CQI IRCA QMS LA flashcards

32 cards. Read the term and the definition here. The deck at the top of this page is optional.

Seven quality management principles

Customer focus, leadership, engagement of people, process approach, improvement, evidence-based decision making and relationship management - the foundation of ISO 9001:2015.

Documented information

Information required to be controlled and maintained by the organization and the medium on which it is contained; ISO 9001:2015 replaces 'documents' and 'records' with this term.

Clause 6.1 risks and opportunities

Requires the organization to determine risks and opportunities that need to be addressed, plan actions, integrate them into QMS processes and evaluate their effectiveness.

Non-applicable clause 8 requirements

Only requirements of clause 8 may be deemed not applicable; justification must be maintained as documented information and the scope statement must explain it.

Audit definition ISO 19011

A systematic, independent and documented process for obtaining objective evidence and evaluating it objectively to determine the extent to which audit criteria are fulfilled.

Audit programme

Set of arrangements for a set of audits planned for a specific time frame and directed at a specific purpose; managed through establish, implement, monitor, review and improve.

Second-party audit

An external audit performed by or on behalf of a party having an interest in the organization, typically a customer auditing a supplier or a purchasing organization auditing a provider.

Audit criteria

Set of requirements used as a reference against which objective evidence is compared; may include standards, procedures, regulations, contracts and management system requirements.

Auditor competence

Demonstrated ability to apply knowledge and skills; it comprises education, training, experience, audit knowledge and skills, and personal attributes.

Independence in auditing

Auditors must be free from bias and conflict of interest and, wherever practicable, independent of the activity being audited; internal auditors cannot audit their own work.

Lead auditor competence

Additional ability to manage an audit, lead the team, plan and prioritize, communicate with client and auditee, resolve conflict and reach audit conclusions.

Due professional care

Audit principle requiring auditors to exercise care and judgment in accordance with the importance of the task and the confidence placed in them by clients and interested parties.

Audit plan contents

Includes objectives, scope, criteria, dates and locations, expected time, roles, resources, audit methods and sampling; agreed with the client and communicated to the auditee.

Working documents

Checklists, sampling plans, forms and the audit plan used by the audit team; retained until no longer needed and protected for confidentiality.

Documentation review purpose

To determine whether the auditee's documented information conforms to the audit criteria and to identify areas requiring attention and sampling during the audit.

Audit scope

The extent and boundaries of an audit, including locations, organizational units, activities, processes and time period covered, as stated in the audit plan.

Objective evidence

Verifiable data, records or statements of fact pertaining to the audit criteria; evidence is gathered through interviews, observation and review of documents.

Open questions

Questions beginning with what, how, when, where or why that invite explanation and yield richer information than closed questions, which can be leading or narrow.

Opening meeting purpose

To confirm the audit plan, scope and criteria, introduce the team, explain methods, confirm communication, confidentiality and safety arrangements, and agree the closing meeting.

Audit sampling

Examining less than the total population of available information; the sample should be representative and based on risk, and findings may indicate a systemic issue.

Nonconformity definition

Non-fulfilment of a requirement; graded as major or minor by the audit team according to the audit programme's classification rules and the assessed risk.

Major nonconformity

A significant failure such as absence of a required system element, a systemic breakdown, or a lapse that would likely cause the QMS to fail to deliver conforming product.

Minor nonconformity

An isolated lapse or single observed departure from a requirement that is not systemic and does not by itself indicate a breakdown of the management system.

Nonconformity statement content

States the requirement not fulfilled (criterion), the objective evidence observed, and where and when it was found, so the auditee can investigate the cause.

Audit report content

Objectives, scope and criteria, dates and locations, audit team, findings, conclusions and any statement of conformity; issued within the agreed time frame and owned by the client.

Corrective action

Action to eliminate the cause of a nonconformity and prevent recurrence; it is distinct from correction, which only fixes the immediate nonconformity.

Follow-up audit

Verification of the implementation and effectiveness of corrective action, carried out by desk review or on site and sometimes deferred to the next scheduled audit.

Closing meeting purpose

To present findings and conclusions, explain nonconformity grading, agree correction and corrective action timescales, and confirm follow-up arrangements with the auditee.

Stage 1 certification audit

Assesses readiness for stage 2, including documented information, scope, completion of internal audit and management review, and identification of areas of concern.

Surveillance audit frequency

At least once a calendar year after initial certification, except in the recertification year; the certification cycle is typically three years.

Impartiality in certification

Certification bodies shall not provide consultancy and shall manage conflicts of interest; auditors cannot audit organizations they have consulted for within the defined period.

Lead auditor role

Plans and leads the audit, assigns tasks, communicates with the client, controls the audit, determines findings and conclusions, and signs the audit report.