PECB ISO 9001 Foundation flashcards

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 elements of an organization used to establish quality policies and objectives, and the processes needed to achieve those objectives.

Customer focus principle

The quality management principle stating that the primary focus of quality management is meeting customer requirements and striving to exceed customer expectations.

Process approach

The systematic management of activities as interrelated processes that function as a coherent system, with defined inputs, outputs, and interactions, to achieve consistent and predictable results.

PDCA cycle

An iterative method for improvement: Plan establishes objectives and processes, Do implements, Check monitors and measures, and Act takes action to improve performance.

Risk-based thinking

Considering uncertainty and its potential effect on objectives, and taking proportionate action to address risk, without necessarily requiring a formal documented risk management process.

Continual improvement

A recurring activity to enhance performance, distinct from corrective action, which reacts to a specific nonconformity by eliminating its cause.

Documented information

Information required to be controlled and maintained by an organization, comprising documents that prescribe what to do and records that evidence results achieved.

Evidence-based decision making

The quality management principle that decisions based on the analysis and evaluation of data and information are more likely to produce desired results.

Relationship management principle

The quality management principle that organizations manage relationships with interested parties, such as suppliers, to optimize their impact on performance.

Interested party

A person or organization that can affect, be affected by, or perceive itself to be affected by a decision or activity of the organization.

Top management

The person or group of people who directs and controls an organization at the highest level, responsible for establishing policy and providing resources.

Quality objective

A result to be achieved related to quality, which should be consistent with the quality policy, measurable, monitored, communicated, and updated as appropriate.

Outsourced process

A process needed by the QMS that is performed by an external provider, which the organization must control to ensure conformity of products and services.

Context of the organization

The combination of internal and external issues, and interested party requirements, that can affect the organization's ability to achieve the intended results of its QMS.

Quality policy

A statement of the organization's overall intentions and direction related to quality, established by top management and communicated and understood within the organization.

Nonconformity

The non-fulfilment of a requirement, whether specified, generally implied, or obligatory, identified during audit, inspection, or routine operational control.

Corrective action

Action taken to eliminate the cause of a nonconformity and prevent recurrence, which must be proportionate to the effects of the nonconformity encountered.

Internal audit

A systematic, independent, and documented process for obtaining objective evidence and evaluating it objectively to determine the extent to which audit criteria are fulfilled.

Management review

A planned activity in which top management evaluates the QMS's continuing suitability, adequacy, and effectiveness, considering defined inputs and producing decisions and actions.

Design and development

The set of processes that transform requirements for an object into more detailed requirements, including planning, inputs, controls, outputs, and changes during development.

Control of externally provided processes

Requirements ensuring that externally provided processes, products, and services conform to specified requirements, including criteria for selection, evaluation, and monitoring of providers.

Monitoring and measurement

Determining the status and value of an activity, process, or output using defined methods and criteria, with evidence retained as documented information.

Nonconforming output

Output that does not conform to requirements, which must be identified and controlled to prevent unintended use or delivery, and handled by a defined action.

Documented information control

The requirement that documented information be available and suitable for use where and when needed, and protected from loss of integrity or unauthorized change.

Competence

The ability to apply knowledge and skills to achieve intended results, determined by education, training, or experience, with evidence retained as documented information.

Certification body

An independent third party that conducts conformity assessment audits against a standard and issues a certificate; accreditation is to ISO/IEC 17021-1.

Stage 1 audit

The initial certification audit stage that evaluates the organization's readiness, documentation, and scope to determine whether Stage 2 can proceed.

Stage 2 audit

The certification audit stage that evaluates the implementation and effectiveness of the QMS against all applicable requirements of the standard.

Surveillance audit

A periodic on-site audit conducted after certification, at least annually, to verify continued conformity and effective maintenance of the certified QMS.

Recertification audit

An audit performed before the certificate expires, typically at three-year intervals, to confirm continued conformity and renew the certification.

Major nonconformity

A nonconformity that affects the capability of the management system to achieve intended results, or a significant doubt about the effectiveness of the system.

Scope of the QMS

The boundaries and applicability of the quality management system, stated with justification for any requirement determined not applicable to the organization.