Food Safety Practice Tests - VII

ISO 9001:2015 Lead Auditor Model Paper 1

This is another practice test aimed at ISO 9001:2015 practitioners who are planning to sit for the lead auditor exam after successful classroom lessons. These are open-book exams, where participants are expected to use their own copy of ISO 90001:2015 standard for the references. Further, in an actual exam, there may be essay questions based on the training or certification institute, where the candidate can also use the training course materials, a copy of the ISO 19011:2018 standard, any personal notes made by the candidate during the training course and a hard copy dictionary if necessary. The answers are given at the end of the paper but try not to look at them first and try to complete the paper beforehand.

 
 
 ISO 9001:2015 Lead Auditor Practice Test – Model Paper 1
Time: 01 Hour
Answer all the questions
 
1.     What is the purpose of ISO 9000:2015?
A.    Provides guidance on the application of ISO 9001:2015
B.     Provides guidance on how to achieve sustained success by a quality management approach
C.    Explains the fundamental concepts, principles, and vocabulary of quality management
D.    An international standard that acts as a model for quality assurance
 
2.     Scheduled quality system audits should be supplemented when:
A.    Significant changes are made in the quality system, such as a major reorganization or procedure revisions
B.     It is suspected that the quality of an item is in jeopardy due to quality system deficiencies
C.    A systematic, independent assessment of quality system effectiveness is considered necessary
D.    All of the above
 
3.     Which of the below is not one of the seven quality management principles?
A.    Leadership
B.     Planning  
C.    Customer focus
D.    Improvement
 
4.     How does ISO 9000 define Management Systems?
A.    Set of interrelated or interacting elements of an organization to establish procedures and outline these within the documentation
B.     Set of interrelated or interacting elements of an organization to effectively record quality processes
C.    Set of interrelated or interacting elements of an organization to establish policies and objectives, and processes to achieve those objectives
D.    Set of interrelated or interacting elements of an organization to identify risks and improve efficiency
 
5.     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 organization?
A.    The auditee

B.     Top management
C.    The external auditor
D.    The employees within the organization
 
6.     What clause of the ISO 9001 standard requires an organization to determine, provide and maintain the infrastructure needed to achieve conformity to product requirements?
A.    Clause 8.2.2
B.     Clause 6.1.2
C.    Clause 7.1.1
D.    Clause 9.2.2
 
7.     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?
A.    Enhanced management processes, review of customer satisfaction, react to non-conformity, and implementation
B.     Correction, corrective action, continual improvement, breakthrough change, innovation, and re-organization
C.    Continual improvement, enhanced customer service, re-organization, and risk analysis
D.    Correction, corrective action, ongoing improvement, documentation review, risk analysis, and continual review of the quality management system
 
8.     Which clause of the ISO 9001 standard requires an organization to establish, implement, maintain, and continually improve a quality management system?
A.    Clause 4.1
B.     Clause 6.1
C.    Clause 7.1
D.    Clause 8.1
 
9.     How does ISO 9000:2015 define a process?
A.    Set of interrelated or interacting activities that uses inputs to deliver an intended result
B.     A full lifecycle of events which includes inputs such as materials and information, management, resources, and outputs
C.    A cycle that includes inputs, actions, and outputs to ensure quality is met
D.    Set of interrelated or interacting activities which uses inputs to deliver a result that meets or exceeds the ISO 9001 standards of quality
 
10.  When planning the quality management system, organizations 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?
A.    Give assurance that the quality management system can achieve its intended result(s)
B.     Enhance desirable effects
C.    Achieve improvement
D.    All of the above
 
11.  Which clause of the ISO 9001 standard requires an organization to evaluate the effectiveness of its quality management system?
A.    Clause 9.1.1
B.     Clause 6.2
C.    Clause 8.4
D.    Clause 4.4
 
12.  Only one of the below is a core element of a management system?
A.    Onsite audit of suppliers
B.     Customer satisfaction forms
C.    Quality Policy
D.    Failure Mode and Effect Analysis (FMEA)
 
13.  Which ISO standard provides guidelines for codes of conduct for organizations, including guidance to an organization in determining that its customer satisfaction provisions meet customer needs and expectations?
A.    ISO 10007 Quality management systems
B.     ISO 10001 Quality management
C.    ISO 10012 Measurement management systems
D.    ISO 10005 Quality Management systems
 
14.  Within ISO 9001:2015, what does “shall” indicate?
A.    A requirement
B.     A recommendation
C.    A permission
D.    A capability
 
15.  What clause of the ISO 9001 standard requires an organization to determine and manage the risks and opportunities that can affect the conformity of products and services?
A.    Clause 4.4
B.     Clause 6.1.1
C.    Clause 6.1.2
D.    Clause 8.2.3
 
16.  ISO 9001:2015 requires organizations to appoint a Management Representative.
A.    True
B.     False
 
17.  In ISO 9001:2015, there is no requirement related to Preventive Actions.
A.    True
B.     False
 
18.  Mandatory Procedures are required in ISO 9001:2015?
A.    True
B.     False
 
19.   ISO 9001:2015 has introduced the concept of risk-based thinking in quality management?
A.    True
B.     False
 
20.  The scope of the quality management system needs to be available and be maintained as documented information?
A.    True
B.     False
 
21.  In 9001:2015, what does clause 7.2 relate to?
A.    Leadership and commitment
B.     Documented information
C.    Planning of changes
D.    Competence
 
22.  What is the benefit of an organization adopting a quality management system?
A.    Facilities opportunities to enhance customer satisfaction
B.     Addresses risks and opportunities to enhance customer satisfaction
C.    Improves the organization's overall performance and provides a sound basis for sustainable development initiatives
D.    All of the above
 
23.  Per the ISO 9001 standard, an organization is required to plan an audit program that considers the results of what?
A.    Employee surveys
B.     Sales of similar products from other suppliers
C.    Top management perceptions
D.    Previous audits
 
 
24.  The ISO 9001 standard requires an organization to implement effective arrangements for communicating what to customers?
A.    Other customer audit findings
B.     All internal reorganizations
C.    Enquiries, contracts, or order handling including amendments
D.    All redlines made to process documentation
 
25.  Confirmation of the ability of computer software to satisfy the intended application would typically include:
A.    A certificate from the software supplier to confirm the software’s intended application
B.     Its verification and configuration management to maintain its suitability for use
C.    Review from employees not directly related to the intended application for verification
D.    Testing its configuration from an outside source
 
26.  How does ISO 9001 define Quality Assurance?
A.    Part of quality management focuses on ensuring customer satisfaction
B.     A documented quality process to ensure quality is upheld throughout the full management system
C.    Part of quality management focuses on ensuring management reviews the quality of all produce and goods
D.    Part of quality management focuses on providing confidence that quality requirements will be fulfilled
 
27.  What should an organization do if a piece of measuring equipment is found out of conformance to requirements?
A.    Identify the product separately and sell the product at a discount
B.     Dispose of all products ran through piece of equipment
C.    Assess and record the validity of the previous measuring results
D.    Rerun product through the piece of equipment to verify conformance
 
28.  What does Clause 6 of ISO 9001:2015 provide details of?
A.    Leadership
B.     Planning
C.    Operation
D.    Improvement
 
29.  The non-fulfillment of a specified requirement is called a?
A.    Concession
B.     Nonconformity
C.    Corrective action
D.    None of the above
 
30.  What does PDCA stand for?
A.    Plan, Design, Confirm, Act
B.     Prepare, Do, Critique, Appraisal
C.    Plan, Do, Check, Act
D.    Prepare, Do, Critique, Assess
 
31.  Which clause of the ISO 9001 standard requires an organization to monitor information related to customer satisfaction?
A.    Clause 7.2
B.     Clause 6.1.1
C.    Clause 8.2.1
D.    Clause 9.1.2
 
32.  Which of the following is not an example of poor quality?
A.    The price of the product is significantly higher than that of all other products in the market
B.     The product is delivered later than promised
C.    The product is delivered with no instructions for use
D.    The product stops working unexpectedly
 
33.  Where the customer provides no documented statement of requirement, the customer requirements shall be?
A.    Verified after accepted
B.     Confirmed before acceptance
C.    Validated after realization of the product
D.    Rejected unless documented
 
34.  What does the application of the process approach in a quality management system enable?
A.    The consideration of processes in terms of added value
B.     The achievement of effective process performance
C.    An understanding and consistency in meeting requirements
D.    All of the above
 
35.  Which clause of the ISO 9001 standard requires an organization to determine and provide the resources needed to implement and maintain the quality management system?
A.    Clause 7.1
B.     Clause 6.1.1
C.    Clause 8.1
D.    Clause 7.2
 
36.  Customer property may include?
A.    Production equipment
B.     Facilities
C.    The product returned for servicing under warranty
D.    All of the above
 
37.  Infrastructure does not include?
A.    Human resources
B.     Buildings
C.    Information Systems
D.    Hardware
 
38.  Which clause of the ISO 9001 standard requires an organization to ensure that external providers conform to the organization's quality management system requirements?
A.    Clause 7.2
B.     Clause 8.4.2
C.    Clause 8.1.4
D.    Clause 8.4.1
 
39.  Which of the following is/are not required to be included in the Quality manual?
A.    Details and justification for any exclusions
B.     The document control procedure or related reference
C.    The internal audit procedure or related reference
D.    The quality policy
 
40.  The ISO 9001 Standard requires from top management to ensure that?
A.    The organizational chart is in place
B.     Responsibilities and authorities are defined and communicated within the organization
C.    A documented procedure describes the responsibilities and authorities within the organization
D.    Documented job descriptions are in place
 
41.  Which clause of the ISO 9001 standard requires an organization to identify the interested parties relevant to the quality management system and their requirements?
A.    Clause 4.2
B.     Clause 6.1.3
C.    Clause 5.1.2
D.    Clause 7.1
 
42.  The organization shall determine, collect and analyze data, to demonstrate the suitability and effectiveness of the quality management system, regarding?
A.    Market trends
B.     Production cost issues
C.    Suppliers
D.    None of the above
 
43.  An alternative name for the Plan-Do-Check-Act Cycle?
A.    The ISO 9001 Cycle
B.     The Planning Cycle
C.    The Deming Cycle
D.    Quality Management System
 
44.  Which of the following tools can best be used to visually represent the interrelationship of processes?
A.    Work Instructions
B.     Procedures
C.    Quality Manual
D.    Process flow diagrams
 
45.  Which clause of the ISO 9001 standard requires an organization to plan, implement and control the processes needed to meet product requirements?
A.    Clause 7.5.1
B.     Clause 6.2
C.    Clause 7.1.5
D.    Clause 8.2
 
46.  The organisation needs to retain documented information to have the confidence that the processes are being carried out as planned?
A.    True
B.     False
 
47.  The needs and expectations of interested parties need to be maintained as documented information?
A.    True
B.     False
 
48.  The scope of the quality management system needs to be available and be maintained as documented information?
A.    True
B.     False
 
49.  The context of the organization needs to be maintained as documented information?
A.    True
B.     False
 
50.  ISO 9001:2015 requires organizations to prepare a Quality Manual?
A.    True
B.     False
 
51.  Which clause of the ISO 9001 standard most specifically focuses on controlling the core operational process(es) of an organization?
A.    Clause 8.5.6
B.     Clause 8.5.1
C.    Clause 4.4
D.    Clause 7.5.3
 
52.  of the following is not a definition of Quality?
A.    Meeting customer requirements
B.     Fitness for purpose
C.    The extent to which a set of inherent characteristics fulfill requirements
D.    A premium product or service
 
53.  Which quality control activity is used to ‘determine conformity to specified requirements?
A.    Inspection
B.     Monitoring
C.    Review
D.    Quality Assurance
 
54.  Action to eliminate the cause of nonconformity and to prevent recurrence is called a?
A.    Nonconformity
B.     Preventive action
C.    Correction
D.    Corrective action
 
55.  What must be considered when determining the scope of the management system, according to ISO 9001:2015?
A.    Requirements of the relevant interested parties
B.     Internal and external issues
C.    Products and services of the organization
D.    All of the above
 
56.  Which of the following actions does not reflect the process approach?
A.    Defining objectives and the processes required to achieve them
B.     Encourage and recognize the contributions of people
C.    Determining interactions and interdependency of processes
D.    Managing risks that can affect the outputs of processes
 
57.  ISO 9001:2015 provides a number of examples of improvement. Which of the following is not listed as an example of improvement?
A.    Breakthrough change, innovation, and re-organization
B.     Corrective action
C.    Preventive action
D.    Correction
 
58.  The Annex SL Framework is designed to?
A.    Make it harder for organizations to understand ISO management systems
B.     Make things more complex so that Quality Managers have higher salaries
C.    Make it easier for everyone to understand management systems and implement multiple ISO standards
D.    None of the above
 
59.  Which of the following is not one of the principles of Quality Management?
A.    Process Approach
B.     Evidence-based decision making
C.    Engagement of People
D.    Context of the organization
 
60.  A combination of internal and external issues that can have an effect on an organization’s approach to developing and achieving its objectives is called?
A.    The environment of the organization
B.     External provider
C.    Context of the organization
D.    Quality management systems realization
 
 

 
ISO 9001 Lead Auditor Practice Tests
Module Paper 1
 

Answer Key
01	C	02	D	03	B	04	C
05	B	06	C	07	B	08	C
09	A	10	D	11	A	12	C
13	B	14	A	15	D	16	B
17	B	18	A	19	A	20	A
21	D	22	D	23	D	24	C
25	B	26	D	27	C	28	B
29	D	30	C	31	D	32	A
33	B	34	D	35	C	36	D
37	A	38	D	39	D	40	B
41	C	42	C	43	C	44	D
45	D	46	A	47	B	48	A
49	A	50	B	51	B	52	D
53	A	54	D	55	D	56	B
57	D	58	C	59	B	60	C