Chapter 5: What the Process Approach Actually Requires (Plain Language)

The process approach boils down to four concrete requirements:

1. Define your processes (what work actually happens)
2. Document inputs and outputs (what goes in, what comes out)
3. Show sequence and interaction (what triggers what, what depends on what)
4. Assign ownership (who is accountable for each process)

Clause 4.4 doesn't demand perfection or a 50-page process document. It demands that you know your business and can show someone else. That's it.

Here's where most Canadian manufacturing plants stumble: they conflate "having procedures" with "understanding their processes." Your quality manual might describe a procedure for handling customer complaints. But what triggers a complaint? What processes feed data into that complaint handling?

What's the upstream manufacturing defect that caused the complaint in the first place? Where does that defect originate? A true process approach answers all of those questions by connecting the dots.

ISO auditors consistently cite "lack of proper process approach" as a top three nonconformance at manufacturing sites in Canada. This isn't because plants don't have processes—they do. It's because leadership can't *articulate* the relationships between those processes.

A shop floor supervisor runs the machine correctly. The quality inspector measures the part correctly. The shipper boxes the parts correctly. But if nobody has documented how those three processes interact, and what happens when the output of one process doesn't meet the input requirements of the next, you have a compliance gap.