William A. Levinson’s picture

By: William A. Levinson

The martial arts rank, Shodan, for a first-degree black belt, does not mean “expert”; it means “first step.” ISO 9001:2015 is similarly a valuable and vital first step toward world-class performance, but it is only that—a first step. It covers only by implication many of the risks and opportunities that IATF 16949 covers explicitly, such as six of the Toyota Production System’s (TPS) Seven Wastes as well as crippling supply-chain interruptions, inadequate metrology systems, and more.

IATF 16949 is actually ISO 9001:2015 plus additional requirements, which makes it easy for ISO 9001 users to implement relevant clauses of IATF 16949. ISO 9001 users don’t need to implement all the additional clauses—if they did, they might as well register to IATF 16949—but many of IATF 16949’s key clauses are as relevant to nonautomotive applications as they are to automotive ones. This article will cover what look like the most important ones, although others also might be helpful.

Jennifer Lopez’s picture

By: Jennifer Lopez

Globalization of the medical device market as well as its supporting supply chains continues to increase year after year. This has forced regulatory bodies to grapple with finding a way to narrow the gap between international and domestic regulation. In spring 2018 the United States Food and Drug Administration (FDA) announced its intention to adopt the internationally recognized quality management standard ISO 13485:2016 for medical devices. According to the FDA, the revisions are intended to modernize and reduce compliance and record-keeping burdens on device manufacturers by harmonizing current domestic and international requirements.

For FDA-regulated manufacturers, the required actions to close the gap between the FDA’s existing Quality System Regulation (QSR) 21 CFR part 820 and ISO 13485:2016 should not increase manufacturers’ regulatory administration significantly. However, it is important that manufacturers are aware of and prepared for these changes, and they understand what the changes will mean for their businesses. They can do this by seeking industry insight on best practices.

ISO’s picture

By: ISO

Innovation isn’t just about having a few bright ideas. It’s about creating value and helping organizations continuously adapt and evolve. ISO is developing a new series of International Standards on innovation management, the third of which has just been published.

Innovation is an increasingly important contributor to the success of an organization, enhancing its ability to adapt in a changing world. Novel and innovative ideas give rise to better ways of working, as well as new solutions for generating revenue and improving sustainability. It is closely linked to an organization’s resilience, in that it helps stakeholders understand and respond to challenging contexts, and seize the opportunities that might bring and leverage the creativity of both its own people and those it deals with.

Ultimately, big ideas and new inventions are often the result of a long series of little thoughts and changes, all captured and directed in the most effective way. One of the most efficient ways of doing just that is through implementing an innovation management system.

Stephanie McArdle’s default image

By: Stephanie McArdle

The FDA has announced an end to the alternative summary reporting (ASR) program for medical device manufacturers and will make the data publicly accessible.

The ASR program originally launched in 2000 when device manufacturers sought an “alternative summary” reporting exemption. ASR permitted medical device manufacturers to send the FDA an accounting of device injuries and malfunctions on a periodic basis (e.g., quarterly or annually) in lieu of fulfilling their standard public reporting obligations. The ASR program actually ended in 2017, but evidence shows that device exemptions were still accepted by the FDA.

Grant Ramaley’s picture

By: Grant Ramaley

Although the “new approach” to regulating medical devices has always given more urgency to higher-risk medical devices, this is not the case for the European Medical Device Regulation (MDR). Class 1 medical devices must fully comply with the regulation by May 26, 2020, or be shut out of the region. 

This could be more problematic for dental products, which are inherently lower risk. Rubber dams and dental operating lights will have to comply before MRIs and pacemakers. 

To ensure that medical device manufacturers of class 1 devices understand that they must comply immediately on May 27, 2020, when the new regulation goes into effect, the European Commission states this plainly in its “Fact Sheet to Medical Device Manufacturers.”

Multiple Authors
By: Chad Kymal, Gregory F. Gruska

During the early 1980s, GM, Ford, and Chrysler established the Automotive Industry Action Group (AIAG), a not-for-profit organization with the mission “To improve its members’ competitiveness through a cooperative effort of North American vehicle manufacturers and their suppliers.” In the late 1980s, U.S. automotive suppliers, through the auspices of the American Society for Quality (ASQ), approached the VPs of purchasing for GM, Ford, and Chrysler and explained the burden of multiple standards that were being imposed on the supply base. Not only where there multiple OEM standards, there were hundreds of tier one standards as well.

Jyoti Madhusoodanan’s picture

By: Jyoti Madhusoodanan

A frog the size of a fingernail. A poncho-clad farmer leading his mule. A tree, some intertwining leaves, a silhouetted figure holding a pot. Such logos are stamped on labels of coffee, cocoa, mangoes, jeans, and myriad other products, certifying that the object for sale is in some way “sustainable”—made, in other words, in a way that meets humanity’s needs without jeopardizing the ability of future generations to meet their own.

Rick Gould’s default image

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.

In 2010, the United Nations formally declared that access to clean water and safe sanitation are fundamental human rights. Aligned to this, the United Nations’ Sustainable Development Goal Six (SDG 6), which states that everyone should have access to safe sanitation by 2030. This, in turn, would eliminate open defecation, which billions must still endure. According to the Joint Monitoring Program for Water Supply and Sanitation, the official United Nations mechanism tasked with monitoring progress toward SDG 6, 2.3 billion people lack any form of sanitation at all, and more than 200 million tons of human waste go untreated each year.

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.

1. Why did the MDD need an update?

There were many reasons the MDD needed to be updated. For instance, when the MDD came into law in 1992, software as a medical device (SaaMD) did not yet exist. Software was something that controlled electric machines, and apps that patients could use to monitor their own health were still nearly 20 years away.

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.

Syndicate content