Basic concepts

There is a number of key concepts and definitions that underpin conformity assessment (e.g. functional approach) and that are key to understand what conformity assessment is about and why it matters to consumers, manufactures, services providers and regulators. These concepts are outlined in this section.

Standards
ISO/IEC 17000:2020

Conformity assessment

Vocabulary and general principles

What Conformity Assessment is about?

Everyone has an interest in finding out whether something (or somebody, organization or system) meets their expectations.

Does the product do what I expect? Is that person competent to carry out the work I want them to do? Will the shop provide the right item at the right price when I need it? Is my product safe? Products and services are like promises. Business customers, consumers, users and public officials have expectations about products and services relating to features like quality, ecology, safety, economy, reliability, compatibility, interoperability, efficiency and effectiveness.

The process for demonstrating that these features meet the requirements of standards, regulations and other specifications is called conformity assessment. There are different conformity assessment techniques, examples include testing, inspection, validation, verification certification and accreditation. These conformity assessment activities can result in different statements of conformity such as supplier’s declaration of conformity or a certificate. Simply put, conformity assessment helps to ensure that products and services deliver on their promises.

The International Organization for Standardization (ISO) and the International Electrotechnical Commission (IEC) have published joint International Standards on conformity assessment. These International Standards are the internationally accepted basis for conformity assessment and are used by many regulators around the world.

Regulations and Conformity Assessment

Regulations feature in most economies and most have some direct or indirect interaction with both standards and conformity assessment.

Often regulations require compliance with a national, regional or international standard, technical specification or code of practice. Some regulations may only specify parts of standards, such as those aspects affecting safety and might not cover product performance or quality aspects.

Regulations can include requirements for how compliance is to be demonstrated and communicated (for example, regulations may require testing of a product by a recognised testing laboratory and the subsequent marking of those products if they have fulfilled the requirements).

By relying on conformity assessment in accordance with International Standards, regulators and the market can be assured that statements of conformity in relation to the products, processes, services, systems, installations, projects, data, designs, material, claims, persons, bodies or organisations are well-founded and legitimate.

Conformity assessment in accordance with International Standards assists in avoiding regulation that may add unnecessary costs to the economy and reduce competitiveness of domestic production, and that may be substantially different to those in other economies which can lead to technical barriers to trade.

Functional approach to Conformity Assessment

The functional approach is a basic concept underpinning all conformity assessment and can be used as a good starting point when developing conformity assessment frameworks to support regulations. The functional approach consists of three main functions, each of them involves different activities and the output from one function is the input to the next. Surveillance can be used where there is a need to provide continuing assurance of conformity, although conformity assessment can end when attestation is performed.

Selection involves planning and preparation activities in order to collect or produce all the information and input needed for the subsequent determination function.
Determination activities are used to develop information regarding fulfilment of the specified requirements by the object of conformity assessment or its sample.
Review, decision & attestation are the final stages of the process. Review is the activity of checking before taking the decision as to whether it has been adequately demonstrated that the object of conformity fulfils the specified requirements. The decision is the attestation which results in a statement of conformity (e.g. a certificate and/or mark of conformity) being issued.