Online Access Free ISO-9001-Lead-Auditor Exam Questions

(When raising a non-conformity during an audit, which two of the following items should you include in the non-conformity statement?)

• A.Action the auditee has to implement to eliminate the non-conformity
• B.The name of the technical expert of the audit team that confirmed the existence of the non-conformity
• C.A target time to implement the corrective action
• D.Relevant audit evidence
• E.The name of the person (auditee) responsible for the non-conformity
• F.A description of or reference to audit criteria

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.

Correct 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.

Which type of audit risk is the risk that a significant defect may occur in the QMS, although the organization has internal control mechanisms in place?

• A.Operational risk.
• B.Control risk.
• C.Inherent risk.
• D.Detection risk.

An audit team of three people is conducting a Stage 2 audit to ISO 9001 of an engineering organisation that manufactures sacrificial anodes for the oil and gas industry in marine environments. These are aluminium products designed to prevent corrosion of submerged steel structures. You, as one of the auditors, find that the organisation has shipped anodes for Project DK in the Gulf of Mexico before the galvanic efficiency test results for the anodes have been fully analysed and reported as required by the customer. The Quality Manager explains that the Managing Director authorised the release of the anodes to avoid late delivery as penalties would be Imposed. The customer was not informed since the tests very rarely fall below the required efficiency. You raise a nonconformity against clause 8.6 of ISO 9001.
At the Closing meeting, the audit team leader presents the findings of the audit and comes to the above nonconformity. The Quality Manager produces the test report for Project DK, which shows an acceptable galvanic efficiency, and presents an email from the customer confirming acceptance of the anodes. He asks that the nonconformity be withdrawn.
Which two of the following responses by the audit team leader would be acceptable?

• A.Accept the Quality Manager's request without reviewing the documentation.
• B.Thank the Quality Manager for his contribution but dismiss the information as irrelevant after a quick review.
• C.Ask the auditor (you) who raised the issue, to state what you think should happen
• D.Advise management that the information provided will be reviewed at the audit follow-up stage.
• E.Refuse to accept the documentation produced and maintain the nonconformity.
• F.Indicate that the nonconformity is evidence of a system failure that needs to be rectified.

Which of the following three options could be considered potential threats to impartiality in an audit context?

• A.Intimidation
• B.Self-audit
• C.Familiarity
• D.Experience
• E.Competence