CMDA key terms

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 regulations used as a reference against which audit evidence is compared; they define what the auditor evaluates.

Records, statements of fact, or other information that are relevant to the audit criteria and can be verified; evidence may be qualitative or quantitative.

Verifiable data or facts, such as records, observations, or measurements, that support the existence or truth of something and are not based solely on opinion.

The extent and boundaries of an audit, including the organizational units, processes, locations, and time period covered; it defines what the audit will and will not examine.

A description of the activities and arrangements for an audit, including schedule, auditees, areas to examine, and assigned auditors.

A set of interrelated audit activities planned for a specific time frame and directed toward achieving a specific purpose, often covering multiple audits.

An auditor who is designated to manage an audit team, including planning, conducting, reporting, and following up on the audit.

The demonstrated ability to apply knowledge, skills, and personal attributes needed to perform audit activities effectively and ethically.

Freedom from conditions that threaten objectivity, such as being audited by someone with responsibility for the activity being audited.

The presence of objectivity and absence of bias or conflict of interest in audit decisions and reporting; auditors must base conclusions on evidence rather than personal or commercial interests.

Selecting a subset of records, items, or processes for examination when examining all available evidence is impractical, to draw conclusions about the whole.

A meeting at the start of an audit to confirm scope, criteria, schedule, roles, and audit methods with the auditee.

A meeting at the end of an audit to present findings, conclusions, and any required follow-up to the auditee and relevant management.

A planned conversation with auditees to gather information and clarify evidence, using open and probing questions while avoiding leading or judgmental language.

Failure to meet a requirement specified in audit criteria, such as a regulation, standard, procedure, or contractual obligation.

A nonconformity that significantly affects product safety, regulatory compliance, or the effectiveness of the quality management system, or that indicates a systemic failure.

A nonconformity that is isolated or limited in impact and does not indicate a systemic breakdown of the quality management system.

A statement of fact noted during an audit that does not constitute a nonconformity but may indicate a risk, weakness, or opportunity for improvement.

A suggestion, not a requirement, identifying a possible way to enhance effectiveness or efficiency without implying a failure to meet criteria.

Action taken to eliminate the cause of a detected nonconformity and prevent recurrence; it addresses root cause rather than only correcting the observed problem.

Action taken to eliminate the cause of a potential nonconformity or other undesirable situation to prevent occurrence.

A structured process for correcting problems and preventing their recurrence or occurrence, typically including investigation, root cause analysis, action planning, implementation, and effectiveness verification.

A systematic method to determine the underlying reason a problem occurred, rather than merely describing symptoms or the immediate cause.

A set of interrelated processes, responsibilities, and resources used to direct and control an organization with regard to quality.

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

A structured set of procedures and records used to control the design process and ensure that device design requirements are met and verified before release.

A compilation of records documenting the design history of a finished device, demonstrating that the design was developed in accordance with the approved design plan.

A systematic process for identifying, evaluating, controlling, and monitoring risks to patients, users, and others throughout the device lifecycle.

An international standard that provides a framework and requirements for applying risk management to medical devices, including risk analysis, evaluation, control, and monitoring.

Establishing by objective evidence that a process consistently produces a result or product meeting predetermined requirements; it is required when output cannot be fully verified by subsequent inspection or testing.

Installation, operational, and performance qualification: sequential validation activities confirming equipment is installed correctly, operates as intended, and performs consistently under production conditions.

A compilation of records containing the procedures and specifications for a finished device, including production, quality assurance, packaging, and labeling requirements.

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

Top management's periodic evaluation of the quality management system to ensure its continuing suitability, adequacy, and effectiveness, including decisions on improvement.

An audit conducted by an organization on itself, or by a party on its behalf, to evaluate its own quality management system or processes.

An audit performed at a supplier's site or remotely to evaluate the supplier's ability to meet specified quality and regulatory requirements.

An independent audit by a certification body to assess whether an organization's management system conforms to a standard and can be certified.

A periodic audit after initial certification to verify continuing conformity and effective maintenance of the management system; it is usually narrower than a recertification audit.

A documented record of audit results, including scope, criteria, findings, conclusions, and any recommendations, provided to relevant parties.