ISO 9001 LI key terms

A set of interrelated or interacting processes and documented information that an organization uses to direct and control activities so that products and services consistently meet customer and applicable requirements.

Managing the organization as a network of interrelated processes, understanding how each process's inputs, outputs and interactions affect the ability to achieve intended results, rather than managing departments in isolation.

A four-phase method - Plan, Do, Check, Act - for managing and continually improving processes: set objectives and plan, implement, monitor results against requirements, then act to improve performance.

Considering uncertainty and its potential effects on process and system performance when planning and operating the QMS, so that adverse effects are prevented and opportunities for improvement are captured.

A person or organization that can affect, be affected by, or perceive itself to be affected by a decision or activity - for example customers, employees, suppliers, regulators, owners or the local community.

The combination of internal and external issues - legal, technological, competitive, cultural and organizational - that are relevant to the organization's purpose and affect its ability to achieve intended QMS results.

Information that must be controlled and maintained by the organization, in any medium and from any source, covering both documents that provide guidance and records that provide evidence of results.

The person or group of people who direct and control the organization at the highest level - the level that can authorize resources and delegate authority within the QMS.

A short statement, issued by top management, of the organization's overall intentions and direction related to quality; it provides a framework for setting quality objectives and is communicated and understood.

A result to be achieved that is related to quality, set for relevant functions, levels and processes, and that is measurable, monitored and consistent with the quality policy.

Seven foundational principles - customer focus, leadership, engagement of people, process approach, improvement, evidence-based decision making and relationship management - that underpin ISO 9001 and guide its interpretation.

A structured comparison of the organization's current practices and documentation against ISO 9001 requirements, used at the start of a project to identify what already exists and what must be built.

A documented statement of the boundaries and applicability of the quality management system, listing the products, services, sites and processes covered, and justifying any ISO 9001 requirement that is not applicable.

A schedule of activities, responsibilities, resources, milestones and deliverables that guides the organization from gap analysis through planning, operation, internal audit and readiness for certification.

A high-level diagram showing the sequence and interaction of the organization's core, support and management processes, and the flow of inputs and outputs between them.

A controlled record listing identified risks and opportunities, their causes and consequences, an assessment of likelihood and impact, assigned owners, and the planned actions and status of those actions.

A one-page analysis tool that describes a process through its inputs, outputs, activities, people, equipment, methods and performance measures, used to define processes and their interactions.

The combination of education, training, skills and experience needed for a person to perform assigned work correctly; it must be determined, provided, evaluated and evidenced by the organization.

The planning and control of the activities needed to deliver products and services, including defined criteria, resources, monitoring, and control over outsourced processes and external providers.

Equipment, software and personnel used to verify conformity, controlled to ensure results are valid - including identification, calibration or verification against traceable standards, and protection from damage or adjustment.

An organization or person outside the QMS that supplies a process, product or service used by the organization; its selection, evaluation, monitoring and performance must be controlled.

A product or service that does not meet requirements at any stage of its realization; it must be identified and controlled to prevent unintended use or delivery, and appropriate action taken.

A systematic, independent and documented examination of the QMS by the organization itself, against planned arrangements, its own requirements and ISO 9001, to determine whether it is effectively implemented.

A planned top-management examination of the QMS, using defined inputs such as audit results and performance data, which produces decisions and actions on improvement, change and resources.

A measurable value, selected to show how effectively a process or the QMS achieves key objectives, tracked over time and usually compared with a target or trend.

Converting monitored and measured data into information about performance, trends and the effectiveness of the QMS, and using that information to support decisions and improvement.

The customer's perception of the degree to which its requirements and expectations have been fulfilled, monitored by the organization as one measure of QMS output and effectiveness.

Action taken to eliminate the cause of a detected nonconformity so that it does not recur, including review of the problem, determination of causes and evaluation of the need for changes to the QMS.

A structured technique such as 5 Whys or a cause-and-effect diagram used to trace a problem back to its underlying cause rather than its symptom, so that corrective action can be effective.

Failure to meet a requirement - of the standard, of the organization's own QMS, of the customer, or of a legal regulation; documented and followed up with correction and corrective action as needed.

Recurring activity to enhance performance, driven by data and analysis, the quality policy and objectives, audit findings and management review, rather than a series of one-off corrective actions.

An independent third party, typically accredited, that audits an organization's QMS against ISO 9001 and issues a certificate confirming conformity within a defined scope.

Formal recognition by a national or international authority that a certification body is competent and impartial to carry out ISO 9001 audits in specific technical areas.

The initial, often partly documentation-focused assessment in which the auditor reviews the organization's readiness, understanding and planning before on-site evaluation of implementation begins.

The main certification audit, conducted on site, which evaluates the implementation and effectiveness of the QMS against all applicable ISO 9001 requirements and the organization's own arrangements.

Periodic audits during the three-year certification cycle that check continued conformity, handling of changes and follow-up of previous findings in key parts of the QMS.

A significant failure to fulfil a requirement, or a systemic problem, that undermines the QMS's ability to achieve intended results; it typically blocks certification until corrected and verified.