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PECB ISO-9001-Lead-Auditor Exam - Topic 1 Question 26 Discussion

Actual exam question for PECB's ISO-9001-Lead-Auditor exam
Question #: 26
Topic #: 1
[All ISO-9001-Lead-Auditor Questions]

A small deaning services organisation is about to start work on a hospital dleaning contract for the local Health Trust. You, as auditor, are conducting a Stage 2 audit to ISO 9001 and review the contract with the Service Manager. The contract requires that a cleaning plan is produced. You: "How was the cleaning plan for the contract developed?" Service Manager: "We have a basic template that covers the materials, labour requirements and cleaning methods to be employed. Some of that is specified by the customer." You: "How does the plan deal with locations like the intensive care wards and the operating theatres, which are included in the contract?" Service Manager: "The basic plan covers general wards, but we will do more frequent cleaning in those areas if the hospital requests it." You: "Are you aware of the regulatory requirements for cleaning standards in hospitals?" Service Manager: "No. We depend on the hospital to look after that side of things in the contract." You decide to raise a non-conformity against section 8.2.2.a.1 of ISO 9001. You decide to raise another non-conformity against section 8.2.4 of ISO 9001 when finding that the cleaning plan was amended without the agreement of the Health Trust. A different cleaning chemical was substituted to that specified in the contract. At the follow- up audit, the corrective action proposed was to "obtain a concession from the Health Trust for use of the new chemical." Which one of the following options is the reason why you did not accept this action taken?

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Suggested Answer: B

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Joaquin
3 months ago
The process for contract changes is super important!
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Shonda
3 months ago
Wait, they think the Health Trust will just agree to a change?
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Iola
3 months ago
Agree, they need proper training for new chemicals.
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Luis
4 months ago
I can't believe they don't know the cleaning regulations.
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Vincent
4 months ago
The cleaning plan should definitely meet regulatory standards!
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Jesusa
4 months ago
I think the effectiveness of the substitute chemical is also a concern, but I’m leaning towards the process issue being more critical in this case.
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Vallie
4 months ago
I feel like we practiced a similar scenario where staff training was a key point. If they haven't trained on the new chemical, that could be a big risk.
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Charlena
4 months ago
I'm not entirely sure, but I think the Health Trust's agreement is crucial for any changes. If they don't approve, it could lead to issues.
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Joye
5 months ago
I remember discussing the importance of having a clear process for changes in contracts during our training. It seems like they skipped that step here.
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Becky
5 months ago
Hmm, the question is asking why the proposed corrective action was not accepted. I'll need to carefully consider the options and choose the one that best fits the scenario described.
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Beth
5 months ago
This is a good opportunity to demonstrate my understanding of ISO 9001 and the importance of following contractual agreements. I feel confident I can provide a solid answer.
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Timothy
5 months ago
Ah, I see the issue now. The service manager's proposed corrective action doesn't address the root cause of the problem, which is the unauthorized change to the cleaning chemical. I'll need to explain why that's not an acceptable solution.
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Johnathon
5 months ago
I'm a bit confused about the details of the hospital cleaning contract and the ISO 9001 requirements. I'll need to review those carefully before attempting to answer this.
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Angelo
5 months ago
This seems like a tricky question, but I think I can handle it. The key is to focus on the contract requirements and the ISO 9001 standards that were violated.
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Providencia
10 months ago
Wait, they're using a 'basic template' for a hospital cleaning contract? That's like using a 'basic template' for brain surgery - what could go wrong?
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Meghann
9 months ago
Service Manager: The substitute chemical may not be as effective as the original.
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Elza
9 months ago
You: The basic plan covers general wards, but we will do more frequent cleaning in those areas if the hospital requests it.
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Rosamond
10 months ago
Service Manager: We have a basic template that covers the materials, labour requirements and cleaning methods to be employed. Some of that is specified by the customer.
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Reta
10 months ago
Substituting chemicals without the customer's approval? That's a bold move, let's see how it plays out.
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Ernest
8 months ago
You: That's a risky assumption to make.
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Cathrine
9 months ago
Service Manager: We assumed they would be okay with it.
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Buck
9 months ago
You: But did you consider if the Health Trust would approve the change?
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Laurena
9 months ago
Service Manager: We thought the new chemical would work better.
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Kaycee
10 months ago
Hah, 'obtain a concession' - sounds like they want to sweet-talk their way out of this one. Good luck with that.
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Adrianna
11 months ago
The proposed corrective action is wishful thinking. They need to address the contract change process properly, not just hope the Health Trust will go along with it.
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Jerry
9 months ago
The substitute chemical may not be as effective as the original.
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Susana
10 months ago
The action assumes that the Health Trust will agree to the change.
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Elke
11 months ago
The Service Manager seems to have a limited understanding of the hospital's regulatory requirements. Relying on the customer to manage that is a concerning oversight.
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Tamekia
9 months ago
Agreed, relying solely on the customer for that aspect is risky.
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Kristian
9 months ago
The Service Manager should take responsibility for ensuring compliance with regulations.
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Nidia
9 months ago
Yes, it's important to have a thorough understanding of the standards in place.
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Thomasena
9 months ago
We need to ensure that all regulatory requirements are met for the hospital contract.
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German
11 months ago
I think the reason the Magdalene did not accept the proposed action is because the process for making changes to the contract has not been addressed.
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Gary
11 months ago
We thought it would be more effective for the job.
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Magdalene
11 months ago
Why was a different cleaning chemical used without agreement?
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