# Quality Manual Structure

ISO 9001:2015 does not require a quality manual. Most certified companies still keep one because it is the
single place that states the scope (mandatory), shows the process map (4.4) and tells auditors and new staff
where everything is. Write it as a **map of the company's QMS**, not a copy of the standard.

## Recommended structure (8-15 pages)

| Section | Content | Clause |
|---------|---------|--------|
| Revision block | Revision, date, approver, change summary | 7.5.2 |
| 1 Scope | Products/services, sites, activities; requirements not applicable with justification | 4.3 |
| 2 Context | Where issues and interested parties are recorded and how often reviewed; climate-change relevance | 4.1, 4.2 |
| 3 Processes | Process map, interaction table (owner, inputs, outputs, KPI, documents) | 4.4 |
| 4 Policy | The policy text or a reference to the controlled copy | 5.2 |
| 5 Leadership | Org chart reference, key authorities (stop production, release product, concessions) | 5.1, 5.3 |
| 6 Planning | Where risks, opportunities, objectives and change planning live | 6 |
| 7 Support | Resources, calibration, competence, communication, document control references | 7 |
| 8 Operation | Pointers to operational procedures; special processes; outsourced processes and their controls | 8 |
| 9 Evaluation | KPIs, customer satisfaction method, audit programme, management review frequency | 9 |
| 10 Improvement | NCR/CAPA process, how improvement projects are chosen | 10 |
| Appendix | Clause cross-reference; list of procedures and registers | - |

## Writing rules

- **Say what you do, in your words.** "Every order over GBP 10k is reviewed by Sales and Quality before
  acceptance (QP-02)" beats "The organization shall review requirements".
- **Point, don't duplicate.** One sentence and a document number per topic; detail lives in procedures.
- **Name roles, not people.** People change; roles survive revisions.
- **Show outsourced processes** (heat treatment, plating, calibration labs) and how they are controlled.
- **Keep it true.** Auditors sample the manual against reality; an aspirational manual creates nonconformities.

## Remove 2008-era content

| Old content | 2015 replacement |
|-------------|------------------|
| Management representative | Responsibilities assigned under 5.3 (any role) |
| Preventive action procedure | Risk-based thinking (6.1) and the risk register |
| Six mandatory procedures | Only documented information the company needs, plus the mandatory list |
| Clause 7.3 Design | Clause 8.3 Design and development |
| "Documents and records" | "Documented information" (maintain / retain) |
| Exclusions limited to clause 7 | Requirements "not applicable" anywhere, but only if conformity is not affected |

## Process interaction

An interaction table is enough for most auditors; a diagram helps staff. Each core process lists:
owner, trigger/input, output/customer, KPI with target, controlling documents, key risks. Support processes
(purchasing, maintenance, HR, calibration, IT) and management processes (review, audit, improvement) feed every
core process. Include outsourced processes in the map with the control method.