Quality Management Systems – Questions & Answers

1. “Person or group of people who directs and controls an organization at the highest level” is the definition of:

A. Quality Management Department
B. Production Control Department
C. Top Management
D. None of the above


2. ISO 9001 requires which of the following to be documented?

A. A procedure for the auditing of suppliers
B. A procedure for internal auditing
C. A procedure for training
D. All of the above

3. Identify the specific ISO 9001 clause number that is applicable to the following: “The organization shall determine and manage the work environment needed to achieve conformity to product requirements”

A. 6.4
B. 4.2.1
C. 7.1
D. None of the above


4. This is an example of a quality management system document:

A. Work Instructions
B. Documented Procedures
C. Internal audit program
D. All of the above


5. How long must Quality Objectives be set for?

A. Depends on the shelf-life of the product
B. 3 years (one certification cycle)
C. As determined by the organization
D. Indefinitely


6. When used within a quality management system, the process approach emphasizes the importance of:

A. Understanding and meeting requirements
B. The need to consider process in terms of added value
C. Obtaining results of process performance and effectiveness
D. All of the above


7. ISO 9001 Standard, specifies requirements for:

A. A food safety management system
B. Quality management system
C. An occupational health and safety management system D.
A production control system


8. Which of the following is not a method for defining responsibility and authority within an organization?

A. An organizational chart
B. A job description
C. On the job training
D. None of the above


9. The organization shall identify the product status with respect to monitoring and measurement requirements:

A. After the production has ended
B. Only for the stages related to customers
C. Throughout product realization
D. None of the above


10. When auditing an organization that implements a quality management system, it is necessary:

A. To use certified auditors
B. To have a copy of ISO 9001:2015
C. To audit every one of the personnel, even though they may have the same responsibilities, in order to be as confident as possible
D. None of the above

11. The non-fulfillment of a specified requirement is called a:

A. Concession
B. Nonconformity
C. Corrective action
D. None of the above


12. Which of the following is NOT an example of poor quality?

A. Price of the product is significantly higher than that all other products in the market
B. Product is delivered later than promised
C. Product is delivered with no instructions for use
D. Product stops working unexpectedly


13. 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

14. 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

15. Customer property may include:

A. Production equipment
B. Facilities
C. Product returned for servicing under warranty
D. All of the above


16. 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


17. The ISO 9001 Standard requires from top management to ensure that:

A. 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

18. Infrastructure does NOT include:

A. Human resources
B. Buildings
C. Information Systems
D. Hardware


19. 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

20. In the Customer Service Department of a large catalogue retailer, the auditors were reviewing the corrective action process. The audit team leader noticed that a recurring customer complaint was that the organization was in a stock out situation during sales events. In each of the last four occurrences the auditor discovered that the root cause was listed as “ineffective contract review.” The corrective action was listed as “procedure training.” When asked to explain this, the Supervisor reported that they perform their contract review on the flyers they mail out because it isn’t feasible to do it on each order. He further pointed out that “ISO allows that.” The auditor said that she knew that, but could he explain why they kept stating that “procedure training” was their corrective action when it was obviously not effective. The Supervisor responded that there really isn’t anything more they could do, when they have a sale, they only offer a limited number of the items at the sales price, and they obviously are poor judges of their customer’s response. The auditor asked if they state in their flyer that they are only offering a certain number, to which the supervisor replied, “You’re kidding right? Of course not” The above incident can be reported as:

A. Non Conformity against 8.5.2 clause
B. Non Conformity against 8.2.4 clause
C. Opportunity for improvement against 8.5.3 clause
D. None of the above


Please feel free to write your comments, suggestions or corrections.


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