ISO 9001 MCQs
ISO 9001 MCQs
These ISO 9001 multiple-choice questions and their answers will help you strengthen your grip on the subject of ISO 9001. You can prepare for an upcoming exam or job interview with these 100+ ISO 9001 MCQs.
So scroll down and start answering.
1: What does ISO stand for?
A. the Internal Standards Option
B. the International Standards Opportunity
C. the Internal Systems Organization
D. the International Organization for Standardization
2: The ISO 9001 standard requires planning from top management. What shall be measurable and consistent with the quality policy?
A. quality documents
B. quality manual
C. quality objectives
D. quality records
3: The ISO 9001 standard requires an organization to handle nonconforming product how?
A. as long as the nonconformity is low risk, deliver product and record as no action required
B. by taking action to eliminate the detected nonconformity
C. release product as long as it works as intended
D. by asking the customer if they will take the product as is
4: The implementation of a organization's ISO 9001 management system is influenced by:
A. its products, processes, and size
B. the county of its physical location
C. the government
D. the IRS
5: The ISO 9001 standard requires the organization's quality manual to include:
A. a description of the size of the organization
B. the names of all top management
C. a description of the interaction between the processes of the quality management system
D. a definition of the organization's products
6: What does product design and development validation of the ISO 9001 standard require?
A. to ensure the customer has approved all documents used to build the product
B. to ensure the organization isn't guilty of patent infringement
C. to ensure that the resulting product is capable of meeting all specified requirements and intended uses
7: Clause 4.2 of the ISO 9001 standard requires a organization's quality management system to include a:
A. statement of work
B. documented quality objective statement
C. non-disclosure agreement
D. confidentiality agreement
8: The ISO 9001 standard requires an organization to establish a quality manual that includes:
A. customer references
B. the number of employees
C. the justification for not documenting confidential processes
D. a justification of any exclusions to the requirements of the standard
9: The ISO 9001 standard requires an organization to establish processes to ensure that monitoring and measuring equipment is controlled. This includes:
A. only one employee is allowed to use the equipment per customer order
B. measuring equipment shall be calibrated and/or verified
C. the equipment shall be maintained after every part has been measured
D. the equipment is only allowed to be programmed for one type of product
10: The ISO 9001 standard requires top management of an organization to ensure the quality policy includes what?
A. a definition of the responsibilities and authorities
B. a definition of the quality management system
C. a record of each change made to it
D. a commitment to continually improve the effectiveness of the quality management system
11: An organization shall conduct internal audits when?
A. once a month
B. per each process
C. annually
D. determined planned intervals
12: The ISO 9001 standard requires an organization to apply suitable methods for monitoring and measuring the quality management system processes and shall demonstrate the ability to achieve planned results. When planned results are not achieved, what should happen?
A. stop all production to determine next steps
B. correction and corrective action shall be taken
C. rewrite the quality management system processes to achieve the planned results
D. inform the customer of the situation and ask them what should happen next
13: What does product design and development verification of the ISO 9001 standard require?
A. to ensure the customer has approved all processes required to build the product
B. to patent the product design
C. to ensure the outputs have met the input requirements of the design and development
D. to ensure the product does not look like any other customer's product already sold
14: How does the ISO 9001 standard define an "outsourced process?"
A. a process that only one customer requires
B. a process that the organization defines as "optional" and the process is better performed by an external party
C. a process that does not "fit" within the organization's quality management system
D. a process that the organization needs for the quality management system and which the organization chooses to have performed by an external party
15: The required documentation for the ISO 9001 standard can be:
A. only hard copy documentation
B. in any form or type of medium
C. only electronically filed
D. only filed offsite
16: How does an organization become ISO 9001 certified?
A. Through customer audits
B. The International Organization of Standardization certifies the organization meets the ISO 9001 standard requirements
C. The organization itself certifies it meets ISO 9001 standard requirements
D. Through an independent certification body that determines the product, service or system in question meets ISO 9001 standard requirements
17: When nonconforming product is corrected, it shall be subject to what?
A. re-verification to demonstrate conformity to the requirements
B. selected certification body approval
C. International Organization of Standardization approval
D. customer approval
18: Why would an organization implement a quality management system that meets ISO 9001 standard requirements?
A. the organization is required to by state laws
B. all customers require it
C. the International Organization of Standardization requires organizations to meet the ISO 9001 standard requirements
D. to improve the efficiency and effectiveness of company operations
19: The ISO 9001 standard requires the output from the management review shall include any decisions and actions related to what?
A. the determined number of procedural changes for the year
B. the required semi-annual change to the quality policy
C. the process changes specific to the next 6 months
D. improvement of product related to customer requirements
20: The ISO 9001 standard requires the organization to provide training, where applicable, or take other actions to achieve the necessary what?
A. competence
B. number of trained employees
C. number of training records to meet state laws
D. number of training classes to meet its requirements
21: The ISO 9001 standard requires an organization to review its quality management system at planned intervals. Why?
A. to ensure its continuing effectiveness
B. to ensure its not breaking any laws
C. to ensure it is profitable
D. to ensure its records are up to date
22: Under 4.0, the ISO 9001 standard requires an organization to control required documents. One of these controls is:
A. to ensure changes and current revision status of documents are identified
B. to dispose of obsolete documents
C. to update documents at point of use
D. to ensure that documents are all electronically available
23: ISO 9001 is considered compatible with what other ISO standard?
A. ISO 13485
B. ISO 17025
C. ISO 14001
D. ISO 14971
24: Who should the Management Representative be of an organization?
A. sales representative
B. outsourced consultant
C. member of the organization's management
D. trained employee
25: The ISO 9001 standard requires a organization to ensure its personnel are aware of what?
A. the processes they can affect down-stream from them
B. all statements of work
C. every written procedures of the organization
D. the established quality objectives
26: The ISO 9001 standard requires an organization to determine requirements specified by the customer to include requirements for what?
A. only refunds
B. only returns
C. delivery and post-delivery activities
D. only complaints
27: Audits are a vital part of ISO 9001's management system approach as they enable the organization to:
A. determine if they are profitable
B. determine if they have too many employees
C. check if they need to hire a certification body
D. check how far their achievements meet their objectives
28: The ISO 9001 standard requires an organization to take action to eliminate the causes of nonconformities in order to what?
A. inform the customer of the nonconformities
B. not hide its problems
C. be completely transparent with its issues
D. prevent recurrence
29: The ISO 9001 standard promotes the adoption of a process approach because:
A. this is the only approach that can work with ISO 9001
B. this approach is much easier to manage
C. this approach enhances customer satisfaction by meeting customer requirements
30: The ISO 9001 standard requires an organization to ensure records of evidence of conformity are what?
A. uploaded electronically
B. sent offsite for storage
C. approved and signed off by top management
D. legible, readily identifiable and retrievable
31: The ISO 9001 standard requires a organization to determine and maintain the infrastructure needed to achieve conformity to product requirements. Infrastructure includes what?
A. noise
B. weather
C. software and hardware
D. temperature and humidity
32: How does an organization monitor and measure customer satisfaction?
A. 0 complaints received
B. 0 returned product counts
C. repeat orders
D. customer data on delivered product quality
33: Per the ISO 9001 standard, an organization is required to plan an audit program that considers the results of what?
A. employee surveys
B. top management perceptions
C. sales of similar products from other suppliers
D. previous audits
34: The ISO 9001 standard refers to a methodology as PDCA. What does PDCA stand for?
A. Plan, Do, Check, Act
B. Procedures, Documents, Corrections, Actions
C. Process, Documents, Certification, Actions
D. Process, Data, Correct, Analyze
35: Per the ISO 9001 standard, documents required by the organization's quality management system shall be:
A. controlled
B. hard copy
C. approved
D. electronic
36: An organization must perform what to check how its quality management system is working?
A. customer audits
B. internal audits
C. management reviews
D. external audits
37: Clause 7.0 of the ISO 9001 standard is Product Realization. The standard requires a organization to plan and develop the processes needed for product realization. What does planning product realization include?
A. the need to determine what inputs will come from OSHA for product realization
B. the need to determine the required monitoring activities specific to the product
C. the need to specify the exact amount of documents that are required to meet product requirements
D. the need to determine the amount of customer visits that are required to meet product requirements
38: The ISO 9001 standard can be applied to:
A. only organizations that provide customers with products but not services
B. only manufacturing type of organizations
C. only larger organizations that have 100 employees or more
D. any organization, large or small, whatever its product or service and regardless of its sector of activity.
39: What purpose would an organization seek an ISO 9001 certification?
A. Because the organization is required to by city regulations
B. It's the law
C. Because OSHA requires organizations to be certified to ISO 9001
D. To provide the organization's customers assurance of consistent, good quality products or services
40: The ISO 9001 standard requires an organization to plan and implement the monitoring, measurement, analysis and improvement of processes needed to what?
A. determine if product can be exported to other countries
B. satisfy state laws regarding records of conformity
C. determine if employees are content with their jobs
D. continually improve the effectiveness of the quality management system
41: The ISO 9001 standard requires top management to ensure that appropriate communication processes are established within the organization and that communication takes place regarding what?
A. the effectiveness of the profit sharing estimates
B. the location of each record controlled
C. the effectiveness of the quality management system
42: ISO 9001 requires an organization to implement a quality management system to demonstrate:
A. the organization's ability to meet environmental regulations
B. the organization's ability to consistently provide product that meets customer requirements
C. the organization's ability to pay employees
D. the organization's ability to meet employment regulations
43: Design and Development of product requires planning per the ISO 9001 standard. What should the organization determine during planning of design and development?
A. the non-intended use risks involved with the product
B. the stage at which no changes will be allowed during the design phase
C. the number of employees required to design the product
D. the design and development stages
44: The organization is required to conduct a review prior to the commitment to supply a product to the customer and shall ensure that the organization has the ability to meet what?
A. the defined quality policy
B. the defined requirements
C. the changes requested by the certification body
D. the changes requested by an external auditor
45: The ISO 9001 standard requires an organization to implement effective arrangements for communicating what to customers?
A. all internal reorganizations
B. enquiries, contracts, or order handling including amendments
C. other customer audit findings
D. all redlines made to process documentation
46: The organization is required to determine and provide the resources needed to enhance customer satisfaction by what?
A. meeting top management expectations
B. meeting OSHA requirements
C. meeting customer requirements
D. meeting ISO 9001 standard requirements
47: When monitoring and measuring product, what type of records shall be maintained by the organization per ISO 9001?
A. a written approval record from the customer for each lot
B. an internal corrective action report for all issues found for each lot
C. an audit record per lot
D. evidence of conformity with the acceptance criteria
48: The recommendations for improvement is considered an input for what?
A. design review
B. customer audit
C. management review
D. external audit
49: How should auditors conduct internal audits per the ISO 9001 standard?
A. Every year a new auditor shall be selected to conduct internal audits
B. Auditors shall audit their own departments
C. Each auditor shall only audit once a year to maintain objectivity
D. Auditors shall not audit own work
50: Under 4.0, the ISO 9001 standard requires an organization to monitor, measure and analyze processes to determine if they are:
A. effective
B. all linked
C. correct
D. approved by the customer
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