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

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?

A Health Trust has contracted with Servitup, a catering services company 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.

You find that two internal audits have been carried out in the first year by the Catering Manager. One of

them indicates that complaints from patients are increasing in number, mainly due to food being served

too cold. The DCM comments that the trolley thermometer is often unreliable.

Which two of the following actions would be " correction " in dealing with the complaints?

You are conducting a Stage 1 audit at an organisation that services refrigeration equipment for a large customer base. The scope of certification is “Provision of refrigeration equipment maintenance and repair services”. You are interviewing the Managing Director to learn more about the organisation and to explore how the requirements for policy, objectives, and risks and opportunities in ISO 9001 are addressed.

The Managing Director explains that they only use sub-contract refrigeration engineers and do not have any full-time refrigeration engineers, which helps to optimise overhead costs. The full-time staff employed are essentially a small team of office staff who process customer enquiries, schedule jobs and process invoices.

The Managing Director adds that the ISO 9001 requirements for competence of personnel extends to both sub-contract and full-time staff. He also states that the full-time staff are aware of the Quality Policy, objectives and plans to address risk and opportunities.

You ask if the sub-contract engineers have been informed of the Quality Policy, objectives and plans to address risks and opportunities, to which the Managing Director replies that this is not applicable as they only use sub-contractors who operate ISO 9001 certificated quality management systems. The documented information provided to the auditor confirms this.

Which clause in ISO 9001 is most likely not to have been fulfilled in this instance?