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Standards Primer - What Is Conformity Assessment?

Standards establish requirements. A supplier needs to be able to communicate to the purchaser and user that its product, process or service conforms to a standard. This is the purpose of conformity assessment.

Conformity assessment is the name given to the processes that are used to demonstrate that a product, service or management system or body meets specified requirements. When applied to product, it is usually known as certification, and involves testing to an established standard and providing a mark or some other indication of conformity.

Certification testing may be done by a government agency such as NIOSH, FDA or MSHA; the product manufacturer, either at its own facility or a contract testing lab, or by an independent third-party assessor.

Government certification programs exist in the US mostly when public health and safety are involved. For example, the FDA certifies new drugs and medical devices before they are allowed on the market, and NIOSH tests and certifies respirators and breathing apparatus.

In the U.S., manufacturer’s self-certification is the most common approach. Manufacturers test their products, or have them tested, and declare that they meet the standard. This may be a label on the product - often in a form required by the standard - as well as information provided in packaging, literature and advertising.

This system often seems mysterious to the rest of the world, accustomed to more rigorous government oversight and regulation. But self-certification works in the US for several reasons. We have a legal system that severely penalizes products that don't measure up, a consumer base that’s generally well-informed and vigilant, a market large enough to give those consumers a wide choice of products, and laws that govern truth in labeling and advertising.

Where self-certification will not satisfy the market demand or regulatory requirements, manufacturers rely on third-party certification. In this case, an independent organization conducts ongoing testing of a product, to see if it meets the performance requirements of a recognized standard. It may also require an assessment of the company’s quality systems to ensure that the manufacturer’s internal production controls are designed and operated so that every product that comes off the line will meet the standard’s requirements. When these conditions are met, the third party grants the manufacturer the use of its certification mark.

This is the most common method of certification outside the US, and in some US markets as well. For example, the UL mark of Underwriters Laboratories is familiar on electrical products. In the safety equipment marketplace, the most familiar certification marks are the SEI mark of the Safety Equipment Institute, the CSA mark in Canada, and the CE mark that indicates conformity with European requirements.

SEI is the only third-party certification organization in this country dedicated to safety equipment. Its programs cover industrial safety equipment, fire and rescue equipment, and some sports equipment such as bicycle and riding helmets. SEI was founded by ISEA in 1981, but is now completely independent.

For each product in its program, SEI has selected a nationally recognized standard, a qualified laboratory to do the testing, and a quality systems auditor. Products that pass display the SEI label, and their manufacturers undergo periodic follow-up testing and quality audits.

Keep in mind that SEI is not the only testing body for PPE, and SEI certified products are not necessarily superior to products whose manufacturers self-certify.

First of all, what is a standard?
Where do standards come from?
What is ANSI?
Who develops ANSI standards?
Who else develops standards?
What is conformity assessment?
Where does OSHA fit in?
How do products get approved around the world?