Taran March @ Quality Digest’s picture

By: Taran March @ Quality Digest

In regulated industries, every step of the production process must be verified to some sort of guidance or standard. What this comes down to, practically speaking, is an enormous amount of time and effort spent on actions outside the sphere of production. Every day of production seems to create a day of compliance verification. The most effective way for companies to cope is by standardizing their processes for meeting standards.

There are a lot of processes that need to be standardized. Beyond the common standard operating procedures (SOP), there are protocols to ensure proper setup, operation, and performance of equipment and software. There’s required and verified training for personnel. And there’s setting up restrictions so that only authorized individuals can access a system. All of these processes must be documented, and those documents verified.

Rajesh Talpade’s picture

By: Rajesh Talpade

In April 2018, the U.S. Food and Drug Administration (FDA) permitted the marketing of the first medical device to use artificial intelligence (AI). The device, called IDx-DR, is a software program that uses an AI algorithm to analyze images of the eye taken with a retinal camera called the Topcon NW400. A medical professional uploads the digital images of the patient’s retinas to a cloud server where the IDx-DR software is installed. The software then provides the doctor with one of two results: Refer the patient to an eye care specialist, or rescreen in 12 months. Overall, the technology accelerates diagnosis and treatment of diabetes-related damage to the retina. This is one example of how medical devices using AI are traversing regulatory pathways into mainstream healthcare.1

The concept of AI has been around and progressing in linear fashion for decades. In one scenario, the technology was referred to as artificial neurons capable of performing logical functions. During the early 1950s, computer scientists developed AI programs that could best their human counterparts at games of chess and checkers. While this might be a highlight at parties, the innovation of this technology went far beyond board games.2

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By: Ann Brady

Better buying power, greater efficiencies, and more innovative ideas are not just for big businesses. The publication of ISO 44003 is helping smaller players flex their collective muscle by making the most of strategic partnerships.

How many of us cooped up at home during the lockdowns and travel restrictions of the past year haven’t dreamed of seeking out a simpler life, with easy access to nature, in a warm climate, sleeping underneath the stars? Some residents of a village in Jordan near the ancient city of Petra have done just that, leaving their bricks-and-mortar homes to live illegally in the caves of this UNESCO World Heritage Site hidden among the pink sandstone cliffs of south Jordan.

Their move, however, was driven more by economic necessity than realizing a fantasy. These are Bedouins who used to make their living from the thousands of tourists who flocked to the “Rose City” daily—the café owners, the donkey and camel owners, the jewelry sellers. A report in The Times newspaper highlights their plight, saying the unfolding pandemic has been an “unmitigated disaster” for the small businesses of the region as tourism quickly dried up.

Clare Naden’s picture

By: Clare Naden

Remember the days when large paper maps filled the car, and holidays were booked by a travel agent? Neither do most people. Technology had already revolutionized the world of travel before Covid-19, and the trend has been catapulted as many more things move to digital. From virtual-reality tours to drone photography, new technology is continuing to reshape the way we experience travel and tourism.

Today’s businesses in the travel, tourism, and hospitality industry are using technology to enhance the customer experience and ensure traveler safety. ISO standards underpin much of the technology-driven shifts. As these innovations have come on the scene, the customer experience at every stage of their journey has also evolved, including safety first. Here are our top five innovations that that will change the way you travel.

Healthy travels

As countries start reopening their borders to tourists, they are looking at ways to harmonize tools to manage the Covid-19 pandemic in a more integrated manner. One of these involves apps that are recognized and trusted across and within regions.

Rick Gould’s picture

By: Rick Gould

Ever since people could tie logs together to form rafts and use them to transport goods by water, seaborne trade has flourished and grown. Historians believe that the first international trade routes were developed 5,000 years ago between the Arabian Peninsula and Pakistan, while by the 18th century, trade routes spanned the globe. Transporting goods and people by sea is an efficient and cost-effective process, and today, shipping is big business with more than 90 percent of the world’s trade, in volume, carried by sea, according to the International Maritime Organization (IMO).

Although trade is beneficial, trading through ports is complex. When ships enter and leave ports, vital information about cargoes, crews, vessel details, and many other data must be exchanged with the authorities ashore. Access to accurate and complete data records is essential to making the right decisions at the right time. Ship operators are required to provide numerous types of records, certifications, and data relating to their cargoes, passengers, safety, environmental protection, and customs declarations.

Ann Brady’s default image

By: Ann Brady

Innovation is the fuel that drives a successful business. Organizations that give their managers and employees the tools to respond to and make the most of opportunities, both internal and external, are well placed to grow profits, improve the health and well-being of their employees, and thereby, the wider society.

With effective innovation management systems in place, organizations both large and small not only can be in a better position to achieve their business growth goals, but also more agile and better prepared in their response to unexpected challenges and disruptions. But how does this hold up against a global health crisis?

Multiple Authors
By: Boris Babic, Sara Gerke, Theodoros Evgeniou, I. Glenn Cohen

For many of us, our electronic device can be a communications lifeline, entertainment system, and professional networking hub. If trends continue, it may become our health advisor as well.

Direct-to-consumer (DTC) medical apps are a growing segment of the $10 billion market for healthcare solutions, incorporating machine learning (ML) and artificial intelligence (AI). Most are designed to flag symptoms that may require attention from a healthcare professional. For instance, the Apple Watch’s heartbeat sensor periodically checks for irregular rhythms associated with atrial fibrillation (AFib), a disorder that can cause strokes and hospitalization.

Despite their increasing accessibility to consumers, these apps have yet to generate much interest from regulators. At first glance, this may seem sensible. The apps do not claim to dispense advice or treatment, but rather notifications of possible early warning signs.

It is short-sighted, however, to let DTC medical apps slip under the regulatory radar. As we describe in a recent article for Nature, they could turn out to have costs that insurers or taxpayers might ultimately be responsible for.

ISO’s picture


There’s more than one path to service management. It refers to all the activities, policies, and processes that organizations use for deploying, managing, and improving IT service provision. In today’s technology-driven corporate landscape, the two leading methodologies come from the world of software development and information technology (IT).

Implementing a service management system in a structured way brings many benefits to an organization, such as greater efficiencies and improved customer relations. Organizations generally use a predefined framework of best practices and standard processes to provide a disciplined approach to service implementation. More recently, however, a new approach has taken the world by storm, putting a fresh spin on how to better develop and deliver software.

Enter Agile, a methodology that has given greater flexibility to the corporate world. Why is it so popular? Because it brings agility and creativity to the way we develop projects. It also dovetails neatly with more structured frameworks such as ISO/IEC 20000-11 for IT service management (ITSM) systems.

Steven Severt’s picture

By: Steven Severt

When it comes to ongoing certification of your quality management system (QMS), whether it’s certified to ISO 9001, ISO 13485, IATF 16949, or AS9100, how many times have you found yourself “preparing for an external audit?”

Picture the scene: You’ve got the dates set on the calendar months in advance for when the certifying body (CB) auditor will be onsite. For several weeks, you’ve been communicating in company memos and meetings about the upcoming visit. You’ve started to lay out Gannt charts and action-item lists for things that you need various departments and individuals to check up on and clean up as you inch closer to the arrival day. You’ve developed a carefully curated path to lead the auditor so that they see only the things that you want them to see. You’ve trained personnel in that area on the proper responses to auditor questions. You must make sure that everything appears to be in order when the auditor arrives.

Notice the statement, “Everything appears to be in order.”

ISO 9001:2015 Clause 5.1.1 c) states simply that it’s top management’s responsibility to “...demonstrate leadership and commitment with respect to the quality management system by... ensuring the integration of the quality management system requirements into the organization’s business processes.”

Dawn Bailey’s picture

By: Dawn Bailey

In 2020, MESA, a small business in Oklahoma, became to date the first and only three-time Baldrige Award recipient.

From a one-person consulting firm founded in 1979, MESA has grown to support a workforce of more than 250 people. The largest privately owned company in its market, it is a manufacturing and field services firm headquartered in Tulsa, with 10 U.S. locations. According to Terry May, MESA president and founder, MESA’s national footprint positions it as the third largest company in the underground petroleum pipeline industry. MESA’s specialty is cathodic protection, an electrochemical process that prevents corrosion on underground or submerged pipelines and storage tanks. 

A culture that values people

Speaking at the first virtual Baldrige Quest for Excellence conference, May said, “We’ve accomplished some extraordinary things and created an incredible team of people that we call ONE MESA.... If you ask us what makes us unique, I have an easy answer. It’s our people.”

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