ISO 9001:2015 - Operational Requirements
Clause 8 of ISO 9001:2015 addresses the planning and control of operational processes. This includes requirements for products and services, design and development, control of external provisions, and production and service provision.
8.1 Operational Planning and Control
| Planning Element |
Requirements |
Implementation Methods |
| Process Requirements |
Criteria establishment |
Process documentation |
| Resource Determination |
Resource allocation |
Capacity planning |
| Process Controls |
Control implementation |
Control plans |
| Documentation |
Evidence maintenance |
Records management |
| Change Management |
Planned changes |
Change control process |
8.2 Requirements for Products and Services
| Aspect |
Requirements |
Controls |
| Customer Communication |
Information exchange |
Communication channels |
| Requirements Determination |
Specification review |
Review process |
| Review Process |
Capability confirmation |
Review records |
| Changes |
Change management |
Change documentation |
8.3 Design and Development
Planning Requirements
| Stage |
Requirements |
Controls |
| Planning |
Stage determination |
Project planning |
| Inputs |
Requirements definition |
Input verification |
| Controls |
Review processes |
Stage gates |
| Outputs |
Verification criteria |
Output validation |
| Changes |
Change control |
Change records |
Documentation Requirements
| Document Type |
Content |
| Design Plans |
Stage definitions, resources |
| Input Records |
Requirements, constraints |
| Review Records |
Decisions, actions |
| Verification Records |
Test results, approvals |
| Validation Records |
Performance evidence |
8.4 Control of External Providers
| Control Element |
Requirements |
Implementation Methods |
| Selection Criteria |
Provider evaluation |
Evaluation process |
| Performance Monitoring |
Monitoring system |
Performance metrics |
| Information Provision |
Clear requirements |
Specifications |
| Verification |
Inspection activities |
Verification plans |
8.5 Production and Service Provision
| Control Type |
Requirements |
Implementation |
| Controlled Conditions |
Process parameters |
Control documentation |
| Identification/Traceability |
Product status |
Identification system |
| Customer Property |
Protection measures |
Control procedures |
| Preservation |
Product integrity |
Storage conditions |
| Post-delivery |
Support activities |
Service procedures |
8.6-8.7 Release and Nonconforming Outputs
Release Requirements
| Stage |
Requirements |
| Verification |
Planned arrangements |
| Authorization |
Approval process |
| Documentation |
Release records |
| Traceability |
Authorizing person |
Nonconformity Control
| Action |
Requirements |
| Identification |
Detection methods |
| Containment |
Control measures |
| Disposition |
Decision process |
| Documentation |
Records maintenance |
Implementation Best Practices
- Document operational criteria clearly
- Establish robust process controls
- Maintain detailed records
- Monitor process performance
- Control design changes effectively
- Evaluate external providers regularly
- Implement traceability systems
- Control nonconforming outputs
- Verify process outputs
- Maintain evidence of conformity