ISO 9001:2015 Quality Management Systems and Principles

Vocabulary flashcards covering the seven quality management principles (QMPs), history, and clause structure of the ISO 9001:2015 standard.

Principle

A basic belief, theory, or rule that has a major influence on the way in which something is done.

Quality Management Principles (QMPs)

A set of fundamental beliefs, norms, rules, and values accepted as true that can be used as a basis for quality management and to guide an organization's performance improvement.

ISO 9001:2008

The 3rd Revision of the ISO 9000 standard, established in 2008.

ISO 9001:2015

The 4th Revision of the ISO 9000 standard, established in 2015, which builds on seven quality management principles to consistently create value for customers.

Customer Focus

Quality Management Principle 1, stating that the primary focus of quality management is to meet customer requirements and strive to exceed customer expectations.

Leadership (QMP 2)

The quality management principle stating that leaders at all levels establish unity of purpose and direction and create conditions in which people are engaged in achieving the organization's quality objectives.

Engagement of People

Quality Management Principle 3, which states that competent, empowered, and engaged people at all levels throughout the organization are essential to enhance its capability to create and deliver value.

Process Approach

Quality Management Principle 4, stating that consistent and predictable results are achieved more effectively and efficiently when activities are understood and managed as interrelated processes that function as a coherent system.

Improvement (QMP 5)

The quality management principle asserting that successful organizations have an ongoing focus on improvement to maintain performance, react to condition changes, and create new opportunities.

Evidence-Based Decision Making

Quality Management Principle 6, stating that decisions based on the analysis and evaluation of data and information are more likely to produce desired results.

Relationship Management

Quality Management Principle 7, stating that for sustained success, an organization manages its relationships with interested parties, such as suppliers and partner networks.

Interested Parties

Stakeholders—such as suppliers, partners, customers, investors, employees, and society as a whole—whose needs, expectations, and relationships can affect or drive organizational performance.

Context of the Organization (Clause 4)

The ISO 9001:2015 requirements clause covering understanding the organization and its context, identifying interested parties' needs and expectations, determining the scope of the QMS, and managing QMS processes.

Leadership (Clause 5)

The ISO 9001:2015 requirements clause covering leadership and commitment, organizational policy, and organizational roles, responsibilities, and authorities.

Planning (Clause 6)

The ISO 9001:2015 requirements clause covering actions to address risks and opportunities, quality objectives and planning to achieve them, and planning of changes.

Support (Clause 7)

The ISO 9001:2015 requirements clause covering resources, competence, awareness, communication, and documented information.

Operation (Clause 8)

The ISO 9001:2015 requirements clause addressing operational planning, product and service requirements, design and development, control of external provisions, production and service provision, product release, and control of nonconforming outputs.

Performance Evaluation (Clause 9)

The ISO 9001:2015 requirements clause covering monitoring, measurement, analysis, and evaluation, internal audit, and management review.

Improvement (Clause 10)

The ISO 9001:2015 requirements clause addressing general improvement, nonconformity and corrective action, and continual improvement.