PECB QMS ISO 9001:2015 Lead Auditor Exam ISO-9001-Lead-Auditor Question # 74 Topic 6 Discussion

PECB QMS ISO 9001:2015 Lead Auditor Exam ISO-9001-Lead-Auditor Question # 74 Topic 6 Discussion

ISO-9001-Lead-Auditor Exam Topic 6 Question 74 Discussion:
Question #: 74
Topic #: 6

During a third-party audit of a pharmaceutical organisation (CD9000) site of seven COVID-19 testing laboratories in various terminals at

a major international airport, you interview the CD 9000's General Manager (GM), who was accompanied by Jack, the legal compliance

expert. Jack is acting as the guide in the absence of the Technical Manager due to him contracting COVID-19.

You: "What external and internal issues have been identified that could affect CD9000 and its quality management system?"

GM: "Jack guided us on this. We identified issues like probable competition of another laboratory organisation in the airport, legal

requirements on COVID-19 continuously changing, the shortage of competent laboratory analysists, the epidemic declining soon,

shortage of chemicals for the analysis. It was quite a good experience."

You: "Did you document these issues?"

GM: "No. Jack said that ISO 9001 does not require us to document these issues."

You: "How did you determine the risks associated with the issues and did you plan actions to address them?"

GM: "I am not sure. The Technical Manager is responsible for this process. Jack may be able to answer this question in his absence."

Select two options for how you would respond to the General Manager's suggestion:


A.

I would not accept the legal compliance expert answering the question.


B.

I would ask to audit the Technical Manager by phone.


C.

I would delay the audit until the return of the technical manager


D.

I would look for evidence that the actions resulting from the risk assessment had been taken.


E.

I would ask for a different guide instead of the legal compliance expert.


F.

I would ask the consultant to leave the meeting since he is not an employee of the organisation.


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