ISO-9001-Lead-Auditor Practice Questions

Which statement regarding the drafting of the audit conclusions is correct?

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 2:

Bell is a Canadian food manufacturing company that operates globally. Their main products include nuts, dried fruits, and confections. Bell has always prioritized product quality and has maintained a good reputation for many years. However, the company's production error rate increased significantly, leading to more customer complaints.

To increase efficiency and customer satisfaction, Bell implemented a Quality Management System (QMS) based on ISO 9001. The top management established a QMS implementation team comprising five middle managers from various departments, including Leslie, the quality manager.

Leslie was responsible for assigning responsibilities and authorities for QMS-related roles. He also suggested including a top management representative in the QMS team, but top management declined due to other priorities.

The team defined the QMS scope as:

"The scope of the QMS includes all activities related to food processing."

Leslie established a quality policy and presented it to the team for review before top management approval. Top management also proposed a new strategy for handling customer complaints, requiring biweekly customer surveys to monitor customer perceptions.

Which situation presented in scenario 2 is NOT compliant with ISO 9001?

How much time is usually spent on the Stage 1 audit?

You are carrying out an audit at an organisation seeking certification to ISO 9001 for the first time. The organisation offers health and safety training to customers. Training courses are offered either as open courses, delivered at a public venue, or online, or as courses that are tailored to meet specific requirements. The business operates from a single office and those who deliver the training are either full-time employees or subcontractors.

You are interviewing the Training Manager (TM).

You: "What quality objectives apply to the training process?"

TM: "One of the quality objectives we aim for is a 90% minimum exam pass rate for all open training courses."

You: "How do you measure this objective?"

The Training Manager shows you a record on her computer and you see the following:

Which two of the following statements are true?

Scenario 4:

TD Advertising is a print management company based in Chicago. The company offers design services, digital printing, storage, and distribution. As TD expanded, its management recognized that success depended on adopting new technologies and improving quality.

To ensure customer satisfaction and quality improvement, the company decided to pursue ISO 9001 certification.

After implementing the QMS, TD hired a well-known certification body for an audit. Anne Key was appointed as the audit team leader. She received a document listing the audit team members, audit scope, criteria, duration, and audit engagement limits.

Anne reviewed the document and approved the audit mandate. The certification body and TD’s top management signed the certification agreement.

Before contacting TD, Anne reviewed the audit scope and noticed that TD made changes to it due to the adoption of new printing equipment. However, Anne disagreed with the changes, stating they would affect the audit timeline. She considered withdrawing from the audit.

Based on scenario 4, conducting which of the activities below is NOT the responsibility of Anne?

What competence, among others, should each audit team member have?

What must the auditor consider in order to mitigate audit risks and obtain reasonable assurance?

You are a member of the audit team of a second-party audit of an organisation with 625 employees. The audit procedure recommends using sampling criteria which requires the review of the documented competence for 25 personnel. The audit team leader developed an audit plan allocating one hour to audit the Human Resources department (from 11:30 am to 12:30 pm). She told you that she could not allocate any additional time.

What would you do?

Which of the following is a record related to the audit program that should be managed and maintained?