Clause 6: "Planning"

Question 1

What shall the organization consider when planning for the QMS?

Answer 1

When planning for the quality management system, the organization shall consider the issues
- “Understanding the organization and its context”
and
- “Understanding the needs and expectations of interested parties”
and
- determine the risks and opportunities that need to be addressed to
- give assurance that the quality management system
can achieve its intended result(s);
- enhance desirable effects;
- prevent, or reduce, undesired effects;
- achieve improvement.

Question 2

The organization shall plan:

Answer 2

• actions to address these risks and opportunities;
• how to integrate and implement the actions into its
  quality management system processes;
• how to evaluate the effectiveness of these actions.
  Actions taken to address risks and opportunities shall be proportionate to the potential impact on the conformity of products and services!

Question 3

How shall the organization establish quality objectives?

Answer 3

The organization shall establish quality objectives at relevant
- functions,
- levels and
- processes
needed for the quality management system.

Question 4

The quality objectives shall:

Answer 4

The quality objectives shall:

• be consistent with the quality policy;
• be measurable;
• take into account applicable requirements;
• be relevant to conformity of products and services and to
• enhancement of customer satisfaction;
• be monitored;
• be communicated;
• be updated, as appropriate

Question 5

What shall the organization determine when planning how to achieve the quality objectives?

Answer 5

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;
• when it will be completed;
• how the results will be evaluated.

Question 6

How to plan changes?

Answer 6

When the organization determines the need for changes to the quality management system, the changes shall be carried out in a planned manner.
The organization shall consider:
- the purpose of the changes and their potential
consequences;
- the integrity of the quality management system;
- the availability of resources;
- the allocation or reallocation of responsibilities and
authorities.