You work for organisation A. You are asked to lead an internal audit of A ' s quality management system. It has a head office in Plant A1 and a second Plant A2 nearby. Due to the COVID-19 pandemic, production in A2 was discontinued and it was rented to a logistics organisation B, not related to A. There are no A employees working in A2. Organisation A expects to reassume production in A2 as soon as possible.
Which of the following actions would you consider appropriate when planning the internal audit of A ' s quality management system?

• A. Visit Plant A2 to interview personnel of company B
• B. Visit Plant A2 to interview A ' s security personnel and B ' s maintenance department
• C. Visit Plant A2 to interview B ' s quality manager
• D. Interview the A2 plant manager, now working in Plant A1

You are carrying out an audit at an organisation seeking certification to ISO 9001 for the first time. The organisation offers health and safety training to customers.
You are interviewing the Quality Systems Manager (QSM).
You: " What risks and opportunities have the business identified? "
QSM: " I ' 1l show you. This was discussed with the Managing Director at the latest management review. " Narrative: The QSM shows you the latest management review record and points to the following table:

You: " How is the business planning to address these risks and opportunities? " QSM: " The MD said that they already knew about them so it was not necessary. "

XYZ Corporation is an organisation that employs 100 people. As audit team leader, you are conducting a certification audit at Stage 1. When reviewing the quality management system (QMS) documentation, you find that quality objectives have been set for every employee in the organisation except top management.
The Quality Manager complains that this has created a lot of resistance to the QMS, and the Chief Executive is asking questions about how much it will cost. He asks for your opinion on whether this is the correct method of setting objectives.
Three months after Stage 1, you return to XYZ Corporation to conduct a Stage 2 certification audit as Audit Team Leader with one other auditor. You find that the Quality Manager has cancelled the previous quality objectives for all employees and replaced them with a single 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 the latest Quality Improvement Request that was included in the last management review.

After further auditing, the issues below were found. Select two statements that apply to the term
`nonconformity ' .

• A. Quality improvements not aligning with the quality policy.
• B. No quality objectives planned for the top management team
• C. Decisions on improvement action timescales not involving departmental managers.
• D. Evaluation of the results of the improvement action not always documented by the Quality Manager.
• E. Limited knowledge of the content of Quality Improvement Requests by departmental staff.
• F. Top management claim not to be aware of the improvement request (QI/12/20/HR-3) initiated by the Quality Manager.

You, as auditor, are in dialogue with the quality lead and managing director of a small business that supplies specialist laboratory equipment and furniture.
You: " I ' d like to look at how you manage change in the organisation. What changes have you made as a business, say, over the last 12 months? " Auditee: " We have made some strategic changes, the main one being that we no longer manufacture our own products in house. " You: " That sounds like quite a significant change. What has been the impact of that? " Auditee: " We now mainly sell other manufacturers ' products, under their brand names, and have outsourced manufacture of our own brand products to one of our suppliers. Unfortunately, we had to make six members of our staff redundant. This represents about 20% of our workforce, so this has been quite a challenging time. " You: " I ' m sure. What were the reasons for making the change? " Auditee: " Our manufacturing section was a small operation, and we struggled to cope with fluctuations in demand. During busy periods, we found it hard to meet lead times, and in quiet periods we had staff with little to do. This was having an impact on customer satisfaction and meant we had to charge premium prices that made our product uncompetitive. " You: " How did you go about the change? " In relation to the auditor ' s question about how the change was managed, the auditee mentions the steps listed below. Match the ISO 9001 clauses to the steps.
To complete the table, click on the blank section you want to complete so it is highlighted in red and then click on the ISO 9001 clauses listed below. Alternatively, drag and drop each clause to show which step the requirement applies to.

XYZ Corporation is an organisation that employs 100 people. As the audit team leader, you are conducting a certification audit at Stage 1. When reviewing the quality management system (QMS) documentation, you find that quality objectives have been set for every employee in the organisation except top management. The Quality Manager complains that this has created a lot of resistance to the QMS, and the Chief Executive is asking questions about how much it will cost. He asks for your opinion on whether this is the correct method of setting objectives.
How would you respond with the following options? Select three.

• A. Suggest that the Quality Manager obtains external consultancy on the use of quality objectives.
• B. Inform the Quality Manager that you will comment on the subject in your audit report.
• C. Suggest asking the certification body for guidance on this matter.
• D. Advise the Quality Manager that you will raise an opportunity for improvement if the quality objectives are not addressed properly.
• E. Indicate that ISO 9001 requires a minimum of two quality objectives.
• F. Advise the Quality Manager that, as an auditor, you cannot provide advice to the organisation on how it should operate its QMS.
• G. Suggest that all employees undertake a training course on ISO 9001.
• H. Advise the Quality Manager to read the ISO 9001 standard and interpret in relation to the organisation ' s requirements.