31 0 68KB
Internal Audit of ISO 9001:2015 Quality Management System
Examination Paper
Company
:
Name
:
___________________________
Department : Date
:
___________
INSTRUCTIONS: 1. 2.
Please answer all questions in 30 minutes. Mark your answer at the appropriate space on your answer sheet with 2B pencil. Only ONE (1)
3. 4.
answer shall be marked for each question. Follow the instructions of the test controller and stop writing when you are told to do so. Test paper along with answer sheet must be returned at the end of the test.
Internal Audit of ISO 9001:2015 Quality Management System Training Course- Post-training Examination
1.
Which of the following best describe ISO 9001:2015? (I) (II) (III) (IV) a. b. c. d.
2.
Context of the organization Business environment Quality policy Quality management system
“Systematic, independent and documented process for obtaining objective evidence and evaluating it objectively to determine the extent to which the audit criteria are fulfilled” is the definition of a. b. c. d.
4.
I & III II & III I & II I, II & IV
“Combination of internal and external issues that can have an effect on an organization’s approach to developing and achieving its objectives” is the definition of a. b. c. d.
3.
Quality management systems- requirements Intended to be used in conjunction with ISO 14001 environmental management system ISO 9001 is certifiable by accredited certification bodies ISO 9001 is only applicable to manufacturers, regardless of size or complexities
Audit Internal inspection Laboratory testing Internal audit procedure
Mandatory documented information required by ISO 9001:2015 standard includes (I) (II) (III) (IV) a. b. c. d.
5.
Scope of the quality management system Quality objectives Design and development changes Maintenance of infrastructure
I, II & IV I, II & III II, III & IV I, II, III & IV
In what clause of ISO 9001:2015 standard is the requirement for conducting internal audit specified? a. b. c. d.
Page 2 of 7
Clause 4 Context of the organization Clause 5 Leadership Clause 8 Operation Clause 9 Performance evaluation
Internal Audit of ISO 9001:2015 Quality Management System Training Course- Post-training Examination
6.
Audit is a systematic, independent and documented process for obtaining objective evidence and evaluating it objectively to determine the extent to which the audit criteria are fulfilled. Which are the following can be used as objective evidence? (I) (II) (III) (IV) a. b. c. d.
7.
I & II I & IV II & IV All of the above
Audit criteria include (I) (II) (III) (IV) a. b. c. d.
8.
ISO 9001:2015 standard Customer contract requirements Quality manual Operating procedures
I, II & III I, II & IV II, III & IV I, II, III & IV
audit shall be performed at planned intervals by internal auditors of the organization implementing ISO 9001:2015 quality management system. Please fill in the blank with the best answer. a. b. c. d.
9.
Training attendance records Supplier evaluation records Customer satisfaction survey reports Quality objective reports
Site Annual Internal Supplier
Purpose of conducting internal audits includes the following EXCEPT a. b. c. d.
To check compliance of the quality management system against ISO 9001:2015 requirements To check improvement needs To raise non-conformance report for areas not complied to the ISO 9001:2015 standard To check effectiveness of the quality management system
10. Extent and boundaries of an audit are defined as a. b. c. d. Page 3 of 7
Audit scope Audit criteria Audit Evidence Audit schedule
Internal Audit of ISO 9001:2015 Quality Management System Training Course- Post-training Examination
11. Which of the following are the principles of auditing? (I) (II) (III) a. b. c. d.
Ethical conduct Evidence based approach Due professional care
I & II II & III I, II & III I & III
12. As long as a piece of critical monitoring equipment is periodically examined by the operators who know and use it, a formalized maintenance and calibration program is not necessary, TRUE or FALSE? a. True b. False
13. In preparing for an audit, one of the key points in an audit team selection is: a. b. c. d.
Selecting all qualified lead auditors Ensuring one of the auditors is in a senior management position Selecting auditors who are independent of the area to be audited Having the team leaders choose the people they like to work with
14. ISO 9001:2015 Quality management principles includes (I) (II) (III) (IV) a. b. c. d.
Leadership Process approach System approach Customer focus
I, II & III II, III & IV I, II & IV I, III & IV
15. Which of the following suppliers require controls to ensure quality requirements have been met? (I) Office stationery products (II) Bulk materials (III) Transporter (IV) Third party warehouse a. b. c. d.
Page 4 of 7
I, II & III II, III & IV I, III & IV I, II & IV
Internal Audit of ISO 9001:2015 Quality Management System Training Course- Post-training Examination
16. QC inspection programs shall be established to monitor and measure conformity of products. Which of the following shall be inspected during internal audit? (I) (II) (III) (IV) a. b. c. d.
Name of the QC inspector Inspection methods and frequency Inspection records Location of QC laboratory
I, II & III I, II & IV I, III & IV II, III & IV
17. During site audit on proper storage of raw materials, which of the following storage conditions complies with the ISO 9001:2015 requirements? a. b. c. d.
Areas near to the production machines Storage areas with proper identification of raw materials Outside the factory In the office
18. Which of the following best define “Corrective Action”? a. b. c. d.
Action to eliminate a detected nonconformity Action to eliminate the cause of a nonconformity and to prevent recurrence Investigate root cause of a detected nonconformity Segregate non-conforming item to reject area
19. A third party audit is a. b. c. d.
An internal audit An audit by customer or client An audit by an independent organization All of the above
20. Please arrange the following according to the correct internal audit steps (I) (II) (III) (IV) a. b. c. d.
Page 5 of 7
Carry out internal audit according to audit schedule Prepare audit schedule and select internal auditors Take corrective action on non-conformance raised during audit Conduct closing meeting to summarize audit findings
II, IV, I, II II, I, IV, III IV, II, I, III III, I, II, IV
Internal Audit of ISO 9001:2015 Quality Management System Training Course- Post-training Examination
21. Auditor shall not audit their own works or areas of responsibilities, TRUE or FALSE? a. True b. False
22. Which of the following can be used to check quality compliance of raw materials? (I) (II) (III) (IV) a. b. c. d.
Test reports/ certificate of analysis provided by supplier for each batch of materials supplied ISO 9001 certificates from supplier proving the supplier compliance with ISO 9001 standards Incoming material inspection records Material delivery order
I & II II & III II & IV I & III
23. Evidence that can be audited to verify the implementation and effectiveness of trainings conducted includes: (I) (II) (III) (IV) a. b. c. d.
Training attendance records Training effectiveness evaluation records Certificates of attendance Training plan
I & II I & III II & III I, II, III & IV
24. Corrective action shall be carried out whenever a complaint from customer is received. As an internal auditor, how do you check if proper action has been taken to solve the complaint issues? a. By checking the customer complaint record indicating root cause of complaint, corrective action
taken and verification of action taken
b. By interviewing the sales personnel on customer feedback pertaining to the complaint issues c. Contact the customer to verify if the complaint issue has been solved d. By checking the management review meeting minutes to confirm the complaint has been
discussed and solved 25. Which of the following DOES NOT comply with the good storage requirements? a. b. c. d.
Page 6 of 7
Store on pallet or racking Mix raw material and finished product as long as all items are packed properly Label raw material Store room is clean and well ventilated
Internal Audit of ISO 9001:2015 Quality Management System Training Course- Post-training Examination
26. Internal audit shall be conducted? a. b. c. d.
At planned intervals Once a year Whenever changes to the quality management system occur Prior to the surveillance audit by certification body
27. ISO 9001:2015 requirements include a. b. c. d.
Health and safety requirements Operational planning and control Quality costing All of the above
28. Which of the following are required to enable traceability of finished product? (I) (II) (III) (IV) a. b. c. d.
Label raw materials with receiving date and batch number Record production activities including materials used in job sheets Conduct mock recall on a yearly basis Maintain finished product delivery records
I, II & III I, III & IV I, II & IV II, III & IV
29. What information is being sought during a third party audit of a quality management system? a. b. c. d.
A list of nonconformities to ISO 9001:2015 Objective evidence of conformity with ISO 9001:2015 A management commitment to quality assurance All of the above
30. To act as an internal auditor of a quality management system a person has to (I) (II) (III) (IV) a. b. c. d.
Page 7 of 7
Be registered as a certificated auditor Have undergone a formal ISO 9001:2015 internal audit training Be independent from the areas to be audited Have been a quality system manager
I & II II & III I, II & III II, III & IV