Quality Manual Development Guidelines
A quality manual is the foundational document of a quality management system, providing an overview of how the organization addresses quality requirements. While ISO 9001:2015 doesn't explicitly require a quality manual, it remains a valuable tool for documenting and communicating the QMS.
Manual Structure
| Section |
Content |
Purpose |
| Introduction |
Organization context |
Background information |
| Scope |
QMS boundaries |
Coverage definition |
| References |
Applicable standards |
Compliance framework |
| System Description |
QMS overview |
System understanding |
| Processes |
Process interactions |
System integration |
Content Requirements
| Element |
Requirements |
Documentation |
| Policy |
Quality commitment |
Policy statement |
| Objectives |
Quality goals |
Target metrics |
| Organization |
Roles/responsibilities |
Organization chart |
| Resources |
Required resources |
Resource plans |
Documentation Guidelines
Format Requirements
| Aspect |
Requirements |
| Structure |
Logical organization |
| Language |
Clear, concise writing |
| Layout |
Consistent formatting |
| Identification |
Unique references |
| Version Control |
Revision tracking |
Document Control
| Control Element |
Requirements |
| Review |
Regular assessment |
| Approval |
Authorization process |
| Distribution |
Access control |
| Changes |
Change management |
Process Documentation
| Component |
Description |
Documentation Method |
| Process Map |
Flow visualization |
Flow diagrams |
| Interactions |
Process relationships |
Interaction matrix |
| Controls |
Control measures |
Control plans |
| Resources |
Required inputs |
Resource lists |
| Performance |
Measurement criteria |
KPI documentation |
Manual Maintenance
Review Process
| Activity |
Frequency |
| Content Review |
Annual |
| Process Verification |
Semi-annual |
| Update Assessment |
As needed |
| Compliance Check |
Quarterly |
Change Management
| Change Type |
Requirements |
| Minor Updates |
Document revision |
| Major Changes |
Full review process |
| System Changes |
Impact assessment |
| Standard Updates |
Compliance review |
Best Practices
- Keep content clear and concise
- Use consistent terminology
- Maintain logical structure
- Include process maps
- Reference related documents
- Control document versions
- Review regularly
- Update promptly
- Ensure accessibility
- Train users effectively