Section 6 - Planning

Some possible audit scenarios on ISO 9001:2015 Section 6 are as follows:

Scenario 1:
 An auditor is conducting an audit on a bakery that produces and sells various
types of bread, cakes, and pastries. The auditor reviews the documented
information on the quality objectives and finds that they are not consistent with
the quality policy or the strategic direction of the bakery. The quality objectives
are not measurable, relevant, or updated, nor are they communicated or
monitored within the bakery. The auditor interviews the management and
learns that they have not established quality objectives at relevant functions,
levels, and processes needed for the quality management system, nor have they
planned how to achieve them. The auditor concludes that this is a
nonconformity because the bakery has failed to comply with the requirements
of ISO 9001:2015 clause 6.2 Quality objectives and planning to achieve them.

Scenario 2:
 An auditor is conducting an audit on a software company that develops and
sells web applications for various clients. The auditor reviews the evidence of
actions to address risks and opportunities and finds that they are not
proportionate to the potential impact on the conformity of products and
services. The auditor interviews the management and learns that they have not
considered the issues referred to in 4.1 and the requirements referred to in 4.2
when planning for the quality management system, nor have they determined
the risks and opportunities that need to be addressed. The auditor also learns
that they have not planned actions to address these risks and opportunities, nor
have they integrated and implemented them into their quality management
system processes or evaluated their effectiveness. The auditor concludes that
this is a nonconformity because the software company has failed to comply
 with the requirements of ISO 9001:2015 clause 6.1 Actions to address risks and
opportunities.

Scenario 3:
 An auditor is conducting an audit on a furniture company that manufactures
and delivers various types of furniture for different customers. The auditor
reviews the records of changes to the quality management system and finds that
they are not carried out in a planned manner. The auditor interviews the
management and learns that they have not considered the purpose of the
changes and their potential consequences, nor have they ensured the integrity of
the quality management system. The auditor also learns that they have not
considered the availability of resources or the allocation or reallocation of
responsibilities and authorities when making changes to the quality
management system. The auditor concludes that this is a nonconformity
because the furniture company has failed to comply with the requirements of
ISO 9001:2015 clause 6.3 Planning of changes.

Scenario 4:
One possible audit scenario on ISO 9001:2015 Section 6 that is more indirect,
realistic, and tricky is as follows:

An auditor is conducting an audit on a marketing company that provides digital

marketing and social media management services for various clients. The auditor
reviews the quality objectives and finds that they are consistent with the quality policy
and the strategic direction of the marketing company. The quality objectives are
measurable, relevant, and updated, and they are communicated and monitored within
the marketing company. The auditor interviews the management and learns that they
have planned how to achieve their quality objectives by determining what will be
done, what resources will be required, who will be responsible, when it will be
completed, and how the results will be evaluated. The management also shows the
auditor the documented information on the quality objectives and the plans to achieve
them.
However, the auditor also reviews the records of the performance of the quality
objectives and finds that they are not meeting the targets or the expectations of the
clients. The auditor interviews some of the employees and learns that they are not
aware of their roles or responsibilities in achieving the quality objectives, nor are they
provided with adequate training or feedback. The auditor also learns that some of the
clients have complained about the quality of the services or have cancelled their
contracts due to dissatisfaction. The auditor concludes that this is a nonconformity
because the marketing company has failed to ensure that the actions taken to achieve
the quality objectives are effective and result in conformity of products and services
and enhancement of customer satisfaction. The auditor reports this nonconformity to
the management and recommends that they review and improve their processes for
achieving their quality objectives and for ensuring customer focus.

Scenario 5:

An auditor is conducting an audit on a pharmaceutical company that produces and

sells various types of drugs and medical devices for different markets. The auditor
reviews the evidence of actions to address risks and opportunities and finds that they
are proportionate to the potential impact on the conformity of products and services.
The auditor interviews the management and learns that they have considered the
issues referred to in 4.1 and the requirements referred to in 4.2 when planning for the
quality management system, and that they have determined the risks and opportunities
that need to be addressed. The management also shows the auditor the documented
information on the risks and opportunities and the actions to address them, and how
they have integrated and implemented them into their quality management system
processes and evaluated their effectiveness.

However, the auditor also reviews the records of the changes to the quality
management system and finds that they are not carried out in a planned manner. The
auditor interviews the management and learns that they have not considered the
purpose of the changes and their potential consequences, nor have they ensured the
integrity of the quality management system. The auditor also learns that they have not
considered the availability of resources or the allocation or reallocation of
responsibilities and authorities when making changes to the quality management
system. The auditor concludes that this is a nonconformity because the pharmaceutical
company has failed to comply with the requirements of ISO 9001:2015 clause 6.3
Planning of changes.