ISO 9001:2015 Mandatory & Recommended Documents

Introduction to Documented Information

ISO 9001:2015 uses the term “documented information” instead of “documents” and “records”. This gives organizations flexibility in how they maintain their QMS documentation.

Key Principles

✅ Less Prescriptive: No mandatory quality manual or procedure documents
✅ Flexibility: Choose format that works for your organization
✅ Evidence-Based: Focus on evidence of conformity
✅ Controlled: Must be controlled regardless of format

Mandatory Documented Information

These are explicitly required by ISO 9001:2015:

1. QMS Scope (Clause 4.3)

What: Clear statement of QMS boundaries
Must include:

• Organizational units/sites covered
• Products and services
• Processes included
• Any exclusions with justification

Example:

“This QMS applies to the design, manufacture, and servicing of industrial pumps at our facility in [City]. Excludes installation as performed by customers.”

2. Quality Policy (Clause 5.2)

What: Top management’s commitment statement
Must include:

• Appropriate to purpose and context
• Framework for quality objectives
• Commitment to requirements
• Commitment to continual improvement

Download Quality Policy Template

3. Quality Objectives (Clause 6.2)

What: Measurable targets aligned with policy
Format: Table or dashboard
Must include:

• Objective statement
• Measurable metric
• Target value
• Timeframe
• Responsible person

4. Competence Records (Clause 7.2)

What: Evidence of employee competence
Examples:

• Training records
• Certificates
• Qualifications
• Performance appraisals
• Skills matrices

5. Monitoring & Measuring Equipment Records (Clause 7.1.5)

What: Calibration and verification records
Must include:

• Equipment identification
• Calibration schedule
• Calibration results
• Next due date
• Traceability to standards

6. Design & Development Records (Clause 8.3) if applicable

What: Design process documentation
Includes:

• Design inputs
• Design controls
• Design outputs
• Design reviews
• Design validation
• Design changes

7. External Provider Evaluation (Clause 8.4)

What: Supplier approval and monitoring
Must document:

• Selection criteria
• Evaluation results
• Approval status
• Performance monitoring
• Re-evaluation

8. Product/Service Conformity (Clause 8.6)

What: Evidence of release authorization
Examples:

• Inspection reports
• Test results
• Release signatures
• Traceability records

9. Nonconformity & Corrective Action Records (Clauses 8.7, 10.2)

What: Problem documentation and resolution
Must include:

• Nonconformity description
• Action taken
• Root cause analysis
• Corrective action
• Effectiveness verification

10. Monitoring & Measurement Results (Clause 9.1)

What: Performance data and analysis
Examples:

• KPI dashboards
• Customer satisfaction surveys
• Process metrics
• Product quality data

11. Internal Audit Program & Results (Clause 9.2)

What: Audit planning and findings
Must include:

• Audit schedule
• Audit reports
• Findings (conformities, NCs, observations)
• Corrective actions
• Follow-up verification

12. Management Review Records (Clause 9.3)

What: Top management QMS review
Must document:

• Review inputs
• Discussions
• Decisions made
• Actions assigned
• Follow-up

Recommended Documentation (Not Mandatory)

While not required, these greatly help implementation:

Process Documentation

Procedures (Optional but Helpful)

Common procedures organizations create:

1. Document Control Procedure

   • How documents are created, approved, updated
   • Version control
   • Access and distribution

2. Control of Records Procedure

   • Record retention periods
   • Storage and retrieval
   • Protection and backup

3. Internal Audit Procedure

   • Audit planning
   • Auditor selection
   • Reporting and follow-up

4. Corrective Action Procedure

   • NC reporting
   • Root cause analysis
   • Action implementation
   • Effectiveness verification

5. Management Review Procedure

   • Schedule and agenda
   • Input requirements
   • Output documentation

Forms & Templates

Useful forms to create:

Document Control Requirements (Clause 7.5.3)

All documented information must be controlled to ensure:

Availability & Protection

✅ Available: Where and when needed
✅ Accessible: To authorized personnel
✅ Protected: From loss, misuse, deterioration
✅ Retained: For appropriate period
✅ Disposed: Appropriately when obsolete

Control Activities

Document Hierarchy

Typical 4-level structure (optional):

Level 1: Quality Policy
         ↓
Level 2: Process Maps & Procedures
         ↓
Level 3: Work Instructions & Forms
         ↓
Level 4: Records & Evidence

Documentation Formats

Digital vs. Paper

Common Tools

• Document Management Systems: SharePoint, Google Drive, Confluence
• Quality Software: ETQ, MasterControl, Qualio
• Simple: Network folders with access control

External Documents

Don’t forget to control external documents:

Examples:

• Customer specifications
• Standards (ISO 9001, industry standards)
• Regulations
• Supplier documents
• Codes of practice

Control Requirements:

• Identification
• Distribution to relevant areas
• Periodic review
• Removal of obsolete versions

Record Retention

Define retention periods based on:

Example Retention Schedule:

Simplified Documentation Approach

For Small Organizations:

Minimum documentation:

1. QMS Scope (1-page)
2. Quality Policy (1-page)
3. Quality Objectives (1-page spreadsheet)
4. Process Map (1-page flowchart)
5. Combined procedure manual (10-20 pages covering key processes)
6. Forms/templates (5-10 key forms)
7. Record-keeping system (simple filing structure)

Total: Could be as few as 30-50 pages!

Documentation Best Practices

DO:

✅ Keep it simple and practical
✅ Use flowcharts and visuals
✅ Make documents easy to find
✅ Regular review and updates
✅ Train people on how to use documents
✅ Link related documents

DON’T:

❌ Create documents just for auditors
❌ Copy-paste from other companies
❌ Make overly complex hierarchies
❌ Use jargon and technical language unnecessarily
❌ Forget to communicate changes
❌ Let documents gather dust

Document Templates Available

Download ready-to-use templates:

Mandatory Documents:

• QMS Scope Template
• Quality Policy Template
• Quality Objectives Template

Procedures:

• Document Control Procedure
• Internal Audit Procedure
• Corrective Action Procedure

Forms:

• Nonconformity Report Form
• Internal Audit Checklist
• Supplier Evaluation Form

Common Documentation Mistakes

1. Over-Documentation

Problem: Creating procedures for everything
Solution: Document what adds value

2. Outdated Documents

Problem: Documents not updated with changes
Solution: Regular review schedule

3. Poor Access

Problem: Employees can’t find documents
Solution: Simple naming, clear organization

4. Version Confusion

Problem: Multiple versions in circulation
Solution: Strong document control

5. No Training on Documents

Problem: People don’t know documents exist
Solution: Include in onboarding and training

Next Steps

1. Review This List → Identify what you already have
2. Gap Analysis → Determine what’s missing
3. Prioritize → Start with mandatory items
4. Create Templates → Download Template Pack
5. Implement Controls → Set up document management system

Need help? See our Document Control Guide