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Exam ISO-9001-Lead-Auditor Topic 6 Question 217 Discussion
Actual exam question for PECB's ISO-9001-Lead-Auditor exam
Question #: 217
Topic #: 6
Question #: 217
Topic #: 6
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.
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.
Suggested Answer:
Explanation:
Actions and Applicable ISO 9001:2015 Clauses
* We identified risks and opportunities.# Clause 6.1 (Actions to address risks and opportunities)
* We found suitable suppliers.# Clause 8.4 (Control of externally provided processes, products and services)
* We determined the need to keep updated with new IT technologies.# Clause 4.1 (Understanding the organization and its context)
* We put together a plan for the change to IT provision outsourcing.# Clause 6.3 (Planning of changes)
* We monitored the performance of the new suppliers.# Clause 8.4.2 (Type and extent of control of external providers)
* We monitored our productivity targets to understand why they were being missed.# Clause 9.1.1 (Monitoring, measurement, analysis and evaluation - General)
* We communicated the plan internally.# Clause 7.4 (Communication)
* We looked at the data at the management review and decided we needed to do something different.# Clause 9.3.2 (Management review inputs) ISO 9001:2015 requires organizations to manage change in a planned, risk-based, and controlled manner, particularly when changes affect product realization and customer satisfaction.
* Clause 6.1 requires organizations to identify risks and opportunities arising from changes, such as outsourcing software development.
* Clause 4.1 supports understanding internal and external issues, including rapid changes in IT technology that affect strategic direction.
* Clause 6.3 requires changes to the QMS (such as outsourcing a core activity) to be planned, considering purpose, consequences, resources, and responsibilities.
* Clause 8.4 and 8.4.2 ensure that when processes are outsourced, the organization selects suitable providers and monitors their performance to ensure conformity.
* Clause 7.4 requires effective internal communication so that personnel understand changes and their roles.
* Clause 9.1.1 requires monitoring and measurement of performance indicators (such as productivity targets) to understand performance issues.
* Clause 9.3.2 requires top management to review performance data and determine actions when the QMS is no longer achieving intended results.
ISO-aligned conclusion:
The auditee's actions demonstrate a systematic and compliant approach to managing change, covering context analysis, risk-based thinking, planning, control of outsourced processes, performance monitoring, communication, and management review, all in line with ISO 9001:2015 requirements.
by Nick at Apr 01, 2026, 09:14 PM
Here are all the actual test exam dumps for IT exams. Most people prepare for the actual exams with our test dumps to pass their exams. So it's critical to choose and actual test pdf to succeed.
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