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

- Scope of the QMS (Quality Management System) - usually documented as the QMS Scope document.
- Quality policy - usually documented as the Quality Policy.
- Quality Objectives and Plans for Achieving Them - usually documented as the List of Quality Objectives.
- Criteria for evaluation and selection of suppliers - usually documented as the Criteria for evaluation and selection of suppliers document.
- Compliance Obligations Document - usually documented as the List of External Documents, if applicable.

Examples of mandatory records include:

- Monitoring and measuring equipment calibration records - usually documented as Maintenance and Calibration Record.
- Records of training, skills, experience, and qualifications - usually documented as Training certificates and CVs.
- Product/service requirements review records - usually documented as Customer Requirement Review Checklist.
- Record about design and development outputs review - usually documented as Project Plan and Review.
- Records of design and development controls - usually documented as Design Review Minutes.
- Records of design and development outputs - usually documented as Design Review Minutes.
- Design and development change records - usually documented as Change Review Record.
- Characteristics of product to be produced and service to be provided - usually documented as Product Specification.
- Records about customer property - usually documented as Notification to a Customer about Changes on his Property.
- Production/service provision change control records - usually documented as Production/Service Change Review Record.
- Record of conformity of product/service with acceptance criteria - usually documented as Record of Traceability.
- Record of nonconforming outputs - usually documented as Non-conformity Record.
- Monitoring and measurement results - usually documented as Matrix of Key Performance Indicators and Data Analysis Report.
- Internal audit program - usually documented as Internal Audit Program.
- Results of internal audits - usually documented as Internal Audit Report.
- Results of the management review - usually documented as Management Review Minutes.
- Results of corrective actions - usually documented as Corrective Action Form.