What are the criteria for reviewing documented information?

• A. Archive, volume, and confidentiality of documented information
• B. Language of documented information, internal audit reports, client feedback
• C. Content, format, and the procedure for managing documented information

What is an advantage of group interviews?

• A. Auditors pay more attention to each interviewee
• B. Less time-consuming
• C. Equal duration of time for each interviewee to answer questions

You are leading a Stage 2 certification audit of a multi-site organisation and have received the audit schedule below; Head Office and Site 1 - Day 1 Site 2 (150 km from HQ) - Days 2 and 3 During Day 1 of the audit, the client informs you that the laboratory at Site 2 has been closed for decontamination due to a serious outbreak of an infectious disease among workers. In Site 2, all other functions could be audited as planned.
As the audit team leader, what would you do?
Choose the best acceptable action you could take:

• A. Complete the audit on day 3 and report back to the certification body for a certification decision.
• B. Ask the audit Programme Manager for direction.
• C. Continue the audit on days 2 and 3 and return later to audit the Site 2 laboratory.
• D. Immediately cancel the audit since the audit plan cannot be completed.

During a second-party audit, the auditor examines the records that are available for the external provider, ABC Forgings, to whom manufacturing has recently been outsourced.
There are standard external provider checklists for three competitors for the contract and there are inspection records from the trial manufacturing batches produced by ABC Forgings. There is no documented evidence of the criteria used to confirm the appointment of ABC Forgings, and no contract or terms and conditions.
Ongoing monitoring indicates that external provider performance is satisfactory, but no documented information has been retained.
Select two options for the evidence which demonstrates a nonconformity with clause 8.4 of ISO 9001.

• A. The auditee required the outsourced products on an urgent basis before the completion of the paperwork.
• B. The auditee trusted the external provider because of a long-standing relationship with them.
• C. The external provider asked for the contract details to be verbal only.
• D. There were no receipt inspection records of the incoming materials.
• E. The auditee did not retain documentation on the selection and evaluation of the external provider.
• F. There was no documentation which provided evidence of any monitoring of the external provider.

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:
Scenario 7 states that Sean planned audit activities on his own. Is this acceptable?

• A. Yes, it is the responsibility of the audit team leader to plan audit activities
• B. No, audit activities should be planned by top management
• C. No, the audit team leader should always cooperate with the other members of the team to plan audit activities