PECB ISO-9001-Lead-Auditor - QMS ISO 9001:2015 Lead Auditor Exam
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 of the following indicates that Bell has defined its quality objectives?
You are carrying out an audit at a single-site organisation seeking certification to ISO 9001 for the first time. The organization 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 one of the following options is the definition of the context of an organisation?
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:
You are conducting a third-party audit to ISO 9001 and the next item on your audit plan is ' internal auditing ' .
When reviewing a sample of audit records up to 5 years previously, you find that many contain non-conformance reports and no actions have been taken. You interview the Quality Manager.
You: " I have noted that many of the older files contain non-conformances that have not had any corrective action taken. "
Quality Manager: " Because the business is always changing, the departmental managers tell me that the non-conformances are no longer applicable. I made a decision that any non-conformance over 3 years old is automatically closed "
You: " Do you obtain any confirmation beforehand from the appropriate departments that the non-conformances are no longer applicable. "
Quality Manager: " No, because they are so old I consider that they are no longer appropriate. Please remember that we take a risk-based approach which means we audit where and when it is considered important to do so.
Select one course of action you would now take from the options.
You are auditing an organisation that has been certified to ISO 9001 for 10 years. The organisation is a privately owned, multi-site car tyre fitting company. You are auditing one of the sites.
You have confirmed with the Workshop Supervisor that tyre batch numbers shall be recorded in the Work Schedule. You have sampled recent Work Schedule records and written the following in your audit notes:
No batch numbers for tyres fitted to customers’ cars were recorded in the Work Schedule for job numbers 1/5, 1/16, 2/2, 2/7, 3/2, 3/5, 3/7 and 3/9. 15 jobs completed over the past five days were sampled. The Workshop Supervisor and the Tyre Fitter were aware of this missing information in the records, but no action had been taken.
You decide to raise a non-conformity.
Scenario 6: Davis Clinic (DC) is an American medical center focused on integrated health care. Since its establishment DC was committed to providing qualitative services for its clients, which is the reason why the company decided to implement a quality management system (QMS) based on ISO 9001. After a year of having an active QMS in place, DC applied for a certification audit.
A team of five auditors, from a well-known certification body, was selected to conduct the audit. Eva was appointed as the audit team leader. After three days of auditing, the team gathered to review and examine their findings. They also discussed the audit findings with DC ' s top management and then drafted the audit conclusions.
In the closing meeting, which was held between the audit team and the top management of DC. Eva presented two nonconformities that were detected during the audit. Eva stated that the company did not retain documented information regarding its outsourced services for an analysis laboratory and regarding the conducted management reviews. During the closing meeting, the audit team required from DCs top management to come up with corrective action plans within two weeks. Although the top management did not agree with the audit findings, the audit team insisted that the auditee must submit corrective actions within the given time frame in order for the audit activities to continue.
Once the action plans were evaluated, the audit team began preparing the audit report. Eva required from the team to provide accurate descriptions of the audit findings and the audit conclusions. The report was then distributed to all the interested parties involved in the audit, including the certification body Based on the report, the certification body together with Eva, as the audit team leader, made the certification decision.
Based on the scenario above, answer the following question:
According to Scenario 6, the audit team required DC’s top management to submit corrective action plans within two weeks. Is this action acceptable?
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?
Whistlekleen is a national dry cleaning and laundry organization with 50 shops. You are conducting a surveillance audit of the Head Office and are sampling customer complaints. You find that 80% of complaints originate from five shops in the same region. Most of these complaints relate to damage to customer laundry. The Quality Manager tells you that those are the oldest shops in the organization. The cleaning equipment needs replacing, but the organization cannot afford it now. Complaining customers are offered a financial incentive to close the complaint.
On raising the matter with senior management, you are told that there are plans to replace the equipment in these shops over the next five years.
Select the one option which correctly describes the non-conformity to be raised against ISO 9001.
