Quality Management Systems Final Notes

ISO 14000

A series of international environmental management standards developed by ISO, focusing on minimizing environmental impact.

ISO 9000

A set of standards for quality management systems that ensure consistent product quality.

Environmental Management Systems (EMS)

Framework to manage environmental responsibilities through an EMS, covering planning, implementation, and monitoring.

PDCA Cycle

A four-stage iterative process (Plan-Do-Check-Act) used for continual improvement and problem resolution.

PDSA Cycle

A variation of PDCA that emphasizes deeper learning and theory-building in the improvement process.

SDCA Cycle

A framework that focuses on standardizing processes to ensure stability and consistent quality before improvement.

Annex SL

The common framework adopted by ISO for all new and revised management system standards since 2012.

Triple Bottom Line

A sustainability framework that considers economic, environmental, and social performance.

Stakeholder Pressure

The growing demand from stakeholders for organizations to demonstrate sustainability and accountability.

Operational Efficiency

The ability to deliver products or services at the lowest cost while maintaining quality.

Process Capability

The inherent ability of a process to produce output within specified limits.

Risk Management

The identification, evaluation, and prioritization of risks followed by coordinated efforts to minimize, control, and monitor impacts.

Integration of ISO 9000 and ISO 14000

The combination of quality and environmental management systems to enhance performance and reduce waste.

Quality Management Systems (QMS)

Organizational systems focused on improving the processes related to product quality.

ISO 14001:2015

The core standard of the ISO 14000 family, focusing on effective environmental management systems.

ISO 13485

International standard for Quality Management Systems specifically designed for the medical device industry.

IATF 16949

International standard for automotive quality management systems, developed by the International Automotive Task Force.

Statistical Quality Control (SQC)

The application of statistical methods to monitor and control a process.

Kaizen

A Japanese philosophy of continuous improvement in processes and practices.

Process Mapping

A visual representation of the workflow and processes within an organization.

Shewhart Cycle

The original feedback loop for process management developed by Walter A. Shewhart.

SWOT Analysis

A strategic planning tool to identify strengths, weaknesses, opportunities, and threats.

Root Cause Analysis

A problem-solving method used to identify the root causes of faults or problems.

Control Charts

Graphical tools used to track process variations over time.

Document Control

The process of managing and regulating documents to ensure their accuracy and accessibility.

Supplier Qualification

The process of evaluating and approving suppliers based on their ability to meet specified requirements.

Unique Device Identification (UDI)

A system that provides a unique identifier for medical devices, ensuring traceability.

Corrective Action Preventive Action (CAPA)

Procedures for investigating and addressing nonconformities to prevent recurrence.

Continual Improvement

An ongoing effort to enhance products, services, or processes.

Defect Prevention

Measures taken to prevent defects in products during the manufacturing process.

Data-Driven Decision Making

Making decisions based on data analysis rather than intuition.

Traceability

The ability to track the history, application, or location of an entity by means of recorded identification.

Lifecycle Quality

Quality management throughout all stages of a product’s lifecycle.

ISO 9001:2015 Clauses

The structured requirements of ISO 9001:2015 that align with the PDCA logic.

Management Review

Regular evaluations of a management system to ensure its continuing suitability and effectiveness.

Internal Audits

Systematic examinations of a quality system performed by the organization's internal team.

Nonconforming Products Control

Procedures to handle products that do not meet specified requirements.

Organizational Context

The internal and external factors that affect an organization's objectives and operations.

Customer-Specific Requirements

Unique needs and expectations defined by customers for specific products or services.

Environmental Compliance

Adhering to environmental laws, regulations, and standards.

Cross-Functional KPIs

Performance metrics that span multiple departments, linking quality performance to sustainability.

Compliance Auditing

The process of ensuring that an organization meets regulatory requirements.

Waste Reduction

Strategies aimed at lowering the amount of waste produced by a company.

Supplier Performance Monitoring

Assessing and tracking the efficiency and effectiveness of suppliers.

Organizational Leadership

The role of management in guiding and influencing the organization’s direction.

Feedback Loop

A system where the outputs of a process are circled back and used as inputs for future processes.

Cultural Change

Modifying the beliefs and behaviors of employees within an organization.

Auditing Process

A systematic review of the quality and effectiveness of processes.

ISO Certification

A formal recognition that an organization is compliant with an ISO standard.

Value Stream Mapping

A visual tool for analyzing the flow of materials and information currently required to bring a product or service to a consumer.

Process Control

The management of process outputs to ensure consistency in production.

Supplier Evaluation Criteria

Standards used to assess potential suppliers during selection.

Agile Management

An approach to project management that emphasizes flexibility and adaptability.

Regulatory Compliance

Meeting the requirements set by governing bodies and regulatory agencies.

Non-Conforming Output Control

The procedures used to manage products that do not conform to quality standards.

Continuous Monitoring

The ongoing assessment of processes to ensure they meet quality standards.

Engagement Practices

Methods used to involve employees in decision-making and improvement processes.

Operational Auditing

Examining operations to enhance efficiency and effectiveness.

Holistic Management Approach

An organizational strategy that considers all parts of the organization in decision-making.

ISO Family of Standards

A collection of related standards issued by ISO that are interconnected in their objectives.

Customer Satisfaction Measurement

Metrics used to assess the degree to which customer needs and expectations are met.