What is ISO Certification and Why Does it Matter?

When purchasing a new product from an unfamiliar company, it can be difficult to know whether or not it will arrive as advertised, and perform its specified functions safely and effectively. Companies offer guarantees and testimonials, which can be valuable aids in making a decision, but ultimately, these remain tied to the company offering them. A strong Quality System backed by third-party auditing and recognized certification provides a more objective and reliable method by which a company can show its customers that it is dedicated to building safe and reliable products.

Because audited quality systems are complex and multi-faceted, JTECH Medical spoke with two experts on both sides of the equation: George Hammer, Director of Quality Assurance at Shippert Medical Technologies, who has built and managed quality systems at drug companies and medical device manufacturers; and Richard Poser, PhD, President and Principal Consultant of First Quality, Inc., who specializes in performing audits and consulting on creating effective quality systems for medical device manufacturers and drug companies. Regardless of whether they manage the system or audit it, the consensus is that a good quality system benefits everyone involved.

"Having a good quality system that is functioning properly is a huge benefit to both the consumer and the company," says Hammer. "It's great for consumers, who get a safer and more reliable product, and it's great for management because the quality system gives them a clear picture of how everything is functioning."

Indeed, one of the most important features of a good quality system is communication, which comes in the form of documentation. From planning stages to production to testing, consistent and standardized documentation is key to ensuring that products meet design requirements and perform the jobs they are meant to perform.

"At the core of a good quality system you have three elements,” says Poser. “First, you have a set of policies: why are we doing what we’re doing? Second, you have a number of standards: what have we achieved, and at what point have we achieved them? And third, you have documentation: exactly how did we achieve these standards, and what do we have to prove it?”

Through these elements, companies are able to have a better grasp on the design and production process of their products to ensure that they meet desired standards. And depending on what a company makes and where they sell it, they may be required to have their quality system audited and certified to ensure that it meets standards set by regulatory agencies, such as the Food and Drug Administration (FDA), ISO 9001:2008 (quality certification by the International Organization for Standardization), or the CE Mark from the European Commission.

"Some companies may not be required to prove their compliance with FDA standards because they operate on a very small scale," says Hammer. "But most drug and medical device manufacturers are required to meet a minimum standard set by the FDA in order to sell in the United States, and a company must obtain a CE mark in order to sell many types of products in Europe."

Though they may not have some of the same safety issues as drugs or implants, functional evaluation devices are also included within the scope of the FDA's standards.

"Accuracy and reliability are critical to patient care," says Poser. "Therefore, it is important that functional evaluation devices begin with a requirement outlining what they are going to do, the company designs to this specification, and then tests to ensure that the criteria are met. And crucially, each of these steps has to be carefully documented, or, as far as a regulatory agency is concerned, it never happened."

Prior to this regulation from the FDA, companies were largely left to their own devices when it came to product safety and reliability. The regulatory agency's inception and authority came in response to consumer demand to specifically address the former.

"The FDA largely came about due to complaints from consumers concerning contaminated or rotten food," says Hammer. "Because of this, its first activity was aimed primarily at safety, but it later added a requirement for efficacy. In the end, the FDA helps mitigate risk for a lot of consumers because they have a level of expertise that allows them to ask more detailed questions."

And while the FDA's regulations undoubtedly make products safer, the question as to whether or not it makes them better is not nearly as firmly decided.

"Initially, the FDA developed guidelines that stated as long as the product doesn't hurt someone, we can let the free market determine efficacy - doctors would continue to prescribe what worked for their patients, and not prescribe what didn't work," says Poser. "In the drug industry, clinical trials have become the new standard: if you prove your product works as well or better than an existing drug, you can sell it with a statement from the FDA. Drug companies are then allowed to market the drug and educate physicians through 'detail sales representatives.' Doctors no longer have the responsibility of determining a drug's efficacy so long as they prescribe within the use approved by the FDA."

"Conforming to this standard has largely resulted in better products, but with a larger upfront investment required of the company that must be paid back in profits before the initial patent period ends and generics are free to come to the market without the huge costs of clinical trials. Therefore, we get much better drugs at much higher costs, but there is not really a market for slightly better drugs at a lower cost."

"The efficacy of products is largely driven by the consumer," says Hammer, "but the audit process can provide a company with good questions and feedback that allows them to make a better quality system, and therefore, a better product."

While certification may allow a company to show its customers that it takes the safety and quality of its products seriously, it is the audit process itself that truly provides the company with the feedback it needs to reach the highest standards.

"Good auditors have a sixth sense," says Hammer. "At 3 in the afternoon, they are able to remember a process or event that they saw at 8 in the morning, and figure out the best way to bring them together. Good auditors can tell if a system is functioning well, or if there are any holes in it—and they don't have to please anyone with their decision."

Often, the auditor will work with the company to figure out the best method for correcting any holes in the system, in order to get the best functioning quality system for the company, its products, and its consumer.

"As educational auditors, our role is to help a company improve their quality system rather than just point out flaws. After we perform the audit, we sit down with the company and put together a plan to fix the problems," says Poser. "Part of the auditor's job is to help the company make a successful quality system and improve their efficiency. To that end, once we've drafted the plan, we continue to check-in with the company until they are ready to be re-inspected."

Overall, the audited certification process can take between 6 and 18 month, depending on what level of certification a company is working towards, and how much time the company is devoting solely to the development and perfection of their quality system.

"When all is said and done, certification can cost upwards of $200,000 or more in labor time," says Poser. "So it becomes a business decision: do we wait until we have to be certified in order to market in a territory that demands certification, or do we certify ahead of time to distinguish ourselves from other companies? Ultimately, by being audited and certified, a company not only gains access to certain markets, they also gain a sense of pride in their quality system. It has been inspected by a third party and has met the high level of standard. That's a great feeling for a company and its employees to know that they have a strong system in place to ensure that they are putting out the best products possible."

For more information about Richard Poser and First Quality, Inc., please write to This email address is being protected from spambots. You need JavaScript enabled to view it.; for more information about Shippert Medical, please visit their website at www.shippertmedical.com.

Shippert Medical    This email address is being protected from spambots. You need JavaScript enabled to view it.    JTECH Medical Certifications

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