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.
A. the Internal Standards Option
B. the International Standards Opportunity
C. the Internal Systems Organization
D. the International Organization for Standardization
A. quality documents
B. quality manual
C. quality objectives
D. quality records
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
A. its products, processes, and size
B. the county of its physical location
C. the government
D. the IRS
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
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
A. statement of work
B. documented quality objective statement
C. non-disclosure agreement
D. confidentiality agreement
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
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
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
A. once a month
B. per each process
C. annually
D. determined planned intervals
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
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
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
A. only hard copy documentation
B. in any form or type of medium
C. only electronically filed
D. only filed offsite
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
A. re-verification to demonstrate conformity to the requirements
B. selected certification body approval
C. International Organization of Standardization approval
D. customer approval
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
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
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
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
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
A. ISO 13485
B. ISO 17025
C. ISO 14001
D. ISO 14971
A. sales representative
B. outsourced consultant
C. member of the organization's management
D. trained employee
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
A. only refunds
B. only returns
C. delivery and post-delivery activities
D. only complaints
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
A. inform the customer of the nonconformities
B. not hide its problems
C. be completely transparent with its issues
D. prevent recurrence
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
A. uploaded electronically
B. sent offsite for storage
C. approved and signed off by top management
D. legible, readily identifiable and retrievable
A. noise
B. weather
C. software and hardware
D. temperature and humidity
A. 0 complaints received
B. 0 returned product counts
C. repeat orders
D. customer data on delivered product quality
A. employee surveys
B. top management perceptions
C. sales of similar products from other suppliers
D. previous audits
A. Plan, Do, Check, Act
B. Procedures, Documents, Corrections, Actions
C. Process, Documents, Certification, Actions
D. Process, Data, Correct, Analyze
A. controlled
B. hard copy
C. approved
D. electronic
A. customer audits
B. internal audits
C. management reviews
D. external audits
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
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.
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
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
A. the effectiveness of the profit sharing estimates
B. the location of each record controlled
C. the effectiveness of the quality management system
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
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
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
A. all internal reorganizations
B. enquiries, contracts, or order handling including amendments
C. other customer audit findings
D. all redlines made to process documentation
A. meeting top management expectations
B. meeting OSHA requirements
C. meeting customer requirements
D. meeting ISO 9001 standard requirements
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
A. design review
B. customer audit
C. management review
D. external audit
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
A. effective
B. all linked
C. correct
D. approved by the customer
A. test equipment, calipers, microscopes
B. quality policy, management review, audit results
C. procedures, quality manual, nonconforming material reports
D. external auditors, customer surveys, supplier score cards
A. quality manager
B. International Organization of Standardization
C. each employee
D. top management
A. when an organization needs to report the potential nonconformities to the certification body
B. determining potential nonconformities and their causes
C. when an organization needs to report the potential nonconformities to the customer
D. the need of the products to be recalled due to the potential nonconformities
A. corrective action
B. preventive action
C. management review
D. internal audit
A. quality objectives
B. all scheduled reviews
C. customer requirements
D. all the requirements detailed in its quality manual
A. packaging, delivery, and replacement
B. handling, packaging, and storage
C. handling, testing, and delivery
D. labeling, verification, and delivery
A. all organizational employees' role within the product development cycle even if an employee doesn't have one
B. the responsibilities and authorities for design and development
C. how records will be maintained for the product life cycle
A. assess and record the validity of the previous measuring results
B. identify the product separately and sale product at a discount
C. dispose of all product ran through piece of equipment
D. rerun product through piece of equipment to verify conformance
A. include personnel of all departments to determine the viability of the product
B. include an ISO certification representative to approve product design
C. identify any problems and propose necessary actions
D. include a customer representative to approve the design of the product
A. testing its configuration from an outside source
B. its verification and configuration management to maintain its suitability for use
C. a review from employees not directly related to the intended application for verification
D. a certificate from the software supplier to confirm the software's intended application
A. by organizing an annual organization communication
B. by ensuring the availability of resources
C. by attending organization all-hands meetings
D. by attending internal audits
A. Management Responsibility
B. Continual Improvement
C. Customer Requirements
D. Resource Management
A. an approval from top management for the release of the product before delivery
B. the availability of work instructions
C. a record documenting all personnel involved with the production of the product
D. a cleanroom environment
A. replacement activities after a re-sale of product
B. non-intended use of product
C. resale of product
D. final disposal
A. the organization shall request a signed quality agreement from each supplier they purchase product from
B. the company will measure and test every purchased product to ensure it meets requested requirements
C. the organization shall establish and implement inspection activities
D. the organization shall audit every supplier to ensure they meet quality requirements
A. make sure the certification body is not accredited
B. only use certification bodies that know he organization's specific product or service
C. only use certification bodies rated by the better business bureau
D. bear in mind that the cheapest could be more costly in the long run if its auditing is below standard
A. documented procedures
B. customer contracts
C. customer property provided for use
D. records of evidence
A. ensuring that all corrective actions taken were closed prior to release of the product
B. evidence that all suppliers used for purchased product were audited prior to release of product
C. customer satisfaction data
D. ensuring that at least one preventive action was issued prior to release of product
A. record keeping
B. verification
C. documentation
D. testing
A. changes to orders
B. customer ship to address
C. if personnel had been trained appropriately to build the order
D. re-verification of purchase price
A. procedures
B. records
C. processes
D. product
A. 2
B. 10
C. 6
D. 8
A. ISO 9001 Audit Committee
B. Committee to Quality Management System Certification
C. CASCO (Committee on Conformity Assessment)
D. Committee of the Audit Process for ISO 9001
A. resource needs
B. improvements to the quality management system processes
C. improvement of product related customer requirements
D. changes that could affect the quality management system
A. Employees
B. Customer
C. Owners
D. Producers
A. Employees
B. Stake holders
C. Customers
D. Employers
E. Management
A. customer focus
B. process approach
C. system approach to management
D. continual improvement
Special Instructions:The following question may have more than one correct answer options
According to ISO9001, Monitoring and Measurement is required for:
A.
Delivery
B.
Process
C.
Product
D.
None of the above
A. ISO/TC 207
B. ISO/TC 206
C. ISO/TC 205
D. ISO/TC 204
A. Clause 8
B. Clause 6
C. Clause 7
D. Clause 9
Special Instructions:The following question may have more than one correct answer options
Documented procedure for control of records must define controls for their:
A.
identification
B.
storage and protection
C.
retention and retrieval
D.
none of the above
Special Instructions:The following question may have more than one correct answer options
ISO9001 certified organization is permitted to use an approved logo of the certifying body on its following items:
A.
Stationery
B.
Product
C.
Advertising Material
D.
Anywhere
A. True
B. False
A. quality audit
B. quality assurance
C. quality conformance
D. quality evaluation
A. Customer focus
B. Process approach
C. System approach to management
D. Continual improvement
A. manufacturing
B. product validation
C. product planning and control
D. product realization
A. Method
B. Process
C. Procedure
D. System
A. only before dispatching to the customer
B. suitably throughout production process
C. only while planning the production process
D. only while determining the cost of the product
A. need not be identified
B. can not be used for production
C. must be identified prior to use
D. should not be used for more than one year
A. during production process
B. as and when required
C. before using the equipment
D. only before ISO audit
A. ISO 9000:2005
B. ISO 19011:2002
C. ISO 14001:9000
D. ISO 14001:9001
A. Control
B. Co-ordinate
C. Check
D. Create
A. quality assurance department
B. external quality auditors
C. accounts department
D. personnel department
A. product verification
B. product validation
C. product specification
D. product application
A. Element based
B. Dictatorial
C. Process based
D. Manager based
A. ISO 9000
B. ISO 9001
C. ISO 9004
D. ISO 14001
A. Customer's Reception
B. Communication process
C. Manufacturing Processes
D. quality management system
A. True
B. False
A. full members
B. correspondent members
C. subscriber members
D. partial members
A. At any time
B. As and when convenient
C. At planned interval
D. Never