ISO-9001-Lead-Auditor Exam Question 71
Which of the following is a principle of maintaining audit work documents?
ISO-9001-Lead-Auditor Exam Question 72
The following actions need to be carried out during a third-party audit planning stage. Which two actions correspond to the individual(s) managing the audit program before the involvement of the audit team leader'
ISO-9001-Lead-Auditor Exam Question 73
You are conducting an audit at a single-site organisation seeking certification to ISO 9001 for the first time.
The organisation manufactures cosmetics for major retailers and the name of the retailer supplied appears on the product packaging. Sales turnover has increased significantly over the past five years You are interviewing the new Product Development Manager. You note that a software application called SWIFT is used to help control the product development process.
You have gathered audit evidence as outlined in the table. Match the ISO 9001 clause 8.3 extracts to the audit evidence.

The organisation manufactures cosmetics for major retailers and the name of the retailer supplied appears on the product packaging. Sales turnover has increased significantly over the past five years You are interviewing the new Product Development Manager. You note that a software application called SWIFT is used to help control the product development process.
You have gathered audit evidence as outlined in the table. Match the ISO 9001 clause 8.3 extracts to the audit evidence.

ISO-9001-Lead-Auditor Exam Question 74
You are carrying out an audit to ISO 9001 at an organisation which offers regulatory consultancy services to manufacturers of cosmetics.
You are interviewing the Technical Director (TD), who manages a team of regulatory experts responsible for providing regulatory services to customers.
You: "How do you ensure your regulatory team's competence concerning regulatory requirements is maintained?" TD: "The two Regulatory Experts we employ full-time have years of experience of working in the cosmetics industry." You: "How is their regulatory competence maintained?" TD: "They are dedicated individuals with lots of contacts in the sector." You: "How does the business enable them to maintain their understanding of current regulatory requirements?" TD: "We leave that up to them."

You are interviewing the Technical Director (TD), who manages a team of regulatory experts responsible for providing regulatory services to customers.
You: "How do you ensure your regulatory team's competence concerning regulatory requirements is maintained?" TD: "The two Regulatory Experts we employ full-time have years of experience of working in the cosmetics industry." You: "How is their regulatory competence maintained?" TD: "They are dedicated individuals with lots of contacts in the sector." You: "How does the business enable them to maintain their understanding of current regulatory requirements?" TD: "We leave that up to them."

ISO-9001-Lead-Auditor Exam Question 75
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.

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.







