Quality Management Systems & Principles Flashcards
7 cards from real ISO AUDITOR practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 7 Quality Management Systems & Principles flashcards as text
During an audit, you find the organization has no documented procedure for handling nonconforming outputs. Which ISO 9001:2015 clause is most directly violated?
Answer: Clause 8.7
Clause 8.7 specifically requires documented information about actions taken on nonconforming outputs and the authority deciding how to deal with them.
The 'continual improvement' principle differs from 'continuous improvement' in that it:
Answer: Allows for breakthrough improvements as well as incremental ones
Continual improvement encompasses both breakthrough and incremental improvements, whereas continuous implies an uninterrupted, steady pace of change.
An auditor reviews an organization's quality objectives. Which characteristic is REQUIRED by ISO 9001:2015?
Answer: They must be consistent with the quality policy
ISO 9001:2015 Clause 6.2.1 requires that quality objectives be consistent with the quality policy, among other criteria.
Which scenario best illustrates the 'process approach' as defined in ISO 9001:2015?
Answer: Interrelated processes are managed as a system with defined inputs, outputs, and interactions
The process approach involves managing interrelated processes as a coherent system, understanding how inputs and outputs link across the organization.
ISO 9001:2015 requires organizations to retain documented information as evidence of competence. This falls under which clause?
Answer: Clause 7.2
Clause 7.2 (Competence) requires retaining documented information as evidence that people are competent to perform work affecting quality.
A certified organization changes its manufacturing location. According to ISO 9001:2015, the FIRST action regarding the QMS should be:
Answer: Assess whether the change affects the QMS scope and processes
ISO 9001:2015 Clause 6.3 requires the organization to assess the potential consequences of planned changes on the QMS before implementing them.
Which of the following is NOT one of the seven quality management principles of ISO 9000:2015?
Answer: Zero defect manufacturing
Zero defect manufacturing is not one of the seven QMPs; the principles focus on customer focus, leadership, engagement, process approach, improvement, evidence-based decisions, and relationship management.