Context of the Organization (Clause 4)
What term describes internal and external issues that can affect an organization’s ability to achieve intended results?
Context of the organization
Who is responsible for demonstrating leadership and commitment to the QMS?
Top Management
What two key elements must be considered when planning actions under Clause 6.1?
Risks and opportunities
What type of resources does Clause 7 require to be determined and provided?
People, infrastructure, environment, and knowledge
What are two key methods organizations use to monitor and measure QMS performance?
Internal audits and management review
What document identifies the interested parties and their relevant requirements?
Quality Manual
What must top management ensure about the quality policy?
That it is appropriate, communicated, understood, and available
What is the purpose of addressing risks and opportunities in the QMS?
To ensure the QMS achieves intended results and prevent undesired effects
What clause requires control of documented information?
Clause 7.5
What management activity ensures that the QMS remains suitable, adequate, and effective?
Management review
What is the purpose of determining the scope of the quality management system?
To define the boundaries and applicability of the QMS
What term describes assigning and communicating authority and accountability within the organization?
Organizational Roles, Responsibilities, and Authorities This type of audit is conducted by your own organization to verify compliance with ISO 9001.
What are the measurable results that support the achievement of quality objectives called?
Key Performance Indicators (KPIs)
Under Clause 8, what is required before the release of products or services to customers?
Verification and approval for release
What must be done when nonconformities occur?
They must be corrected, controlled, and actions taken to prevent recurrence
What subclause requires the organization to establish, implement, maintain, and continually improve the QMS?
Clause 4.4 – Quality Management System and its Processes
What clause emphasizes that customer focus must be promoted throughout the organization?
Clause 5.1.2
What must be maintained and retained as evidence of planning under Clause 6?
Documented information on actions and results
What are the two key types of controls needed for externally provided processes, products, and services?
Supplier evaluation and incoming verification
What is the goal of corrective action according to Clause 10.2?
To eliminate the cause of nonconformity to prevent recurrence
What tool or method can be used to analyze external and internal issues affecting the organization? (Hint: often represented as four boxes)
SWOT Analysis
Name two ways leadership can demonstrate commitment to continual improvement.
Providing resources and promoting improvement culture
What concept replaces preventive action in the 2015 revision of ISO 9001?
Risk-based thinking
What is the main purpose of operational planning and control (Clause 8.1)?
To ensure processes are implemented under controlled conditions to meet requirements
What are the two main ways continual improvement can be demonstrated under Clause 10?
Use of data analysis and implementation of improvement initiatives