Accreditation: Confirmation by a third party that formally demonstrates that a conformity assessment body has the competence, impartiality, and consistent approach to perform specific conformity assessment activities.
Accreditation body: Authorized body that performs accreditations. An accreditation body may derive its authority from a government, an authority, contracts, market acceptance, or program owners.
Requirement: Minimum value or expectation that is specified, usually assumed, or mandatory.
Notified body: State-designated and state-monitored organization that acts on behalf of a manufacturer to accompany and control the conformity assessment of a manufacturer of industrial products.
Digital Certificate of Conformity (DCoC): is a data structure that describes a digital conformity assessment certificate for certification (see DIN EN ISO/IEC 17065). For simplicity, this document uses the term “certificate” to refer to the final document of a certification, which is otherwise also referred to as a “conformity assessment certificate for a certification” or “certification document(ation)”. The D-CoC comprises a series of elements, attributes, data types, and conditions for the representation and exchange of certification-related information generated in different systems and by different actors. This document provides an overview of the sub-data structure that comprises the administrative content of the certificate. This structure applies to all certification programs relating to products in accordance with MessEG, 2014/32/EU, 2014/31/EU, and 2014/34/EU.
D-CoC document family: This document is part of the D-CoC document family, which covers the structure of certificates from different certification systems and programs. The following documents contain separate data structures for the contents of the certificate that are specific to the respective certification system/program:
• D-CoC M B is specific to the certification of legally regulated measuring instruments based on a type examination;
• D-CoC M D is specific to the certification of legally regulated measuring instruments based on the evaluation of the quality assurance system with regard to the production process;
• D-CoC M F is specific to the certification of legally regulated measuring instruments with the type based on a product test;
• D-CoC M G is specific to the certification of legally regulated measuring instruments when testing a single device;
• D-CoC Ex B is specific to the certification of explosion-proof products based on a type examination.
Digital standard/SMART standard: Standard whose content is applicable and readable for machines, software, or other automated systems and can also be made available digitally in an application/user-specific manner (transferable). They can be assigned to one of levels 3 to 5 in accordance with the IEC's “utility model.” In Level 3, digital standards are machine-readable, in Level 4 they are machine-interpretable, and in Level 5 they are capable of performing self-learning and self-optimizing analyses. In contrast, standards in Level 0 are purely paper-based, in Levels 1 they are machine-representable (format e.g. PDF or Word) and in Level 2 they can be structurally captured by computers (XML format).
Digital twin: Digital twins are digital representations of things from the real world. They describe both physical objects and non-physical things such as services by providing all relevant information and services via a uniform interface. For the digital twin, it is irrelevant whether its counterpart already exists in the real world or will only exist in the future. Even if, for example, a production plant is only in the planning stage, it can already have a digital twin that describes the central characteristics of this plant. Similarly, a workpiece whose production has only just begun could already have a digital twin that describes not only the current characteristics of the workpiece, but also all the characteristics that the workpiece will have at the time of its completion.
Specified requirement: A requirement or expectation that is laid down. Specified requirements may be laid down in normative documents such as legislation, standards, and technical specifications.
Subject of conformity assessment: An object (e.g., product, process, service, system, etc.) to which the specified requirements apply.
Inspection: Examination of an object of conformity assessment to determine its conformity with detailed requirements or, based on expert judgment, with general requirements. An examination may include direct or indirect observations, which may involve measurements or readings from measuring instruments. Inspections may be limited to examinations in conformity assessment programs or contracts.
Calibration: Activity that, under specified conditions, first establishes a relationship between the values provided by standards with their measurement uncertainties and the corresponding indications with their associated measurement uncertainties, and then uses this information to establish a relationship that allows a measurement result to be obtained from an indication.
Conformity: Fulfilment of a requirement.
Conformity assessment: Demonstration that specified requirements are fulfilled. The conformity assessment process may result in the specified requirements not being fulfilled. Conformity assessment includes activities such as testing, inspection, validation, verification, certification and accreditation.
Conformity assessment program: A set of rules and procedures that describe the subject of conformity assessment, identify the specified requirements, and describe the procedure for conducting conformity assessment. A conformity assessment program can be operated at the international, regional, national, subnational, or industry sector level.
Conformity assessment body: Body that performs conformity assessment activities but does not perform accreditation.
Declaration of conformity: Confirmation of the conformity of an object (product, process, service, body, QMS) by a first party (supplier).
Market surveillance: The activities carried out and measures taken by market surveillance authorities to ensure that products comply with the requirements of applicable EU harmonization legislation and that the public interest covered by that legislation is protected.
Measurement: Process by which one or more values that can reasonably be attributed to a quantity are determined experimentally. A measurement involves comparing quantities and includes counting. A measurement requires a description of the quantity together with the intended purpose of a measurement result, as well as a measurement procedure and a calibrated measurement system.
Metrology: The science of measurement and its application. Metrology encompasses all theoretical and practical aspects of measurement, regardless of measurement uncertainty and field of application.
Notification: Notification is the process whereby the notifying authority informs the European Commission and the other Member States that a conformity assessment body has been designated to carry out conformity assessments in accordance with an EU harmonization act. It fulfills the requirements laid down in that act with regard to notified bodies.
Testing: Determination of one or more characteristics of an object of conformity assessment according to a specified procedure. The procedure may be designed to control variables within the test as a contribution to the accuracy or reliability of the results. The results of the test may be presented in the form of specified units or objective comparisons with agreed references. The result of the test may include comments (e.g., opinions and interpretations) on the test results and compliance with the specified requirements.
Quality: The degree to which a set of inherent characteristics (i.e., distinguishing features) of an object (e.g., a product, service, process, system) fulfills requirements.
Quality infrastructure (QI): The (national) system of various institutions and processes that ensures the quality and safety of products, processes, and services, as well as consumer protection. This system includes the following elements, among others: standardization, conformity assessment, metrology, accreditation, and market surveillance.
Page: The descriptions first page (provider), second page (user), and third page (independent third party) are used to designate conformity assessment activities in relation to a given subject of conformity assessment. They should not be confused with the designations of corresponding pages (parties) in contract law.
Smart contract: A smart contract is a type of digital contract that is implemented as a small program on a blockchain and executes simple if-then rules. The terms of the agreement between the contracting parties are written directly into lines of code. Smart contracts are self-executing, meaning that they come into effect automatically when certain predefined events occur and therefore do not require human supervision. If these conditions are met, the algorithm automatically initiates a transaction, which is then validated and stored in a block. Smart contracts thus enable trustworthy transactions and agreements between different parties.
Monitoring: systematic, repetitive conformity assessment activities as a basis for maintaining the validity of a conformity statement.
Validation: Confirmation of the plausibility of a specific use or application by providing objective evidence that specified requirements have been met. Validation can be applied to claims to confirm the information stated in a claim in relation to its intended future use.
Verification: Confirmation of truthfulness by providing objective evidence that specified requirements have been met. Verification can be applied to claims to confirm the information stated in a claim that relates to events that have already occurred or to results that have already been achieved.
Asset Administration Shell: An Asset Administration Shell is a concept from Industry 4.0 that serves to facilitate communication and interaction between different machines and systems. An Asset Administration Shell is a digital representation of a physical entity, such as a machine or a product. It contains all relevant information about the entity, such as its properties, states, functions, and interfaces. This enables different machines and systems to communicate with each other and exchange information in order to optimize and automate processes. The administration shell is therefore an important building block for the implementation of Industry 4.0 concepts and the realization of smart factories.
Certification: Confirmation of conformity by an independent third party, based on an object of conformity assessment, excluding accreditation.