Conformity Assessment

What is Conformity Assessment?

The term conformity assessment refers to a situation in which an organization tries to determine if the requirements of a standard are being met; that is, it is an audit. Conformity assessment by an accredited third party is the basis for the “certification” or “registration” of an organization to the standard.

The process of conformity assessment demonstrates whether a product, service, process, claim, system or person meets the relevant requirements. Such requirements are stated in standards, regulations, contracts, programs, or other normative documents.

Explaining Conformity Assessment

Conformity assessment enables buyers, sellers, consumers, and regulators to have confidence that products sourced in the global market meet specific requirements. It is the demonstration that specified requirements relating to a product, process, system, person, or body are fulfilled.

Conformity assessment procedures provide a means of ensuring that the products, services, systems, persons, or bodies have certain required characteristics and that these characteristics are consistent from product to product, service to service, system to system, etc. Conformity assessment can include a supplier's declaration of conformity, sampling and testing, inspection, certification, management system assessment and registration, the accreditation of the competence of those activities, and recognition of an accreditation program's capability.

Standards are interwoven into all aspects of these activities and can have a major impact on the outcome of a conformity assessment scheme or program. Conformity assessment activities form a vital link between standards (which define necessary characteristics or requirements) and the products themselves. Together standards and conformity assessment activities impact almost every aspect of life in the United States.

A specific conformity assessment scheme or program may include one or more conformity assessment activities. While each of these activities is a distinct operation, they are closely interrelated.

Conformity assessment activities can be performed by many types of organizations or individuals. Conformity assessment can be conducted by:

• a first party, which is generally the supplier or manufacturer;
• a second party, which is generally the purchaser or user of the product;
• a third party, which is an independent entity that is generally distinct from the first or second party and has no interest in transactions between the two parties; and
• the government, which has a unique role in conformity assessment activities related to regulatory requirements.

Objectives of the Conformity Assessment Procedure and How it Works in Practice

Objectives of the Conformity Assessment Procedure

• To demonstrate that a product placed on the market complies with all legislative requirements.
• The procedure should ensure the confidence of consumers, public authorities, and manufacturers regarding the conformity of products.

How does it work in practice?

• Product legislation describes the conformity assessment procedures for each product.
• Manufacturers may choose between different conformity assessment procedures, if applicable.
• The manufacturer carries out the assessment. The conformity assessment process involves a conformity assessment body if required by the applicable legislation

The Need for Conformity Assessment

Before a product can enter a market, it generally needs to be able to demonstrate to the buyer or regulator that it is safe and performs as promised in terms of energy efficiency, reliability, sustainability, and many other criteria. Conformity assessment provides the necessary proof, based on standards. With conformity assessment:

• Governments have it easier to verify the resilience of infrastructure and are better able to protect their populations from unnecessary risks
• Insurers get confirmation that risks have been properly managed and relevant safety considerations included
• Buyers receive proof of a product's or system's safety, performance, and reliability
• Investors are able to trust that industry-wide best-practice has been applied and their investment is as secure as it can be
• Users of equipment and consumers can be confident that electrical and electronic devices are safe to use and perform to expectations

Why is Conformity Assessment Important?

The main areas of concern are user and product safety, consumer health, and the environment. Conformity assessment encompasses the areas:

• Testing
• Surveillance
• Inspection
• Auditing
• Certification
• Registration
• Accreditation

Conformity assessment is important to suppliers, consumers, and regulators. It enables producers to demonstrate that their product(s) meet relevant design and safety Standards and gives consumers confidence when selecting products in the marketplace. Those who require this confidence are “acceptance interests,” individuals or organizations that have an interest in conformity and whose confidence in conformity provides some tangible benefit to the supplier. The conformity assessment process used to provide this confidence must be as cost-effective as possible to maximize its value for both the supplier and the consumer.

See Also

Audit Trail