PECB ISO-9001-Lead-Auditor Question Answer
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 the manufacture of our own brand products to one of our suppliers.”
You: “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. The steps represent different elements of the Plan/Do/Check/Act cycle.
Select three steps which apply to the ‘check’ element of the cycle.

