PECB ISO 9001 Foundation key terms

A set of interrelated or interacting elements an organization uses to establish quality policy and objectives, and the processes needed to achieve those objectives and deliver conforming outputs.

Managing activities as interrelated processes that transform inputs into outputs, so that the system's results are understood and controlled as a coherent whole rather than as isolated tasks.

A set of interrelated or interacting activities that uses or converts inputs to deliver an intended result, with defined responsibilities, resources, controls and performance indicators.

The dependencies and handoffs between processes, including sequence, information flow and combined effects, which must be understood and managed to achieve planned results.

A way of working that considers uncertainty and its potential effects when planning and operating the QMS, so that preventive action is built into processes rather than added after problems appear.

The effect of uncertainty on an expected result, which can be negative; in a QMS, risks are identified and addressed to increase the likelihood of achieving planned outcomes and preventing undesired effects.

A favourable circumstance arising from uncertainty that can be exploited to achieve improved results, such as new markets, new technology or improved efficiency, and which is addressed alongside risks.

Planned measures integrated into QMS processes and their operation, proportionate to the potential impact, intended to give assurance that the system achieves intended results and prevents or reduces undesired effects.

The person or group of people who directs and controls an organization at the highest level, with authority to provide resources and to integrate QMS requirements into the organization's business processes.

The active involvement of top management in establishing quality policy and objectives, promoting the process approach and risk-based thinking, ensuring resources, and communicating the importance of conformity.

The principle of understanding current and future customer needs, meeting requirements and striving to exceed expectations, with customer satisfaction monitored as a measure of QMS performance.

The customer's perception of the degree to which their expectations have been fulfilled, monitored through feedback such as complaints, surveys, returns and repeat business.

A person or organization that can affect, be affected by, or perceive itself to be affected by a decision or activity, such as customers, employees, suppliers, regulators or owners.

The combination of internal and external issues, and interested parties and their relevant requirements, that the organization must consider when establishing and operating its QMS.

The documented boundaries and applicability of the quality management system, including the products and services covered and any justified exclusion of requirements that do not affect conformity.

A short statement, issued by top management, of the organization's overall intentions relating to quality, providing a framework for setting quality objectives and a commitment to meet applicable requirements.

A measurable result to be achieved relating to quality, consistent with the quality policy, set for relevant functions, levels and processes, and monitored with defined plans for achievement.

A measurable value used to track how well a process or the QMS achieves intended results, providing evidence for evaluation and decisions about improvement.

Determining the status of a system, process, product or activity by observation or checking at planned intervals, distinct from measurement, which assigns a value.

A process of experimentally obtaining one or more values that can reasonably be attributed to a quantity, supported by suitable and maintained equipment where required.

A need or expectation that is stated, generally implied, or obligatory, including customer requirements, legal and regulatory requirements, and the requirements of the standard itself.

Fulfilment of a requirement, whether that requirement comes from the customer, a regulation, the standard or the organization's own documented arrangements.

Non-fulfilment of a requirement, which must be controlled, corrected and, where appropriate, analysed to remove the cause so that it does not recur.

Action taken to eliminate a detected nonconformity, such as rework, repair, regrading, or informing the customer, without necessarily addressing the underlying cause.

Action taken to eliminate the cause of a nonconformity and prevent recurrence, proportionate to the effects encountered and recorded as evidence of what was done.

Ongoing activity to enhance performance, ranging from small incremental changes to breakthrough change, supported by data analysis and evaluation of the QMS's effectiveness.

Recurring activity to enhance performance over time, planned and driven through objectives, data analysis, audits, management review and actions arising from nonconformities.

The extent to which planned activities are realized and planned results are achieved, used to judge whether processes and the QMS itself are delivering what was intended.

Information required to be controlled and maintained by an organization, covering both documents that provide guidance and records that provide evidence of results achieved.

Information and the medium on which it is contained, such as a procedure, work instruction, drawing or form, that provides guidance on how something should be done.

Documented information retained as evidence of results achieved or activities performed, which is not revised but controlled for identification, storage, protection, retrieval and retention.

A specified way to carry out an activity or process, which may be documented or not, and which describes responsibilities, sequence and controls for consistent execution.

A detailed, task-level document describing how a specific operation is performed, often used where the consequences of error are significant or the task is complex.

The ability to apply knowledge and skills to achieve intended results, determined through education, training or experience and evaluated to confirm its effectiveness.

The state of staff understanding the quality policy, their contribution to QMS effectiveness, and the implications of not conforming with requirements.

A systematic, independent and documented examination of the QMS against planned arrangements and standard requirements, performed by objective auditors at planned intervals.

A planned, top-management examination of the QMS's suitability, adequacy and effectiveness, using defined inputs and producing decisions and actions on improvement, resources and change.

A process needed for the QMS that an external provider performs, for which the organization must determine and apply controls to ensure it meets requirements.

An organization or person that supplies a product or service to the organization, evaluated, selected and monitored according to criteria based on their impact on conformity.