Richard A. Vincins’s picture

By: Richard A. Vincins

Through the 1990s, the application of a quality system relied primarily upon the Food and Drug Administrations’ (FDA) good manufacturing practice requirements or the FDA 21 CFR Part 820 Quality System Regulation. At that time, the international standards for quality management systems (QMS) were ISO 9001, ISO 9002, or ISO 9003, depending upon the scope of the organization’s quality system. Fast forward to 2009 and in the medical devices manufacturing industry, we now rely primarily upon ISO 13485 and the FDA Part 820 Quality System Regulation (QSR) to assure compliance. ISO 13485 and the quality system regulation are the de facto standards utilized by medical device and in vitro diagnostic companies for compliance with QMS requirements. There are other regulatory standards that may be specific to regions or countries that must be reviewed separately for organizations specific needs.

In this article, we will discuss how to utilize these standards for assuring harmonized compliance and assist in marketing devices around the world. We will focus primarily on ISO 13485—"Medical devices—Quality management system—Requirements for regulatory purposes," and how this international standard is utilized for meeting global regulatory requirements.

Beamex’s default image

By: Beamex

For process manufacturers, regular calibration of instruments across a manufacturing plant is common practice. In plant areas where instrument accuracy is critical to product quality or safety, calibration every six months—and even more frequently—is not unusual. However, the final step in any calibration process—documentation—is often neglected because of a lack of resources or the pressure and time constraints of everyday activities.

Many manufacturers are outsourcing all or some of their calibration maintenance activities, so now the contractor, too, is under pressure to calibrate plant instruments quickly and accurately. The contractor must also ensure the results are documented for quality assurance purposes, and provide full traceability.

The purpose of calibration itself is to determine the accuracy of an instrument or sensor. Although technology has greatly improved the accuracy of instruments, regulatory bodies often need to know just how inaccurate a particular instrument is and whether it drifts in and out of specified tolerance over time.


Barry Johnson’s picture

By: Barry Johnson

When someone mentions design for Six Sigma (DFSS), the initial thought usually turns to developing new, innovative products. While DFSS has its roots in product development, individual components of the toolset can be applied in a variety of ways.

Recently, the use of DFSS has exploded in service industries such as health care and finance as organizations of all types strive to develop processes and products that will excite their customers. This article shares an example of how DFSS tools were used in the public service sector as one library looked to enhance the beauty of their campus.


Design for Six Sigma is a disciplined methodology with a collection of tools to ensure products and processes are developed systematically to provide reliable results that exceed customer requirements. A key function of DFSS is to understand and prioritize the needs, wants, and desires of customers, and translate those requirements into products and processes that will consistently meet those needs.

Alan S. Bandes’s default image

By: Alan S. Bandes

Ultrasonic leak detection has been used for a variety of applications ranging from energy reduction by locating compressed air leaks to quality assurance inspections, such as locating wind noise and water leaks in automobiles. The secret to success is to understand the nature of what type of leak produces a detectible ultrasound and what does not, along with the techniques that can be used for effective leak identification. Once understood, there are instances where the limits of detection can be enhanced to help locate a leak in difficult situations.

Typically, ultrasound leak detection is used to locate leaks where the pressure differential is enough to produce a turbulent flow as the gas moves from the high-pressure to the low-pressure side of a leak. Most often any leak with a rate below 1 × 10-3 std. cc/sec will not generate a detectable, turbulent flow. For this reason, the majority of leak applications for ultrasound are limited to leaks above this threshold. One of the advantages of ultrasound is that leak detection is not limited to a specific fluid. The technology is open to identifying leaks in all types of gas and even fluid systems.

Phillip Smith’s default image

By: Phillip Smith

Automated inspection and gauging systems can help companies to improve overall product quality and grow their business while reducing manufacturing costs, helping them to become more competitive in this difficult business climate. Whether they are producing automotive, medical, consumer, or virtually any other product, all companies have some type of quality inspection or gauging as part of their production process. Some companies specify that their production line operators are responsible for verifying product quality. Other companies utilize quality technicians offline to manually gauge or visually check smaller audit groups of products to verify critical dimensions, the presence of features, or to look for defects. As machine vision inspection cameras and laser-gauging sensors have become more cost effective, many companies are implementing automated inspection and gauging systems in their facilities. These systems can be as simple as standalone cameras or sensors integrated into existing machinery, or as specialized as custom-designed and built turnkey automated inspection machines. No matter what type of system is ultimately selected, automated inspection and gauging offers companies many benefits over the older manual processes and they can help companies to compete more effectively for new business.

Dirk Dusharme @ Quality Digest’s picture

By: Dirk Dusharme @ Quality Digest

Investing in capital equipment always involves an analysis of the return on investment (ROI), but never as much as during a recession. The question this year is often, "Our company is already tightening its belt, is this equipment going to help us save a lot of money in a relatively short time frame?" As reported in Quality Digest Daily, the market for large-scale 3-D metrology equipment could pick up in 2009, but a lot of that hinges on buyers having a clear understanding of the equipment’s ROI and 3-D equipment manufacturers doing a good job of communicating cost vs. benefit.

There is no event in the United States better situated to communicate the value and ROI of large scale 3-D metrology than the Coordinate Metrology Systems Conference. This year’s CMSC, its 25th, will be held in Louisville, Kentucky, July 20–24. It is the only show dedicated specifically to large-scale 3-D measurement equipment and software.

Gary Johanning’s picture

By: Gary Johanning

Three-dimensional (3-D) assembly refers to the use of high-accuracy, in-place, 3-D coordinate measurement devices for the digital assembly of parts. This process is often referred to as computer-aided manufacturing (CAM) or gaugeless manufacturing. Whatever the name, 3-D assembly is replacing classical techniques centered on the use of tools, gauges and other mechanical processes of part assembly. In a nutshell, 3-D assembly can produce more accurate assemblies more rapidly and at lower cost.


Thomas Hinton’s picture

By: Thomas Hinton

There’s a new wave of environmental consciousness rolling across the landscape of U.S. business. In certification circles, we refer to it as the Green Wave. But companies are discovering that going green isn’t easy, and getting green certified is even tougher. Research data from the American Consumer Council (ACC) suggests that fewer than 22 percent of companies that apply for green certification would pass the bar in terms of earning ACC’s Green C certification, a tough standard that gauges a company’s environmental compliance and corporate social responsibility.

Transforming a business from the status quo into a green company reminds me of the quality movement’s early days as companies scrambled to implement Deming’s 14 points and play catch-up with the Japanese and Germans. Books by Philip Crosby, Joseph Juran, Tom Peters, and Masaaki Imai were required reading for anyone who was serious about launching a quality initiative.

Some 25 years later, U.S. businesses are behind once again. This time, however, we’re trying to catch the Green Wave and compete with companies in Europe, Asia, and South America that have already gained a foothold with consumers who are demanding green products and services. This includes everything from energy to carpet, and clothing to automobiles.

Robert Sanville’s picture

By: Robert Sanville

There are several different tools available for the measurement and inspection of parts and products. The specific application often determines the best choice as each tool has its own benefits and drawbacks. Over the years, these tools have become more advanced to keep up with improved quality standards. In this column, I’ll briefly discuss various measurement tools and how they are used, focusing on the advantages of portable CMMs, and why they are the preferred tool in many instances.

Manufacturers are increasingly implementing quality methods such as Six Sigma and working toward compliance to quality standards such as ISO 9001 to continuously improve their products and processes. In addition to reducing or eliminating product defects, these measures strive to detect problems in the manufacturing process. This allows companies to prevent adding value to (trying to improve) already-defective works in progress. To be successful with this approach, manufacturers need to measure every step of their processes, including the various stages of product assembly that may never have been measured before.’s default image


The conventional wisdom is that the United States no longer produces much. The notion that globalization has dealt a fatal blow to the U.S. manufacturing sector is a widespread one. It has become common to hear people declare that "everything is made in China!" Not only do most believe the United States is no longer the manufacturing giant it once was, but they also think it has fallen behind emerging countries that are set to usurp the United States' once-secure lead.

The impression that the United States is no longer on top of the global manufacturing game is reasserted over and over by our day-to-day shopping experiences. Clothes, electronics, toys, and household goods are likely to be made outside the country, and yes, probably in China. We can't be blamed for thinking the United States no longer produces anything useful. However, our daily experience tells us only one side of the story. After all, most of us are never in the market for a communication satellite or an aircraft carrier, big ticket items that are very likely to be made in America. The United States may not be making many of our $20 toys, but it's certainly manufacturing our planes.

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