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

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:
Scenario 6 indicates that although the top management did not agree with the audit findings, the audit team began preparing the audit report. Is this acceptable?

• A. No, the audit report should have been prepared before the audit findings were presented in the closing meeting
• B. No, during the closing meeting, the audit team had to inform the auditee about the complaint and appeal handling process
• C. Yes, the audit team had to begin preparing the audit report although the top management did not agree with the audit findings

Scenario 7: POLKA is a car manufacturing company based in Stockholm, Sweden. The company has around
14,000 employees working in different sectors which help with the design, painting, assembling, and test drives of the final product. The company is widely known for its qualitative products and affordable prices. In order to retain their reputation, POLKA implemented a quality management system (QMS) based on ISO
9001.
Before applying for certification, the company decided to conduct an internal audit to check whether there are any nonconformities in their QMS and if the requirements of ISO 9001 are being fulfilled. The top management appointed Sean, the internal auditor, as the team leader of the internal audit team. Sean required from the top management to have unrestricted access to the employees and executives of POLKA and to the documented information. Furthermore, Sean required to establish a team with a large number of auditors, considering the size and the complexity of the organization. The top management of POLKA agreed with Sean ' s requirements.
The top management, in cooperation with Sean, assigned 10 more employees to the audit team. Following that. Sean planned the audit activities and assigned the roles and responsibilities to each auditor. They began by interviewing employees of different manufacturing departments to check whether they are aware of the process of the QMS implementation. While conducting these activities, one of the auditors asked Sean for permission to audit the department in which he worked on a daily basis, as he was very familiar with the processes of the department.
Along the way, the teams findings showed that the staff were trained, documented information was updated, and the QMS fulfilled the requirements of ISO 9001. The internal audit took three weeks to complete, and on the last week the audit team held a final meeting The team shared their results and together drafted the audit report This report was submitted to the top management of the company. The report was maintained as documented information, and was available to the relevant interested parties.
Based on the scenario above, answer the following question:
Sean requested unrestricted access to the employees, executives, and documented information of POLKA. Is this in accordance with audit best practices?

• A. Yes, but the internal auditor should make such a request to the CEO directly as only the CEO of the company can approve such a request
• B. No, such requests are acceptable only if a third-party audit is being conducted
• C. Yes, unrestricted access for the internal auditor should be provided by the company

(Select the six statements that are required as part of a second-party audit to ISO 9001 carried out by an organisation to a key supplier (ABC), taking into account recommendations from ISO 19011.)

• A. ISO 9001 audit of ABC's external providers at least once per year.
• B. Evaluate the suitability and adequacy of ABC's management system concerning its context and strategic direction.
• C. Review the results of previous audits to ABC, if appropriate.
• D. Consider the concerns of ABC's interested parties.
• E. Review the handling of ABC's customer complaints since the last visit.
• F. Check for any failure to meet ABC's financial responsibilities.
• G. Audit an external provider to which ABC has outsourced a process.
• H. Confirm the effectiveness of ABC's internal audit and management review processes.
• I. Audit the use of certification marks on ABC's marketing materials.
• J. Review changes to the ABC's context and operations since the last visit.

(Which one of the following characteristics of documented information does not need to demonstrate conformity to the requirements of clause 7.5 of ISO 9001?)

• A. Translatable to other languages
• B. Under change control
• C. Identifiable
• D. Retrievable

" 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:

• A. Standard
• B. Organization scope
• C. Quality manual
• D. Management system