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quality-documentation-manager
Document control system management for medical device QMS. Covers document numbering, version control, change management, and 21 CFR Part 11 compliance. Use for document control procedures, change control workflow, document numbering, version management, electronic signature compliance, or regulatory documentation review.
Installation
Follow the repository instructions for this skill and your agent. Review the files and dependencies before adding it to your workflow.
SkillHub CLI
skillhub install alirezarezvani/quality-documentation-managerInspect the source and compatibility requirements, then follow its installation steps.
Give your agent the source link and ask it to inspect instructions and dependencies before explaining the installation steps.
Skill instructions
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 Numbering System
- Approval and Review Process
- Change Control Process
- 21 CFR Part 11 Compliance
- Reference Documentation
- Tools
Document Control Workflow
Implement document control from creation through obsolescence:
- Assign document number per numbering procedure
- Create document using controlled template
- Route for review to required reviewers
- Address review comments and document responses
- Obtain required approval signatures
- Assign effective date and distribute
- Update Document Master List
- 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| Superseded | Replaced by newer revision | Remove from active use |
| Obsolete | No longer applicable | Archive per retention schedule |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/proc... |
Source information
- Source
- github
- Repository
- openclaw/skills
- Path
- skills/alirezarezvani/quality-documentation-manager
- Version
- —
- Commit
- c461077f8eab1d14044cb2be98cd701cc056a9b4
- Classification source
- rules
- Status
- active
- Visibility
- public
These signals come from indexed source analysis and may lag behind changes. Check the current source files.
Extracted content
SKILL.md
# 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/proc...
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