6.1.1 Take into consideration your planning for the QMS by ensuring that you take into account the issues referred to in clause 4.1, the requirements in 4.2 and determine the
risks and opportunities that need to be addressed.
Do this by
a) Ensuring that your QMS can achieve its intended results.
b) Enhancing desirable effects within your organisation once undesirable causes have been identified.
c) Aiming to prevent or reduce undesirable causes and effects.
d) Focusing on improvement.
6.1.2 We aim to address risk and opportunity by focusing on those items mentioned at
Do this by
a) Acting to identify and address risk and opportunity.
b) Integrate the actions into your organisation and QMS if appropriate. (Reduce, Avoid, Accept, Transfer risk).
c) Evaluate the effectiveness of any actions.
Establish quality objectives and make it available as documented information in the management review minutes, clause 9.
The quality objectives should be
a) Consistent with your policy by being written to enable planned continual improvement.
b) Measurable where practical.
c) Considering past experiences and applicable requirements.
d) Relevant to your organisation and will hopefully maintain or increase customer satisfaction as a result.
e) Monitored at management review.
f) Updated on occasion to reflect completion of the objective or improvements that will enable you to complete the objective eventually.
g) Changed, removed or revised as the organisation grows.
When considering the planning of your objectives
a) Plan what shall be done.
b) What resources will be required?
c) Who will be responsible?
d) When it will (or may) be completed (this is always revisable).
e) Evaluation shall be completed by management.
When we require changes to our organisation, we shall do this in a planned manner.
Planning is completed by (as an example)
Do this by considering
a) The changes, the purpose of completing the change and the potential consequence.
b) How the change shall affect the integrity of the organisation and change the QMS procedures if required.
c) Resources available.
d) Allocation or reallocation of responsibilities.
I hope this helps