ISO Compliance & Quality Traceability Matrix

In Plain Language: Organizations must establish, document, and follow a clear set of rules for how medical software is developed and maintained.

In Plain Language: All engineering policies, guidelines, and quality records must be written down, accessible, and version-controlled.

In Plain Language: Quality records, audit logs, and test results must remain readable, readily identifiable, and protected from accidental deletion or alteration.

In Plain Language: Engineering leadership must plan software release cycles and sprints in a structured way that preserves compliance during system changes.

In Plain Language: Every engineering role on a project must have documented responsibilities, with clear separation between authors and independent approvers.

In Plain Language: Engineers building medical software must possess verified skills in secure coding, clinical testing, and regulatory requirements.

In Plain Language: Teams must plan the sequence of development activities — from design and coding to automated CI/CD and production monitoring.

In Plain Language: Teams must formally capture clinical user needs, hospital workflows, and statutory constraints before designing features.

In Plain Language: Engineers must document their architectural design plans, design passes, and review milestones before implementing code.

In Plain Language: Requirements must be specific, testable, non-conflicting, and include threat modeling hazard considerations.

In Plain Language: Source code, API schemas, container images, and database schemas must completely satisfy design inputs and include acceptance criteria.

In Plain Language: Every code change must undergo formal peer review evaluating correctness, security, test coverage, and documentation.

In Plain Language: Teams must write automated tests (unit, integration, regression, SAST) proving that the code performs exactly as specified.

In Plain Language: Software must be tested in simulated clinical environments to confirm it fulfills actual user workflows and clinical intentions.

In Plain Language: Cloud deployments must follow automated, reproducible pipelines with zero manual server configuration drift.

In Plain Language: Teams must regularly verify that daily engineering practices adhere to documented quality processes and checklist gates.

In Plain Language: Production applications must be continuously monitored for performance anomalies, error rates, latency spikes, and uptime.

In Plain Language: Security rules and engineering policies must be written down, approved by leadership, and acknowledged by all developers.

In Plain Language: Specific security roles (Security Advisor, Information Assurance Analyst) must be defined with clear authority and accountabilities.

In Plain Language: Organizations must collect and analyze threat data (CVEs, adversary attack vectors) to proactively update system defenses.

In Plain Language: Security cannot be an afterthought; it must be planned into every sprint, user story, and architectural decision.

In Plain Language: Teams must have pre-planned runbooks for detecting, containing, and responding to cybersecurity breaches within regulatory SLAs.

In Plain Language: Organizations must document how they satisfy HIPAA, FDA QSR, FedRAMP, and SOX regulations.

In Plain Language: Teams must use formal checklists to ensure every code change complies with documented security and quality policies.

In Plain Language: Authors cannot approve their own code or deploy directly to production; duties must be separated to prevent unauthorized changes.

In Plain Language: Teams must scan code and dependencies continuously for CVEs and fix high-severity vulnerabilities within defined SLAs.

In Plain Language: Application telemetry (logs, metrics, traces) must be analyzed in real time to detect security anomalies and intrusions.

In Plain Language: Cloud networks must use micro-segmentation, DDoS traffic scrubbing, and mutual TLS to block unauthorized network traffic.

In Plain Language: Sensitive data must be encrypted with modern NIST-approved ciphers (AES-256) and keys rotated automatically via HSMs.

In Plain Language: Security controls must be applied continuously across the software development lifecycle from design to production.

In Plain Language: Developers must write code that eliminates input injection, sanitizes outputs, and hashes passwords securely.

In Plain Language: Software must undergo automated security testing and annual third-party ethical penetration testing before release.

In Plain Language: Every production release or infrastructure configuration change must be tracked in Git and approved by designated leads.