ISO 13485 LA key terms

An instrument, apparatus, implement, machine, implant, reagent, or software intended by its manufacturer for diagnostic or therapeutic purposes, whose primary action in or on the body is not achieved by pharmacological, immunological, or metabolic means.

The purpose for which a device is used, as stated by the manufacturer in its labelling, instructions, or promotional materials, including the target population, clinical condition, and setting of use.

A reagent, calibrator, control material, kit, instrument, apparatus, or system intended for the in vitro examination of specimens derived from the human body to provide diagnostic or health-related information.

A management principle whereby the organization identifies interrelated activities, defines their inputs, outputs, and interactions, and manages them as a system to achieve consistent results and continual improvement.

A four-stage improvement cycle of Plan, Do, Check, and Act applied to processes and the quality management system to establish objectives, implement them, monitor results, and drive corrective action.

The principle that decisions, controls, and audit effort should be proportionate to the probability and severity of harm, guiding both the design of the quality management system and the prioritization of audits.

A systematic process of identifying hazards, estimating and evaluating associated risks, implementing controls, and monitoring effectiveness throughout the device lifecycle, documented in a risk management file.

The set of interrelated processes, responsibilities, resources, and documented information an organization establishes to direct and control quality and to consistently meet customer and regulatory requirements.

Information that must be controlled and maintained by the organization, comprising documents that provide guidance and records that furnish evidence of results achieved.

A document describing the scope of the quality management system, the documented procedures or references to them, and the interaction between the processes of the system.

The controls applied to preserve the identity, legibility, integrity, confidentiality, and retention of records for defined periods, protecting them from alteration, loss, or unauthorized access.

A planned, top-management evaluation of the quality management system's suitability, adequacy, and effectiveness, using defined inputs and producing decisions and actions on improvement, resources, and changes.

A measurable target related to quality that the organization sets, consistent with its quality policy, and monitors to demonstrate the effectiveness of the quality management system.

Confirmation by objective evidence that device requirements for a specified intended use or application have been fulfilled, typically performed on production units or simulated production units under defined conditions.

Confirmation by objective evidence that design output meets design input requirements, carried out through testing, inspection, analysis, or other documented methods during design and development.

The ability to follow the history, application, or location of an item or activity, and for devices, to link materials, components, and production records to finished devices and distribution.

A globally unique identifier assigned to a device model or production unit that enables its unambiguous identification and supports traceability, adverse event reporting, and post-market surveillance.

The systematic collection and analysis of data on devices already placed on the market, used to verify safety and performance and to feed corrective action and design changes.

The process of detecting, assessing, and reporting adverse incidents and field safety corrective actions to competent authorities within defined timelines, as required by applicable regulatory requirements.

A systematic, independent, and documented process for obtaining objective evidence and evaluating it objectively to determine the extent to which audit criteria are fulfilled.

The set of policies, procedures, requirements, standards, or laws used as a reference against which objective evidence is compared to determine conformity.

Verifiable data, records, statements of fact, or observations obtained through interview, examination, or measurement that support the existence or truth of something.

The result of evaluating collected evidence against audit criteria, classified as conformity, nonconformity, or an observation, and recorded with supporting evidence.

A documented failure to fulfil a specified requirement, supported by objective evidence, and classified by its significance to the effectiveness of the quality management system or to device safety.

The principle that auditors do not audit their own work or activities for which they have direct responsibility, preserving objectivity and impartiality of audit conclusions.

The demonstrated combination of education, training, experience, and personal attributes needed to conduct audits effectively, maintained through continuing professional development.

The set of one or more audits planned for a specific time frame and directed toward a specific purpose, including arrangements, resources, and schedules needed for its implementation.

A description of the activities and arrangements for an individual audit, covering objectives, scope, criteria, schedule, team roles, and logistics.

The extent and boundaries of an audit, stating which processes, sites, product lines, organizational units, and time periods are included or excluded.

The person assigned to manage a specific audit, including preparing the plan, allocating tasks, leading the opening and closing meetings, and approving the audit report.

A formal meeting at the start of an on-site audit confirming the audit plan, scope, criteria, schedule, communication channels, and confidentiality arrangements with the auditee.

Selecting a subset of records, items, or activities from a population to draw conclusions about the whole, with sample size and selection influenced by risk and evidence availability.

A formal meeting at the end of an audit where findings, conclusions, and audit report timing are presented, with an opportunity for the auditee to clarify or challenge them.

Action taken to eliminate the cause of a detected nonconformity and prevent recurrence, including investigation of root cause and verification of effectiveness.

Verification that corrective actions arising from audit findings have been implemented and are effective, completed within agreed timelines and recorded in the audit programme.

The recurring activity of enhancing the quality management system and its processes by setting objectives, analysing data, and implementing changes that increase effectiveness.

A process needed by the quality management system that the organization chooses to have performed by an external party, remaining responsible for conformity and for controlling the arrangement.

The criteria and activities used to evaluate, select, monitor, and re-evaluate external providers so that purchased product and services conform to specified requirements.