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.

Some history

ISO 9001:2008 clause 4.1 was so vague that a guidance document was needed. It was the subject of so many interpretations that Technical Committee (TC) 176 of the International Organization for Standardization (ISO) published guidance document ISO TC/176 SC 2/N 630R2—“Guidance on outsourced processes.”

The most impactful guidance from that publication was the definition that an outsourced process is one that the organization may conduct internally but has chosen to subcontract the work to an outside organization. It also states that the company must exhibit the same level of control over outsourced processes as it would over processes within its own QMS.

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


Accounts Hacked

Date of Hack


3 billion

Aug. 2013


500 million


Ryan E. Day’s picture

By: Ryan E. Day

I love standards, and whether you know it, you love standards, too. For example, let’s say a bulb in your lamp goes bad. You drive down to the local hardware store, buy a bulb, come back home, change out the bulb, plug the lamp back in, and... it lights up. You just benefited from at least seven U.S. and international standards. How does that work, and what does American National Standards Institute (ANSI) have to do with it?

William A. Levinson’s picture

By: William A. Levinson

The Pareto principle calls for focus on the vital few rather than the trivial many. While none of ISO 9001’s clauses are trivial—a nonconformance for any of them requires corrective action—ISO 9001 users can avoid most nonconformances by focusing on the clauses that are the most frequent trouble sources, and also on what look like frequent common root causes for most of the nonconformances.

Penny Ouellette at Orion Registrar provided a valuable service by identifying the clauses in question.1 The following information is based on nonconformance reports (NCRs) collected by the ANSI National Accreditation Board (ANAB), as accumulated roughly halfway into the transition from ISO 9001:2008 to ISO 9001:2015. The NCRs were written against the following sections of the standard.

4.4.1 Quality management system and its processes

7.2 Competence

8.4.1 Control of externally provided processes, products, and services

9.1.2 Customer satisfaction

9.2.1 Internal audit

9.3.2 Management review inputs

Dirk Dusharme @ Quality Digest’s picture

By: Dirk Dusharme @ Quality Digest

As the United States struggles with rising healthcare costs, reducing the amount of money pharmaceutical companies spend dealing with regulation, while at the same time meeting drug safety requirements, would seem to be competing interests.

The goal of any honest pharmaceutical company is to make money producing a safe product that consumers need and getting it to market as quickly as possible. But the U.S. Food and Drug Administration’s (FDA) job is to make sure drugs are safe, and that means oversight (some would say excessive oversight), and oversight means costs and delays for manufacturers.

The FDA isn’t blind to this issue. In an October 2005 FDA/ISPE workshop, Dr. Janet Woodcock, director for the FDA Center for Drug Evaluation and Research (CDER) stated that a common goal of industry, consumers, and regulators was to have a “a maximally efficient, agile, flexible pharmaceutical manufacturing sector that reliably produces high-quality drugs without extensive regulatory oversight.”1

Laurel Thoennes @ Quality Digest’s picture

By: Laurel Thoennes @ Quality Digest

Compliance to U.S. Food and Drug Administration (FDA) regulations has come a long way in the past 30 years. Here are the main changes. Have they affected your business?

1988: Food and Drug Administration Act
Officially establishes the FDA as an agency of the Department of Health and Human Services and broadly spells out the responsibilities for research, enforcement, education, and information

1988: The Prescription Drug Marketing Act
Requires drug wholesalers to be licensed by the states; restricts reimportation from other countries; and bans sale, trade, or purchase of drug samples, and traffic or counterfeiting of redeemable drug coupons

Graham Freeman’s picture

By: Graham Freeman

Many industries have no clear boundary between safety and quality culture. In fact, they are often closely integrated. Quality failures and nonconformances that require rework have been correlated with increased accidents and recordable injury rates in manufacturing organizations. These injuries are frequently the result of fatigue, workplace pressure, and the pressure from extra work due to quality failures.

Among the important elements of people, processes, and tools, people are the primary point of failure in increasingly automated systems. Unlike machines, we are subject to fatigue, information overload, and stress that can have a serious impact on our ability to work safely and efficiently. However, people are also where dynamic sense-making, decision-making, and situational awareness reside, which are vital ingredients in complex and high-reliability organizations (HRO).

The aviation industry represents the best example of an HRO, in which automated systems such as navigation and air traffic control are integrated with highly developed human competencies. As a result, the industry sees an extremely small number of safety violations relative to the millions of hours of commercial aviation operation annually.

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Wendy White’s picture

By: Wendy White

Starting a new facility in the food-processing industry is an enormous undertaking. There are thousands of things that must be accomplished, from hiring and training new staff to ordering and installing equipment. This scenario is a perfect example of “too much to do and not enough time to do it.”

To further complicate the situation, most customers require one or more audits of the site’s food safety quality (FSQ) system before the first sellable product can be produced on the line. These qualifying assessments range from a casual, on-site visit by the customer to a global food safety initiative (GFSI) audit.

Meeting the ever-increasing standards of something as daunting as a full-blown GFSI audit can be an intimidating prospect, and success can be achieved only through strategic planning. There is so much to be done to get the plant running before looming deadlines, which often leaves little time to prepare for initial audits. This is a race against the clock, but success is possible through alignment, engagement, planning, and prioritization.

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Dirk Dusharme @ Quality Digest’s picture

By: Dirk Dusharme @ Quality Digest

We tied up last year in a neat little bow, talking about how stories define ourselves and our work; waste is waste, no matter your political leanings; and putting numbers from the news in context.

“The Gift of Being Small”

This article by Quality Digest’s Taran March wonderfully illustrates how we, and everything we do, is influenced by our “story”—our history up to the current moment.

“ISO 14001, ISO 50001 Benefit the Environment and the Bottom Line”

No matter your views on global warming, you can't escape the fact that waste is waste. If it goes up the stack, into the water, or piles up in a corner, it’s causing harm... at least to the bottom line.

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