Pass the PECB ISO 9001 ISO-9001-Lead-Auditor Questions and answers with Dumpstech

What is the responsibility of the audit committee during an internal audit?

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.

During a third-party audit of a pharmaceutical organisation (CD9000) site of seven COVID-19 testing laboratories in various terminals at

a major international airport, you interview the CD 9000 ' s General Manager (GM), who was accompanied by Jack, the legal compliance

expert. Jack is acting as the guide in the absence of the Technical Manager due to him contracting COVID-19.

You: " What external and internal issues have been identified that could affect CD9000 and its quality management system? "

GM: " Jack guided us on this. We identified issues like probable competition of another laboratory organisation in the airport, legal

requirements on COVID-19 continuously changing, the shortage of competent laboratory analysists, the epidemic declining soon,

shortage of chemicals for the analysis. It was quite a good experience. "

You: " Did you document these issues? "

GM: " No. Jack said that ISO 9001 does not require us to document these issues. "

You: " How did you determine the risks associated with the issues and did you plan actions to address them? "

GM: " I am not sure. The Technical Manager is responsible for this process. Jack may be able to answer this question in his absence. "

Select two options for how you would respond to the General Manager ' s suggestion:

For each of the following scenarios, select four that are corrective actions.

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.

After reviewing the documented information, Li Na claimed that it was not necessary to report the minor nonconformities that were identified; instead, they would be discussed in the next audit phase. Is this acceptable?

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.

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?

You work for an organisation, ' ABC ' , which provides packaged food to the public. You are asked to lead a team (you as the leader and two other

auditors) to audit an external provider, ' XYZ ' , which provides packaging materials to your organisation. It is 4 pm, and the audit is dlose 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 pm.

' XYZ ' has two manufacturing lines: M1 is a clean room for primary packaging materials (i.e. will be in direct contact with the food), and M2 is for

secondary materials (i.e. will not be in direct contact with food).

Auditor 1 audited the two manufacturing lines.

You: " What findings would you report? "

Auditor 1: " I have one issue. Earlier today in the morning I saw some secondary material stocked in the clean room. I would propose raising a

nonconformity. "

You: " How would you write the nonconformity? "

Auditor 1: " In the clean room, there was a pallet with secondary materials. "

What additional information would you add to this text to complete the nonconformity report? Select six.

Which of the following is a responsibility of a guide in an audit?

Select six of the activities that are specifically required by ISO 17021-1 as part third-party (Certification Body) surveillance audit processes.