Quality Manager Qmr

What it does

When your agent uses it

• Leading management reviews
• Setting quality policy and objectives
• Monitoring quality KPIs and cost of quality
• Exercising QMR governance and regulatory oversight responsibilities

Example prompts

• “/quality-manager-qmr”

Requirements

• Python 3

Workflow steps

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

1. 1Schedule management review (minimum annually, typically quarterly or semi-annually)
2. 2Notify all required attendees minimum 2 weeks prior
3. 3Collect required inputs from process owners
4. 4Compile input summary report with trend analysis
5. 5Prepare presentation materials with supporting data
6. 6Distribute agenda and input package 1 week prior
7. 7Conduct review meeting per agenda
8. 8Validation: 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 19392f7. 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 2 files 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 4.7k tokens when it runs, and up to ~10k if it reads all its reference files. Until then it costs about 115 tokens; SKILL.md has 1,560 words of instructions outside code blocks.

Always · name and description, kept in context so the agent knows when to use it

~115

When it runs · the whole SKILL.md, loaded when a task matches

~4.7k

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

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 alirezarezvani/claude-skills at commit 19392f7, republished under its MIT licence (© alirezarezvani). 1,560 words, ~4,659 tokens.

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. Use when leading management reviews, setting quality policy and objectives, monitoring quality KPIs and cost of quality, or exercising QMR governance and regulatory oversight responsibilities.

triggers

management review, quality policy, quality objectives, QMR responsibilities, quality system effectiveness, quality KPIs, cost of quality, quality performance…

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]

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]

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

© alirezarezvani, 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 ra-qm-team/skills/quality-manager-qmr of alirezarezvani/claude-skills.

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

Open the folder on GitHubat commit 19392f7