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PECB Exam ISO-9001-Lead-Auditor Topic 2 Question 19 Discussion

Actual exam question for PECB's QMS ISO 9001:2015 Lead Auditor exam
Question #: 19
Topic #: 2
[All QMS ISO 9001:2015 Lead Auditor Questions]

Noitol is an organisation specialising in the design and production of e-learning training materials for the insurance market. During an ISO 9001 audit

of the development department, the auditor asks the Head of Development about the process used for validation of the final course design. She states that they usually ask customers to validate the product with volunteers. She says that the feedback received often leads to key improvements.

The auditor samples the design records for a recently completed course for the 247 Insurance organisation. Design verification was carried out but there was no validation report. The Head of Development advises that this customer required the product on an urgent basis, so the validation stage

was omitted. When asked, the Head estimates that this occurs about 50% of the time. She confirms that they always ask for feedback and often make changes. There is no record of feedback in the design file for the course.

The auditor raises a nonconformity against ISO 9001. Which one of the following options is the basis for the nonconformity?

Show Suggested Answer Hide Answer
Suggested Answer: C

Contribute your Thoughts:

Genevive
10 hours ago
Haha, I bet the Head of Development was sweating bullets during that audit! 'Urgent basis' my foot, they just wanted to cut corners. C is definitely the right answer here.
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Candida
5 days ago
This is a tricky one. While C seems like the obvious answer, I'm curious about the humorous comment you mentioned. Any chance you could share that with us?
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Tatum
20 days ago
That makes sense, but I still think option C is more relevant because design validation is not always conducted.
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Lashaunda
21 days ago
I disagree, I believe it's option A because improvements made to course designs should be documented.
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Valentin
27 days ago
Hmm, I'm not sure about this one. The question mentions that they always ask for feedback and often make changes, so I'm leaning towards A as the correct answer.
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Tegan
10 hours ago
I agree, it's important to document the feedback received from customers for future reference.
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Heike
2 days ago
I think A is the correct answer. The improvements made to course designs should be documented.
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Tatum
1 months ago
I think the nonconformity is based on option C.
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Lonna
1 months ago
I think the correct answer is C. The auditor clearly stated that the validation stage was omitted about 50% of the time, which is a direct violation of the ISO 9001 requirement for design validation.
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Merlyn
16 days ago
That's correct. The nonconformity is based on the fact that design validation is not consistently carried out as required by ISO 9001.
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Stephen
19 days ago
Design validation is not always conducted. It is omitted about half of the time.
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Jade
25 days ago
I think the correct answer is C.
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Laticia
25 days ago
The auditor clearly stated that the validation stage was omitted about 50% of the time, which is a direct violation of the ISO 9001 requirement for design validation.
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