Catherine Cooksey’s picture

By: Catherine Cooksey

New employees at the National Institute of Standards and Technology (NIST) are often surprised to learn that our agency is part of the U.S. Department of Commerce. How could this be? On the surface it seems that the missions of the two organizations couldn’t be more different. The Department of Commerce would appear to be concerned with, well, commerce, while NIST is well known for its Nobel Prize-winning scientific and technological work.

But the connection can be explained through our agency’s mission statement: “To promote U.S. innovation and industrial competitiveness by advancing measurement science, standards, and technology in ways that enhance economic security and improve our quality of life.”

Clare Naden’s picture

By: Clare Naden

Never have we been more acutely aware of the importance of reliability when it comes to laboratory testing. As the ongoing Covid-19 pandemic has highlighted, the development of accurate diagnostic tests plays an important role in outbreak management.

Whether a laboratory develops its own test methods or incorporates ones that already exist, there is a lot to be considered, and the task bequeathed to them is great. Apart from the general risks of contamination, inadequate equipment, or failings in processes that must be rigorously managed, the procedures and tools required for each test can potentially differ.

Since the beginning of the pandemic, ISO has been collaborating with experts in many fields to establish where standards can really make a difference. As a result, experts on ISO’s technical committee for laboratory testing and in vitro diagnostic (IVD) test systems are currently working on international best-practice guidelines to assist laboratories.

Shaneé Dawkins’s picture

By: Shaneé Dawkins

What do first responders do? It’s an easy question, and I used to think I knew the answer. Firefighters put out fires; police officers enforce the law; emergency medical system (EMS) workers treat injuries; 911 operators answer 911 calls and dispatch first responders to the scene. Simple, right?

I am a computer scientist at the National Institute of Standards and Technology (NIST) conducting research focused on human-centered computing and human-computer interaction. I have worked in the field for more than a decade, researching ways to help people with their real-world technology problems. My research, by nature, requires me to learn about different communities in order to assess their technological needs. For public safety, I thought I had a pretty decent grasp of the community. After all, what they do is woven into all our lives.

Grant Ramaley’s picture

By: Grant Ramaley

As the 2020 pandemic threatened world health, a large number of unscrupulous companies began generating fake International Organization for Standardization (ISO) quality management system (QMS) certificates in an attempt to fool governments into buying personal protective equipment (PPE), ventilators, thermometers, and Covid-19 test kits. The credibility of ISO 13485 certificates used to certify medical devices suddenly became a crisis.

Aside from the obvious fake certificates, other companies were paying to get certificates with little or no oversight as to how they were earned. If the goal of getting certified is to gain worldwide recognition, it’s important to understand what makes an ISO certificate valid, especially when paying thousands of dollars for an ISO QMS certificate that may not be considered valid by ISO. Companies may think they are getting a credible certificate but find themselves exposed later when trying to sell their products to those who require certificates issued from accredited certification bodies.

Natalie Weber’s picture

By: Natalie Weber

Unlike Covid-19, remote audits aren’t unprecedented. Remote audits didn’t start with the pandemic, although it has forced more companies to use them than previously. At MasterControl, we’ve been doing remote audits for years for our international customers. It saves time and expense, and it’s every bit as effective as an in-person audit.

However, this is only true because we operate in a digital environment. Using a paper system would significantly hinder remote audits.

This is largely still the case. The difference between pre-pandemic remote audits and those of the “new normal” is the sheer number that are being done, in many cases by those who have never done them before. Doing a remote audit is difficult to wrap your head around if your audit usually requires scouring binders for paperwork and completing a site walk. Mastering remote audits now will be worth it even after the pandemic is over.

Suneel Kumar’s picture

By: Suneel Kumar

Remote auditing (RA) has become a norm during the Covid-19 pandemic. Remote auditing is one of the audit methods prescribed in ISO 19011:2018—“Guidelines for Auditing Management Systems.” Although RA has surged due to pandemic constraints, this method of operation will surely gain ground as a routine audit technique.

During a remote audit, auditors engage with a company via technology to assess its QMS as per ISO 9001:2015. The audit covers the usual steps, including a documented information review, interviews, and presentation of the findings, by using various information and communications technology (ICT) platforms.

Remote audits can be divided into:
• Fully off-site remote audit
• Partial off-site remote audit
• Onsite remote audit

In the case of a fully off-site remote audit, the assessment audit is carried out completely away from the site. Partial off-site audits are conducted through a combination of remote and onsite checks to verify compliance. For onsite remote audits, the audit is carried out at the site but through synchronous ICT platforms.

Tom Taormina’s picture

By: Tom Taormina

Each article in this series presents new tools for increasing return on investment (ROI), enhancing customer satisfaction, creating process excellence, and driving risk from an ISO 9001:2015-based quality management system (QMS). They will help implementers evolve quality management to overall business management. In this article we look at the clauses and subclauses of Section 10 of the standard.

10 Improvement

Define “improvement.” In quality parlance it typically means reducing defects and making processes more efficient and mistake-proof. For the CFO it might be improving the return on investment numbers on the financials. For the marketing director it might be expanding market share. For the CEO it might be exceeding the expectations of the board of directors.

The theme of this series includes “presents new tools for increasing return on investment (ROI), enhancing customer satisfaction, creating process excellence, and driving risk from an ISO 9001:2015-based quality management system (QMS).” To conclude the theme, we will look at Clause 10 from a more holistic perspective.

10.1 General

10.1 and excellence

Del Williams’s picture

By: Del Williams

Approximately 48 million people in the United States (one in six) get sick, 128,000 are hospitalized, and 3,000 die each year from foodborne diseases, according to the Centers for Disease Control and Prevention. Consequently, the FDA Food Safety Modernization Act (FSMA) is transforming the nation’s food safety system by shifting the focus from responding to foodborne illness to preventing it.

As part of the focus on preventing foodborne illness, 3-A Sanitary Standards, an independent, not-for-profit corporation for advancing hygienic equipment design for the food, beverage, and pharmaceutical industries, has recently updated its standards. The company, which maintains a large inventory of design criteria for equipment and processing systems developed to promote acceptance by USDA, FDA, and state regulatory authorities, no longer accepts “3-A compliant” as a legitimate claim.

Carson MacPherson-Krutsky’s picture

By: Carson MacPherson-Krutsky

Since the days of painting on cave walls, people have been representing information through figures and images. Nowadays, data visualization experts know that presenting information visually helps people better understand complicated data. The problem is that data visualizations can also leave you with the wrong idea—whether the images are sloppily made or intentionally misleading.

Take, for example, the bar graph presented during an April 6, 2020, press briefing by members of the White House Coronavirus Task Force. It’s titled “COVID-19 testing in the U.S.” and illustrates almost 2 million coronavirus tests completed up to that point. President Trump used the graph to support his assertion that testing was “going up at a rapid rate.” Based on this graphic, many viewers likely took away the same conclusion—but it is incorrect.

Tom Taormina’s picture

By: Tom Taormina

Each article in this series presents new tools for increasing return on investment (ROI), enhancing customer satisfaction, creating process excellence, and driving risk from an ISO 9001:2015-based quality management system (QMS). They will help implementers evolve quality management to overall business management. In this article we look at the clauses and subclauses of Section 9 of the standard.

Clause 9—Performance evaluation

Clause 9 is the part of the standard that we can use to truly quantify business excellence and risk avoidance. I will propose paradigm shifts that will make the outputs of this clause more informative for senior management and will include actionable recommendations that can contribute to the success factors that are immediately palatable and implementable for the leadership.

9.1.1 Monitoring, measurement, analysis, and evaluation—General

9.1.1 and excellence
This subclause requires that the organization must establish what needs to be monitored, measured, analyzed, and evaluated.

Syndicate content