ISO 13485:2016 Vocabulary Flashcards

These flashcards cover key terms and definitions related to ISO 13485:2016, focusing on quality management systems for medical devices.

Quality Management System (QMS)

A structured system of processes and procedures to ensure that an organization meets customer and regulatory requirements for the consistent provision of products or services.

Medical Device

An instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software, material, or article intended for use in humans for specific medical purposes.

Regulatory Requirements

Requirements outlined in laws, regulations, or directives that organizations must comply with when producing medical devices.

Risk Management

The systematic approach to identifying, evaluating, controlling, and monitoring risks associated with the safety and performance of medical devices.

Design and Development

The comprehensive process of creating and developing a medical device, including planning, input determination, output verification, and validation.

Nonconforming Product

A product that does not meet specified requirements or standards set forth for it, identified upon inspection or measurement.

Customer Focus

The commitment of an organization to understanding and meeting the needs and expectations of its customers.

Management Review

A systematic evaluation process to assess the performance and effectiveness of the quality management system at planned intervals.

Document Control

The process whereby documents are reviewed, approved for adequacy, and managed to ensure correctness and up-to-date status.

Traceability

The ability to track and trace the history, application, or location of an item, such as a medical device, throughout its lifecycle.

Clinical Evaluation

The assessment and analysis of clinical data to verify the clinical safety and performance of a medical device.

Sterile Medical Device

A medical device that is validated to meet sterility requirements as necessary for its intended use.

Corrective Action

Action taken to eliminate the cause of an existing nonconformity or any other undesirable situation to prevent recurrence.

Preventive Action

Action taken to eliminate the cause of a potential nonconformity or of any undesired situation to prevent occurrence.

Advisory Notice

A notice issued to provide supplementary information or advise on action to be taken related to a medical device.

Supplier Evaluation

The process of assessing and selecting suppliers based on their ability to provide products that meet specified requirements.

Validation

Confirmation through the provision of objective evidence that the requirements for a specific intended use or application have been fulfilled.

Quality Objectives

Specific goals set by an organization relevant to quality, aimed at guiding performance and improvement efforts.

Infrastructure

The physical and organizational structures and facilities needed for the operation of a medical device organization.