# Scope Statement and Requirements Not Applicable (4.3)

## A good scope statement

States **what** (products and services), **where** (every site, including remote or warehouse sites) and
**which activities** (design, manufacture, distribution, service). It appears on the certificate, so
customers read it.

| Weak | Strong |
|------|--------|
| "Manufacturing" | "Manufacture of CNC-machined aluminium and steel components to customer drawings for the pump and valve industry" |
| "All activities" | "Design, manufacture and servicing of industrial air compressors at Leeds (manufacture) and Hull (service)" |

## When a requirement may be declared not applicable

ISO 9001:2015 4.3 allows a requirement to be determined not applicable only if it **does not affect the
ability or responsibility to ensure conformity of products and services and customer satisfaction**. In practice:

| Clause | Valid when | Invalid when |
|--------|------------|--------------|
| 8.3 Design and development | All products are made to designs owned by the customer; no design authority | The company selects materials, changes tolerances, designs tooling sold to customers or develops service offerings |
| 7.1.5 Monitoring and measuring resources | No measurement is used to verify conformity (rare: pure service brokers) | Any gauge, scale or test equipment confirms conformity |
| 8.5.3 Customer/external provider property | No customer material, tooling, IP, data or personal data is handled | Customer drawings or personal data are held (they are customer property) |
| 8.5.5 Post-delivery activities | No warranty, service, recall, or legal post-delivery obligation | Warranty or product liability obligations exist |

Clauses 4, 5, 6, 7 (except 7.1.5), 9 and 10 always apply. Outsourcing a process does **not** make it
not-applicable: it is controlled under 8.4.

## Writing the justification

Name the fact that makes it not applicable and how conformity is still assured:
> "8.3 Design and development is not applicable: all parts are manufactured to drawings supplied and owned by
> the customer, who retains design authority. Acme makes no design decisions; deviations are referred to the
> customer through the concession process (QP-06)."

Review the justification every year: a new product line or a customer asking for design input can make it invalid.