ISO 9001 2015 LEAD AUDITOR MODULE Q & A.docx

ISO 9001 : 2015 QUESTIONS AND ANSWERS

1. 1. What is the purpose of ISO 9000:2015?
 Explains the fundamental concepts, principles and vocabulary of quality management - The
correct answer
 Provides guidance on the application of ISO 9001:2015 - Your answer - you got this wrong
 Provides guidance on how to achieve sustained success by a quality management
approach
 An international standard which acts as a model for quality assurance
2. How does ISO 9001 define Quality Assurance?
 Part of quality management focusing on providing confidence that quality requirements will
be fulfilled - The correct answer
 Part of quality management focusing on ensuring customer satisfaction
 A documented quality process to ensure quality is upheld throughout the full management
system - Your answer - you got this wrong
 Part of quality management focusing on ensuring management reviews the quality of all
produce and goods
3. What does PDCA stand for?
 Plan, Design, Confirm, Act
 Plan, Do, Check, Act - You answered this correctly
 Prepare, Do, Critique, Appraisal
 Prepare, Do, Critique, Assess
4. What does Clause 6 of ISO 9001:2015 provide details of?

2.  Planning - You answered this correctly
 Operation
 Leadership
 Improvement
5. Which of the below is not one of the seven quality management principles?
 Customer focus
 Leadership
 Planning - You answered this correctly
 Improvement
6. How does ISO 9000 define “Management Systems”?
 Set of interrelated or interacting elements of an organisation to establish procedures and
outline these within documentation
 Set of interrelated or interacting elements of an organisation to establish policies and
objectives, and processes to achieve those objectives - You answered this correctly
 Set of interrelated or interacting elements of an organisation to effectively record quality
processes
 Set of interrelated or interacting elements of an organisation to identify risks and improve
efficiency
7. Who is responsible for reviewing the quality management system at planned intervals to
ensure its continuing suitability, adequacy, effectiveness and alignment with the strategic
direction of the organisation?
 The auditee

3.  The employees within the organisation
 Top management - You answered this correctly
 The external auditor
8. Within clause 10.1 of the ISO 9001:2015 standard, what examples of improvement are
provided in relation to improving and implementing any necessary actions to meet customer
requirements and enhance customer satisfaction?
 Enhanced management processes, review of customer satisfaction, react to nonconformity
and implementation
 Continual improvement, enhanced customer service, re-organisation and risk analysis
 Correction, corrective action, ongoing improvement, documentation review, risk analysis
and continual review of the quality management system
 Correction, corrective action, continual improvement, breakthrough change, innovation and
re-organisation - You answered this correctly
9. How does ISO 9000:2015 define a process?
 Set of interrelated or interacting activities which uses inputs to deliver a result that meets or
exceeds the ISO 9001 standards of quality - Your answer - you got this wrong
 A full lifecycle of events which includes inputs such as materials and information,
management, resources and outputs
 A cycle which includes inputs, actions and outputs to ensure quality is met
 Set of interrelated or interacting activities that uses inputs to deliver an intended result - The
correct answer

4. 10. When planning the quality management system, organisations shall consider the issues and
requirements referred to in 4.1 and 4.2 and determine the risks and opportunities that need to be
addressed to;
 give assurance that the quality management system can achieve its intended result(s)
 enhance desirable effects
 achieve improvement
 all of the above - You answered this correctly
11. Which ISO standard provides guidelines for codes of conduct for organisations, including
guidance to an organisation in determining that its customer satisfaction provisions meet
customer needs and expectations?
 ISO 10007 Quality management systems
 ISO 10012 Measurement management systems
 ISO 10001 Quality management - You answered this correctly
 ISO 10005 Quality management systems
12. Within ISO 9001:2015, what does “shall” indicate?
 a recommendation
 a permission
 a capability
 a requirement - You answered this correctly
13. In 9001:2015, what does clause 7.2 relate to?
 Leadership and commitment

5.  Competence - You answered this correctly
 Documented information
 Planning of changes
14. What is the benefit of an organisation adopting a quality management system?
 Addresses risks and opportunities to enhance customer satisfaction
 Improves the organisations overall performance and provides a sound basis for sustainable
development initiatives
 Facilities opportunities to enhance customer satisfaction
 All of the above - You answered this correctly
15. What does the application of the process approach in a quality management system enable?
 An understanding and consistency in meeting requirements
 The consideration of processes in terms of added value
 The achievement of effective process performance
 All of the above - You answered this correctly