Clause 7.5 of ISO 9001:2015 governs how organizations create, update, and control documented information. The 2015 revision replaced the terms “documents” and “records” with the unified term “documented information” and significantly reduced prescriptive documentation requirements — a quality manual is no longer mandatory.
What the Standard Requires
The QMS must include documented information required by ISO 9001 and documented information determined necessary for QMS effectiveness. When creating and updating, ensure appropriate identification and description, format and media, and review and approval for suitability and adequacy.
Required Documented Information (Maintain)
- QMS scope (4.3) and process descriptions (4.4)
- Quality policy (5.2) and quality objectives (6.2)
- Operational planning criteria and controls (8.1)
- Customer requirements including changes (8.2)
- Design and development inputs, controls, and outputs (8.3)
- External provider evaluation criteria (8.4)
Required Documented Information (Retain as Evidence)
- Competence records (7.2) and calibration records (7.1.5)
- Design and development review, verification, and validation results (8.3)
- Product/service release records (8.6) and nonconforming output records (8.7)
- Monitoring, measurement, analysis, and evaluation results (9.1)
- Internal audit program and results (9.2)
- Management review results (9.3) and corrective action records (10.2)
Common Pitfalls
- Over-documenting with procedures that add no value
- Under-documenting and relying on undocumented tribal knowledge
- Not controlling document versions, leading to use of obsolete information
- Failing to retain records required as evidence of conformity
Related Ecesis Solutions
Document Management
Version-controlled procedures and records
Audits & Inspections
Schedule, conduct, and track audit findings
Nonconformity Tracking
Report, investigate, and resolve nonconformities
Training Management
Track competence requirements and records
Change Management
Structured review of planned changes
Compliance Obligations
Track requirements and evaluation schedules
