CPM ISO 9001 & QMS Deployment 3

Question 1

What is the purpose of a 'scope statement' in an ISO 9001 QMS?

Accepted Answer

To define the boundaries and applicability of the QMS

Answer

The scope statement defines what products, services, locations, and processes are covered by the QMS, setting its boundaries.

Question 2

During an ISO 9001 internal audit, the auditor finds no documented evidence of management reviews for 18 months. This constitutes a:

Accepted Answer

Major nonconformity

Answer

Failure to conduct management reviews at planned intervals is a major nonconformity because it violates a mandatory ISO 9001:2015 Clause 9.3 requirement.

Question 3

Which of the following BEST describes 'documented information' as used in ISO 9001:2015?

Accepted Answer

Information required to be controlled and maintained by the organization

Answer

ISO 9001:2015 uses the term 'documented information' to cover both documents (maintained) and records (retained), in any medium or format.

Question 4

A plant experiences a recurring defect rate spike every Monday morning. What QMS tool is BEST suited to identify the root cause?

Accepted Answer

Fishbone (Ishikawa) diagram

Answer

A fishbone diagram systematically explores all potential causes (people, methods, machines, materials, environment, measurement) tied to a specific effect.

Question 5

In ISO 9001:2015, 'interested parties' (stakeholders) are addressed in which clause?

Accepted Answer

Clause 4.2

Answer

Clause 4.2 requires organizations to determine relevant interested parties and their requirements relevant to the QMS.

(CPM) Certified Plant Manager Practice Test

(CPM) Certified Plant Manager Practice Test

CPM ISO 9001 & QMS Deployment 3