Why do we need standards?
Standards can serve different purposes. They can:
1. Provide reference criteria that a product, process or service must meet.
2. Provide information that enhances safety, reliability and performance of products, processes and services.
3. Assure consumers about reliability or other characteristics of goods or services provided in the marketplace.
4. Give consumers more choice by allowing one firm’s products to be substituted for, or combined with, those of another.
Although we take for granted the advantage of being able to order shoes or clothes simply by referring to a size, this is only possible because manufacturers follow some industrial standards in making shoes and clothes.
In contrast, incompatibility between electrical plugs and receptacles is a prime example of different countries failing to follow the same standards. When North Americans want to use a portable computer or other electrical appliance in Europe or Asia, they can be frustrated to find that the plug and voltage are not compatible.
With the world becoming a global village, the need and benefits of standardization are becoming more and more important internationally for manufacturing, trade and communications. Quality systems and other management standards can provide common references to the kind of process, service or management practice expected. The Internet functions effectively because globally agreed-upon interconnection protocols exist. Global communication would be very difficult without international standardization.
Health care workers are well aware of incompatible consumables or replacement parts in medical devices of similar function that are made by different manufacturers (e.g. IV set, X-ray cassettes). The lack of available consumables and repair parts is an important cause of medical equipment problems that are constantly encountered in developing countries.
Most medical devices are used globally. The safety, performance and consistent quality of medical devices is, therefore, an international public health interest. Thus, global harmonization of medical device standards and regulations is critical.
Why do we need standards?
