CQI IRCA QMS LA key terms

A set of interrelated or interacting processes and resources an organization uses to direct and control quality, aimed at meeting customer and applicable requirements and enhancing satisfaction.

Managing activities as interrelated processes that together transform inputs into outputs, so the system's results are understood and controlled as a whole rather than as isolated tasks.

Considering uncertainty and its potential effects when planning and running the quality management system, so risks and opportunities are identified and addressed rather than reacted to after the event.

The combination of internal and external issues, and interested parties and their relevant requirements, that can affect how an organization's quality management system is designed and operated.

Information an organization must control and maintain, including documents needed to support operation of its processes and records that provide evidence that planned results were achieved.

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, procedures or standards against which audit evidence is compared to decide whether the audited activity conforms and performs as intended.

Arrangements for one or more audits planned for a specific period, covering schedule, resources and activities, and typically managed to improve the organization's audit performance over time.

The stated purpose of a single audit, such as determining conformity, evaluating effectiveness or identifying improvement opportunities, which drives the audit scope, criteria and evidence needed.

The extent and boundaries of an audit, including the organizational units, locations, processes, functions and period of time covered, agreed with the auditee before the audit begins.

An audit performed by an external organization that is independent of both the auditee and its customer, typically to certify conformity with a standard such as ISO 9001.

The ability to apply knowledge, skills and demonstrated behaviour to achieve intended results, including the education, training and experience needed to perform audit tasks effectively.

Basing judgements only on the evidence found and being free from bias, conflict of interest or pressure that could influence audit conclusions; auditors must remain independent of the activity being audited.

The duty to keep information obtained during an audit secure and disclose it only with the auditee's permission or as required by law, protecting both audit evidence and personal or commercial data.

Applying the skill, judgement and diligence that a reasonable auditor would exercise, taking care in evidence gathering and reporting to produce credible, fair and defensible audit conclusions.

The behavioural qualities expected of an auditor, such as being ethical, open-minded, diplomatic, observant, perceptive, adaptable and tenacious, which support effective communication and sound judgement during audits.

A description of the activities, timing, locations, team assignments and resources for a specific audit, prepared to keep the audit focused and achievable within agreed time and scope.

A preparatory examination of the auditee's system documentation, such as policies, process descriptions and records, to understand the system and identify areas needing attention during the audit.

Materials the audit team prepares and uses during the audit, such as checklists, sampling plans, forms and audit notes, which help structure evidence gathering and support findings.

A formal meeting at the start of an audit to confirm the audit plan, scope, criteria, methods, communications and confidentiality, and to give the auditee an opportunity to ask questions.

Records, statements of fact or other information relevant to the audit criteria that the auditor collects and evaluates; it must be verifiable and sufficient to support findings and conclusions.

Selecting a portion of the available information or items and examining it as a basis for drawing conclusions about the whole, used when examining all evidence would be impractical.

A planned conversation with auditee personnel to gather information and verify evidence; the auditor should ask open questions, listen carefully and confirm understanding of the answers received.

The result of evaluating audit evidence against audit criteria, which may indicate conformity or nonconformity, and which is recorded and communicated to the auditee for action.

A nonconformity that seriously affects the quality management system's ability to achieve intended results or that indicates a systemic failure, typically requiring immediate correction and prompt verification.

A nonconformity that is isolated or does not seriously undermine the effectiveness of the system, but which still requires correction and investigation of cause to prevent recurrence.

An observation on a possible enhancement to the system or its processes that is not a nonconformity; it may be recorded and communicated, but is not binding in the same way as a finding.

A formal meeting at the end of an audit where the audit team presents findings, conclusions and recommendations, explains the basis of grading, and agrees follow-up actions and reporting timelines with the auditee.

A documented record of the audit that provides the audit scope, criteria, findings, conclusions including grading of nonconformities, and, where applicable, recommendations and agreed follow-up actions.

An action taken to remove a detected nonconformity, such as repair, rework or replacement; it fixes the immediate problem but does not by itself address the underlying cause.

Action taken to eliminate the cause of a nonconformity and prevent it from recurring, typically following analysis of root cause and followed by checks that the action was effective.

A structured investigation to identify the underlying reason a nonconformity occurred, rather than just its symptoms, so corrective action can target the true cause and prevent recurrence.

The follow-up activity in which the auditor checks that corrective action has been implemented as planned and is effective in preventing recurrence, and records the result for closure of the finding.

The auditor who is responsible for managing the audit, including planning, team direction, communication with the auditee, resolving differences and approving the audit report and its conclusions.

An independent organization that audits and certifies management systems against standards such as ISO 9001, operating under accreditation and issuing certificates with a defined scope and validity.

A national or international organization that formally recognizes a certification body as competent to perform specific certification activities, providing oversight through assessment and ongoing surveillance.

The initial phase of a certification audit that reviews the client's documentation and readiness, confirms scope and criteria, and identifies areas of concern to be addressed before stage 2.

The main certification audit phase that evaluates implementation and effectiveness of the management system on site, gathering evidence to decide whether certification can be recommended.

A periodic audit after certification, usually annual, to confirm the certified management system continues to conform and remains effective, and to check that changes are properly managed.

A full audit carried out before a certificate expires, typically every three years, to decide whether certification should be renewed for a further cycle.