User
Can you provide examples of the types of documents and records required for ISO 9001:2015 compliance?
Experta
ISO 9001:2015 specifies several mandatory documents and records for compliance. Examples of required documents include:
- **Scope of the QMS** (Clause 4.3): Typically documented as the QMS Scope document.
- **Quality Policy** (Clause 5.2): Usually documented as the Quality Policy.
- **Quality Objectives and Plans for Achieving Them** (Clause 6.2): Documented as the List of Quality Objectives.
- **Criteria for Evaluation and Selection of Suppliers** (Clause 8.4.1): Documented as the Criteria for Evaluation and Selection of Suppliers document.
- **Compliance Obligations Document** (Clause 7.5.3.2): Documented as the List of External Documents, if applicable.
Mandatory records include:
- **Monitoring and Measuring Equipment Calibration Records** (Clause 7.1.5.1): Documented as Maintenance and Calibration Record.
- **Records of Training, Skills, Experience, and Qualifications** (Clause 7.2): Documented as Training Certificates and CVs.
- **Product/Service Requirements Review Records** (Clause 8.2.3.2): Documented as Customer Requirement Review Checklist.
- **Record of Conformity of Product/Service with Acceptance Criteria** (Clause 8.6): Documented as Record of Traceability.
- **Record of Nonconforming Outputs** (Clause 8.7): Documented as Non-conformity Record.
- **Monitoring and Measurement Results** (Clause 9.1.1 and 9.1.3): Documented as Matrix of Key Performance Indicators and Data Analysis Report.
- **Internal Audit Program and Results** (Clause 9.2): Documented as Internal Audit Program and Internal Audit Report.
- **Results of Management Review** (Clause 9.3): Documented as Management Review Minutes.
- **Results of Corrective Actions** (Clause 10.2): Documented as Corrective Action Form.
These documents and records are essential for demonstrating compliance with ISO 9001:2015 standards.