PECB QMS ISO 9001:2015 Lead Auditor - ISO-9001-Lead-Auditor Exam Questions

QUESTION NO: 1
An internal auditor of a manufacturer of polystyrene packaging products for the electronics industry raised a nonconformity against section 10.3 of ISO 9001 in Report IA202. The nonconformity (NC 3) stated:
" The reject rate of ' finished ' product of 9.7% needs improvement as it doesn ' t meet the stated objective of top management of 5%. " Just before the Closing meeting of a third-party audit, the audit team leader is invited to a meeting with the Quality Manager. He tells the audit team leader that a member of the audit team was seen taking photographs of the factory on his phone during the day and wants him suspended from the Closing meeting with any nonconformities raised by him rescinded. The issue of photographs was not discussed during the opening meeting.
Select the three options for how the audit team leader might deal with this situation.

QUESTION NO: 2
You work for an organisation, ' A ' , which provides packaged food to the public. You are asked to lead a team (you as the leader and two other auditors) to audit a supplier, ' B ' , which provides packaging materials to your organisation. It is 4 p.m. and the audit is close 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 p.m.
You, as audit team leader, audited top management, the laboratory, and the storage of raw materials.
Auditor 1 audited the two manufacturing lines and dispatch areas.
You to Auditor 1: " What findings would you report? "
Auditor 1: " When reviewing the Dispatch records, I noticed that during the morning two different trucks (Number 011 and 025) delivered the same batch number of the product (Batch 33555). Truck 011 left the plant at 9.15 am and Truck 025 left the plant at
11.30 am. Procedure P-02 Rev.3 says
that trucks should carry a complete batch. The batch number, once on the truck, is captured using a QR device. " You: " OK, what do you think? " Auditor 2: " I think that this is a nonconformity. " You: " OK. How would you describe the evidence on which the nonconformity will be based " ?
Identify which one of the following statements best describes the identified nonconformity.

QUESTION NO: 3
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 and the name of the retailer supplied appears on the product packaging. Sales turnover has increased significantly over the past five years. The organisation uses a software programme called SWIFT, which is used to record sales, plan production, purchase supplies, print despatch notes, track new product development, perform traceability exercises, carry out mass balance checks, raise invoices, create budgets, and support financial control.
You are nearing the end of the audit and you are reviewing your audit notes. You notice a recurring trend concerning the SWIFT database as shown below:

You ask the Quality Manager to explain how the SWIFT database is controlled. You learn that the Operations Director is responsible for determining and progressing SWIFT software updates. You decide to meet the Operations Director (OD).
You: " Good afternoon. "
OD: " Good afternoon. "
You: " What responsibility do you have concerning the SWIFT database? " OD: " I maintain it. If anyone wishes to propose an update to the database, they send me an email with details of their proposal. I then either process the database update myself, or I send the request to the consultant who designed the database 20 years ago. The necessary software changes are made, and the amended software is immediately released to users. " You: " Would you explain how the software amendments are controlled? " OD: " Of course. I personally update every computer myself. " You: " Do you inform the database users of the changes? " OD: " No I don ' t. They find out for themselves by using the software, or they come to see me if they have any questions. " You: " How do you ensure that the database users use the latest version? " OD: " That ' s easy, I update every computer myself. " You: " During the audit, I noted there were several versions of SWIFT in use (you refer to your audit notes). " OD: " I know. That ' s because some versions work better than others, and depending on user needs and experiences, we allow users to revert to using an earlier version if they find it works better for them. " Based on the scenario, which two of the following statements are true? There is evidence of nonconformity with a requirement defined in ...

QUESTION NO: 4
(Select two applicable benefits of third-party certification of ISO 9001 quality management systems for an organisation:)

QUESTION NO: 5
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.

QUESTION NO: 6
Match each of the following statements into the table below to show whether they apply to first-party audits, second-party audits or third-party audits:

QUESTION NO: 7
In the context of a third-party management system certification audit, which two of the following statements are correct?

QUESTION NO: 8
The ISO 9001 clause 5.1.1 states top management shall demonstrate leadership and commitment with respect to the quality management system.
In the context of the ISO 9001 management system certification, select the one correct description of top management ' s responsibilities.

QUESTION NO: 9
Who assigns a guide to assist the audit team?

QUESTION NO: 10
Scenario 5: Mechanical-Electro (ME) Audit Stages
Mechanical-Electro, better known as ME, is an American company that provides mechanical and electrical services in China. Their services range from air-conditioning systems, ventilation systems, plumbing, to installation of electrical equipment in automobile plants, electronic manufacturing facilities, and food processing plants.
Due to the fierce competition from local Chinese companies and failing to meet customer requirements, ME ' s revenue dropped significantly. In addition, customers ' trust and confidence in the company decreased, and the reputation of the company was damaged.
In light of these developments, the top management of ME decided to implement a quality management system (QMS) based on ISO 9001. After having an effective QMS in place for over a year, they applied for a certification audit.
A team of four auditors was appointed for the audit, including Li Na as the audit team leader. Initially, the audit team conducted a general review of ME ' s documents, including the quality policy, operational procedures, inventory lists, QMS scope, process documentation, training records, and previous audit reports.
Li Na stated that this would allow the team to maintain a systematic and structured approach to gathering documents for all audit stages. While reviewing the documented information, the team observed some minor issues but did not identify any major nonconformities. Therefore, Li Na claimed that it was not necessary to prepare a report or conduct a meeting with ME ' s representatives at that stage of the audit. She stated that all areas of concern would be discussed in the next phase of the audit.
Following the on-site activities and the opening meeting with ME ' s top management, the audit team structured an audit test plan to verify whether ME's QMS conformed to Clause 8.2.1 (Customer Communication) of ISO 9001.
To do so, they gathered information through group interviews and sampling. Li Na conducted interviews with departmental managers in the first group and then with top management. In addition, she chose a sampling method that sufficiently represented customer complaints from both areas of ME ' s operations.
The team members were responsible for the sampling procedure. They selected a sample size of 4 out of 45 customer complaints received weekly for electrical services and 2 out of 10 complaints for mechanical services.
Afterward, the audit team evaluated the evidence against the audit criteria and generated the audit findings.
According to scenario 5, Li Na conducted group interviews with departmental managers and top management by herself. Is this in accordance with audit best practices?

QUESTION NO: 11
An internal auditor of a manufacturer of polystyrene packaging products for the electronics industry raised a nonconformity against section 10.3 of ISO 9001 in Report IA202. The nonconformity (NC 3) stated:
" The reject rate of the finished product of 9.7% needs improvement as it doesn ' t meet the stated objective of top management of 5%. " As the third-party auditor reviewing the internal audit process, you come across the nonconformity. For corrective action, the Quality Manager conducted an investigation into the reject rates. He reported that the collection baskets for products ejecting from the moulding machines were not large enough. About 6% of products fell onto the wet and dirty factory floor. Management stated that replacing the baskets was too costly and ordered the Maintenance Manager to ensure that the floor was kept clean and dry to prevent rejects. The auditor later checked the factory floor, which was wet and dirty in places.
From the following nonconformities, select three that the auditor could raise to ISO 9001.