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Agent skill

Quality Manager Qms Iso13485

by alirezarezvani in alirezarezvani/claude-skills

ISO 13485 Quality Management System implementation and maintenance for medical device organizations.

MITAuto-check passedLegal & Compliance

Install Quality Manager Qms Iso13485

skills CLI
$ npx skills add alirezarezvani/claude-skills --skill quality-manager-qms-iso13485 -a claude-code

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

GitHub CLI
$ gh skill install alirezarezvani/claude-skills quality-manager-qms-iso13485 --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/alirezarezvani/claude-skills.git skills-src && mkdir -p .claude/skills && cp -r skills-src/ra-qm-team/skills/quality-manager-qms-iso13485 .claude/skills/quality-manager-qms-iso13485 && 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-qms-iso13485
GitHub stars
28k
Used in
1 other repo
Token cost
~4.4k tokens
SKILL.md length
1,708 words
Files
4 (incl. scripts, references)
Skills in repo
342
Repo updated
First seen
Licence
MIT

At a glance

ISO 13485 Quality Management System implementation and maintenance for medical device organizations.

  • Works in 8 steps: Conduct gap analysis against ISO… → Document current state vs. required… → Prioritize gaps by → …
  • Working with medical device quality systems
  • SKILL.md covers Table of Contents, QMS Implementation Workflow, Document Control Workflow and Internal Audit Workflow, plus 4 more sections
  • Runs Python scripts from its folder; calls python

What it does

Quality Manager Qms Iso13485 is an agent skill from alirezarezvani/claude-skills. ISO 13485 Quality Management System implementation and maintenance for medical device organizations. Provides QMS design, documentation control, internal auditing, CAPA management, and certification support. Use when working with medical device quality systems, preparing for ISO 13485 audits, managing regulatory compliance documentation, setting up corrective actions, or building audit preparation programs. Useful for quality management, audit preparation, regulatory compliance, medical device documentation, and…

Its SKILL.md is about 4.4k tokens, which your agent loads only when the skill is triggered. The skill folder holds 5 other files, including scripts and reference files (for example `references/iso13485-clause-requirements.md`, `references/qms-process-templates.md` and `scripts/qms_audit_checklist.py`).

It sits in Legal & Compliance, covering Audit readiness and Regulatory compliance. The repository describes itself as: 380 Claude Code skills & agent skills & plugins (30+ Agents, 70+ custom commands, 380+ skills, customizable references, scripts)for Claude Code, Codex, Gemini CLI, Cursor, and 8… The licence is MIT.

When your agent uses it

  • Working with medical device quality systems
  • Preparing for ISO 13485 audits
  • Managing regulatory compliance documentation
  • Setting up corrective actions

Example prompts

  • “/quality-manager-qms-iso13485”

Requirements

  • Python 3

Workflow steps

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

  1. Conduct gap analysis against ISO 13485:2016 requirements
  2. Document current state vs. required state for each clause
  3. Prioritize gaps by
  4. Develop implementation roadmap with milestones
  5. Establish Quality Manual per Clause 4.2.2
  6. Create required documented procedures — see Mandatory Documented Procedures for the full list
  7. Deploy processes with training
  8. Validation: Gap analysis complete; Quality Manual approved; all required procedures documented and trained

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 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 Qms Iso13485 loads about 4.4k tokens when it runs, and up to ~15k if it reads all its reference files. Until then it costs about 144 tokens; SKILL.md has 1,708 words of instructions outside code blocks.

Always · name and description, kept in context so the agent knows when to use it
~144
When it runs · the whole SKILL.md, loaded when a task matches
~4.4k
With references · SKILL.md plus every file in references/, read only if the agent opens them
~15k

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 alirezarezvani/claude-skills at commit 19392f7, republished under its MIT licence (© alirezarezvani). 1,708 words, ~4,442 tokens.

Download SKILL.mdSave it as .claude/skills/quality-manager-qms-iso13485/SKILL.md (or your agent's skills folder). This skill also uses 3 other files; get the full folder from GitHub.
name
quality-manager-qms-iso13485
description
ISO 13485 Quality Management System implementation and maintenance for medical device organizations. Provides QMS design, documentation control, internal auditing, CAPA management, and certification support. Use when working with medical device quality systems, preparing for ISO 13485 audits, managing regulatory compliance documentation, setting up corrective actions, or building audit preparation programs. Useful for quality management, audit preparation, regulatory compliance, medical device documentation, and corrective action workflows.
triggers
ISO 13485, QMS implementation, quality management system, document control, internal audit, management review, quality manual, CAPA process, process…

Quality Manager - QMS ISO 13485 Specialist

ISO 13485:2016 Quality Management System implementation, maintenance, and certification support for medical device organizations.

Table of Contents

QMS Implementation Workflow

Implement ISO 13485:2016 compliant quality management system from gap analysis through certification.

Workflow: Initial QMS Implementation
  1. Conduct gap analysis against ISO 13485:2016 requirements
  2. Document current state vs. required state for each clause
  3. Prioritize gaps by:
    • Regulatory criticality
    • Risk to product safety
    • Resource requirements
  4. Develop implementation roadmap with milestones
  5. Establish Quality Manual per Clause 4.2.2:
    • QMS scope with justified exclusions
    • Process interactions
    • Procedure references
  6. Create required documented procedures — see Mandatory Documented Procedures for the full list
  7. Deploy processes with training
  8. Validation: Gap analysis complete; Quality Manual approved; all required procedures documented and trained

Use the Gap Analysis Matrix template in qms-process-templates.md to document clause-by-clause current state, gaps, priority, and actions.

QMS Structure
LevelDocument TypeExample
1Quality ManualQM-001
2ProceduresSOP-02-001
3Work InstructionsWI-06-012
4RecordsTraining records

Document Control Workflow

Establish and maintain document control per ISO 13485 Clause 4.2.3.

Workflow: Document Creation and Approval
  1. Identify need for new document or revision
  2. Assign document number per numbering convention:
    • Format: [TYPE]-[AREA]-[SEQUENCE]-[REV]
    • Example: SOP-02-001-01
  3. Draft document using approved template
  4. Route for review to subject matter experts
  5. Collect and address review comments
  6. Obtain required approvals based on document type
  7. Update Document Master List
  8. Validation: Document numbered correctly; all reviewers signed; Master List updated
Document Numbering Convention
PrefixDocument TypeApproval Authority
QMQuality ManualManagement Rep + CEO
POLPolicyDepartment Head + QA
SOPProcedureProcess Owner + QA
WIWork InstructionSupervisor + QA
TFTemplate/FormProcess Owner
SPECSpecificationEngineering + QA
Area Codes
CodeAreaExamples
01Quality ManagementQuality Manual, policy
02Document ControlThis procedure
03TrainingCompetency procedures
04DesignDesign control
05PurchasingSupplier management
06ProductionManufacturing
07Quality ControlInspection, testing
08CAPACorrective actions
Document Change Control
Change TypeApproval LevelExamples
AdministrativeDocument ControlTypos, formatting
MinorProcess Owner + QAClarifications
MajorFull review cycleProcess changes
EmergencyExpedited + retrospectiveSafety issues
Document Review Schedule
Document TypeReview PeriodTrigger for Unscheduled Review
Quality ManualAnnualOrganizational change
ProceduresAnnualAudit finding, regulation change
Work Instructions2 yearsProcess change
Forms2 yearsUser feedback

Internal Audit Workflow

Plan and execute internal audits per ISO 13485 Clause 8.2.4.

Workflow: Annual Audit Program
  1. Identify processes and areas requiring audit coverage
  2. Assess risk factors for audit frequency:
    • Previous audit findings
    • Regulatory changes
    • Process changes
    • Complaint trends
  3. Assign qualified auditors (independent of area audited)
  4. Develop annual audit schedule
  5. Obtain management approval
  6. Communicate schedule to process owners
  7. Track completion and reschedule as needed
  8. Validation: All processes covered; auditors qualified and independent; schedule approved

Use the Audit Program Template in qms-process-templates.md to schedule audits by clause and quarter across processes such as Document Control (4.2.3/4.2.4), Management Review (5.6), Design Control (7.3), Production (7.5), and CAPA (8.5.2/8.5.3).

Workflow: Individual Audit Execution
  1. Prepare audit plan with scope, criteria, and schedule
  2. Notify auditee minimum 1 week prior
  3. Review procedures and previous audit results
  4. Prepare audit checklist
  5. Conduct opening meeting
  6. Collect evidence through:
    • Document review
    • Record sampling
    • Process observation
    • Personnel interviews
  7. Classify findings:
    • Major NC: Absence or breakdown of system
    • Minor NC: Single lapse or deviation
    • Observation: Risk of future NC
  8. Conduct closing meeting
  9. Issue audit report within 5 business days
  10. Validation: All checklist items addressed; findings supported by evidence; report distributed
Auditor Qualification Requirements
CriterionRequirement
TrainingISO 13485 awareness + auditor training
ExperienceMinimum 1 audit as observer
IndependenceNot auditing own work area
CompetenceUnderstanding of audited process
Finding Classification Guide
ClassificationCriteriaResponse Time
Major NCSystem absence, total breakdown, regulatory violation30 days for CAPA
Minor NCSingle instance, partial compliance60 days for CAPA
ObservationPotential risk, improvement opportunityTrack in next audit

Process Validation Workflow

Validate special processes per ISO 13485 Clause 7.5.6.

Workflow: Process Validation Protocol
  1. Identify processes requiring validation:
    • Output cannot be verified by inspection
    • Deficiencies appear only in use
    • Sterilization, welding, sealing, software
  2. Form validation team with subject matter experts
  3. Write validation protocol including:
    • Process description and parameters
    • Equipment and materials
    • Acceptance criteria
    • Statistical approach
  4. Execute IQ: verify equipment installed correctly and document specifications
  5. Execute OQ: test parameter ranges and verify process control
  6. Execute PQ: run production conditions and verify output meets requirements
  7. Write validation report with conclusions
  8. Validation: IQ/OQ/PQ complete; acceptance criteria met; validation report approved
Validation Documentation Requirements
PhaseContentEvidence
ProtocolObjectives, methods, criteriaApproved protocol
IQEquipment verificationInstallation records
OQParameter verificationTest results
PQPerformance verificationProduction data
ReportSummary, conclusionsApproval signatures
Revalidation Triggers
TriggerAction Required
Equipment changeAssess impact, revalidate affected phases
Parameter changeOQ and PQ minimum
Material changeAssess impact, PQ minimum
Process failureFull revalidation
PeriodicPer validation schedule (typically 3 years)
Special Process Examples
ProcessValidation StandardCritical Parameters
EO SterilizationISO 11135Temperature, humidity, EO concentration, time
Steam SterilizationISO 17665Temperature, pressure, time
Radiation SterilizationISO 11137Dose, dose uniformity
SealingInternalTemperature, pressure, dwell time
WeldingISO 11607Heat, pressure, speed

Supplier Qualification Workflow

Evaluate and approve suppliers per ISO 13485 Clause 7.4.

Workflow: New Supplier Qualification
  1. Identify supplier category:
    • Category A: Critical (affects safety/performance)
    • Category B: Major (affects quality)
    • Category C: Minor (indirect impact)
  2. Request supplier information:
    • Quality certifications
    • Product specifications
    • Quality history
  3. Evaluate supplier based on:
    • Quality system (ISO certification)
    • Technical capability
    • Quality history
    • Financial stability
  4. For Category A suppliers:
    • Conduct on-site audit
    • Require quality agreement
  5. Calculate qualification score
  6. Make approval decision:

    • 80: Approved

    • 60-80: Conditional approval
    • <60: Not approved
  7. Add to Approved Supplier List
  8. Validation: Evaluation criteria scored; qualification records complete; supplier categorized
Supplier Evaluation Criteria
CriterionWeightScoring
Quality System30%ISO 13485=30, ISO 9001=20, Documented=10, None=0
Quality History25%Reject rate: <1%=25, 1-3%=15, >3%=0
Delivery20%On-time: >95%=20, 90-95%=10, <90%=0
Technical Capability15%Exceeds=15, Meets=10, Marginal=5
Financial Stability10%Strong=10, Adequate=5, Questionable=0
Show full SKILL.md (669 more words)Show less
Supplier Category Requirements
CategoryQualificationMonitoringAgreement
A - CriticalOn-site auditAnnual reviewQuality agreement
B - MajorQuestionnaireSemi-annual reviewQuality requirements
C - MinorAssessmentIssue-basedStandard terms
Supplier Performance Metrics
MetricTargetCalculation
Accept Rate>98%(Accepted lots / Total lots) × 100
On-Time Delivery>95%(On-time / Total orders) × 100
Response Time<5 daysAverage days to resolve issues
Documentation100%(Complete CoCs / Required CoCs) × 100

QMS Process Reference

For detailed requirements and audit questions for each ISO 13485:2016 clause, see iso13485-clause-requirements.md.

Management Review Required Inputs (Clause 5.6.2)
InputSourcePrepared By
Audit resultsInternal and external auditsQA Manager
Customer feedbackComplaints, surveysCustomer Quality
Process performanceProcess metricsProcess Owners
Product conformityInspection data, NCsQC Manager
CAPA statusCAPA systemCAPA Officer
Previous actionsPrior review recordsQMR
Changes affecting QMSRegulatory, organizationalRA Manager
RecommendationsAll sourcesAll Managers
Record Retention Requirements

⚠️ STATUS — QMSR transition (effective 2026-02-02): FDA's Quality Management System Regulation (QMSR) final rule (89 FR 7496) amended 21 CFR Part 820 to incorporate ISO 13485:2016 by reference and removed the legacy QSR subsection structure. The section numbers below (820.30/.181/.184/.198) no longer exist in the CFR — they are retained only as a familiar index. The current authority for record retention is ISO 13485:2016 §4.2.5 (retain "for at least the lifetime of the medical device as defined by the organization, but not less than two years"), with records additions in retained 21 CFR 820.35. Cite the ISO 13485 clauses — not the 820.x numbers — in current compliance documentation.

Record TypeMinimum RetentionCurrent authority under QMSR (legacy QSR shown for index)
Device Master RecordLife of device + 2 yearsISO 13485 §4.2.3 (medical device file)/§4.2.5 (legacy QSR 820.181, historical)
Device History RecordLife of device + 2 yearsISO 13485 §4.2.5 + 21 CFR 820.35 (legacy QSR 820.184, historical)
Design History FileLife of device + 2 yearsISO 13485 §7.3.10/§4.2.5 (legacy QSR 820.30, historical)
Complaint RecordsLife of device + 2 yearsISO 13485 §8.2.2/§4.2.5 + 21 CFR 820.35(b) (legacy QSR 820.198, historical)
Training RecordsEmployment + 3 yearsBest practice
Audit Records7 yearsBest practice
CAPA Records7 yearsBest practice
Calibration RecordsEquipment life + 2 yearsBest practice

Decision discipline: This skill's checklists and tools structure QMS conformity assessment — they do not certify ISO 13485 / QMSR compliance. Final compliance determinations and record-retention decisions are yours to make and must be reviewed and signed off by the named QMR; route FDA-specific regulatory-classification questions to Regulatory Affairs and confirm current 21 CFR 820 / ISO 13485:2016 text at fda.gov before relying on any citation here.

Decision Frameworks

Exclusion Justification (Clause 4.2.2)
ClausePermissible ExclusionJustification Required
6.4.2Contamination controlProduct not affected by contamination
7.3Design and developmentOrganization does not design products
7.5.2Product cleanlinessNo cleanliness requirements
7.5.3InstallationNo installation activities
7.5.4ServicingNo servicing activities
7.5.5Sterile productsNo sterile products
Nonconformity Disposition Decision Tree
Nonconforming Product Identified
            │
            ▼
    Can it be reworked?
            │
       Yes──┴──No
        │       │
        ▼       ▼
    Is rework     Can it be used
    procedure     as is?
    available?        │
        │        Yes──┴──No
    Yes─┴─No     │       │
     │    │     ▼       ▼
     ▼    ▼  Concession  Scrap or
  Rework  Create    approval    return to
  per SOP  rework    needed?    supplier
          procedure     │
                    Yes─┴─No
                     │    │
                     ▼    ▼
                 Customer  Use as is
                 approval  with MRB
                          approval
CAPA Initiation Criteria
SourceAutomatic CAPAEvaluate for CAPA
Customer complaintSafety-relatedAll others
External auditMajor NCMinor NC
Internal auditMajor NCRepeat minor NC
Product NCField failureTrend exceeds threshold
Process deviationSafety impactRepeated deviations

Tools and References

Scripts
ToolPurposeUsage
qms_audit_checklist.pyGenerate audit checklists by clause or processpython qms_audit_checklist.py --help

Audit Checklist Generator Features:

  • Generate clause-specific checklists (e.g., --clause 7.3)
  • Generate process-based checklists (e.g., --process design-control)
  • Full system audit checklist (--audit-type system)
  • Text or JSON output formats
  • Interactive mode for guided selection
References
DocumentContent
iso13485-clause-requirements.mdDetailed requirements for each ISO 13485:2016 clause with audit questions
qms-process-templates.mdReady-to-use templates for gap analysis, audit program, document control, CAPA, supplier, training
Quick Reference: Mandatory Documented Procedures
ProcedureClauseKey Elements
Document Control4.2.3Approval, distribution, obsolete control
Record Control4.2.4Identification, retention, disposal
Internal Audit8.2.4Program, auditor qualification, reporting
NC Product Control8.3Identification, segregation, disposition
Corrective Action8.5.2Root cause, implementation, verification
Preventive Action8.5.3Risk identification, implementation
SkillIntegration Point
quality-manager-qmrManagement review, quality policy
capa-officerCAPA system management
qms-audit-expertAdvanced audit techniques
quality-documentation-managerDHF, DMR, DHR management
risk-management-specialistISO 14971 integration

© 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 3 other files (scripts, references) in ra-qm-team/skills/quality-manager-qms-iso13485 of alirezarezvani/claude-skills.

  • SKILL.md
  • references/iso13485-clause-requirements.md
  • references/qms-process-templates.md
  • scripts/qms_audit_checklist.py

Open the folder on GitHubat commit 19392f7

Used in 1 other repository

We found 1 copy of this SKILL.md (exact, near-identical or edited) in other folders, from 1 other GitHub owner. This page covers the copy in alirezarezvani/claude-skills, which our catalogue first saw on October 7, 2026.

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Categories

Questions about Quality Manager Qms Iso13485

What does Quality Manager Qms Iso13485 do?

ISO 13485 Quality Management System implementation and maintenance for medical device organizations. Quality Manager Qms Iso13485 is an agent skill from alirezarezvani/claude-skills. ISO 13485 Quality Management System implementation and maintenance for medical device organizations.

When should I use Quality Manager Qms Iso13485?

Quality Manager Qms Iso13485 fits situations like: working with medical device quality systems; preparing for ISO 13485 audits; managing regulatory compliance documentation; setting up corrective actions.

How do I install Quality Manager Qms Iso13485 in Claude Code?

Run `npx skills add alirezarezvani/claude-skills --skill quality-manager-qms-iso13485 -a claude-code`. Or copy the skill folder (ra-qm-team/skills/quality-manager-qms-iso13485 in alirezarezvani/claude-skills) into .claude/skills/quality-manager-qms-iso13485 in your project. Claude Code loads it when a task matches its description.

How do I install Quality Manager Qms Iso13485 in Codex?

Run `npx skills add alirezarezvani/claude-skills --skill quality-manager-qms-iso13485 -a codex`. Or copy the skill folder (ra-qm-team/skills/quality-manager-qms-iso13485 in alirezarezvani/claude-skills) into .agents/skills/quality-manager-qms-iso13485 in your project. Codex loads it when a task matches its description.

Can I use Quality Manager Qms Iso13485 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 alirezarezvani/claude-skills --skill quality-manager-qms-iso13485 -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-qms-iso13485, .gemini/skills/quality-manager-qms-iso13485, .github/skills/quality-manager-qms-iso13485 and .opencode/skills/quality-manager-qms-iso13485 in your project.

What does Quality Manager Qms Iso13485 need to run?

Going by SKILL.md and its folder, Quality Manager Qms Iso13485 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 Qms Iso13485 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 Qms Iso13485 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 Qms Iso13485 use?

Quality Manager Qms Iso13485 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 Qms Iso13485 use?

About 4.4k 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 11k tokens, read only when the agent opens those files.

What are the alternatives to Quality Manager Qms Iso13485?

Skills that share tags, products or a category with Quality Manager Qms Iso13485: ISO Standards Readiness Evidence (K-Dense-AI/scientific-agent-skills, 48k stars), Iso42001 (Sushegaad/Claude-Skills-Governance-Risk-and-Compliance, 946 stars), PCI DSS Compliance (wshobson/agents, 40k stars) and GRC Report Context Bootstrap (GRCEngClub/claude-grc-engineering, 419 stars). The comparison table on this page puts their stars, adoption, token cost, safety result and licence side by side.

Who maintains Quality Manager Qms Iso13485?

alirezarezvani (a GitHub user) maintains it in alirezarezvani/claude-skills, which has 27,938 GitHub stars. The repository holds 342 skills in this directory. The repository was last updated on August 30, 2026.

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