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

Actual exam question for PECB's ISO-9001-Lead-Auditor exam
Question #: 19
Topic #: 2
[All ISO-9001-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

by Deangelo at Sep 18, 2024, 07:58 AM

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Shasta
3 months ago
They should definitely document customer feedback better!
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Willard
3 months ago
I think it's more about the design planning not including validation.
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Shawnee
3 months ago
Wait, no validation report at all? That seems off.
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Bettye
4 months ago
Totally agree, validation is key in design processes.
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Sylvie
4 months ago
They skip validation about 50% of the time? That's risky!
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Yesenia
4 months ago
I think option D is a bit tricky. While they released the course urgently, I feel like the main issue is the lack of validation, which points more towards option C.
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Peggy
4 months ago
I recall a practice question where documentation of feedback was emphasized. So, option A might also be a contender since they don't seem to document improvements.
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Stephane
4 months ago
I'm not entirely sure, but I feel like option B could be relevant too. Design planning should definitely include validation, right?
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Bettina
5 months ago
I remember we discussed the importance of design validation in our last class. I think option C makes sense since they omitted validation half the time.
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Rosalind
5 months ago
Hmm, I'm not sure. The question mentions design verification was done, but no validation report. I'll need to think through the differences between those two processes to determine the right answer.
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Evette
5 months ago
This seems straightforward to me. The company is not consistently conducting design validation as required by the standard, which is the basis for the nonconformity. I'd go with option C.
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Stephane
5 months ago
I'm a bit confused on the difference between design verification and validation. I'll need to re-read that section of the standard to make sure I understand the requirements properly before answering.
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Robt
5 months ago
Okay, the key details here are that the company skipped the validation step for a customer request due to urgency, and they don't have records of customer feedback. I think option C is the right answer.
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An
5 months ago
This seems like a tricky one. I'll need to carefully review the requirements for design validation in ISO 9001 to determine the basis for the nonconformity.
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Maryann
5 months ago
I lean towards "listener response," just like in that case study we discussed where a child followed directions without repeating.
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Genevive
1 year 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
1 year 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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Benton
1 year ago
User 4: Maybe the auditor had a joke about skipping validation when in a rush.
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Lizbeth
1 year ago
User 3: I wonder what the humorous comment was that they mentioned.
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Rebeca
1 year ago
User 2: Yeah, it seems like they skip it half the time.
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Rikki
1 year ago
User 1: I think the answer is C. Design validation is not always conducted.
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Rory
1 year ago
A: I wonder what the humorous comment was that the auditor mentioned.
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Maryann
1 year ago
B: Yeah, it seems like they skip it half the time.
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Shawna
1 year ago
A: I think the answer is C. Design validation is not always conducted.
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Tatum
1 year 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
1 year ago
I disagree, I believe it's option A because improvements made to course designs should be documented.
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Valentin
1 year 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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Leoma
1 year ago
Yes, not documenting the feedback and improvements made to course designs could lead to issues in the long run.
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Tegan
1 year ago
I agree, it's important to document the feedback received from customers for future reference.
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Heike
1 year ago
I think A is the correct answer. The improvements made to course designs should be documented.
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Tatum
1 year ago
I think the nonconformity is based on option C.
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Lonna
1 year 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
1 year 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
1 year ago
Design validation is not always conducted. It is omitted about half of the time.
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Jade
1 year ago
I think the correct answer is C.
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Laticia
1 year 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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