ISO 9001:2008 QMS Awareness Questions

Write ‘Yes’ for the statement you agree and ‘No’ for the statement you do not agree.

1. Quality is a fluid concept. - Yes / No
2. It is easy to manage quality. - Yes / No
3. W. Edward Deming says that quality is pride for workmanship. - Yes / No
4. According to the ISO definition of ‘quality’ means ‘degree to which a set of inherent characteristics fulfills customer expectations.’ - Yes / No
5. The fitness for purpose for quality can be judged by the customer, provider or an independent auditor. The independent auditor is the final judge. - Yes / No
6. The system of appraisal known as ‘quality control’ as a traditional method where ‘inspection’ is the king. - Yes / No
7. In order to remain in business, an organization has to provide goods and service of high quality, sale at the right price, meet delivery requirements and make a profit. - Yes / No
8. There can be two members from one country having ISO membership. - Yes / No
9. The objective of ISO is to promote the development of standardization and related activities in the world. - Yes / No
10. ISO 9000 is a mandatory system. - Yes / No
11. ISO 9001:2008 QMS Standard is a government regulation in India. - Yes / No
12. It is necessary to implement ISO 9001:2008 QMS Standard by organizations to seek SSI registration. - - Yes / No
13. Suppliers can establish standards of quality in their management systems and have assessed against ISO 9004:2009 international standard. - Yes / No
14. The quality management principles have been developed for use by the people of the organization in order to have better performance. - Yes / No
15. By predicting customer needs, an organization becomes customer focused organization. - Yes / No
16. Continual improvement is a requirement of ISO 9001:2008 QMS Standard and also a quality management principle. - Yes / No
17. Effective decision can be taken if an organization analyzes data and information in a proactive manner using ‘factual approach to decision making’ principle. - Yes / No
18. A desired result can be achieved more efficiently when all related resources and activities are managed as a process. - Yes / No
19. Appointing a consultant is necessary to implement ISO 9001:2008 QMS Standard. - Yes / No
20. The top management must appoint a ‘quality manager’ to coordinate QMS activities and also to give necessary directions to the people of the organization. - Yes / No
21. The responsibility and authority of ‘management representative’ can be assigned to an outside person. - Yes / No
22. It is necessary for the management representative to undergo lead auditor training. - Yes / No
23. An organization (in the absence of organization’s quality policy and quality objectives) can be granted ISO 9001:2008 QMS certification, if certification body finds the organization having met all other requirements of the ISO 9001:2008 QMS Standard. - Yes / No
24. If an organization has appointed a quality professional, then the organization is not required to appoint management representative for implementing ISO 9001:2008 QMS. - Yes / No
25. For implementing ISO 9001:2008 QMS, it is necessary to appoint a consultant. - Yes / No
26. International organization for Standardization (ISO) audit organizations and issues ISO 9001:2008 certificates. - Yes / No
27. International organization for Standardization (ISO) is the biggest certification body. - Yes / No
28. Management review forms an integral part of the quality management system and it should be conducted at planned intervals. - Yes / No
29. External audit and certification are mandatory requirements of ISO 9001:2008 QMS Standard. - Yes / No
30. An organization can implement ISO 9001:2008 QMS Standard only when it wishes to achieve its certification. - Yes / No
31. On implementing ISO 9001:2008 QMS Standard requirements, quality management system documentation of one organization cannot differ from another organization. - Yes / No
32. The ISO 9001:2008 QMS Standard lays down an emphasis on continual improvement of the quality management system. - Yes / No
33. Where an organization chooses to outsource any process that affects product conformity to requirements, the organization may relax control over such processes. - Yes / No
34. The intention of the ISO 9001:2008 QMS Standard is to imply uniformity in the structure of quality management system and uniformity of documentation. - Yes / No
35. Ensuring control over outsourced processes absolve the organization of the responsibility to fulfill all customer and legal requirements. - Yes / No
36. The quality management system documentation of an organization can be in any form or type of medium. - Yes / No
37. One copy of the quality management system documentation must be in hard copy. - Yes / No
38. It is mandatory for an organization to have documented procedure for control of documents, control of records, internal audit, control of purchasing, corrective action and preventive action. - Yes / No
39. All documents required by the quality management system of the organization are needed to be controlled as per requirements mentioned in clause 4.2.3 of ISO 9001:2008 QMS Standard. - Yes / No
40. Records required by the quality management system of the organization are needed to be controlled as per requirements mentioned in clause 4.2.4 of ISO 9001:2008 QMS Standard. - Yes / No
41. Approval of documents for adequacy may be obtained after issue of documents. - Yes / No
42. Reviewing documents means another look at the documents and this may be carried randomly or periodically. - Yes / No
43. Relevant versions of applicable documents along with obsolete documents must be available at points of use. - Yes / No
44. Management reviews is conducted at the convenience of the top management as and when they wish. - Yes / No
45. The detail and format of the quality manual of one organization cannot differ from another organization, if both organizations are implementing the same ISO 9001:2008 QMS Standard. - Yes / No
46. Quality objectives must be measurable. - Yes / No
47. ISO 9001:2008 QMS Standard stipulates that management review must be conducted at least once in a year. - Yes / No
48. ISO 9001:2008 QMS Standard stipulates that the organization must maintain appropriate record of human resources (such as attendance, leave records). - Yes / No
49. Personnel carrying out work affecting conformity to product requirements must be competent. - Yes / No
50. The organization must determine the necessary competence for all personnel. - Yes / No
51. The term ‘work environment’ relates to physical, environmental and other factors, human resources and also infrastructure facilities that organization has. - Yes / No
52. The term ‘work environment’ has been defined as a set of conditions under which work is performed. - Yes / No
53. No organization can take exclusion from design and development requirements as mentioned in clause 7.3 of ISO 9001:2008 QMS Standard. - Yes / No
54. If an organization is unable to conduct management review at defined intervals due to shortage of staff, then the organization can claim exclusion for management review requirements. - Yes / No
55. Internal audit is a one time activity. - Yes / No
56. An internal auditor is allowed to audit his/her own work. - Yes / No
57. The organization must conduct internal audit at defined intervals, however it is not necessary to maintain records of audit. - Yes / No
58. ISO 9001:2008 QMS Standard has defined the frequency of the internal audit. - Yes / No
59. If an organization has a good monitoring system and it conducts management review at defined intervals then there is no need to conduct internal audit. - Yes / No
60. It is mandatory to have a documented procedure for control of nonconforming product as per ISO 9001:2008 QMS Standard. - Yes / No
61. It is mandatory to have a documented procedure for analysis of data as per ISO 9001:2008 QMS Standard. - Yes / No
62. It is mandatory to have a documented procedure for continual improvement as per ISO 9001:2008 QMS Standard. - Yes / No
63. It is mandatory to have a documented procedure for corrective action as per ISO 9001:2008 QMS Standard. - Yes / No
64. It is mandatory to have a documented procedure for preventive action as per ISO 9001:2008 QMS Standard. - Yes / No

Do self assessment by reading different blog posts.

With best wishes,

KRS