What is commonly missed during Stage 1A
Documented processes and their sequence and interactions
The organization should have a clear business flow or process map showing all major processes and their inputs and outputs, as well as the way each process connects to the next. In many cases, this is separated into:
- MOP – management-oriented processes
- COP – customer/product realization processes
- SOP – support processes
- Outsourced processes used by the organization
If the organization has more than one site, or if a support process is performed elsewhere, those links must also be visible in the process map.
Pain point: Many organizations have a flowchart, but not a real process interaction model. When the auditor asks what output moves from one process to another, the explanation becomes unclear.
Process owners and full names of personnel
The organization should clearly identify who is the process owner for each process, not just list department names.
Pain point: A company may have an organization chart, but if it is not linked to process accountability, it becomes difficult to show who is actually responsible for the effectiveness of each process.
Product Design Exclusion
If the organization does not design the product itself, it should clearly define which sub-requirements are not applicable. This is especially sensitive under clause 8.3, because many organizations try to exclude it too broadly. In practice, even if product design is excluded, the organization may still be responsible for manufacturing process design, so not all of 8.3 can simply be removed.
Pain point: Overly broad exclusions often lead to deeper auditor questions and confusion about the real scope of the system.






