ISO 9001:2015 Practice Flashcards

A set of vocabulary-style flashcards based on the ISO 9001:2015 International Standard transcript, covering key terms, verbal forms, structural concepts, and quality management requirements.

ISO 9001:2015

The fifth edition of the International Standard for Quality Management Systems, published on 2015-09-15.

Shall

A verbal form used in the International Standard to indicate a requirement.

Should

A verbal form used in the International Standard to indicate a recommendation.

May

A verbal form used in the International Standard to indicate a permission.

Can

A verbal form used in the International Standard to indicate a possibility or a capability.

Quality Management Principles

The seven principles upon which the standard is based: customer focus, leadership, engagement of people, process approach, improvement, evidence-based decision making, and relationship management.

Process Approach

A management strategy that incorporates the Plan-Do-Check-Act (PDCA) cycle and risk-based thinking to manage interrelated processes as a system.

PDCA cycle: Plan

Establish the objectives of the system and its processes, and the resources needed to deliver results in accordance with customers’ requirements and the organization’s policies, and identify and address risks and opportunities.

PDCA cycle: Do

Implement what was planned.

PDCA cycle: Check

Monitor and (where applicable) measure processes and the resulting products and services against policies, objectives, requirements and planned activities, and report the results.

PDCA cycle: Act

Take actions to improve performance, as necessary.

Risk-based thinking

The practice of determining factors that could cause processes and the quality management system to deviate from planned results, and putting in place preventive controls to minimize negative effects.

Risk

The effect of uncertainty; it can have positive or negative effects.

Top Management

The person or group of people who direct and control an organization at the highest level, responsible for demonstrating leadership and commitment to the QMS.

Interested Parties

Stakeholders relevant to the quality management system due to their effect or potential effect on the organization's ability to consistently provide products and services.

Quality Policy

A document established by top management that is appropriate to the purpose and context of the organization and provides a framework for setting quality objectives.

Infrastructure

Includes buildings and associated utilities, equipment (hardware and software), transportation resources, and information and communication technology.

Organizational Knowledge

Knowledge specific to the organization, generally gained by experience, used and shared to achieve the organization's objectives.

Competence

The ability of persons to do work under the organization's control based on appropriate education, training, or experience.

Documented Information

Information required to be controlled and maintained by an organization and the medium on which it is contained.

Maintain Documented Information

Terminology used in ISO 9001:2015 to denote what was previously termed 'documents,' 'documented procedures,' 'quality manuals,' or 'quality plans.'

Retain Documented Information

Terminology used in ISO 9001:2015 to denote 'records' used as evidence of conformity.

Measurement Traceability

A requirement or essential part of providing confidence in measurement results where measuring equipment is calibrated or verified against international or national standards.

External Provider

Term used in ISO 9001:2015 to refer to suppliers, partners, or vendors providing processes, products, or services.

Design and Development Controls

Activities including reviews, verification, and validation conducted to ensure the results of design and development meet requirements and are fit for intended use.

Traceability (Operation)

The control of the unique identification of outputs when it is a requirement to track their history or application.

Nonconformity

The non-fulfillment of a requirement.

Corrective Action

Action taken to react to a nonconformity, evaluate the need to eliminate its cause, and prevent its recurrence.

Continual Improvement

The ongoing activity to improve the suitability, adequacy, and effectiveness of the quality management system.

Management Review

A process where top management reviews the QMS at planned intervals to ensure its continuing suitability, adequacy, effectiveness, and alignment with strategic direction.