Standards Features

Miriam Boudreaux's picture
Miriam Boudreaux
The first thing you need to do when you are evaluating a potential supplier based on their ISO 9001 certificate is request that they provide you with a copy of the certificate itself. If the company...
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 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...
Sandrine Tranchard's picture
Sandrine Tranchard
Depression and mental health conditions are on the rise globally. Affecting more than 300 million people of all ages across the world, depression causes immense suffering to people and their...
Barbara A. Cleary's picture
Barbara A. Cleary
Complying to requirements and standards is sufficient to meet the objectives of injury and accident prevention, and ensure the health and safety of all employees—right? In his article, “We’re...
William A. Levinson's picture
William A. Levinson
Among other requirements ISO 9001:2015, clause 4.4.1 requires an organization to identify the inputs and outputs of the processes of the quality management system; identify the sequence and...
Mike Richman's picture
Mike Richman
In our latest episode of QDL from this past Fri., April 21, 2017, we examined the importance of the various steps in the plan-do-check-act (PDCA) cycle, considered what United Airlines could have...
Laurie Locascio's picture
Laurie Locascio
Like a lot of scientists, I am very goal-oriented, so after I got my Ph.D. in toxicology, I set out to become a leader in my field by the time I was 40. To get there, I knew I had to be...
Dirk Dusharme @ Quality Digest's picture
Dirk Dusharme @ Quality Digest
In last week’s Quality Digest Live: Enterprise quality management vs. integrated quality management. Our deteriorating U.S. infrastructure. Stress testing composites. The Fowler Precision Mobile Tech...
Michael Causey's picture
Michael Causey
The FDA has made it abundantly clear that it expects medical device manufacturers and other life sciences firms to have strong cybersecurity management programs. Since the FDA hasn’t always been...
Taran March @ Quality Digest's picture
Taran March @ Quality Digest
As manufacturing becomes increasingly oblivious of where one country stops and another begins, the responsibilities of quality managers have extended beyond the safely measurable and into the...
Chad Kymal's picture
Chad Kymal
What is enterprise quality? Simply put, it is a system where there is one quality manual, and a core of common processes, work instructions, and forms and checklists for a multisite environment....