Chapter 46: Documentation and System Setup Questions

Do I really need to document every single process, or can I keep some things as "tribal knowledge"?

Here's the honest answer: No, you don't need to document every micro-step. But you need to document the processes that directly affect product quality or regulatory compliance. In 2026, the Canadian Standards Association (CSA) still interprets ISO 9001:2015 as requiring documented procedures for design (if you do design), production, service delivery, and management of nonconforming product.

Everything else—how the shop keeps tools organized, the exact wording of your morning standup—can stay as tribal knowledge if you want.

The real risk of skipping documentation isn't the auditor. It's what happens when your quality manager moves to another role or retires. We've seen plants lose years of institutional knowledge when one key person leaves. Documented processes survive staff turnover. They also make training faster, reduce errors on the shop floor, and give you evidence of how things actually work when a customer asks questions.

Start by documenting the non-negotiables. Then document anything that's been a source of errors or customer complaints in the past three years.

What should go into our quality manual, and how detailed does it really need to be?

Your quality manual is your system's overview—not the procedures themselves. Think of it as the table of contents for how your company manages quality. It needs to:

1. State your quality policy
2. Describe your organizational structure and responsibilities (at least at the department level)
3. Explain how you meet ISO 9001's requirements
4. Reference where the detailed procedures live

Many plants get this wrong by writing a 100-page manual that repeats every procedure. That's wasted effort.

A strong quality manual runs 8 to 15 pages and lives on your shared drive. It's updated once a year, maybe twice. It answers: *Who's responsible for what? How do we handle changes? What's our approach to customer feedback?*

Everything else—the exact steps for inspecting a machined part, the template for a corrective action—goes into procedures, work instructions, or system documentation. This separation means your manual stays stable while you update detailed procedures as needed without triggering a full system review.

Do we have to use QMS software, or can we run our system with spreadsheets and shared drives?

You can run a compliant system on Excel and shared folders if your operation is small (under 50 people) and your processes are simple. We've certified plants that use a combination of Google Drive, Smartsheet, and a few custom spreadsheets. The auditor doesn't care about the tool—they care about whether your system actually works and whether you have records to prove it.

That said, once you hit about 60-80 people or your processes get complex (multiple manufacturing lines, multiple shifts, customer-specific requirements), spreadsheets create blind spots. People forget to update versions, two team members edit the same file, nobody knows where the latest inspection data lives.

How often do we need to update procedures and work instructions?

At minimum, once a year during your management review. But realistically, you update them when something changes: a new customer requirement, a machine upgrade, a process improvement from the shop floor, or because an audit or nonconformance exposed a gap.

The goal isn't to rewrite everything constantly—it's to keep documentation aligned with how work actually happens.

We recommend a quarterly "documentation health check" where your quality team reviews which procedures have been revised and which haven't been touched in over two years. If nobody's updated it in two years and the process is still working as documented, that's good. If it hasn't been updated because nobody follows it anyway, that's a red flag worth investigating.

Many plants use a simple tracking spreadsheet or a section in their QMS software that flags procedures for review based on age and change frequency.