ISO 9001:2015 Pre-Assessment

Determine Internal and External Issues is clause 4.1 of ISO9001:2015

• True

• False

Complying to relevant act and statutory is part of ISO 9001 requirements.

• True

• False

Options to address risks can include:

• avoid the risk, taking risk in order to pursue an opportunity,

• Transfer the risk, or retaining risk by informed decision.

• Accept the risk, with monitoring

• All of the above

Within ISO 9001:2015, what does “shall” indicate

• a recommendation

• a capability

• a requirement

• a requirement

Extent and boundaries of an audit are defined as

• Audit scope

• Audit criteria

• Audit evidence

• Audit plan

Auditor shall not audit their own works or area of responsibilities.

• True

• False

The organization shall conduct the Management Review at least twice a year.

• True

• False

Process approaches is clearly indicated in clause 4.4

• True

• False

At minimum, interested party shall included:

• Customer

• Regulatory body

• Vendors

• All of the above

When planning how to achieve its quality objectives, the organization shall determine:

• what will be done;

• what resources will be required;

• who will be responsible; and when it will be completed;

• All of the above