API QUSE flashcards
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32 cards. Read the term and the definition here. The deck at the top of this page is optional.
- Quality management principle count
- ISO 9001 is founded on seven quality management principles, from customer focus and leadership through improvement and evidence-based decision making.
- Process approach definition
- Managing interrelated activities as a system of processes with defined inputs, outputs, controls, and performance measures to achieve intended results consistently.
- PDCA cycle
- Plan sets objectives and processes, Do implements them, Check monitors and measures results, and Act takes action to improve performance.
- Documented information
- Information required to be controlled and maintained by the organisation, covering both documents that are maintained and records that are retained.
- Correction versus corrective action
- Correction eliminates a detected nonconformity; corrective action eliminates its root cause so it does not recur.
- Quality objective requirement
- Objectives must be measurable, consistent with the quality policy, relevant to conformity and customer satisfaction, monitored, and updated as needed.
- Management review inputs
- Inputs include audit results, nonconformities and corrective actions, process performance, resource adequacy, and risks and opportunities.
- Audit definition
- A systematic, independent, and documented process for obtaining objective evidence and evaluating it objectively against agreed audit criteria.
- Audit criteria
- The set of policies, procedures, standards, or requirements used as a reference against which objective evidence is compared during an audit.
- Audit evidence
- Records, statements of fact, or other verifiable information relevant to the audit criteria; only verifiable information qualifies as audit evidence.
- Third-party audit
- An audit performed by an independent external organisation, such as a certification or accreditation body, typically for certification purposes.
- Second-party audit
- An audit performed by or on behalf of a customer or other interested party with a contractual relationship to the audited organisation.
- Audit programme
- The set of arrangements for a specific subject covering multiple audits planned over time; each individual audit is one component.
- Auditor independence
- Auditors must not audit their own work; impartiality requires freedom from bias and conflicting interests that could override objectivity.
- Risk-based audit planning
- Allocating audit time, depth, and sampling to processes with higher risk, complexity, or impact on product and customer.
- Audit plan contents
- Objectives, scope, criteria, dates, sites, team roles, and schedule, communicated to the auditee and revised when circumstances change.
- Audit scope versus criteria
- Scope defines the extent and boundaries of the audit; criteria are the requirements against which evidence is evaluated.
- Pre-audit document review
- Reviewing procedures, records, prior findings, and performance data before the audit to focus sampling and interview questions.
- Audit sampling in planning
- Selecting sample size and coverage based on process volume, risk, and prior performance rather than convenience or availability.
- Opening meeting purpose
- Confirming purpose, scope, criteria, schedule, methods, confidentiality arrangements, and resources including escorts and access.
- Audit duration factors
- Duration depends on scope, complexity, number of personnel, and process risk, estimated during planning and adjusted if scope changes.
- Audit trail technique
- Following a thread from a record back to the process and forward to outputs to test process control, not just record existence.
- Evidence triangulation
- Using interviews, observation, and document review together so conclusions rest on multiple independent sources rather than a single method.
- Nonconformity statement elements
- A finding states the requirement, the objective evidence found, and the gap explaining how the evidence fails the requirement.
- Open versus closed questions
- Start with open questions to gather context, then probe with closed questions to confirm specifics; avoid leading questions.
- Effectiveness verification
- Checking whether a control achieves its intended result, not merely whether a procedure exists and is being followed.
- Objective evidence recording
- Recording evidence at the time of discovery with traceable identifiers such as dates, locations, personnel, and specific documents.
- Audit report contents
- Objectives, scope, criteria, dates and sites, team, findings, conclusions, and any limitations or divergences from the audit plan.
- Findings agreement with auditee
- Findings are reviewed with the auditee for factual accuracy before issue; disagreements on interpretation are recorded, not suppressed.
- Corrective action closure
- A nonconformity closes only when implemented action is verified effective; correction alone does not close it.
- Follow-up verification
- Confirming corrective actions were implemented and effective through document review, re-audit, or sampling of records.
- Audit programme review
- Using audit results, trends, and follow-up status to adjust future audit frequency, scope, and focus.