ISO 9001 LA flashcards
ISO 9001 LA · Build recall with a focused review session.
32 cards. Read the term and the definition here. The deck at the top of this page is optional.
- Quality management system
- A set of interrelated or interacting processes and resources needed to establish quality objectives and achieve results that satisfy customers and applicable requirements.
- Process approach
- Management of interrelated processes as a coherent system, including inputs, outputs, sequence, interaction, controls, and performance, to achieve consistent and predictable results.
- PDCA cycle
- A cycle of Plan, Do, Check, Act: establish objectives and processes, implement them, monitor results against requirements, and improve performance.
- Risk-based thinking
- An approach that determines risks and opportunities affecting product or service conformity and customer satisfaction, and plans actions to address them.
- Seven quality management principles
- Customer focus, leadership, engagement of people, process approach, improvement, evidence-based decision making, and relationship management.
- Documented information
- Information required to be controlled and maintained by the organization, including documents that communicate requirements and records that provide evidence of results.
- Maintain versus retain
- To maintain documented information is to keep procedures or instructions current; to retain documented information is to keep records as evidence of results.
- Quality policy
- Top management's documented statement of quality intentions and direction, including commitment to satisfy applicable requirements and to continually improve the QMS.
- Quality objectives
- Measurable results to be achieved at relevant functions, levels, or processes, consistent with the quality policy and monitored for progress.
- Nonconforming outputs
- Products, services, or process outputs that do not meet requirements; they must be identified, controlled, and prevented from unintended use or delivery.
- Audit
- A systematic, independent, documented process for obtaining objective evidence and evaluating it objectively to determine the extent to which audit criteria are fulfilled.
- Audit criteria
- A set of policies, procedures, requirements, or standards used as a reference against which audit evidence is compared and evaluated.
- Objective evidence
- Verifiable data, records, statements of fact, or information about a process or activity that can be demonstrated to be true.
- Audit finding
- The result of evaluating collected audit evidence against audit criteria; it can indicate conformity or nonconformity with a requirement.
- Audit principles
- Integrity, fair presentation, due professional care, confidentiality, independence, evidence-based approach, and risk-based approach guide auditor conduct and audit reliability.
- Audit plan
- A description of the activities and arrangements for a specific audit, including schedule, locations, methods, team roles, and criteria.
- Document review
- Examination of QMS documented information before or during an audit to understand processes and identify areas requiring further evidence.
- Audit sampling
- Selecting a subset of items from a population to obtain and evaluate evidence about characteristics of that population.
- Audit team leader
- The person responsible for managing an audit and its team, communicating with client and auditee, and issuing the audit report.
- Opening meeting
- A formal meeting at the start of an audit to confirm scope, objectives, criteria, plan, communication arrangements, and resource availability.
- Audit trail
- A sequence of evidence showing how an auditor moved from an audit criterion through collected evidence to a finding or conclusion.
- Nonconformity
- Non-fulfilment of a requirement; in an audit it is supported by objective evidence and a cited requirement or audit criterion.
- Major nonconformity
- A certification-scheme classification for a nonconformity that affects the management system's capability to achieve intended results and usually requires prompt correction.
- Finding classification
- A decision rule assigning nonconformities as major or minor according to certification scheme rules and impact on QMS effectiveness.
- Audit report
- A documented record of audit objectives, scope, criteria, findings, and conclusions that provides the basis for improvement and certification decisions.
- Closing meeting
- A meeting at the end of an audit to present findings and conclusions, explain sampling limitations, and clarify follow-up expectations.
- Corrective action
- Action to eliminate the cause of a nonconformity and prevent recurrence, distinct from correction, which only fixes the immediate problem.
- Audit completion
- The point at which all planned audit activities are finished and the audit report has been issued; follow-up may still continue.
- Audit programme
- A set of one or more audits planned for a specific time frame and directed toward a specific purpose.
- Programme manager
- The person responsible for establishing, implementing, monitoring, reviewing, and improving the audit programme and ensuring adequate resources.
- Audit frequency
- The determination of how often audits occur, based on risk, process performance, changes, complaints, and results of previous audits.
- Programme review
- An evaluation of the audit programme at planned intervals to assess whether its objectives are met and to identify improvements.