PECB ISO 13485 Foundation key terms

An instrument, apparatus, implement, machine, implant, reagent, or software intended by its manufacturer to be used for diagnosis, prevention, monitoring, treatment, or alleviation of disease or injury, whose primary action is not achieved by pharmacological, immunological, or metabolic means.

A device, reagent, calibrator, control material, or system intended to examine specimens derived from the human body to provide information about a physiological or pathological state, a congenital abnormality, or to determine safety and compatibility with potential recipients.

A set of interrelated or interacting elements of an organization, comprising processes, responsibilities, resources, and documented information, used to direct and control the organization with regard to quality and to achieve quality objectives.

A management system specific to the medical device sector that applies ISO 13485 requirements to direct and control an organization's processes so that devices consistently meet customer and applicable regulatory requirements.

An international standard specifying requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.

A management principle whereby the organization identifies its processes, understands their sequence and interaction, and manages them as a system to achieve intended outputs efficiently and consistently.

A set of interrelated or interacting activities that transforms inputs into outputs, with defined responsibilities, resources, controls, and criteria needed to achieve a specified result.

A specified way to carry out an activity or process, typically documented and describing who does what, when, and how, in order to achieve consistent results.

Information required to be controlled and maintained by the organization, together with the medium on which it is contained, covering both documents that provide guidance and records that provide evidence of results.

Documented information retained as evidence of results achieved or activities performed, which must be legible, identifiable, retrievable, and protected from alteration, loss, or deterioration.

The set of controls ensuring documents are reviewed and approved before use, kept current, available where needed, and that obsolete documents are prevented from unintended use.

The laws, regulations, and administrative provisions of the jurisdictions where the device is marketed, including registration, licensing, and reporting obligations that the organization must meet.

The use for which a product is intended according to the specifications, instructions, and information provided by the manufacturer, including the target population and clinical purpose.

A way of planning and controlling quality management activities so that their rigor, formality, and documentation are proportionate to the risk associated with the device and the process.

A systematic process applied throughout the device lifecycle to identify hazards, estimate and evaluate associated risks, control those risks, and monitor the effectiveness of the controls.

The combination of the probability of occurrence of harm and the severity of that harm, where harm means physical injury or damage to health of people or the environment.

A potential source of harm arising from the device, its use, or its environment, which is analyzed during risk management to determine whether risk controls are needed.

The person or group of people who direct and control an organization at the highest level, responsible for establishing quality policy and objectives and providing resources and commitment.

A statement by top management of the organization's overall intentions and direction related to quality, providing a framework for establishing and reviewing quality objectives.

A measurable target or result to be achieved related to quality, consistent with the quality policy, and typically established at relevant functions, levels, and processes of the organization.

A planned, periodic evaluation by top management of the suitability, adequacy, and effectiveness of the quality management system, including consideration of defined inputs and decisions on improvement actions.

The demonstrated ability to apply knowledge and skills to achieve intended results, typically evidenced through education, training, experience, or assessment of performance.

The people needed to operate processes and to meet regulatory and customer requirements, whose adequacy, assignment, and competence the organization must determine and provide.

The facilities, equipment, utilities, and supporting services such as maintenance and information systems needed to achieve conformity of product and to operate processes effectively.

The conditions under which work is performed, including physical, environmental, and other factors such as cleanliness, temperature, and hygiene that can affect product conformity.

Arrangements to prevent contamination of product or work environment by particulates, microorganisms, or other unwanted substances, proportionate to the device and its intended use.

A controlled environment where airborne particle concentration is regulated and classified, used when device manufacturing or processing requires protection from contamination.

The set of planned activities that convert requirements into a device specification, including design inputs, outputs, review, verification, validation, transfer, and control of design changes.

The requirements for the device, including functional, performance, safety, regulatory, and user needs, which must be documented, reviewed, and approved before design work proceeds.

The results of design and development activities, such as drawings, specifications, and software, expressed in terms that allow verification against design inputs and that form the basis for purchasing and production.

Confirmation, through objective evidence such as tests and inspections, that design outputs meet the specified design input requirements.

Confirmation, through objective evidence from testing on production units or simulated use, that the device meets requirements for its specified intended use and user needs.

Confirmation, through the provision of objective evidence, that requirements for a specific intended use or application have been fulfilled, often applied to processes whose output cannot be fully verified.

Confirmation, through the provision of objective evidence, that specified requirements have been fulfilled, commonly applied to purchased product, design outputs, or inspection results.

Documented evidence that a process consistently produces product meeting predetermined requirements, required for processes where subsequent monitoring or measurement cannot fully verify the result.

A process whose output conformity cannot be fully verified by later inspection and testing, so its capability must be validated and its parameters controlled and monitored.

The assessment of a supplier's ability to provide product or services meeting the organization's requirements, using criteria such as audits, samples, and performance history, and determining the controls to apply.

A process that the organization chooses to have performed by an external party, for which it retains responsibility and must apply controls proportionate to the risk involved.

The activity of acquiring product, materials, or services, governed by controls that ensure purchased items conform to specified requirements before release for use or production.

The defined limits or conditions, such as specifications or tolerances, used to decide whether product, process, or documentation meets requirements and can be released.

The set of operations establishing the relationship between values indicated by a measuring instrument and the corresponding known values of a reference standard, performed at defined intervals.

Instruments, gauges, and software used to demonstrate conformity of product, which must be identified, calibrated or verified at specified intervals, adjusted, and protected from damage.

The ability to trace the history, application, or location of an item, including materials, components, and devices, through records such as batch numbers and distribution lists.

Documented means, such as labels, markings, or codes, that allow product to be identified at all stages of production and to prevent mix-ups and confusion.

Written, printed, or graphic information provided with or on a device, including instructions for use, which must be controlled and checked for conformity before release.

Product that does not meet requirements, which must be identified, controlled, segregated where practical, and dispositioned through actions such as correction, concession, rework, or rejection.

The authorization to proceed to the next production stage or to deliver finished product, granted only after planned arrangements have been satisfactorily completed and records reviewed.

Action taken to eliminate the cause of a detected nonconformity and prevent its recurrence, including investigation, determination of causes, and review of the action's effectiveness.

Action taken to eliminate the cause of a potential nonconformity or other undesirable situation in order to prevent its occurrence, proportionate to the potential impact.

The recurring activity of enhancing the quality management system and its processes, using data such as feedback, audits, and nonconformities, and considering the organization's defined scope and regulatory obligations.

A systematic, independent, and documented examination of the quality management system or its processes to determine whether they conform to planned arrangements and are effectively implemented and maintained.

An organization designated by a regulatory authority to assess conformity of medical devices against applicable requirements, often including review of the manufacturer's quality management system.

An undesirable occurrence involving a device that has caused or could have caused harm, which may trigger investigation, reporting, and action under applicable regulatory requirements.

A formal process for reviewing, approving, and recording changes to product, processes, documents, or software before implementation, to assess their impact on conformity and regulatory status.

A detailed, task-level document describing how a specific operation is performed, often referenced by a procedure and used to ensure consistent execution at the point of use.