Quality Management Systems Flashcards
6 cards from real CQE practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 6 Quality Management Systems flashcards as text
ISO 9001 is structured around which management framework?
Answer: Plan-Do-Check-Act (PDCA)
ISO 9001 is built on the Plan-Do-Check-Act (PDCA) cycle, providing a continual improvement framework that runs through all clauses of the standard.
In ISO 9001:2015, 'context of the organization' requires a company to identify:
Answer: Internal and external issues that affect the QMS
Clause 4.1 of ISO 9001:2015 requires organizations to determine both internal and external issues relevant to their purpose that could impact the QMS's intended results.
Which document provides the overall quality intentions and direction of an organization, typically signed by top management?
Answer: Quality policy
The quality policy is a formal statement from top management declaring the organization's overall intentions and direction regarding quality, required by ISO 9001.
What is the main purpose of a Management Review in a Quality Management System?
Answer: To evaluate QMS suitability, adequacy, and effectiveness at planned intervals
Management reviews evaluate whether the QMS continues to be suitable, adequate, and effective, using performance data to drive continual improvement decisions.
In a QMS, 'documented information' under ISO 9001:2015 replaces which older terminology?
Answer: Documents and records
ISO 9001:2015 consolidated the terms 'documents' and 'records' into the single term 'documented information' to modernize and simplify the standard's requirements.
Risk-based thinking in ISO 9001:2015 primarily aims to:
Answer: Prevent undesirable outcomes and pursue opportunities proactively
Risk-based thinking enables organizations to determine factors that could cause their processes and QMS to deviate from planned results, taking preventive action and exploiting opportunities.