1. Purpose and scope
A gap assessment answers a simple question with a lot of care: for each requirement the system must meet, what does the organisation already do, what evidence shows it, and what is missing? The result is not a score but a list of specific gaps, each linked to a process and an owner, which becomes the backbone of the implementation plan. A good assessment saves effort because it shows where existing practice already meets the standard and only needs to be written down or measured.
Most organisations that start this lifecycle are not starting from nothing. A semiconductor business usually has engineering change control, test and inspection, calibration, returns handling and supplier management in some form. The gap assessment finds where these practices fall short of the standard, for example where risk-based thinking is missing, where records are not kept, where the internal audit programme does not reach every shift, or where customer specific requirements are not reflected in the way work is done.
The stage also turns the policy into quality objectives with plans to achieve them, builds the risks and opportunities register, sets competence requirements by role, starts qualifying internal auditors, and chooses an accredited certification body. It ends when the plan, with owners, dates, resources and the certification timing, is approved by top management.
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