Standards Features

Scott Gottlieb's picture
Scott Gottlieb
It is incumbent upon the U.S. Food and Drug Administration (FDA) to ensure that we have the right policies in place to promote and encourage safe and effective innovation that can benefit consumers...
Pam Bethune's picture
Pam Bethune
Every company is in business to take risks. Every action or failure to take action by that company naturally has some form of risk inherent in the process. To survive, a company needs to...
Claire McCluskie's picture
Claire McCluskie
With ISO 13485:2016—“Medical devices—Quality management systems—Requirements for regulatory purposes” published and being implemented, many medical device customers are experiencing some...
Dirk Dusharme @ Quality Digest's picture
Dirk Dusharme @ Quality Digest
In our July 7, 2017, episode of QDL we look at apprenticeships, the Antikythera mechanism, and risk-based thinking in operations. “Demand-Driven Education to Close Skills Gap” Speaking at the...
Amie Whittington's picture
Amie Whittington
Is your governmental hospital exempt under Section 501(c)3? If you have a 403(b) plan, the answer is yes, but even if you don’t, you need to check. The Internal Revenue Service (IRS) is ramping...
Tim Lozier's picture
Tim Lozier
The dynamic of risk management and compliance seems to be experiencing a shift toward risk management in operations, and learning to pay attention to detail in order to leverage it. The biggest...
Intertek's picture
Intertek
Sponsored Content As widely useful and broadly applicable as it may be, the ISO 9001 standard covering general requirements for quality management systems (QMS) cannot address all stakeholder needs...
Intertek's picture
Intertek
Sponsored Content Organizations that build, supply, design, or maintain products, parts, or services for the aerospace industry generally must be certified to the AS9100 family of standards (...
Intertek's picture
Intertek
Sponsored Content For organizations within the aerospace sector, certification to the AS9100 family of standards—including AS9110 for aerospace maintenance, repair, and overhaul (MRO) organizations...
Michael Ray Fincher's picture
Michael Ray Fincher
To meet the 2018 deadline for becoming certified to ISO 9001:2015, organizations are scrambling to overhaul their quality management systems. One major revision to ISO 9001 is the requirement to...
William A. Levinson's picture
William A. Levinson
‘We’ve always done it that way” explains why many suboptimal and even obsolete methods are taken for granted. The range chart for statistical process control (SPC) is, for example, somewhat...
Chad Kymal's picture
Chad Kymal
In the 1990s, Omnex worked with Ford Motor Co. to develop the Ford quality operating system methodology, which with maturity and broad experience has evolved into Omnex’s business operating system (...
Mike Richman's picture
Mike Richman
The June 16, 2017, episode of QDL included my hot take on Hexagon’s ginormous user conference as well as interviews with two of our favorite guests, Chad Kymal of Omnex and Kelly Graves of Internal...
John Flaig's picture
John Flaig
In a similar vein to Donald Wheeler’s excellent article on process capability confusion I would like to submit the following example of thinking that you are doing the math right and getting an...
AssurX's picture
AssurX
The FDA’s Center for Devices and Radiological Health (CDRH) provided a glowing self-assessment in a recent report. The CDRH met its 2016 strategic objectives for several initiatives pertaining to...
Ellen Kominars's picture
Ellen Kominars
While Hank Matousek Sr. was perfectly content in his position as quality control manager at a bearing company during the late 1960s and early 1970s, he had no idea that his employer’s growing...
DNV GL's picture
DNV GL
The internet of things (IoT), robotics, augmented reality, 3D printing... look at megatrends, and despite their unique attributes and myriad differences, you’ll find that they all have one thing in...
Mark Bartholomew's picture
Mark Bartholomew
Ethics lawyers and historians have argued that Donald Trump has blurred the line between his public office and private business interests in an unprecedented fashion. In another sense, it’s part of...
Inderjit Arora's picture
Inderjit Arora
Certifications often drive the implementation of a system approach, based on ISO standards. The primary implementation demand is for ISO 9001. Certifications do have initial costs and then...
Shobhendu Prabhakar's picture
Shobhendu Prabhakar
Whenever the term “nonconformance report” (NCR) comes into project home offices or construction and fabrication sites, it is often seen as a negative, and personnel are typically reluctant to...