ISO-9001-Lead-Auditor Questions and Answers
Question # 1
You work as an external quality consultant for an organisation, “ABCâ€, which provides packaged food to the public. You are asked to lead a team (you as the leader and two other auditors) to audit an external provider, “XYZâ€, which provides packaging materials to “ABCâ€. It is 4 pm, and the closing meeting was scheduled for 5 pm.
You, as the audit team leader, audited Top Management. You explain to the audit team that you identified two non-conformities:
a. There is no documented information on the results of Top Management Reviews, as required in clause 9.3 of ISO 9001:2015.
b. There is no evidence of Top Management commitment as required in clause 5.1 of ISO 9001:2015 (e.g., not ensuring the availability of resources to operate the QMS, not ensuring the establishment of objectives).
All agreed to present these two non-conformities, graded as major.
As the audit team leader, select the best option on how to handle the closing meeting.
Question # 2
Scenario 3:
Fin-Pro is a financial institution in Austria offering commercial banking, wealth management, and investment services. The company faced a significant loss of customers due to failing to improve service quality as they expanded.
To regain customer confidence, top management implemented a QMS based on ISO 9001. After a year, they contacted ACB, a local certification body, to pursue ISO 9001 certification.
The audit team was led by Emilia, an experienced lead auditor, and included three auditors. After an agreement was reached, ACB sent the audit objectives to the audit team.
The audit team began by gathering information about Fin-Pro’s understanding of ISO 9001 requirements. While reviewing documented information, they noticed missing records of training and awareness sessions. They conducted employee interviews to verify attendance.
The team also reviewed the organizational chart and job descriptions to confirm employee competence. They observed the company’s working environment (social, psychological, and physical conditions).
The audit team analyzed the evidence and prepared an audit report with findings and conclusions.
ACB sent the audit objectives to the audit team after an agreement was reached. Is this acceptable?
Question # 3
You, as auditor, are in dialogue with the quality lead and managing director of a small business that supplies
specialist laboratory equipment and furniture.
You: " I ' d like to look at how you manage change in the organisation. What changes have you made as a
business, say, over the last 12 months? "
Auditee: " We have made some strategic changes, the main one being that we no longer manufacture our
own products in house. "
You: " That sounds like quite a significant change. What has been the impact of that? "
Auditee: " We now mainly sell other manufacturers ' products, under their brand names, and have outsourced
manufacture of our own brand products to one of our suppliers. Unfortunately, we had to make six members
of our staff redundant. This represents about 20% of our workforce, so this has been quite a challenging
time. "
You: " I ' m sure. What were the reasons for making the change? "
Auditee: " Our manufacturing section was a small operation, and we struggled to cope with fluctuations in
demand. During busy periods, we found it hard to meet lead times, and in quiet periods we had staff with
little to do. This was having an impact on customer satisfaction and meant we had to charge premium prices
that made our product uncompetitive. "
You: " How did you go about the change? "
In relation to the auditor ' s question about how the change was managed, the auditee mentions the steps
listed below. Match the ISO 9001 clauses to the steps.
To complete the table, click on the blank section you want to complete so it is highlighted in red and then
click on the ISO 9001 clauses listed below. Alternatively, drag and drop each clause to show which step the
requirement applies to.
