API QUSE key terms

A structured set of documented processes, responsibilities, and resources an organization uses to consistently meet customer and regulatory requirements and to improve its performance over time.

A short formal statement from top management expressing the organization's overall intentions and direction regarding quality, which frames how quality objectives are set and reviewed.

A measurable target related to quality that the organization commits to achieve, typically set at relevant functions and levels and tracked for progress.

Managing an organization as a network of interrelated processes, understanding how their inputs, outputs, and interactions affect the ability to achieve intended results.

A set of interrelated or interacting activities that transforms inputs into outputs, with defined start and end points, owners, and measures of performance.

The person assigned authority and accountability for a process, including its design, performance, resources, and improvement, and who is a natural point of contact for auditors.

A specified way to carry out an activity or process, often documented, that describes who does what, when, and how to achieve consistent results.

A detailed, task-level document telling an operator exactly how to perform a specific step or activity, typically more granular than a procedure.

Information the organization must control and maintain, including documents that provide guidance and records that provide evidence of results achieved.

Documented information retained as evidence of results achieved or activities performed, which is not revised but protected from alteration and retained for a defined period.

The practices that ensure documents are approved before use, available where needed, current, legible, and withdrawn or marked when obsolete.

A way of planning and operating a QMS that identifies what could go wrong or right and takes proportionate action to prevent undesirable outcomes and seize opportunities.

The effect of uncertainty on an intended result, usually described in terms of likelihood of occurrence and severity of consequences if it happens.

A favorable circumstance or possibility that an organization can act on to improve results, such as a new market, method, or capability.

The recurring activity of enhancing performance, often through incremental steps, by identifying and acting on opportunities and the causes of poor results.

A four-stage improvement loop of Plan, Do, Check, and Act in which plans are executed, results are checked against targets, and actions are taken to improve.

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

A quantifiable measure chosen to track how well a process or the QMS is achieving a critical objective, used to guide decisions and improvement.

The demonstrated ability to apply knowledge and skills to achieve intended results, often verified through education, training, experience, or assessment.

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 requirements, policies, standards, procedures, or contractual obligations against which audit evidence is compared to reach findings.

A statement of the extent and boundaries of an audit, including the organizational units, locations, processes, and time period covered.

The purpose or intended outcome of an audit, such as verifying conformity, evaluating effectiveness, or assessing readiness for certification.

A description of the activities and arrangements for an audit, covering schedule, areas to be audited, team assignments, and the methods to be used.

A set of one or more audits planned for a specific time frame and directed at a specific purpose, coordinated to achieve overall improvement goals.

The group of auditors and technical experts assigned to conduct an audit, led by an audit team leader who manages its activities.

The auditor designated to manage an audit, including planning, directing the team, controlling the audit process, and delivering the final report.

A person who provides specific knowledge or expertise to an audit team but who does not act as an auditor or perform audit functions.

The combination of education, training, experience, and personal attributes that enables an auditor to conduct audits effectively and make sound judgments.

How often a given area, process, or supplier is audited, set based on risk, past performance, criticality, and required coverage over time.

A structured list of questions or criteria used to guide an audit and record whether each item was verified, helping ensure coverage and consistency.

A short formal meeting at the start of an audit to confirm scope, criteria, schedule, roles, and logistics with the auditee's management.

A meeting at the end of an audit to present the audit findings, explain their basis, and agree on reporting and follow-up arrangements with the auditee.

Verifiable data, records, statements, or observations that support the existence or truth of something, gathered through interview, observation, or document review.

Records, statements of fact, or other information that is relevant to the audit criteria and verifiable, forming the basis for audit findings.

Confirming a fact by cross-checking two or more independent sources, such as an interview, a document, and direct observation, before drawing a conclusion.

Selecting a subset of items from a larger population to examine, with the aim of drawing reasonable conclusions about the whole.

The result of evaluating collected audit evidence against audit criteria, which may indicate conformity or nonconformity and is recorded and reported.

Fulfilment of a requirement, meaning the audited activity or output meets the applicable audit criteria.

The failure to meet a requirement, supported by objective evidence, which must be documented, corrected, and investigated for its cause.

A finding that does not meet the threshold of a nonconformity but indicates a weakness or opportunity for improvement worth noting to the auditee.

The documented sequence of evidence that allows an auditor to trace an activity or record from origin to outcome and back again.

The ability to follow the history, application, or location of an item or activity through recorded identification, often tested by working backward from output to source.

A planned conversation with personnel used to gather evidence about how work is performed and understood, ideally corroborated by observation and records.

The formal document that records the audit scope, criteria, findings, conclusions, and any agreed actions, distributed to relevant parties.

Action taken to eliminate the cause of a detected nonconformity so it does not recur, typically following root cause analysis and verified for effectiveness.

A structured investigation to identify the underlying reason a problem occurred, so that corrective action addresses the cause rather than only the symptom.

A later audit or verification activity that checks whether corrective actions were implemented and effective in preventing recurrence.

The defined length of time records must be kept before disposal, set by regulation, contract, or internal policy and monitored for compliance.