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

Technical experts must operate under the supervision of:

Auditor competence is a combination of knowledge and skills. Which two of the following activities are predominately related to 'knowledge'?

Select the term that best describes the purpose of retaining documented information in a quality management system to ISO 9001.

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.
Scenario 4 mentions that Anne received a document that contained the audit scope, criteria, duration, and the limits to the audit engagement. What did Anne receive in this case?

What is a combined audit?

One of the conflict resolution techniques is toning down. How is the conflict managed in that case?

(As the audit team leader, you are planning an audit at an organisation that is seeking certification to ISO 9001. You have confirmed and agreed on the audit scope and audit date with the auditee. The audit team comprises of you and one other auditor. The auditee has two sites and one of these sites is the Head Office where the top management team are based.
The other site is referred to as Site 1, which is located in another country. Apart from that, each site is essentially similar in terms of customer service provision. The other auditor has been selected to audit Site 1 as she lives nearby.
Select four issues you need to finalise before documenting the audit plan.)

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

A Health Trust has contracted with Servitup, a catering services organisation that has been certified to ISO
9001 for one year. It provides services to
10 small rural hospitals in remote locations involving the purchase and storage of dry goods and fresh produce, preparing meals, and loading heated trolleys for Ward Service by hospital staff. You, as auditor, are conducting the first surveillance audit at one site with the Deputy Catering Manager (DCM).
DCM: "I apologise for the absence of the Catering Manager. He has called in sick today and we are really short of staff." You: "I see. It really shouldn't affect the QMS so the audit can progress as normal." DCM: "The Catering Manager set up the system. I'm afraid I'm not as familiar with it as he is." You: "OK, let's start with the Quality Policy. What are the main issues for the QMS here?" DCM: "Give me a minute. I need to look at the Quality Policy on the noticeboard in his office." As the audit progresses, it is clear that the DCM has a very low knowledge of the QMS. He continually has to look up the answers to your questions or ask staff members about their processes. You decide to raise a nonconformity.
Select one of the following options that best describes the nonconformity.

Which two of the following may be changed once a Stage 2 certification audit has commenced?

You are preparing an audit plan for a third-party ISO 9001 audit of organisation ABC that extracts lithium from mines in Bolivia.
ABC's head office is in Lima, Peru, and it outsources all processes related to Production, Maintenance, Procurement and Human Resources to local Bolivian companies. ABC personnel manage in Bolivia only the Planning function.
Your plan starts in Lima, then you decide to go to Bolivia and fly back to Lima to audit the Quality Function and Top Management and conduct the closing meeting.
What would be your best decision when planning the audit in Bolivia?

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.
Li Na chose a sampling method that sufficiently represents customer complaints from both areas of ME's operations. Which sampling method fits that description?

You are an auditor and are in dialogue with the quality manager and the managing director of a small business that supplies specific IT hardware and software for manufacturers of medical equipment.
You: "I would like to look at how you manage the design and development of your products.
Auditee: "We have made some strategic changes, the main one being that since last month we no longer produce the software of our products in-house." You: "What has been the impact of that?" Auditee: "We now subcontract the provision of the software needed for our hardware. This allowed us to concentrate our efforts on the hardware and let specialised organisations develop the software. For the time being, we have subcontracted our software requirements to three different organisations.
You: "What were the reasons for making the change?"
Auditee: "Our IT software section was a small operation, and we struggled to cope with new technologies.
During busy periods, we
found it hard to meet lead times, and in quiet periods, we had staff with little to do. This was having an impact on customer satisfaction." You: "How did you go about the change?" In relation to the auditor's question about how the change was managed, the auditee mentions the actions listed below. Match the ISO 9001 clauses to show which action the requirement applies to.
To complete the table, click on the blank section you want to complete so it is highlighted in red and then click on the ISO 9001 clauses listed below. Alternatively, drag and drop each clause to show which clause the action applies to.

Which quality management principle does an organization fulfill when it assesses risks, consequences, and impacts before taking action?

"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: