ISO 9001 Lead Auditor Training

Exam Exercise 4 - Short Essay Questions

ISO 9001 Lead Auditor Training - Typical short essay type questions are worth 5 marks each. Your response should cover a breadth of several points as opposed to going into depth on one or two points.  (Tip: Provide bullet point answers covering 5-10 separate points)

1 Explain the characteristics of (and differences between) a first party, second party, and third party QMS audit.

2 A complete audit of an organization's QMS consists of two distinct stages. Briefly describe each of these stages.

3 An auditor is conducting a third party QMS audit and the guide that has been appointed to accompany him is called away by his supervisor. After five minutes, the guide has not returned. What should the auditor do? What should the auditor not do?

4 Identify five clauses where planning of QMS activities is required by ISO 9001 and briefly explain each planning activity.

5 State the typical objective evidence that could be gathered in order to verify conformity with the requirements of clause 7.6 of the ISO 9001 Standard.  Your answer should contain at least five specific examples in order to illustrate your understanding.

6 An experienced auditor has been instructed to carry out a QMS audit of a potential supplier. From initial contacts with the supplier, it is learned that a formal documented QMS does not exist. List five steps the auditor could take in planning for such an audit.

7 An auditor may experience delaying tactics while conducting an audit. Give two examples of such tactics and describe three ways in which the auditor could deal with these situations.

8 State four advantages and one disadvantage of using checklists to perform a QMS audit.

9 At the closing meeting, the quality management representative (QMR) of the organization audited informs the auditor that they have now written a procedure to correct a serious non-conformity that the Registrar auditor found on the first day of a two-day external audit. The QMR proposes that the auditor examine the procedure during the meeting and then withdraw the nonconformity report. How should the auditor respond?

10 List and briefly explain five different ways in which an auditor obtains objective evidence while performing a QMS audit.

11 Explain the purpose and benefits of a preliminary visit to a company by the audit team leader prior to a QMS audit.

12 Arriving for the closing meeting, at the conclusion of an audit in which numerous nonconformities have been recorded, the auditor is told by the quality management representative that none of the senior managers who were contacted are available to attend. What should the auditor do?

13 While in the warehouse during a third party QMS audit, the guide gets into a heated argument with the warehouse clerk over the absence of inspection status labels on skids of paint pails being stored on the racks. The warehouse clerk claims labeling is not necessary because the racks are a designated area for the paint pails to be kept until inspected and approved by the inspection department. The guide turns to the auditor and asks for support. How should a third party auditor respond?

14 At the opening meeting of a third party QMS audit, the management representative (QMR) of the audited company informs the auditor that a recent internal audit has disclosed numerous deficiencies in control of calibration. Corrective action is being planned. The QMR proposes the audit of the calibration department be deleted from the audit plan. How should the auditor respond?

15 What objective evidence could be available in order to verify nonconformity with the requirements of clause 7.4 of the ISO 9001 Standard?

ISO 9001 FAQ provides answers to commonly asked questions about the ISO 9000 family of quality management standards.