Quality - Viewing Quality Through the Lens of Regulatory

In previous articles I described how the quality has been defined in many different ways. In this article I will explain how government regulations, both national and international, have become an integral part of our definition of quality.

You can judge a society to be excellent, even though many OSHA violations are obvious to any visitor? A company today must comply with a series of regulatory requirements. A producer is responsible not only for producing environmentally friendly and safe, but also for the proper disposal of its products. This has been termed "cradle to grave responsibility."

In the U.S., the EPA has established controls on emissions of effluents but has also encouraged reduction of waste as a means of protecting the environment. As a result of the Enron debacle and other corporate scandals, the quality of corporate governance is now overseen by a set of rules known as Sarbanes Oxley (SOX).

All companies striving for excellence must have programs in place to be in compliance with these requirements. Companies wishing to engage in international trade must do even more. Various agencies, FDA and USDA among many, regulate the quality of products entering the country.

For example, an importer of medical devices must ensure that products are manufactured in a factory that is registered with the U.S. FDA and the product has received 510 (k) release for introducing it in the market. Exporters must obtain federal approval for certain exports such as hardware, software, and everything that could be used for military purposes.

The European Union adopted a regulation (RoHS, WEEE) for the manufacture, sale and disposal of electronic products. These requirements are based on confirmation of the absence of heavy metals from lead and other electronic products. Exporters need to understand these requirements to ensure full compliance.

Some products, such as toys, medical devices, machinery, electrical equipment, and others require that the products have a CE marking label affixed before entering the European market. The packaging must also reflect that the product is CE marked before introducing them into the European market. In order to affix the CE marking, the manufacturer must confirm by testing or by other means, that the product complies with European directives and standards that can be applied and which was produced in accordance with a Quality System, as For example, ISO 9001.

Compliance with regulatory requirements, such as CE marking are part of the general equation. No matter how satisfied your European client was with the product in the past, if it falls into one of the categories that require the CE mark, must also comply with the applicable European Directives. Many countries in other continents are adopting the provisions on the European Union CE marking. Similarly, ISO 9001 is gradually been adopted globally. As the world continues to flatten, some of these rules and regulations continue to be harmonized.

So no matter what your definition, do not forget that quality must be seen through the lens of regulatory requirements. Professional quality must become familiar with the rules that apply to their industries as they begin to expand the scope of the profession. The products conform to specifications and product satisfaction are necessary but not sufficient to achieve excellence until the needs of regulatory stakeholders are also satisfied .......