Team Agreements: Definition of Done, Definition of Ready & Working Norms

Last Audited: 2026-08-18
Tier-1 Platform Core
In Plain Language

Formal quality baselines ensuring zero unverified code merges into main branches while establishing documented operational procedures.

Establishing Verifiable Quality Baselines and Operational Procedures

Team agreements eliminate ambiguity about software readiness and peer expectations. In a regulated team, the Definition of Done (DoD) guarantees that zero unverified, untested, or undocumented code enters release branches. Simultaneously, the Definition of Ready (DoR) prevents engineering against vague requirements, while Working Agreements satisfy ISO 27001 Control A.5.37 documented operational procedures.

Definition of Done (DoD)

The Non-Negotiable Quality Baseline
ISO 13485 Cl. 7.3.6 & ISO 27001 Control A.8.28

A formal agreement that defines when a user story is completely built, verified, documented, and ready for release.

Verifiable Checklist Items

  • Clean Code: Code adheres to architecture standards and passes static analysis (linter / SAST) with zero high-severity issues.
  • Automated Tests: Unit and integration tests written, passing in CI, with >= 85% branch coverage on new logic.
  • Peer Code Review: Mandatory 2-person code review completed and approved, verifying segregation of duties.
  • Design Inputs Traced: User story acceptance criteria verified against Software Requirements Specification (SRS).
  • Documentation Updated: API docs, inline comments, and user-facing release notes updated.
  • Security & SBOM: Dependency vulnerability scans passed, and Software Bill of Materials (SBOM) updated.
  • Deployable: Increment deployed and verified in automated staging/QA environment.
Audit Governance: Ensures that every sprint deliverable meets ISO 13485 Clause 7.3.6 and FDA 21 CFR §820.30(f) verification standards before merging.

Definition of Ready (DoR)

The Sprint Ingestion Filter
ISO 13485 Cl. 7.3.3 (Design Inputs) & ISO 27001 Control A.5.8

A quality gate ensuring that a user story is sufficiently detailed, testable, and estimated before being committed in sprint planning.

Verifiable Checklist Items

  • Clear Value Statement: Formatted as "As a [role], I want [feature], so that [benefit]".
  • Testable Acceptance Criteria: Minimum 3 acceptance criteria written in Given/When/Then (Gherkin) format.
  • Design Input Linkage: Cross-referenced to specific parent requirement or clinical workflow item in SRS.
  • Dependencies Resolved: External APIs, UI wireframes, or data schemas are available.
  • Estimated: Sized by the development team (e.g. story points <= 8 to fit within a single sprint).
  • Security & Privacy Impact: Data sensitivity (PHI/PII) flagged and regulatory impact evaluated.
Audit Governance: Prevents wasteful context switching and audit non-conformities caused by engineering against ambiguous specifications.

Team Working Agreements

Day-to-Day Engineering Norms
ISO 27001 Control A.5.37 & ISO 13485 Cl. 5.5.1

Explicit agreements established by the team to govern communication, code review response times, and daily execution.

Verifiable Checklist Items

  • Core Overlap Hours: 10:00 AM – 3:00 PM local time for synchronous collaboration, pairing, and meetings.
  • PR Review SLA: Peer pull requests under 400 lines are reviewed within 24 business hours.
  • Async-First Communication: Important technical decisions and architecture tradeoffs are documented in written ADRs.
  • No Broken Builds: Broken CI pipelines take priority over new feature work; the entire squad assists until green.
  • Blameless Post-Mortems: Incidents and defects are analyzed focusing on system/process resilience, not personal blame.
Audit Governance: Satisfies ISO 27001 Control A.5.37 requiring documented and accessible operational procedures.

Regulated Team Manifesto

Shared Values & Cultural Tenets
ISO 13485 Cl. 5.1 (Management Commitment)

A high-level declaration of how the team balances engineering agility with human safety and regulatory rigor.

Verifiable Checklist Items

  • Patient & User Safety First: We never sacrifice verification rigor or security controls to meet a deadline.
  • Continuous Audit Readiness: We maintain compliance evidence in real-time as code is written, not before audits.
  • Transparency: We surface risks, impediments, and defect escapes openly during retrospectives.
  • Engineering Craftsmanship: We take pride in clean, modular, test-driven, and well-documented software.
Audit Governance: Fosters a pervasive culture of quality required by FDA Quality System Regulation (QSR) and ISO 13485.
Try This With AI: Definition of Done Tailoring Assistant
Governance Prompt

Use this prompt to generate a custom Definition of Done tailored to your application's specific architecture and safety classification:

"Act as a Principal Regulatory Compliance Architect. We are building a [DESCRIBE YOUR SYSTEM, e.g., cloud-native medical imaging viewing platform using Next.js, Node.js, and PostgreSQL] classified under IEC 62304 Class B. Generate a tailored 7-item Definition of Done checklist covering: (1) Automated code verification thresholds, (2) Security SAST/DAST/SBOM gates, (3) Segregation of duties peer review criteria, (4) FDA 21 CFR §820.30(f) verification evidence artifacts, and (5) Specific CI/CD pipeline checks."

Community Discussion & Feedback

Attributed peer feedback and official Netspective architecture notes.

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