Part of quality management focused on setting quality objectives and specifying necessary operational processes and related resources to fulfill the quality objectives.
What is QUALITY PLANNING?
Degree to which a set of inherent characteristics fulfills requirements.
What is QUALITY?
Internal and external factors that affect an organization’s ability to consistently deliver products and services that meet customer and regulatory requirements is part of?
Context of the Organization
Groups or individuals affected by or affecting the organization’s quality management system.
What are INTERESTED PARTIES?
The defined boundaries and applicability of the quality management system, considering internal and external factors, stakeholder requirements and products and services
What is the Scope of the QMS
Part of quality management focused on increasing the ability to fulfill quality requirements
What is Quality IMPROVEMENT?
Category or rank given to different quality requirements for products, processes, or systems having the same functional use.
What is GRADE?
A tool commonly used to assess strengths, weaknesses, opportunities, and threats.
What is a SWOT ANALYSIS?
This group is directly impacted by the quality of products or services provided.
Who are CUSTOMERS?
The clause requiring organizations to determine the processes needed for the quality management system and their interactions.
What is CLAUSE 4.4?
Part of quality management focused on fulfilling quality requirements.
What is QUALITY Control?
Need or expectation that is stated, generally implied, or obligatory.
What is REQUIREMENT?
Factors like economic trends, legal requirements, and technological changes are examples of this.
What is EXTERNAL Issues?
Key stakeholders providing materials or services that contribute to the final product.
Who are SUPPLIERS?
The term for the detailed flow of activities, responsibilities, and resources required to transform inputs into outputs.
What is a PROCESS?
Part of quality management focused on providing confidence that quality requirements will be fulfilled.
What is QUALITY ASSURANCE?
Something sought, or aimed for, related to quality.
What is QUALITY OBJECTIVE?
The term for factors like culture, structure, and resources that impact quality.
What is INTERNAL Issues?
Stakeholders who ensure compliance with laws, regulations, and standards.
Who are REGULATORS?
The standards or benchmarks established to monitor and measure processes, ensuring they achieve intended results.
What are PROCESS PERFORMANCE CRITERIA?
Management with regard to quality.
What is QUALITY MANAGEMENT?
Customer’s perception of the degree to which the customer’s requirements have been fulfilled.
What is CUSTOMER SATISFACTION?
The clause in ISO 9001 that requires identifying relevant internal and external issues.
What is CLAUSE 4.1?
The process of identifying and analyzing the needs and expectations of parties that can affect or be affected by the organization’s decisions.
What is STAKEHOLDER ANALYSIS?
The interconnected activities that transform inputs into outputs and must be managed to ensure consistent quality and customer satisfaction.
What are PROCESSES AND THEIR INTERACTIONS?