What documents are required for ISO 9001 certification?

The short answer

ISO 9001:2015 names a handful of mandatory documents and a longer list of records you must keep. Most SMEs over-document the first list and under-document the second.

Mandatory documents (clauses that say "documented information")

• Scope of the QMS (clause 4.3)
• Quality policy (5.2)
• Quality objectives (6.2)
• Criteria for evaluation and selection of suppliers (8.4)
• Process for the design and development of products and services (8.3) — only if applicable

Mandatory records

• Monitoring and measuring equipment calibration records (7.1.5.1)
• Records of training, skills, experience and qualifications (7.2)
• Product/service requirements review records (8.2.3.2)
• Records about design and development outputs review (8.3) — if applicable
• Records about customer property (8.5.3)
• Production/service provision change control records (8.5.6)
• Records of conformity of product/service with acceptance criteria (8.6)
• Records of nonconforming outputs (8.7.2)
• Monitoring and measurement results (9.1.1)
• Internal audit programme and results (9.2)
• Results of management reviews (9.3)
• Nonconformities and corrective actions (10.2)

What auditors actually want to see

A Stage 2 auditor will typically ask for:

1. Your QMS scope and a process map
2. Your last management review minutes
3. Your last internal audit report and CAPA log
4. Evidence of risk and opportunity assessment
5. Calibration and training records for any role that touches the product

How to organise it

You do not need a separate "Quality Manual." A single shared drive with consistent file names and an index works for most SMEs under 250 people. Use templates that are already cross-referenced to the standard so you spend time running the system, not formatting it.