ISO 9001:2015 - Planning Requirements
Clause 6 of ISO 9001:2015 focuses on planning within the QMS, emphasizing risk-based thinking, quality objectives, and change management. This strategic approach ensures alignment between quality initiatives and organizational goals.
6.1 Actions to Address Risks and Opportunities
| Planning Element |
Requirements |
Implementation Methods |
| Risk Identification |
Consider context and stakeholders |
SWOT analysis, risk assessments |
| Opportunity Analysis |
Identify potential benefits |
Market analysis, innovation reviews |
| Action Planning |
Define response strategies |
Action plans, project planning |
| Integration |
Incorporate into QMS processes |
Process updates, controls |
| Effectiveness |
Evaluate actions taken |
Performance monitoring, reviews |
Risk Assessment Framework
| Risk Level |
Evaluation Criteria |
Required Actions |
| High |
Significant impact, likely |
Immediate mitigation required |
| Medium |
Moderate impact, possible |
Planned control measures |
| Low |
Minor impact, unlikely |
Monitor and review |
| Opportunity |
Potential benefit |
Evaluation and implementation plan |
6.2 Quality Objectives and Planning
| SMART Element |
Requirement |
Example |
| Specific |
Clear and unambiguous |
Reduce defect rate by 10% |
| Measurable |
Quantifiable indicators |
Monthly quality metrics |
| Achievable |
Realistic targets |
Based on current performance |
| Relevant |
Aligned with policy |
Support quality policy goals |
| Time-bound |
Clear timeframe |
Achieve by Q4 2025 |
6.2.2 Quality Objective Planning
Planning Elements
| Element |
Requirements |
| Actions |
What will be done |
| Resources |
What is needed |
| Responsibility |
Who will do it |
| Timeline |
When it will be done |
| Evaluation |
How results are measured |
Documentation Requirements
| Document |
Content |
| Objectives Register |
List of all quality objectives |
| Action Plans |
Detailed implementation plans |
| Progress Reports |
Status updates and metrics |
| Review Records |
Evaluation of achievement |
6.3 Planning of Changes
| Consideration |
Requirements |
Implementation Guide |
| Purpose |
Change justification |
Document reasons and objectives |
| Potential Consequences |
Impact assessment |
Risk analysis and evaluation |
| QMS Integrity |
System maintenance |
Process impact assessment |
| Resource Availability |
Capability assessment |
Resource planning and allocation |
| Responsibilities |
Authority assignment |
Role and responsibility definition |
Planning Best Practices
- Integrate risk-based thinking throughout planning
- Ensure objectives cascade through organization
- Document planning decisions and rationale
- Consider resource implications early
- Maintain focus on customer requirements
- Review and update plans regularly
- Monitor effectiveness of actions taken
- Communicate changes effectively
- Maintain system integrity during changes
- Document lessons learned from implementation