17. Which of the following best describe ISO 9001:2015? (1) Quality management systems- requirements (1I) Intended to be used in conjunction with ISO 14001 environmental management system (II) ISO 9001 is certifiable by accredited certification bodies (IV) ISO 9001 is only applicable to manufacturers, regardless of size or complexities a. 1& II b. II & III C. 1 &II d. I, II & IV Page 2 of 10 18. "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: Context of the organization a. b. Business environment c. Quality policy d. Quality management system 19. "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. Audit b. Internal inspection c. Laboratory testing d. Internal audit procedure 20. Mandatory documented information required by ISO 9001:2015 standard includes Scope of the quality management system (1) Quality objectives (III) Design and development changes (IV) Maintenance of infrastructure (II) a. I, II & IV b. I, II & III c. II, III & IV d. 1, II, III & IV 21. In what clause of ISO 9001:2015 standard is the requirement for conducting internal audit specified? Clause 4 Context of the organization Clause 5 Leadership a. b. Clause 8 Operation C. d. Clause 9 Performance evaluation 22. 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? Training attendance records Supplier evaluation records Customer satisfaction survey reports Quality objective reports (1) (II) (III) (IV) a. 1& I| b. 1& IV Il & IV C. d. All of the above 23. Audit criteria include ISO 9001:2015 standard (1) (II) (III) (IV) Customer contract requirements Quality manual Operating procedures a. I, II & II b. 1, II & IV c. II, III & IV d. 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 24. blank with the best answer. a. Site b. Annual c. Internal d. Supplier Purpose of conducting internal audits includes the following EXCEPT 25. a. To check compliance of the quality management system against ISO 9001:2015 requirements b. To check improvement needs c. To raise non-conformance report for areas not complied to the ISO 9001:2015 standard d. To check effectiveness of the quality management system Purpose of conducting internal audits includes the following EXCEPT 25. To check compliance of the quality management system against ISO 9001:2015 a. requirements b. To check improvement needs c. To raise non-conformance report for areas not complied to the ISO 9001:2015 standard d. To check effectiveness of the quality management system 26. Extent and boundaries of an audit are defined as a. Audit scope b. Audit criteria c. Audit Evidence d. Audit schedule 27. Which of the following are the principles of auditing? (1) (II) (III) Ethical conduct Evidence based approach Due professional care a. 1&II b. II & III I, II & III d. 1& III C. 28. As long as a piece of critical monitoring equipment is periodically used by the operators who know how to use it skillfully, a formalized maintenance and calibration program is not necessary, TRUE or FALSE? a. True b. False