ISO 9001 LI flashcards

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

Seven QMS principles

Customer focus, leadership, engagement of people, process approach, improvement, evidence-based decision making, and relationship management underpin ISO 9001 quality management systems.

Process approach

Managing activities as interrelated processes that transform inputs into outputs, with defined sequence, interactions, criteria, resources, and performance measures to achieve intended results.

PDCA in ISO 9001

Plan covers clauses 4 to 6, Do covers 7 and 8, Check covers 9, and Act covers 10, linking requirements to a continual improvement cycle.

Documented information

Information required to be controlled and maintained by the organization and the medium on which it is contained; ISO 9001 uses maintain for documents and retain for records.

Certification vs accreditation

Certification is third-party attestation that an organization's QMS conforms to ISO 9001; accreditation is authoritative recognition that the certification body competently performs certification activities.

Gap analysis

A structured comparison of the organization's current QMS against ISO 9001 clause requirements, identifying conformities, gaps, priorities, and actions needed before implementation.

QMS scope

Documented statement of the products, services, sites, processes, and boundaries covered by the quality management system, including justified exclusions limited to clause 8.3.

Context of organization

Internal and external issues relevant to the organization's purpose and strategic direction that can affect the QMS and its intended outcomes, assessed under clause 4.1.

Interested party

Person or organization that can affect, be affected by, or perceive itself to be affected by a decision or activity; relevant requirements must be determined under clause 4.2.

Quality policy

Documented top-management statement appropriate to purpose and context, providing a framework for measurable quality objectives and commitment to requirements and continual improvement.

Quality objective

Measurable result to be achieved, consistent with the quality policy, relevant to functions and levels, monitored, communicated, and updated; documented information is maintained under clause 6.2.

Risk-based thinking

Systematic consideration of uncertainty and potential effects, used to determine risks and opportunities, plan actions, integrate them into processes, and evaluate effectiveness under clause 6.1.

Planning of changes

Clause 6.3 requires changes to the QMS to be carried out in a planned manner, considering purpose, consequences, resources, responsibilities, and authorities.

Process planning

Defining process inputs, outputs, sequence, interactions, criteria, methods, resources, competences, responsibilities, risks, and improvement opportunities needed to achieve planned results.

Operational planning and control

Clause 8.1 requires processes needed to meet product and service requirements to be planned, implemented, controlled, and documented, including criteria, resources, and control of outsourced processes.

Design and development inputs

Requirements essential to design and development, including functional, performance, statutory, regulatory, and information derived from similar activities, reviewed for adequacy and completeness.

External provider control

Clause 8.4 requires criteria for evaluation, selection, monitoring, and re-evaluation of external providers, and control type and extent based on potential impact.

Nonconforming outputs

Outputs that do not meet requirements must be identified and controlled to prevent unintended use or delivery, with appropriate action and retained records under clause 8.7.

Competence

Ability to apply knowledge and skills to achieve intended results; organizations must determine necessary competence, ensure it, and evaluate effectiveness of actions taken under clause 7.2.

Internal audit programme

Planned schedule of audits considering process importance, changes, and prior results, with defined criteria, scope, methods, competent impartial auditors, and reporting to management under clause 9.2.

Management review inputs

Clause 9.3 inputs include action status, context changes, satisfaction, objectives, process and product performance, nonconformities, audit results, provider performance, resources, risk actions, and improvement opportunities.

Customer satisfaction monitoring

Clause 9.1.2 requires determining methods to obtain, monitor, and review customer perception of need and expectation fulfillment, with results analyzed and used for improvement.

Measurement traceability

Property of a measurement result whereby it can be related to a reference standard through an unbroken chain of calibrations, each contributing stated uncertainty; required when monitoring and measurement validity depends on it.

KPI

Quantifiable performance measure tied to a critical success factor or process objective, with defined formula, data source, frequency, target, and owner used to evaluate effectiveness.

Correction vs corrective action

Correction eliminates a detected nonconformity, such as rework or replacement; corrective action eliminates the cause to prevent recurrence, requiring root cause analysis and effectiveness review.

Root cause analysis

Structured investigation to identify underlying system or process causes of a nonconformity, using methods such as 5 Whys, fishbone, fault tree, or Pareto analysis.

Continual improvement

Recurring activity to enhance performance, through clause 10.1 opportunities and clause 10.2 corrective actions, supported by PDCA, performance data, and management review.

Corrective action effectiveness

Degree to which planned corrective action eliminates causes of nonconformity and prevents recurrence, verified through data trends, follow-up audits, and process performance.

Stage 1 certification audit

Initial audit evaluating QMS documentation, scope, context, readiness for stage 2, and whether internal audit and management review have been performed; it is not full conformity verification.

Stage 2 certification audit

On-site evaluation of implementation and effectiveness of the QMS against ISO 9001 and applicable requirements, including process performance, operational control, and management commitment.

Major nonconformity

Audit finding that significantly affects QMS capability or product/service conformity, or a total requirement failure; certification is normally withheld until correction and verification are completed.

Surveillance audit

Periodic post-certification audit to verify continued conformity and improvement; first surveillance typically occurs within 12 months of the certification decision, with recertification at least every three years.