ISO 9001 Basic Guidelines
| Chapter (ISO 9001 Clause) | SaaS CI/CD | ECU V-Model Development | Audit Checklist |
|---|---|---|---|
| 1. Scope | – Code Integration- Automated Testing- Deployment and Delivery- Monitoring and Feedback | – ECU V-Model Development | – Clearly defined scope and boundaries documented |
| 2. Documented Information (7.5) | – CI/CD pipeline architecture- Deployment runbooks- Rollback and incident response procedures- Testing strategies and validation criteria | – ECU V-Model process documentation | – Maintained, controlled, accessible documentation- Regular reviews and updates |
| 3. Design and Development Control (8.3) | – Defined pipeline design processes and approval- Version control of pipeline scripts and configurations- Change management procedures | – ECU software requirements- Design specifications- Verification and validation plans | – Documented design and development processes- Records of reviews, approvals, and change management |
| 4. Production and Service Provision (8.5) | – Automated build and deployment logs- Defined environments (development, staging, production)- Standardized deployment practices | – ECU software integration, testing, and release practices | – Documented procedures and environments- Logs and records of build/deploy activities |
| 5. Control of Nonconforming Outputs (8.7) | – Immediate identification and notification of deployment failures- Documented rollback and recovery processes- Issue logging and analysis | – ECU anomaly detection, reporting, corrective actions | – Procedures for identification, containment, and corrective actions documented and followed |
| 6. Monitoring, Measurement, Analysis, and Evaluation (9.1) | – Review of pipeline metrics- Tracking deployment frequency, MTTR, failure rates- Reporting dashboards | – ECU test coverage, verification metrics, validation outcomes | – Documented monitoring metrics and regular reviews- Evidence of analysis and actions taken |
| 7. Improvement (10) | – Regular retrospectives and documented actions- Systematic updates and improvements | – ECU continuous improvement practices, FMEA, corrective actions | – Evidence of continuous improvement and corrective actions |
| 8. Leadership and Commitment (5) | – Defined roles and responsibilities for pipeline management- Leadership oversight and reviews | – ECU management roles, responsibilities, documentation | – Documented leadership reviews and defined responsibilities |
| 9. Training and Competence (7.2) | – Training records for CI/CD processes- Regular skill assessments | – ECU-specific training records and assessments | – Training and competence documentation maintained and updated |
Additional Evidence Required for Audits
Ensure the following documentation and evidence are available and easily retrievable:
- Records of internal audits and management reviews
- Corrective action logs with implementation evidence
- Risk assessments and mitigation documentation
- Customer and stakeholder feedback, including actions taken
- Supplier evaluation records (if applicable)
Comparative Summary Table: Toolkits
| Aspect | CI/CD SaaS Development | ECU V-Model Development |
|---|---|---|
| Methodology | Agile, Iterative | V-Model, Waterfall |
| Documentation | Deployment scripts, runbooks | ECU specifications, verification & validation documents |
| Testing | Automated tests, regression suites | Structured verification, validation testing |
| Metrics | Deployment frequency, MTTR | Test coverage, anomaly detection rate |
| Improvement Approach | Retrospectives, iterative actions | FMEA, structured corrective actions |
| Roles & Responsibilities | Cross-functional agile teams | Clearly defined functional roles |
Metrics Summary Table:
| Aspect | SaaS CI/CD Development | ECU V-Model Development |
|---|---|---|
| Deployment & Release | Deployment frequency, Lead time, Change failure rate, MTTR | Validation pass rate, Field failure rate |
| Quality Assurance | Test coverage, Defect escape rate, Automated test pass rate | Test coverage rate, Anomaly detection, Defect density |
| Incident & Stability | Incident frequency, MTTD, MTBF | Defect removal efficiency, Rework rate |
| Process Compliance | Documentation accuracy, Process adherence | Requirement traceability completion, Compliance rate |
Practical QMS Metrics by Category:
For SaaS CI/CD Development:
Deployment Metrics:
- Deployment Frequency: Number of deployments per day/week.
- Deployment Success Rate: Percentage of successful deployments.
- Lead Time for Changes: Time from code commit to deployment in production.
- Mean Time to Recovery (MTTR): Average recovery time after a deployment failure.
- Change Failure Rate: Percentage of deployments resulting in rollback or fixes.
Testing & Quality Metrics:
- Automated Test Coverage: Percentage of code covered by automated tests.
- Defect Escape Rate: Bugs identified in production compared to staging/testing.
- Automated Test Pass Rate: Percentage of automated tests passing successfully.
- Regression Test Pass Rate: Percentage of regression tests passing without incidents.
Incident & Stability Metrics:
- Incident Frequency: Number of incidents reported post-deployment.
- Mean Time to Detect (MTTD): Average time to detect issues in production.
- Mean Time Between Failures (MTBF): Average uptime between system failures.
For ECU V-Model Development:
Development & Validation Metrics:
- Test Coverage Rate: Percentage of functional and safety requirements tested.
- Validation Pass Rate: Percentage of validation tests passed on the first attempt.
- Verification Efficiency: Number of issues detected per verification test.
- Requirement Traceability Completion: Percentage of requirements clearly traced through the V-model (from specification to validation).
Quality & Defect Metrics:
- Anomaly Detection Rate: Number of anomalies identified per testing phase.
- Defect Density: Number of defects per software size or function.
- Defect Removal Efficiency: Percentage of defects found before customer release.
- Rework Rate: Percentage of total effort or budget spent on rework due to defects.
Reliability & Process Control Metrics:
- Field Failure Rate: Failures reported per ECU after deployment.
- Compliance Rate: Percentage of ECU software that meets regulatory and customer requirements on first submission.
- Process Adherence Rate: Percentage of completed processes following defined procedures without deviation.