You are an auditor and are in dialogue with the quality manager and the managing director of a small business that supplies specific IT
hardware and software for manufacturers of medical equipment.
You: "I would like to look at how you manage the design and development of your products.
Auditee: "We have made some strategic changes, the main one being that since last month we no longer produce the software of our
products in-house."
You: "What has been the impact of that?"
Auditee: "We now subcontract the provision of the software needed for our hardware. This allowed us to concentrate our efforts on
the hardware and let specialised organisations develop the software. For the time being, we have subcontracted our software
requirements to three different organisations.
You: "What were the reasons for making the change?"
Auditee: "Our IT software section was a small operation, and we struggled to cope with new technologies. 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."
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 actions listed
below. Match the ISO 9001 clauses to show which action the requirement applies to.
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 clause the action applies to.
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