Take actions to address risk and opportunities.
Establish quality objectives.
Plan for how quality objectives will be met.
Plan for changes to be made to the QMS.
6.1.1 Triad's QMS has determined the risks and opportunities that need to be addressed in order to give assurance the QMS can achieve its intended results, enhance desirable effects, prevent or reduce undesired effects and achieve improvement.
6.1.1 a Take into account risks and opportunities
4.1, 4.2
6.1.1 b Take into account opportunities
In order to increase the desirable effects (positive impact)
6.1.1 c Take into account risks
In order to reduce the undesirable effects (negative impacts)
6.1.1 d Take into account risks and opportunities
Continual improvement approach, see 10.3
6.1.2 Triad shall plan actions to address risks/opportunities and how to integrate and implement determined actions. Said actions then will be evaluated. Actions shall be proportionate to the potential impacts on conformity.
6.1.2 a Plan actions to address risks and opportunities
Account for risks in every process
6.1.2 b1 Plan the way to implement actions
Define how to integrate actions in the processes, see 4.4
6.1.2 b2 Plan the way to evaluate actions
Follow results
6.1.2 Adapt actions to risks and opportunities
Compared to the potential impact identified
6.2.1 Establish quality objectives for processes
Triad's quality objectives have been established at relevant functions, levels and processes needed to support the QMS.
6.2.1 a Choose quality objectives
Clarify criteria for setting objectives that are consistent with the quality policy
6.2.1 b Use measurable objectives
They must be realistic
6.2.1 c Consider applicable requirements
See 4.2
6.2.1 d Adopt relevant objectives
Ensure the conformity of products/services and to improve customer satisfaction
6.2.1 e Monitor objectives
Establish a frequency
6.2.1 f Communicate objectives and results
All levels
6.2.1 g Update objectives
During Management Review if applicable, see 9.3
6.2.1 Maintain documented information on the quality objectives
See 7.5
6.2.2 Triad will determine how to achieve our quality objectives and define necessary resources and responsibilities.
6.2.2 a Plan HOW to do
6.2.2 b Plan necessary resources
6.2.2 c Plan responsibilities
6.2.2 d Plan deadlines
6.2.2 e Plan the way to evaluate results
When changes are made to the QMS, they are planned. Triad will consider the purpose and potential consequences, the integrity impact to the QMS, the availability of resources and the allocation or reallocation of responsibilities and authorities.
6.3 Plan the need for changes of the QMS
See 4.4
6.3 a-d Plan the changes
Evaluate the purpose and any consequences
Account for the maintenance and integrity of the QMS
Account for the available resources
Account for the Assigned responsibilities and authorities