Quality Documentation Manager
Stand up ISO 13485-style document control—numbering, versions, change control, and 21 CFR Part 11 electronic records—for medical device QMS work.
Overview
quality-documentation-manager is an agent skill most often used in Ship (also Build and Operate) that designs ISO 13485-aligned document control with change management and 21 CFR Part 11 electronic record compliance.
Install
npx skills add https://github.com/alirezarezvani/claude-skills --skill quality-documentation-managerWhat is this skill?
- End-to-end document control workflow from numbering through obsolescence
- Structured numbering system and controlled templates for QMS documents
- Approval, review, and change control processes with explicit routing steps
- 21 CFR Part 11 compliance section for electronic signatures and records
- Table of contents spans audit trail, master list, record retention, and reference tooling
- Six major workflow areas in the table of contents from document control through tools
Adoption & trust: 736 installs on skills.sh; 17.5k GitHub stars; 1/3 security scanners passed (skills.sh audits).
What problem does it solve?
Your medtech startup lacks a defensible document numbering, approval, and change-control system auditors will accept under Part 11.
Who is it for?
Solo regulatory-minded builders and small medtech teams drafting document control procedures before design transfer or submission packages.
Skip if: Non-regulated SaaS with informal Notion docs only, or organizations that already run a validated eQMS vendor workflow end to end.
When should I use this skill?
document control, document numbering, version control, change control, document approval, electronic signature, 21 CFR Part 11, audit trail, controlled document, document master list, or record retention.
What do I get? / Deliverables
You get documented workflows for controlled templates, version governance, electronic signatures, audit trails, and retention aligned to QMS review.
- Document numbering and naming convention
- Approval and change control procedure outline
- Part 11-oriented electronic record and signature controls checklist
Recommended Skills
Journey fit
Spans multiple journey phases - primary shelf plus alternate fits below.
Ship is the canonical shelf because controlled documents, approvals, and Part 11 audit trails gate release in regulated hardware and software as a medical device contexts. Security subphase captures compliance, electronic signatures, and audit-trail expectations rather than informal README edits in Build.
Where it fits
Define numbering conventions and controlled templates before agents draft design or software lifecycle documents.
Route a DHF or SOP update through approval and Part 11-ready signature language pre-release.
Run change control when field feedback forces a controlled revision with audit trail and retention updates.
How it compares
Use instead of generic technical-writing skills that skip controlled numbering, approval routing, and Part 11 record requirements.
Common Questions / FAQ
Who is quality-documentation-manager for?
Indie and small-team medical device builders responsible for QMS documentation, change control, and FDA-style electronic records compliance.
When should I use quality-documentation-manager?
In Build when drafting controlled SOP templates, in Ship before release audits and signature validation, or in Operate when updating master lists and retention rules.
Is quality-documentation-manager safe to install?
Review the Security Audits panel on this Prism page; regulatory text from an agent is not legal advice and must be validated against your notified body and counsel.
SKILL.md
READMESKILL.md - Quality Documentation Manager
# Quality Documentation Manager Document control system design and management for ISO 13485-compliant quality management systems, including numbering conventions, approval workflows, change control, and electronic record compliance. --- ## Table of Contents - [Document Control Workflow](#document-control-workflow) - [Document Numbering System](#document-numbering-system) - [Approval and Review Process](#approval-and-review-process) - [Change Control Process](#change-control-process) - [21 CFR Part 11 Compliance](#21-cfr-part-11-compliance) - [Reference Documentation](#reference-documentation) - [Tools](#tools) --- ## Document Control Workflow Implement document control from creation through obsolescence: 1. Assign document number per numbering procedure 2. Create document using controlled template 3. Route for review to required reviewers 4. Address review comments and document responses 5. Obtain required approval signatures 6. Assign effective date and distribute 7. Update Document Master List 8. **Validation:** Document accessible at point of use; obsolete versions removed ### Document Lifecycle Stages | Stage | Definition | Actions Required | |-------|------------|------------------| | Draft | Under creation or revision | Author editing, not for use | | Review | Circulated for review | Reviewers provide feedback | | Approved | All signatures obtained | Ready for training/distribution | | Effective | Training complete, released | Available for use | | Superseded | Replaced by newer revision | Remove from active use | | Obsolete | No longer applicable | Archive per retention schedule | ### Document Types and Prefixes | Prefix | Document Type | Typical Content | |--------|---------------|-----------------| | QM | Quality Manual | QMS overview, scope, policy | | SOP | Standard Operating Procedure | Process-level procedures | | WI | Work Instruction | Task-level step-by-step | | TF | Template/Form | Controlled forms | | SPEC | Specification | Product/process specs | | PLN | Plan | Quality/project plans | ### Required Reviewers by Document Type | Document Type | Required Reviewers | Required Approvers | |---------------|-------------------|-------------------| | SOP | Process Owner, QA | QA Manager, Process Owner | | WI | Area Supervisor, QA | Area Manager | | SPEC | Engineering, QA | Engineering Manager, QA | | TF | Process Owner | QA | | Design Documents | Design Team, QA | Design Control Authority | --- ## Document Numbering System Assign consistent document numbers for identification and retrieval. ### Numbering Format Standard format: `PREFIX-CATEGORY-SEQUENCE[-REVISION]` ``` Example: SOP-02-001-A SOP = Document type (Standard Operating Procedure) 02 = Category code (Document Control) 001 = Sequential number A = Revision indicator ``` ### Category Codes | Code | Functional Area | Description | |------|-----------------|-------------| | 01 | Quality Management | QMS procedures, management review | | 02 | Document Control | This area | | 03 | Human Resources | Training, competency | | 04 | Design & Development | Design control processes | | 05 | Purchasing | Supplier management | | 06 | Production | Manufacturing procedures | | 07 | Quality Control | Inspection, testing | | 08 | CAPA | Corrective/preventive actions | | 09 | Risk Management | ISO 14971 processes