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PECB ISO-9001-Lead-Auditor Exam - Topic 6 Question 43 Discussion

A small cleaning services organisation is about to start work on a hospital cleaning 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 contractrequires 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 beemployed. 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 includedin the contract?"Service Manager: "The basic plan covers general wards, but we will do more frequent cleaning in those areas if thehospital 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 thecleaning plan was amended without the agreement of the Health Trust. A different cleaning chemical wassubstituted 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?
C) The process for making changes to the contract has not been addressed.
A) Staff have not been trained in the use of the new chemical.
B) The action assumes that the Health Trust will agree to the change.
D) The substitute chemical has not been used before in the Health Trust.
E) The substitute chemical may not be as effective as the original.

PECB ISO-9001-Lead-Auditor Exam - Topic 6 Question 43 Discussion

Actual exam question for PECB's ISO-9001-Lead-Auditor exam
Question #: 43
Topic #: 6
[All ISO-9001-Lead-Auditor Questions]

A small cleaning services organisation is about to start work on a hospital cleaning 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?

Show Suggested Answer Hide Answer
Suggested Answer: C

Contribute your Thoughts:

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I wonder if the effectiveness of the new chemical was ever tested. That could be a big issue if it doesn’t meet the cleaning standards.
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Rikki
5 days ago
I think we practiced a similar question about compliance with regulatory requirements. It’s crucial that they know the standards for hospital cleaning.
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Gary
10 days ago
I’m not sure if the health trust would even approve the new chemical. It feels risky to assume they will just agree.
upvoted 0 times
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Catherin
15 days 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.
upvoted 0 times
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