by Christe Bruderlin-Nelson

You might not know it, but everything from your living room couch to the slot machines in Las Vegas undergoes safety testing, and it can be a matter of life or death. The complexities of safety testing are vast, so even for products emblazoned with a certified safety sticker, there are no safety guarantees. A certification seal on a product simply says that a manufacturer has its products tested at a safety-testing laboratory. Whether that testing lab is accredited is another issue. Further, there are multiple accreditation bodies. How does a manufacturer know that a particular accreditation body is solid and that the accreditation is meaningful? Not just any company can throw up a shingle and accredit safety-testing laboratories, can it?

Why are products safety tested?
Products are safety tested for a variety of reasons, the most obvious of which is to protect public safety. Good customer service is another key driving force that aligns directly with safety. Successful brands generally have a history of going the extra mile and often impose standards upon themselves that no outside source requires. For the average consumer, however, the assumption that the myriad products out there are safe is a true leap of faith. However, consumers are becoming keener, and manufacturers are striving to exceed rather than simply meet safety requirements. Building confidence in product safety continues to be of paramount importance.

Government regulations and industry standards can be impetuses for safety testing as well. Manufacturers that perform more stringent safety tests than government regulations require are likely to publicize their efforts to gain market share. By doing so, they naturally raise the bar for competitors.

Safety testing can be both a bane as well as a source of reassurance in this litigious culture, and using accredited testing laboratories can mean the difference between winning and losing a lawsuit. Philip Smith, public affairs manager at The American Association for Laboratory Accreditation (A2LA), a nonprofit accreditation body, tells a story about a multimillion-dollar lawsuit levied against General Motors that ultimately came down to the credibility of a testing lab. Because General Motors used an accredited lab, it came out on the winning side of the lawsuit. This is not just about private sector businesses, either; even government agencies risk lawsuits and are seeking accreditation.

Testing complexities
The safety-testing or conformity assessment industry has its own unique language, peppered with jargon and a seemingly endless list of acronyms. (See the sidebar, "Quick Guide to Safety Testing" on page 36.) The fundamentals of safety testing comprise regulation, registration, accreditation and certification, and keeping it all straight can be tricky.

Although most people think of a certification sticker as the ultimate sign of quality in safety testing, those in the safety-testing industry emphasize that there are several key steps leading to that point, and there are weaknesses in the system all along the way. How do manufacturers know that a lab is qualified to certify the product? How do they know that the lab is qualified to perform safety tests in a particular product area, say, medical devices? If the lab is accredited, how can the lab trust that the accreditation is meaningful? Who watches over the accreditation bodies?

A certification sticker simply indicates that a product passed a particular test based on the requirements for that product. To be credible, the lab itself must take steps to show that it meets certain regulatory requirements qualifying it to certify products. ISO Guide 65—"General requirements for bodies operating product certification systems," exists to ensure that third-party certification bodies meet certain standards and voluntary audit requirements in a reliable and competent manner.

Regulatory bodies such as government organizations or building code officials enact regulations that can guide industry, but these guidelines might or might not be enforceable. Accreditation and certification bodies might register a product or service, for example, to ISO 9001; this would indicate that the organization uses consistent business practices and maintains a solid quality management system (QMS). However, if a company is ISO 9001-registered, it does not necessarily mean that its products are safe or of high quality. In other words, although it doesn't happen often, a business that keeps great records but has horribly outdated equipment and bad products could still be registered to ISO 9001.

Because being ISO 9001-registered doesn't guarantee the quality or safety of a product, what indicates that the product does what it says it does, and that it does it relatively well? That falls under the umbrella of technical compliance, which is where the ISO/IEC 17025-accredited lab comes in. ISO/IEC 17025—"General requirements for the competence of testing and calibration laboratories," goes beyond ISO 9001 and looks at concepts such as measurement traceability, testing methods, sampling and calibration. Therefore, some QMS standards, such as the automotive QMS, ISO/TS 16949, require that product testing be performed by an ISO/IEC 17025-accredited lab. This gives the manufacturer and its customers confidence that its products meet their advertised claims. For example, a manufacturer of children's car seats would send samples of its seats to a testing lab that was accredited to ISO/IEC 17025 to perform tests in accordance with Federal Motor Vehicle Safety Standard No. 213—"Child Restraint Systems."

For a safety-testing laboratory, accreditation by a recognized accreditation body means that the lab knows what it is doing when it performs a safety test.

Criteria for accreditation
In the rest of the world, one accreditation body per economy typically does all laboratory accrediting; this is usually a government entity or a nonprofit organization performing the service on behalf of the government.

"In the United States, there are close to 150 accreditation bodies," Smith explains. "Except for a handful, all of these are self-declared and unregulated." Although that in and of itself does not mean that they are doing a bad job, it does mean that they have no credentials.

More than 30 years ago, international trade complexities motivated the establishment of the International Laboratory Accreditation Cooperation—an organization that oversees and writes standards delineating a set of criteria to run accreditation bodies. Previously, to sell products in another country, manufacturers would have to pass that country's safety-testing requirements, which was expensive and time-consuming. ILAC requires that all accreditation bodies in a country meet a minimum international standard. As a result, different countries can have faith in each other's products if they have a mutual recognition agreement (MRA) in place stating that both conform to ILAC requirements for accrediting their safety-testing laboratories. Retesting from country to country then becomes unnecessary.

To gain ILAC recognition, accreditation bodies must undergo peer evaluation and review. ILAC invites accreditation bodies that meet the requirements of its process to sign the MRA, indicating that they agree to trust the other members' products. Although most manufacturers in the United States and abroad enjoy the reduction of barriers to trade, it is also beneficial to have the recognition of an international organization when making a case for trade.

Still, of the approximately 150 accreditation organizations in the United States, only four have gone beyond the call of duty to achieve international recognition among the 54 other international signatories. The bodies that have undergone the rigorous evaluation are the A2LA, International Accreditation Service Inc., the National Voluntary Laboratory Accreditation Program, and Assured Calibration and Laboratory Accreditation Select Services.

Choosing a safety-testing laboratory
When it comes to the test lab itself, there are different criteria for different products. Hershal Brewer, accreditation officer for IAS, a nonprofit accreditation body and friendly competitor of A2LA, says that when companies approach a test lab, "they shouldn't worry about price first. Instead, they should explain what the product is, what it is supposed to do and where they will sell it because that makes a huge difference." For example, if a company is going to test a window, it needs to find a safety-testing lab that tests windows and that has the proper accreditation to do so. Moreover, it needs to be capable of testing the window according to the specifications of its final destination. If the window will sell in Los Angeles, it would not require the high-speed, high-impact tests that a window sold in Miami would. On the other hand, a seismic-oriented structure test might be required for a window sold in Los Angeles but not Miami.

It's also important to make sure that a safety-testing lab is accredited and current. "Personnel change, standards change, and it is important to make sure that the lab is keeping up," Smith says. Ask some questions: "Are you still following procedures?" "Do you have good quality control over your documents?" "When was your last accreditation checkup?" and most important, "Who accredits you?"

The easiest way to get started is to go to the ILAC Web site ( www.ilac.org/members_contact_details.html ) and find an appropriate accreditation body in the country where the product will end up; then find a product-appropriate safety-testing laboratory accredited by that body.

Preparing for a safety test
The most important and overlooked step for a manufacturer to take when preparing for safety testing is to read the appropriate standard. It is also important to make sure that the lab calibrates its equipment properly and that the test occurs in the environment dictated by the applicable standard. Environment is important because elements such as temperature and humidity can have a major effect on test results.

Manufacturers should carefully listen to the recommendations of the test lab, especially if the product fails safety testing. It is likely that the lab has tested similar products before and would understand the nuances of the product. The lab will give a full explanation of the reasons for a failure, including the requirements for passing. A lab will also reveal what the failing product did or did not do under the testing conditions. It might have valuable insight into the reasons for the failure.

What to watch out for
One of the biggest public-safety problems facing consumers and manufacturers in general is counterfeiting, particularly from China. The problem goes far beyond entertainment items like CDs and DVDs. In fact, the safety issue is twofold. First, counterfeit products likely haven't undergone the necessary safety testing. A cheap extension cord isn't such a good deal when it sets the house on fire.

Products aren't the only items being counterfeited. Accreditation certificates are now among the list of counterfeit items. Increasingly, products carry counterfeit logos of well-known certification entities such as Underwriters Laboratories or the Canadian Standards Association. It is impossible to test every product, and stopping counterfeiting has proven to be a daunting task.

Another problem is weak accreditation bodies. With so many accreditation bodies in the United States and abroad, quality is hard to assess without going to peer-reviewed organizations. For a multitude of reasons, some safety-testing laboratories seek out mail-order or online accreditation bodies for ISO/IEC 17025 accreditation. This practice is legal, but it can be misleading because there is no on-site inspection of the safety-testing facility. Because of this, simple accreditation means almost nothing. Organizations can also file a self-declaration of conformity (SDOC), which means that the manufacturer self-declares that a product meets certain standards based on internal requirements, safety-testing results, etc. Although more trade-friendly, the SDOC approach varies tremendously from country to country and product to product.

Another issue is laboratory variability. Fire testing is one of the largest areas of safety testing. The National Fire Protection Association works with several accreditation bodies to help increase the quality and uniformity of safety labs. For example, one way to test products for fire safety is to place them in a large chamber and ignite them. Observation of the burning product to see how far and how fast the flames spread as well as the amount and speed of smoke production will determine if the product burns according to a predetermined standard. The problem is that, even with the same chamber in place, the results vary dramatically (up to 100%) from lab to lab. Word can get around about which labs more frequently fail products and which labs are more likely to hand out a passing score. A manufacturer that knows two labs are duly accredited and use the same type of fire-testing chamber might just go to the easier one to get its product to market more quickly.

Certification stickers: think twice
For product manufacturers and the customers that they serve, safety is a top-level priority. Consumers and manufacturers should make sure that the certification stickers on their products are meaningful, and that means tracing all the steps to the safety-testing lab, what body accredits it and who oversees that accrediting body. Manufacturers with an eye for strong customer service will work to ensure that there are no holes in their safety-testing process, and that they are transparent to consumers who want to know. That's just good business.

About the author
Christe Bruderlin-Nelson is a freelance writer and consultant specializing in health care, technology and executive ghostwriting. She has written for more than 40 magazines and peer-reviewed journals, and recently completed a chapter in the leading pediatric neurosurgery textbook. Contact her at techwritercsbn@yahoo.com .