View all detail and faqs for the ISO-9001-Lead-Auditor exam
An organisation wants to certify their ISO 9001:2015-based QMS for the first time. Arrange the activities in the correct sequence from 2 to 5.
To complete the sequence, click on the blank section you want to complete so it is highlighted in red and then click on the applicable text from the options below. Alternatively, drag and drop the
options to the appropriate blank section.
You have been nominated audit team leader of a third-party audit. Which of the following could be the two most relevant objectives of this audit?
Which two of the following work documents are not required for audit planning by an auditor conducting a certification audit?
You are carrying out an audit at a single-site organisation seeking certification to ISO 9001 for the first time. The organisation manufactures
cosmetics for major retailers.
You are interviewing the Manufacturing Manager (MM).
You: "I would like to begin by looking at the cleaning controls."
MM: "We record the cleaning of the equipment at the end of every batch. This document details the minimum cleaning frequency and the
procedures to follow for all areas and each item of equipment. The person who carries out the cleaning puts their initial on the document and records
the time and date alongside."
Narrative: You sample production records over 3-days and note down evidence of nonconformity as per the table below.
Which of the following is a principle of maintaining audit work documents?
"A set of interrelated or interlacing elements of an organization to establish policies and objectives, and processes to achieve those objectives" is the definition of a/an:
During a third-party surveillance audit, the auditor finds that the management review meeting minutes record that the improvement actions set by the previous review have not been completed for a second year running. It states that a new Quality Manager has been brought in at the middle management level to rectify the situation. You learn that top management is not involved in the QMS other than being copied into the minutes of the management review meeting.
The audit reveals that the new Quality Manager was given responsibility by top management to:
a) take accountability for the effectiveness of the QMS,
b) select, approve, and monitor improvement actions without involving and reporting to top management,
c) promote the improvement of the QMS, and
d) make efficient use of the limited financial and personnel resources allocated for the QMS by top management.
The auditor considers whether there is a nonconformity against clause 5.1.1 of ISO 9001:2015.
Select two options of the evidence required for such a nonconformity:
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?
You work for an organisation, 'ABC', 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, 'XYZ', which provides packaging materials to your organisation. It is 4 pm, and the audit is dlose to an end;
you are having an internal meeting with the team to decide what will be presented to the auditee during the Closing meeting. The Closing meeting
was scheduled for 5 pm.
'XYZ' has two manufacturing lines: M1 is a clean room for primary packaging materials (i.e. will be in direct contact with the food), and M2 is for
secondary materials (i.e. will not be in direct contact with food).
Auditor 1 audited the two manufacturing lines.
You: "What findings would you report?"
Auditor 1: "I have one issue. Earlier today in the morning I saw some secondary material stocked in the clean room. I would propose raising a
nonconformity."
You: "How would you write the nonconformity?"
Auditor 1: "In the clean room, there was a pallet with secondary materials."
What additional information would you add to this text to complete the nonconformity report? Select six.
Select the word that best completes the sentence:
