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By: Rick Gould

Well over half the world’s population does not have access to safe sanitation. For many people, this means the indignity and risks that come of having no toilets. The answer, it seems, lies in new sustainable treatment plants. The International Organization for Standardization (ISO) and the Gates Foundation have joined forces to show how clean toilets and standards can change people’s lives forever.

Jon Speer’s picture

By: Jon Speer

The European Medical Device Regulation (MDR) is a new set of regulations that governs the production and distribution of medical devices in Europe, and compliance with the regulation is mandatory for medical device companies that want to sell their products in the European marketplace.

If your company was already compliant with the Medical Devices Directive (MDD), don't be fooled into complacency: The MDR represents brand-new regulations with significant changes.

For those seeking to better understand why the regulations have changed, and what some of the major changes are, let’s take a look at some of the most common questions we hear from our users.

James J. Kline’s picture

By: James J. Kline

The term “risk-based thinking” (RBT) is familiar to those in the quality profession. This familiarity comes in part from its inclusion in ISO 9001:2015, the International Organization for Standardization (ISO) quality management system standard. Although numerous articles and several books have been written on how to implement ISO 9001:2015 in the private sector, little has been done with regards to the public sector.

This reflects two facts. First, the idea of systematically managing the risks governments face is relatively new. Second, where risks are being managed by government organizations, there is no consistent approach. Some are using ISO 9001:2015 and others are using ISO 31000. ISO 31000, revised in 2018, is an enterprise risk management standard.

This article looks at what public-sector organizations are thinking about, and doing, to manage risks.

Ryan E. Day’s picture

By: Ryan E. Day

In the article, “ANSI’s Role in the Wide World of Standards,” (Quality Digest, March 12, 2019), we looked at where standards originate and how companies are involved in developing them. In this article, we’ll outline four points that can help your organization integrate standards into your operations.

Once you’ve decided which standards are applicable to your needs, the question becomes whether your team will benefit from centralized access to standards, and how you will manage updates and collaborate. There are basically two ways to license standards: single-use purchase, and subscription. Each has its own pros and cons.

Ronda Culbertson’s picture

By: Ronda Culbertson

The AS9100 family of standards has completed very important updates, raising the business management quality bar again for aerospace and defense suppliers and OEMs. The transition to the new standards caught quite a few organizations somewhat flat-footed; particularly with the emphases on risk management and top-management participation (leadership). Getting it right is important; certification to one of the standards is rapidly becoming a requirement of the aerospace and defense industry.

The updated standards have proven challenging for small to midsized supplier organizations that need certification to advance their positions in the global supply chain. Even for larger companies and the major OEMs, the new revision of the standards is demanding.

Much like recent updates to core ISO standards (ISO 9001, ISO 14001, and ISO 45000), the revisions to AS9100, AS9110, and AS9120 demand a broader view of quality and organizational impacts. Some of the changes are very specific and technical; others are conceptual.

Multiple Authors
By: Alexandra Killewald, Xiaolin Zhuo

Almost 70 percent of American mothers with children younger than 18 work for pay, but motherhood remains disruptive for many women’s work lives.

Brian S. Smith’s picture

By: Brian S. Smith

Throughout my career, I have been a member of several trade organizations. I believe that standards have meaning, in every field. When I become a member of an organization, I endeavor to learn as much as possible.

For example, I belong to ASQ (American Society for Quality). I enjoy having resources and peers that can educate me and keep me at the top of my field by helping my clients reach their goals.

Ryan E. Day’s picture

By: Ryan E. Day

According to the International Labor Organization, around the world every day 7,600 people die from work-related accidents or diseases—that’s more than 2.78 million people every year. To address the issue, the International Organization for Standardization (ISO) has developed a standard, ISO 45001 “Occupational health and safety management systems—Requirements,” that provides organizations with a framework to improve employee safety, reduce workplace risks, and create better and safer working conditions all over the world.

Published in March 2018, ISO 45001 replaces OHSAS 18001. Companies must migrate to the new standard by March 2021. ISO 45001 is an international standard, ensuring enhanced compatibility with other standards, such as ISO 9001 and 14001. This makes it easier to implement and integrate to a management system, giving increased value for users.

Tom Taormina’s picture

By: Tom Taormina

Outsourcing is historically one of the most misunderstood concepts in quality management system (QMS) implementation and operation. Prior to ISO 9001:2015, the requirement for outsourced processes was limited to a few sentences in the standard’s clause 4.1. This article will present, through a case study, how understanding the implications that outsourcing, according to ISO 9001, is of key importance for a company.

Chad Kymal’s picture

By: Chad Kymal

When we think about IT security, we typically think about the large hacks that were reported in the press. When viewed as a whole, we can understand the magnitude of lost data. It’s no surprise that these hacks are what come to mind when we think about information security.

The table below shows some of the largest hacks that occurred this century. The number of accounts affected range in the millions.

Greatest Security Breaches, 2003–2018, Ranked

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