety management systems–...
Anthony Chirico's picture
Anthony Chirico
In my previous article, I discussed the merits and cautions of the “acceptance number” equal zero (c=0) sampling plans contained within AS9138. A simple formula was provided to determine appropriate...
Chad Kymal's picture
Chad Kymal
Omnex began working in the automotive industry by assisting Ford powertrain suppliers in 1986. The U.S. automotive industry’s Big Three used GM’s Targets for Excellence, Ford’s Q 101, and Chrysler’s...
Anthony Chirico's picture
Anthony Chirico
Aerospace standard AS9138—“Quality management systems statistical product acceptance requirements” was issued this year (2018), a few years after its accompanying guidance materials in section 3.7 of...
Mike Richman's picture
Mike Richman
IMTS was a blast, but it was great to be back home in lovely Northern California this week. On this episode of QDL, we covered the skills that workers need and the innovations that organizations want...
Grant Ramaley's picture
Grant Ramaley
The Dental Trade Alliance learned from its members in February 2018 that the Canadian Health Ministry (“Health Canada”) had contacted the Standards Council of Canada (SCC) and the British Standards...
Richard Pazdur's picture
Richard Pazdur
During the past decade, advances in understanding of cancer biology have led to the development of targeted treatments that are more effective than the chemotherapies of the past century. These...
Nicole Radziwill's picture
Nicole Radziwill
ISO 31000 defines risk as “the effect of uncertainty on outcomes.” Identifying risks and determining ways to respond to them help you learn about your processes, your organization, and the...
Oscar Combs's picture
Oscar Combs
ISO 9001:2015, clause 6.1 requires an organization to identify its risks and take actions to address identified risks. It is very tempting to start with a huge list of potential risks for the...
Jama Software's picture
Jama Software
Requirements are the information that best communicates to an engineer what to build, and to a quality-assurance manager what to test. A requirement has three functions: • Defines what you are...
Henry Zumbrun's picture
Henry Zumbrun
Load cells are a combination of metal, strain gauges, glue, and more. Over time, fatigue ensures that there will be some instability in the system. Load cell stability or drift is usually assumed to...
Mike Richman's picture
Mike Richman
‘Culture” is one of those business-speak words that’s used a lot, but for a good reason—having the right one is the key to unlocking your company’s quality potential. On the other hand, nothing will...