12.5. The Role of Conformity Assessment in the Quality Infrastructure (QI)

According to ISO 17000:2020, Conformity Assessment: Vocabulary and General Principles, conformity assessment is defined as ''a demonstration that specified requirements are fulfilled'' (ISO/IEC, 2020). Additionally, the object of conformity assessment is defined as ''an entity to which these specified requirements apply (e.g., product, process, service, system, installation, project, data, design, material, claim, person, body or organization, or any combination thereof)’’ (ISO/IEC, 2020). Similarly, the first-party conformity assessment activity is ''conformity assessment activity that is performed by the person or organization that provides or that is the object of conformity assessment (e.g., activities performed by providers, designers or owners of the object, investors in the object, and advertisers or promoters of the object)'', the second-party conformity assessment activity is ''conformity assessment activity that is performed by a person or organization that has a user interest in the object of conformity assessment (e.g., purchasers or users of products, or potential customers seeking to rely on a supplier's management system, or organizations representing those interests, such as consumer advocacy organizations, regulators implementing legislation governing products and services for the protection of consumer and public interests, centralized government procurement organizations and private sector purchasing agents'', and the third-party conformity assessment activity is ''conformity assessment activity that is performed by a person or organization that is independent of the provider of the object of conformity assessment and has no user interest in the object of conformity assessment'' (ISO/IEC, 2020). Additionally, the conformity assessment system is defined as ''a set of rules and procedures for the management of similar or related conformity assessment schemes'' and the conformity assessment scheme is defined as ''a set of rules and procedures that describes the objects of conformity assessment, identifies the specified requirements, and provides the methodology for performing conformity assessment activity'' (ISO/IEC, 2020). Generally speaking, conformity assessment activities comprise testing, inspection, and certification ''used in all fields of investigation, innovation, process improvement, productivity, product development, or compliance'' (see Kellerman, 2019).