2. Identify key objectives
Your company has defined objectives for its QMS (§ 6.2). Take a look at them again, and assess what can be gained or lost by a discrepancy between these objectives and the results achieved. Ask yourself the following questions:
What range of results is acceptable without significant consequences for this ability?
What's there to lose if the result is below this range?
What's there to gain if it's beyond that?
For general objectives, work with management, and for operational process objectives, with the people in charge of driving them (pilots).
The standard specifies that "actions to address risks and opportunities must be proportional to the potential impact on product and service compliance" (§ 6.1.2). Focus on...
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Identify key objectives
Assessing uncertainties in results
ToolReference standards
ISO 9000:2015 – Quality management systems – Essential principles and vocabulary
ISO 9001:2015 – Quality management systems – Requirements
ISO 31000:2009 – Risk management — Principles and guidelines
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