Agent skill

Quality Manager Qmr

by LeoYeAI in LeoYeAI/openclaw-master-skills

Senior Quality Manager Responsible Person (QMR) for HealthTech and MedTech companies.

MITAuto-check passedLegal & Compliance

Install Quality Manager Qmr

skills CLI
$ npx skills add LeoYeAI/openclaw-master-skills --skill quality-manager-qmr -a claude-code

Project install by default; add -g for ~/.claude/skills/.

GitHub CLI
$ gh skill install LeoYeAI/openclaw-master-skills quality-manager-qmr --agent claude-code

Project scope by default; add --scope user for a personal install. Needs GitHub CLI 2.90.0 or later (public preview).

Manual copy
$ git clone --depth 1 https://github.com/LeoYeAI/openclaw-master-skills.git skills-src && mkdir -p .claude/skills && cp -r skills-src/skills/quality-manager-qmr .claude/skills/quality-manager-qmr && rm -rf skills-src

Use ~/.claude/skills/ instead of .claude/skills for a personal install. The folder must contain SKILL.md.

Claude Code skills documentation · loads skills from .claude/skills/

Facts

Skill name
quality-manager-qmr
GitHub stars
2.2k
Token cost
~4.5k tokens
SKILL.md length
1,492 words
Files
5 (incl. scripts, references)
Skills in repo
1,235
Repo updated
First seen
Licence
MIT

At a glance

Senior Quality Manager Responsible Person (QMR) for HealthTech and MedTech companies.

  • Works in 8 steps: Schedule management review (minimum… → Notify all required attendees minimum 2… → Collect required inputs from process… → …
  • Tasks that involve Regulatory compliance
  • SKILL.md covers Table of Contents, QMR Responsibilities, Management Review Workflow and Quality KPI Management Workflow, plus 3 more sections
  • Runs Python scripts from its folder; calls python

What it does

Quality Manager Qmr is an agent skill from LeoYeAI/openclaw-master-skills. Senior Quality Manager Responsible Person (QMR) for HealthTech and MedTech companies. Provides quality system governance, management review leadership, regulatory compliance oversight, and quality performance monitoring per ISO 13485 Clause 5.5.2.

Its SKILL.md is about 4.5k tokens, which your agent loads only when the skill is triggered. The skill folder holds 6 other files, including scripts and reference files (for example `_meta.json`, `references/management-review-guide.md` and `references/quality-kpi-framework.md`).

It sits in Legal & Compliance, covering Regulatory compliance and OKRs and executive reporting. The repository describes itself as: 🧠 Curated collection of 1209+ best OpenClaw skills — weekly updated by MyClaw.ai. The licence is MIT.

When your agent uses it

  • Tasks that involve Regulatory compliance
  • Tasks that involve OKRs and executive reporting

Example prompts

  • “/quality-manager-qmr”

Requirements

  • Python 3

Workflow steps

8 steps, taken from the first numbered list in SKILL.md.

  1. Schedule management review (minimum annually, typically quarterly or semi-annually)
  2. Notify all required attendees minimum 2 weeks prior
  3. Collect required inputs from process owners
  4. Compile input summary report with trend analysis
  5. Prepare presentation materials with supporting data
  6. Distribute agenda and input package 1 week prior
  7. Conduct review meeting per agenda
  8. Validation: All required inputs reviewed; decisions documented with owners and due dates

What it can do on your machine

Read from SKILL.md and the folder at commit e5199b5. It shows what the files ask for, not the result of running them.

  • Tool permissions

    Pre-approves nothing: there is no allowed-tools line, so your agent's usual permission prompts apply.

    From allowed-tools in the SKILL.md frontmatter.

  • Runs code

    Ships 1 file in scripts/ (Python), which the agent can run.

    Shell commands in SKILL.md call:

    • python

    From the folder's file list and the shell code blocks in SKILL.md.

  • Network

    No URLs in SKILL.md.

    From URLs in SKILL.md, links to its own repository left out.

  • Credentials

    Names no API keys, tokens, secrets or passwords.

    From names ending in _API_KEY, _TOKEN, _SECRET, _KEY or _PASSWORD in SKILL.md.

Context cost

Quality Manager Qmr loads about 4.5k tokens when it runs, and up to ~10k if it reads all its reference files. Until then it costs about 67 tokens; SKILL.md has 1,492 words of instructions outside code blocks.

Always · name and description, kept in context so the agent knows when to use it
~67
When it runs · the whole SKILL.md, loaded when a task matches
~4.5k
With references · SKILL.md plus every file in references/, read only if the agent opens them
~10k

Estimates: characters ÷ 4, the usual rule of thumb; real counts depend on the model's tokenizer. Scripts and assets cost tokens only if the agent reads them.

Safety

Auto-check passed

The automated check found no risky patterns in SKILL.md.

Automated static check — not a guarantee. Review scripts before installing. It scans the text of SKILL.md for risky patterns (piping downloads into a shell, reading credential files, hidden Unicode, destructive commands); the scripts in this folder are not scanned.

SKILL.md

The full file from LeoYeAI/openclaw-master-skills at commit e5199b5, republished under its MIT licence (© LeoYeAI). 1,492 words, ~4,495 tokens.

Download SKILL.mdSave it as .claude/skills/quality-manager-qmr/SKILL.md (or your agent's skills folder). This skill also uses 4 other files; get the full folder from GitHub.
name
quality-manager-qmr
description
Senior Quality Manager Responsible Person (QMR) for HealthTech and MedTech companies. Provides quality system governance, management review leadership, regulatory compliance oversight, and quality performance monitoring per ISO 13485 Clause 5.5.2.
triggers
management review, quality policy, quality objectives, QMR responsibilities, quality system effectiveness, quality KPIs, cost of quality, quality performance…

Senior Quality Manager Responsible Person (QMR)

Quality system accountability, management review leadership, and regulatory compliance oversight per ISO 13485 Clause 5.5.2 requirements.


Table of Contents


QMR Responsibilities

ISO 13485 Clause 5.5.2 Requirements
ResponsibilityScopeEvidence
QMS effectivenessMonitor system performance and suitabilityManagement review records
Reporting to managementCommunicate QMS performance to top managementQuality reports, dashboards
Quality awarenessPromote regulatory and quality requirementsTraining records, communications
Liaison with external partiesInterface with regulators, Notified BodiesMeeting records, correspondence
QMR Accountability Matrix
DomainAccountable ForReports ToFrequency
Quality PolicyPolicy adequacy and communicationCEO/BoardAnnual review
Quality ObjectivesObjective achievement and relevanceExecutive TeamQuarterly
QMS PerformanceSystem effectiveness metricsManagementMonthly
Regulatory ComplianceCompliance status across jurisdictionsCEOQuarterly
Audit ProgramAudit schedule completion, findings closureManagementPer audit
CAPA OversightCAPA effectiveness and timelinessExecutive TeamMonthly
Authority Boundaries
Decision TypeQMR AuthorityEscalation Required
Process changes within QMSApprove with ownerMajor process redesign
Document approvalFinal QA approvalPolicy-level changes
Nonconformity dispositionAccept/reject with MRBProduct release decisions
Supplier quality actionsQuality holds, auditsSupplier termination
Audit schedulingAdjust internal audit scheduleExternal audit timing
Training requirementsDefine quality training needsOrganization-wide training budget

Management Review Workflow

Conduct management reviews per ISO 13485 Clause 5.6 requirements.

Workflow: Prepare and Execute Management Review
  1. Schedule management review (minimum annually, typically quarterly or semi-annually)
  2. Notify all required attendees minimum 2 weeks prior
  3. Collect required inputs from process owners:
    • Audit results (internal and external)
    • Customer feedback (complaints, satisfaction, returns)
    • Process performance and product conformity
    • CAPA status and effectiveness
    • Previous review action items
    • Changes affecting QMS (regulatory, organizational)
    • Recommendations for improvement
  4. Compile input summary report with trend analysis
  5. Prepare presentation materials with supporting data
  6. Distribute agenda and input package 1 week prior
  7. Conduct review meeting per agenda
  8. Validation: All required inputs reviewed; decisions documented with owners and due dates
Required Attendees
RoleRequirementInput Responsibility
CEO/General ManagerRequiredStrategic decisions
QMRChairOverall QMS status
Department HeadsRequiredProcess performance
RA ManagerRequiredRegulatory changes
Production ManagerRequiredProduct conformity
Customer QualityRequiredComplaint data
Management Review Input Template
MANAGEMENT REVIEW INPUT SUMMARY

Review Period: [Start Date] to [End Date]
Review Date: [Scheduled Date]
Prepared By: [QMR Name]

1. AUDIT RESULTS
   Internal audits completed: [X] of [X] planned
   External audits completed: [X]
   Total findings: [X] major / [X] minor
   Open findings: [X]
   Finding trends: [Analysis]

2. CUSTOMER FEEDBACK
   Complaints received: [X]
   Complaint rate: [X per 1000 units]
   Customer satisfaction score: [X.X/5.0]
   Returns: [X] units ([X]%)
   Top issues: [Categories]

3. PROCESS PERFORMANCE
   [Process 1]: [Metric] vs [Target] - [Status]
   [Process 2]: [Metric] vs [Target] - [Status]
   Out-of-spec processes: [List]

4. PRODUCT CONFORMITY
   First pass yield: [X]%
   Nonconformance rate: [X]%
   Scrap cost: $[X]
   Top defect categories: [List]

5. CAPA STATUS
   Open CAPAs: [X]
   Overdue: [X]
   Effectiveness rate: [X]%
   Average age: [X] days

6. PREVIOUS ACTIONS
   Total from last review: [X]
   Completed: [X] | In progress: [X] | Overdue: [X]

7. CHANGES AFFECTING QMS
   Regulatory: [List changes]
   Organizational: [List changes]
   Process: [List changes]

8. RECOMMENDATIONS
   [Collected improvement opportunities]
Management Review Output Requirements
OutputDocumentationOwner
QMS improvement decisionsAction items with due datesAssigned per item
Resource needsResource plan updatesDepartment heads
Quality objectives changesUpdated objectives documentQMR
Process improvement needsImprovement project chartersProcess owners

See: references/management-review-guide.md


Quality KPI Management Workflow

Establish, monitor, and report quality performance indicators.

Workflow: Establish Quality KPI Framework
  1. Identify quality objectives requiring measurement
  2. Select KPIs per objective using SMART criteria:
    • Specific: Clear definition and calculation
    • Measurable: Quantifiable with available data
    • Actionable: Team can influence results
    • Relevant: Aligned to quality objectives
    • Time-bound: Defined measurement frequency
  3. Define target values based on baseline data and benchmarks
  4. Assign data source and collection responsibility
  5. Establish reporting frequency per KPI category
  6. Configure dashboard displays and trend analysis
  7. Define escalation thresholds and alert triggers
  8. Validation: Each KPI has owner, target, data source, and escalation criteria
Core Quality KPIs
CategoryKPITargetCalculation
ProcessFirst Pass Yield>95%(Units passed first time / Total units) × 100
ProcessNonconformance Rate<1%(NC count / Total units) × 100
CAPACAPA Closure Rate>90%(On-time closures / Due closures) × 100
CAPACAPA Effectiveness>85%(Effective CAPAs / Verified CAPAs) × 100
AuditFinding Closure Rate>90%(On-time closures / Due closures) × 100
AuditRepeat Finding Rate<10%(Repeat findings / Total findings) × 100
CustomerComplaint Rate<0.1%(Complaints / Units sold) × 100
CustomerSatisfaction Score>4.0/5.0Average of survey scores
KPI Review Frequency
KPI TypeReview FrequencyTrend PeriodAudience
Safety/ComplianceDaily monitoringWeeklyOperations
Production QualityWeeklyMonthlyDepartment heads
Customer QualityMonthlyQuarterlyExecutive team
Strategic QualityQuarterlyAnnualBoard/C-suite
Performance Response Matrix
Performance LevelStatusAction Required
>110% of targetExceedingConsider raising target
100-110% of targetMeetingMaintain current approach
90-100% of targetApproachingMonitor closely
80-90% of targetBelowImprovement plan required
<80% of targetCriticalImmediate intervention

See: references/quality-kpi-framework.md


Quality Objectives Workflow

Establish and maintain measurable quality objectives per ISO 13485 Clause 5.4.1.

Workflow: Annual Quality Objectives Setting
  1. Review prior year objective achievement
  2. Analyze quality performance trends and gaps
  3. Align with organizational strategic plan
  4. Draft objectives with measurable targets
  5. Validate resource availability for achievement
  6. Obtain executive approval
  7. Communicate objectives organization-wide
  8. Validation: Each objective is measurable, has owner, target, and timeline
Quality Objective Structure
QUALITY OBJECTIVE [Number]

Objective Statement: [Clear, measurable statement]
Aligned to Policy Element: [Quality policy section]
Target: [Specific measurable target]
Baseline: [Current performance]
Owner: [Name and title]
Due Date: [Target achievement date]

Success Criteria:
- [Criterion 1]
- [Criterion 2]

Measurement Method: [How progress is tracked]
Reporting Frequency: [Monthly/Quarterly]

Supporting Initiatives:
- [Initiative 1]
- [Initiative 2]

Resource Requirements:
- [Resource 1]
- [Resource 2]
Objective Categories
CategoryExample ObjectivesTypical Targets
Customer QualityReduce complaint rate<0.1% of units sold
Process QualityImprove first pass yield>96%
ComplianceMaintain certificationZero major NCs
EfficiencyReduce quality costs<4% of revenue
CultureIncrease training completion>98% on-time
Quarterly Objective Review
Review ElementAssessmentAction
Progress vs. targetOn track / Behind / AheadAdjust resources if behind
RelevanceStill valid / Needs updateModify if conditions changed
ResourcesAdequate / InsufficientRequest additional if needed
BarriersIdentified obstaclesEscalate for resolution

Quality Culture Assessment Workflow

Assess and improve organizational quality culture.

Workflow: Annual Quality Culture Assessment
  1. Design or select quality culture survey instrument
  2. Define survey population (all employees or sample)
  3. Communicate survey purpose and confidentiality
  4. Administer survey with 2-week response window
  5. Analyze results by department, role, and tenure
  6. Identify strengths and improvement areas
  7. Develop action plan for culture gaps
  8. Validation: Response rate >60%; action plan addresses bottom 3 scores
Show full SKILL.md (577 more words)Show less
Quality Culture Dimensions
DimensionIndicatorsAssessment Method
Leadership commitmentManagement visible support for qualitySurvey, observation
Quality ownershipEmployees feel responsible for qualitySurvey
CommunicationQuality information flows effectivelySurvey, audit
Continuous improvementSuggestions submitted and implementedMetrics
Training and competenceEmployees feel adequately trainedSurvey, records
Problem solvingIssues addressed at root causeCAPA analysis
Culture Survey Categories
CategorySample Questions
Leadership"Management demonstrates commitment to quality"
Resources"I have the tools and training to do quality work"
Communication"Quality expectations are clearly communicated"
Empowerment"I am encouraged to report quality issues"
Recognition"Quality achievements are recognized"
Culture Improvement Actions
Gap IdentifiedPotential Actions
Low leadership visibilityQuality gemba walks, all-hands quality updates
Inadequate trainingCompetency-based training program
Poor communicationQuality newsletters, department huddles
Low reportingAnonymous reporting system, no-blame culture
Lack of recognitionQuality award program, team celebrations

Regulatory Compliance Oversight

Monitor and maintain regulatory compliance across jurisdictions.

Multi-Jurisdictional Compliance Matrix
JurisdictionRegulationRequirementStatus Tracking
EUMDR 2017/745CE marking, Notified BodyTechnical file, annual review
USA21 CFR 820FDA registration, QSR complianceAnnual registration, inspections
InternationalISO 13485QMS certificationSurveillance audits
GermanyMPG/MPDGNational implementationCompetent authority filings
Compliance Monitoring Workflow
  1. Maintain regulatory requirement register
  2. Subscribe to regulatory update services
  3. Assess impact of regulatory changes monthly
  4. Update affected processes within 90 days of effective date
  5. Verify training completion for regulatory changes
  6. Document compliance status in management review
  7. Maintain inspection readiness checklist
  8. Validation: All applicable requirements mapped; no expired registrations
Regulatory Authority Interface
ActivityQMR RolePreparation Required
Notified Body auditPrimary contactAudit package, personnel schedules
FDA inspectionHost, escort coordinatorInspection readiness review
Competent Authority inquiryResponse coordinatorTechnical file access
Regulatory meetingAttendee or delegateBriefing materials
Inspection Readiness Checklist
AreaReadyAction Needed
Document control system current☐
Training records complete☐
CAPA system current, no overdue items☐
Complaint files complete☐
Equipment calibration current☐
Supplier qualification files complete☐
Management review records available☐
Internal audit program current☐

Decision Frameworks

Escalation Decision Tree
Issue Identified
      │
      ▼
Is it a regulatory violation?
      │
  Yes─┴─No
  │      │
  ▼      ▼
Escalate to    Is it a safety issue?
Executive          │
immediately    Yes─┴─No
               │      │
               ▼      ▼
          Escalate to   Does it affect
          Safety Team   multiple departments?
                             │
                         Yes─┴─No
                         │      │
                         ▼      ▼
                    Escalate to  Handle at
                    Executive    department level
Quality Investment Prioritization
CriteriaWeightScore Method
Regulatory requirement30%Required=10, Recommended=5, Optional=2
Customer impact25%Direct=10, Indirect=5, None=0
Cost savings potential20%>$100K=10, $50-100K=7, <$50K=3
Implementation complexity15%Simple=10, Moderate=5, Complex=2
Strategic alignment10%Core=10, Supporting=5, Peripheral=2
Resource Allocation Matrix
Resource TypeAllocation AuthorityEscalation Threshold
Quality personnelQMR>1 FTE addition
Quality equipmentQMR>$25K
External consultantsQMR>$50K or >30 days
Quality systemsExecutive approval>$100K

Tools and References

Scripts
ToolPurposeUsage
management_review_tracker.pyTrack review inputs, actions, metricspython management_review_tracker.py --help

Management Review Tracker Features:

  • Track input collection status from process owners
  • Monitor action item completion and aging
  • Generate metrics summary for review
  • Produce recommendations for review focus areas
References
DocumentContent
management-review-guide.mdISO 13485 Clause 5.6 requirements, input/output templates, action tracking
quality-kpi-framework.mdKPI categories, targets, calculations, dashboard templates
Quick Reference: Management Review Inputs (ISO 13485 Clause 5.6.2)
InputSourceRequired
FeedbackCustomer complaints, surveysYes
Audit resultsInternal and external auditsYes
Process performanceProcess metricsYes
Product conformityInspection, NC dataYes
CAPA statusCAPA systemYes
Previous actionsPrior review recordsYes
ChangesRegulatory, organizationalYes
RecommendationsAll sourcesYes
Quick Reference: Management Review Outputs (ISO 13485 Clause 5.6.3)
OutputDocumentation Required
Improvement to QMS and processesAction items with owners
Improvement to productProject initiation if needed
Resource needsResource plan updates

SkillIntegration Point
quality-manager-qms-iso13485QMS process management
capa-officerCAPA system oversight
qms-audit-expertInternal audit program
quality-documentation-managerDocument control oversight

© LeoYeAI, MIT. Rendered from Markdown: HTML in the file is shown as text, images as links, and headings moved down two levels. Raw file

Files

SKILL.md and 4 other files (scripts, references) in skills/quality-manager-qmr of LeoYeAI/openclaw-master-skills.

  • SKILL.md
  • _meta.json
  • references/management-review-guide.md
  • references/quality-kpi-framework.md
  • scripts/management_review_tracker.py

Open the folder on GitHubat commit e5199b5

Compare with similar skills

Quality Manager Qmr next to the 5 skills that share the most tags, products or categories with it. Stars are the repository's; “used in” counts other GitHub owners with a copy.

Quality Manager Qmr compared with similar skills
SkillStarsUsed inTokensAuto-checkLicenceRepo updated
Quality Manager Qmr this skillLeoYeAI/openclaw-master-skills2.2k—~4.5kAutomated safety check: PassMIT
Quality Manager Qmralirezarezvani/claude-skills28k—~4.7kAutomated safety check: PassMIT
HIPAA Pre-Deployment Compliance Checkmaziyarpanahi/openmed5.5k—~2kAutomated safety check: PassApache-2.0
Hipaa ComplianceSushegaad/Claude-Skills-Governance-Risk-and-Compliance9461 repos~2.3kAutomated safety check: PassMIT
ISO Standards Readiness EvidenceK-Dense-AI/scientific-agent-skills48k1 repos~4.6kAutomated safety check: NotesMIT
Iso42001Sushegaad/Claude-Skills-Governance-Risk-and-Compliance9461 repos~3.7kAutomated safety check: PassMIT

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Questions about Quality Manager Qmr

What does Quality Manager Qmr do?

Senior Quality Manager Responsible Person (QMR) for HealthTech and MedTech companies. Quality Manager Qmr is an agent skill from LeoYeAI/openclaw-master-skills. Senior Quality Manager Responsible Person (QMR) for HealthTech and MedTech companies.

When should I use Quality Manager Qmr?

Quality Manager Qmr fits situations like: tasks that involve Regulatory compliance; tasks that involve OKRs and executive reporting.

How do I install Quality Manager Qmr in Claude Code?

Run `npx skills add LeoYeAI/openclaw-master-skills --skill quality-manager-qmr -a claude-code`. Or copy the skill folder (skills/quality-manager-qmr in LeoYeAI/openclaw-master-skills) into .claude/skills/quality-manager-qmr in your project. Claude Code loads it when a task matches its description.

How do I install Quality Manager Qmr in Codex?

Run `npx skills add LeoYeAI/openclaw-master-skills --skill quality-manager-qmr -a codex`. Or copy the skill folder (skills/quality-manager-qmr in LeoYeAI/openclaw-master-skills) into .agents/skills/quality-manager-qmr in your project. Codex loads it when a task matches its description.

Can I use Quality Manager Qmr in Cursor, Gemini CLI or GitHub Copilot?

Cursor, Gemini CLI, GitHub Copilot and OpenCode also load SKILL.md folders. With the skills CLI, run `npx skills add LeoYeAI/openclaw-master-skills --skill quality-manager-qmr -a cursor` (or -a gemini-cli, github-copilot or opencode for the others). To copy it by hand, put the folder in .cursor/skills/quality-manager-qmr, .gemini/skills/quality-manager-qmr, .github/skills/quality-manager-qmr and .opencode/skills/quality-manager-qmr in your project.

What does Quality Manager Qmr need to run?

Going by SKILL.md and its folder, Quality Manager Qmr needs Python for the scripts in its folder and the command-line tools its instructions call (python). Our summary lists: Python 3.

Does Quality Manager Qmr access the network?

SKILL.md contains no URLs. Any network use would come from the scripts or tools the agent runs. This is read from the text; nothing was executed.

Is Quality Manager Qmr safe to install?

Our automated static check of SKILL.md found no risky patterns, such as piping downloads into a shell, reading credential files or hidden Unicode. It is not a guarantee. The check reads SKILL.md only: the scripts in the folder are not scanned, so read them before running anything.

What licence does Quality Manager Qmr use?

Quality Manager Qmr is published under the MIT licence (the repository's licence). It allows redistribution, so the full SKILL.md is shown on this page.

How many tokens does Quality Manager Qmr use?

About 4.5k tokens (SKILL.md is roughly 18k characters). Agents keep only the skill's name and description in context until a task matches; then they load SKILL.md in full. Its references folder adds about 5.5k tokens, read only when the agent opens those files.

What are the alternatives to Quality Manager Qmr?

Skills that share tags, products or a category with Quality Manager Qmr: Quality Manager Qmr (alirezarezvani/claude-skills, 28k stars), HIPAA Pre-Deployment Compliance Check (maziyarpanahi/openmed, 5.5k stars), Hipaa Compliance (Sushegaad/Claude-Skills-Governance-Risk-and-Compliance, 946 stars) and ISO Standards Readiness Evidence (K-Dense-AI/scientific-agent-skills, 48k stars). The comparison table on this page puts their stars, adoption, token cost, safety result and licence side by side.

Who maintains Quality Manager Qmr?

LeoYeAI (a GitHub user) maintains it in LeoYeAI/openclaw-master-skills, which has 2,161 GitHub stars. The repository holds 1,235 skills in this directory. The repository was last updated on July 20, 2026.

Source: LeoYeAI/openclaw-master-skills on GitHub. Facts on this page come from the repository at the commit we read; the author's words are quoted as theirs.