ISO 9001:2015 specifies several mandatory documents and records for compliance. Examples of required documents include:

- Scope of the QMS (Clause 4.3)
- Quality policy (Clause 5.2)
- Quality Objectives and Plans for Achieving Them (Clause 6.2)
- Criteria for evaluation and selection of suppliers (Clause 8.4.1)
- Compliance Obligations Document (Clause 7.5.3.2, if applicable)

Examples of mandatory records include:

- Monitoring and measuring equipment calibration records (Clause 7.1.5.1)
- Records of training, skills, experience, and qualifications (Clause 7.2)
- Product/service requirements review records (Clause 8.2.3.2)
- Records about design and development outputs review (Clause 8.3.2)
- Records of design and development controls (Clause 8.3.4)
- Records of design and development outputs (Clause 8.3.5)
- Design and development change records (Clause 8.3.6)
- Characteristics of product to be produced and service to be provided (Clause 8.5.1)
- Records about customer property (Clause 8.5.3)
- Production/service provision change control records (Clause 8.5.6)
- Record of conformity of product/service with acceptance criteria (Clause 8.6)
- Record of nonconforming outputs (Clause 8.7)
- Monitoring and measurement results (Clause 9.1.1 and 9.1.3)
- Internal audit program and results (Clause 9.2)
- Results of the management review (Clause 9.3)
- Results of corrective actions (Clause 10.2)