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

Scenario 1: AL-TAX is a company located in California which provides financial and accounting services. The company manages the finances of 17 companies and now is seeking to expand their business even more The CEO of AL-TAX, Liam Durham, claims that the company seeks to provide top-notch services to their clients Recently, there were a number of new companies interested in the services provided by AL-TAX.

In order to fulfill the requirements of new clients and further improve quality, Liam discussed with other top management members the idea of implementing a quality management system (QMS) based on ISO 9001. During the discussion, one of the members of the top management claimed that the size of the company was not large enough to implement a QMS. In addition, another member claimed that a QMS is not applicable for the industry in which AL TAX operates. However, as the majority of the members voted for implementing the QMS. Liam initiated the project.

Initially, Liam hired an experienced consultant to help AL-TAX with the implementation of the QMS. They started by planning and developing processes and methods for the establishment of a QMS based on ISO 9001. Furthermore, they ensured that the quality policy is appropriate to the purpose and context of AL TAX and communicated to all employees. In addition, they also tried to follow a process that enables the company to ensure that its processes are adequately resourced and managed, and that improvement opportunities are determined.

During the implementation process, Liam and the consultant focused on determining the factors that could hinder their processes from achieving the planned results and implemented some preventive actions in order to avoid potential nonconformities Six months after the implementation of the QMS. AL-TAX conducted an internal audit. The results of the internal audit revealed that the QMS was not fulfilling all requirements of ISO 9001. A serious issue was that the QMS was not fulfilling the requirements of clause 5.1.2 Customer focus and had also not ensured clear and open communication channels with suppliers.

Throughout the next three years, the company worked on improving its QMS through the PDCA cycle in the respective areas. To assess the effectiveness of the intended actions while causing minimal disruptions, they tested changes that need to be made on a smaller scale. After taking necessary actions, AL-TAX decided to apply for certification against ISO 9001.

Based on the scenario above, answer the following question:

The CEO of AL-TAX hired an experienced consultant to help with the implementation of the QMS. Is this required from ISO 9001?

Which two of the following are included in the objectives of the 'Stage 1 initial certification audit'?

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 general principles of sampling procedure, did the audit team select a valid sample for electrical services?

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.

A small deaning services organisation is about to start work on a hospital dleaning contract for the local Health Trust. You, as auditor, are conducting a Stage 2 audit to ISO 9001 and review the contract with the Service Manager. The contract requires that a cleaning plan is produced. You: "How was the cleaning plan for the contract developed?" Service Manager: "We have a basic template that covers the materials, labour requirements and cleaning methods to be employed. Some of that is specified by the customer." You: "How does the plan deal with locations like the intensive care wards and the operating theatres, which are included in the contract?" Service Manager: "The basic plan covers general wards, but we will do more frequent cleaning in those areas if the hospital requests it." You: "Are you aware of the regulatory requirements for cleaning standards in hospitals?" Service Manager: "No. We depend on the hospital to look after that side of things in the contract." You decide to raise a non-conformity against section 8.2.2.a.1 of ISO 9001. You decide to raise another non-conformity against section 8.2.4 of ISO 9001 when finding that the cleaning plan was amended without the agreement of the Health Trust. A different cleaning chemical was substituted to that specified in the contract. At the follow- up audit, the corrective action proposed was to "obtain a concession from the Health Trust for use of the new chemical." Which one of the following options is the reason why you did not accept this action taken?

You work for an organisation which provides packaged food to the public. You are asked to lead a team (you as the leader and two other auditors) of a one-day audit of HMB, a supplier of hamburgers. It is 4 pm, and the audit is coming 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 is scheduled for 5 pm.

You, as the audit team leader, audited HMB’s Top Management and the two production lines of hamburger production (PL1 and PL2).

Auditor 1 audited the laboratory.

You to Auditor 1: “What findings would you report?”

Auditor 1: “When reviewing the laboratory records, I noticed that during the whole morning, HMB’s supervisors of each production line sent samples to be analysed by the laboratory. The samples from PL1 included the reference to the raw meat batch being used and the name of the sub-supplier, while the reports from PL2 referred only to the name of the sub-supplier. HMB’s Procedure P-02 Rev.3 says that samples sent to the laboratory have to include reference to the raw meat batch being used, to ensure traceability of the products.”

You to Auditor 2: “OK, what do you think?”

Auditor 2: “I think that this is a non-conformity.”

You to Auditor 1: “OK. How would you describe the evidence on which the non-conformity will be based?”

Identify which one of the following statements best describes the identified evidence.

At the end of an initial third-party certification audit, the audit team enters the closing meeting room to hold the closing meeting. Only two people are present and waiting for them, the Health and Safety Supervisor and the Administrative Officer. Neither has participated in the audit. However, the team had previously agreed with the auditee Quality Manager on a major non-conformity.

They said:

Health and Safety Supervisor says: "Good evening. We are sorry to inform you that the General Manager was convened by the CEO of the organization to analyze an unexpected, very serious situation with the personnel.

The Administration Officer: "Concerning the major non-conformity, the General Manager called us on the phone asking us to tell you that he agrees with the non-conformity and that the correction will be taken this week, and the corrective action is to be implemented before the end of this month. He also asked us to tell you that it would be a pity to postpone the recommendation for certification due to this ongoing issue that can be solved so easily. Do you want me to describe to you what he told me he would do?"

Which one of the following would be the correct response (as team leader) to the General Manager's request?

The procedures of an organisation require that all purchase orders have to be signed by the Purchasing Manager, or, in her absence, by the Production Manager. During an audit carried out in November 2020, an auditor determined that during three weeks in February 2020, the purchase orders were not signed. You raise a nonconformance under Clause 8.4.3 of ISO 9001:2015.

Which one of the following answers would you accept as a 'correction' from the Purchasing Manager?

What is reliability in the context of service quality?