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:

• A. I would ask for a different guide instead of the legal compliance expert.
• B. I would look for evidence that the actions resulting from the risk assessment had been taken.
• C. I would ask the consultant to leave the meeting since he is not an employee of the organisation.
• D. I would not accept the legal compliance expert answering the question.
• E. I would ask to audit the Technical Manager by phone.
• F. I would delay the audit until the return of the technical manager

In the context of a third-party audit, select the issue which is not expected to be included in the audit plan.

• A. Scope of the audit
• B. Expectations of the organisation ' s management
• C. Number of sites to be audited
• D. Risk to achieving audit objectives

You visit XYZ Corporation to conduct a Stage 2 certification audit as Audit Team Leader with one other auditor. You find that the Quality Manager has set a single quality objective for himself. This states that "The Quality Manager will drive multiple improvements in the QMS in the next year". The Quality Manager indicates that this gives him the authority to issue instructions to department managers when quality improvement is needed. He says that this approach has the full backing of senior management. He shows you his latest Quality Improvement Request for the HR Manager.

Select two options for statements which align with ISO 9001 6.2.

• A. The improvement is not measurable.
• B. Quality objectives do not align with the quality policy.
• C. Evaluation of the results of the improvement action is documented by the Quality Manager.
• D. The Human Resource Manager was consulted on the timescale for the action.
• E. Top management is not informed of the improvement request.
• F. Quality objectives for the top management team are not relevant.

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?

• A. Yes, all identified nonconformities throughout the audit need to be documented and communicated at the end of the audit.
• B. No, identification of minor nonconformities or areas of concern that could become nonconformities need to be documented and communicated to the auditee before proceeding to the next audit phase.
• C. Yes, during the review of documented information, only major nonconformities need to be documented if detected.