PECB ISO-9001-Lead-Auditor Practice Test Questions Answers

Which two of the following should be included in an audit plan?

You are auditing an organisation that has been certificated to ISO 9001 for ten years. The organisation is a privately-owned, multi-site car tyre fitting

organisation. You are auditing one of the sites. You are auditing the car tyre fitting service. You are interviewing the Site Manager (SM).

You: "Would you explain the car tyre fitting service?"

SM: "Of course. Customers typically call us by phone with their requirements. We ask them what they want. We check whether we have the tyres

they need in stock. If we don't have the tyres in stock, we contact our supplier to confirm when they would be able to supply the tyres. We then

determine the cost. We then check what availability we have in our busy schedule to fit the new tyres. We then inform the customer with details of

cost and when we can fit the tyres. If the customer is happy to proceed with the booking, we update our Work Schedule. The same process applies

for customers who walk into our office and for online requests."

You: "What information do you retain should there be a defect reported by a manufacturer of tyres that you have fitted?"

SM: "We maintain records of customer names, addresses and contact phone numbers. We maintain a record of the type of tyre fitted and the tyre

manufacturers batch information. We also maintain a record of the registration numbers of the vehicles we have fitted tyres to. All records are in our

Work Schedule."

Which two of the following options you would take to enable you to gather further audit evidence to validate what the Site Manager

has told you?

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

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?

Scenario 6: Davis Clinic (DC) is an American medical center focused on integrated health care. Since its establishment DC was committed to providing qualitative services for its clients, which is the reason why the company decided to implement a quality management system (QMS) based on ISO 9001. After a year of having an active QMS in place, DC applied for a certification audit.

A team of five auditors, from a well-known certification body, was selected to conduct the audit. Eva was appointed as the audit team leader. After three days of auditing, the team gathered to review and examine their findings. They also discussed the audit findings with DC's top management and then drafted the audit conclusions.

In the closing meeting, which was held between the audit team and the top management of DC. Eva presented two nonconformities that were detected during the audit. Eva stated that the company did not retain documented information regarding its outsourced services for an analysis laboratory and regarding the conducted management reviews. During the closing meeting, the audit team required from DCs top management to come up with corrective action plans within two weeks. Although the top management did not agree with the audit findings, the audit team insisted that the auditee must submit corrective actions within the given time frame in order for the audit activities to continue.

Once the action plans were evaluated, the audit team began preparing the audit report. Eva required from the team to provide accurate descriptions of the audit findings and the audit conclusions. The report was then distributed to all the interested parties involved in the audit, including the certification body Based on the report, the certification body together with Eva, as the audit team leader, made the certification decision.

Based on the scenario above, answer the following question:

The audit team delayed audit activities until DC’s top management submitted their action plans. Is this acceptable?