Glossary

Terms and what they actually mean

In conformity assessment, words sound similar but do not mean the same thing: testing versus inspection, accreditation versus certification, calibration versus adjustment are different things. The differences are here.

33 terms

Conformity assessment(Conformity assessment): Demonstration that a product, process or system meets specified requirements. Testing, inspection and certification are different activities under this umbrella.
Testing(Testing): Measurement of one or more properties of a product according to a defined method. Testing produces a result; it does not decide whether that result is acceptable.
Inspection(Inspection): Examination of a product, process or facility and determination of conformity to general requirements based on professional judgment. It differs from testing in that it includes judgment.; Related page
Surveillance(Surveillance): Monitoring and verification of a product or process by an independent party during production or shipment stage. In commerce, it often refers to pre-shipment inspection.; Related page
Audit(Audit): Systematic evaluation of a management system or process against defined criteria through collection and assessment of evidence.; Related page
Verification(Verification): Independent confirmation that a statement or data is accurate and reliable. Frequently used for greenhouse gas declarations and sustainability reports.; Related page
Calibration(Calibration): Determination of the relationship between a measuring instrument's indication and the known reference value. Calibration does not adjust the device; it documents deviation and uncertainty.; Related page
Measurement uncertainty(Measurement uncertainty): Parameter characterizing the range within which the true value of a measured quantity reasonably lies. It directly affects decisions for borderline results.
Metrological traceability(Metrological traceability): Ability to trace a measurement result back to a national or international standard through an unbroken chain of calibrations. It is the basis for result comparability.
Proficiency testing(Proficiency testing): Programs in which laboratories analyze the same samples and their results are compared. It is one of the principal objective evidences of laboratory performance.
Non-destructive testing(Non-destructive testing): Inspection methods that detect discontinuities without causing permanent damage: ultrasonic, radiographic, magnetic particle, dye penetrant and eddy current.; Related page
Accreditation(Accreditation): Formal recognition by an authorised accreditation body that a conformity assessment organisation is competent to perform specific activities. Accreditation always has an associated scope.; Related page
Scope of accreditation(Scope of accreditation): List that defines which tests, by which methods and for which products an organisation is authorised to perform. A test outside the scope is not accredited.; Related page
ISO/IEC 17025: Standard that specifies general requirements for the competence of testing and calibration laboratories. It is the basis of laboratory accreditation.
ISO/IEC 17020: Standard that defines requirements for the operation of inspection bodies. Inspection and surveillance activities are accredited under this scheme.
ISO/IEC 17065: Standard that specifies requirements for organisations that provide certification of products, processes and services. Product certification falls under this scheme.
ISO/IEC 17021-1: Standard that specifies requirements for organisations providing management system certification. System certifications such as ISO 9001 fall under this scheme.
Notified body(Notified body): Organisation notified to the Commission by a Member State to carry out conformity assessment activities under EU legislation. A separate notification is required for each piece of legislation.
Declaration of conformity(Declaration of conformity): Written statement by the manufacturer declaring that the product meets the applicable regulatory requirements, at the manufacturer's own responsibility. It is the document behind the CE mark.
Technical file(Technical file): Compilation of documents that demonstrate product compliance with regulations: drawings, risk assessment, applied standards, test reports and declaration of conformity.
Harmonised standard(Harmonised standard): Standard published in the EU Official Journal which, when applied, is presumed to meet the requirements of the related EU legislation (presumption of conformity).
Conformity assessment module(Conformity assessment module): Procedures defined in EU legislation that specify how conformity shall be demonstrated (such as modules A, B, C, D, H). Module selection depends on the product's risk class.
CE marking(CE marking): Visible marking that indicates the manufacturer's declaration that the product meets the requirements of all applicable EU legislation. It is not a quality mark by itself.
Type approval(Type approval): Approval by a designated body that a vehicle or component type meets the requirements of the applicable regulation. The laboratory provides the report; the approval body grants the approval.; Related page
Authorised representative(Authorised representative): Natural or legal person established in the target market, authorised in writing to perform specified tasks on behalf of the manufacturer. Required in some markets.
Pre-Export Verification of Conformity(Pre-Export Verification of Conformity): Conformity verification programme that some countries require to be conducted in the country of shipment before import. A conformity certificate is issued upon completion.; Related page
Maximum Residue Limit(Maximum Residue Limit): Maximum level of pesticide or residue permitted by regulation in food. It is not a toxicology threshold but the expected upper limit of good agricultural practice.
Retained sample(Retained sample): Second set of samples taken from the same batch and retained. If results are contested, it allows retesting.; Related page
Acceptance criterion(Acceptance criterion): Limit that a test result must meet to be considered acceptable. It comes from product standards or customer specifications, not from test method standards.
Tailoring(Tailoring): Selection and severity adjustment of environmental test conditions to match the product's real-world operating life. It is the core approach of MIL-STD-810.; Related page
Shelf life study(Shelf life study): Planned monitoring study that demonstrates how long a product remains safe and acceptable under stated storage conditions.; Related page
Bioburden(Bioburden): Total number of viable microorganisms on a product before sterilization. The sterilization dose is determined based on this load.
Impartiality(Impartiality): Freedom of conformity assessment decisions from conflicts of interest. An organisation performing both consulting and certification violates this principle.; Related page