OpenClaw
10-of-my-most-popular-text-to-image-series-prompts-78b0897e
generate a bunch of images, then you curate the results to handpick the best ones
☆ 0查看技能
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.
安装与使用
请根据来源仓库和你的 AI 工具说明安装此技能。先阅读技能文件和依赖要求，再添加到工作流。
SkillHub CLI
skillhub install alirezarezvani/quality-documentation-manager打开来源仓库，查看说明和兼容环境后，按来源提供的命令或步骤安装。
将来源链接提供给你的 Agent，让它先读取说明、核对依赖，并向你说明将执行的安装步骤。
技能说明
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| Superseded | Replaced by newer revision | Remove from active use |
| Obsolete | No longer applicable | Archive per retention schedule |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... |
来源信息
- Source
- github
- Repository
- openclaw/skills
- Path
- skills/alirezarezvani/quality-documentation-manager
- Version
- —
- Commit
- c461077f8eab1d14044cb2be98cd701cc056a9b4
- 分类来源
- rules
- 状态
- active
- 可见性
- public
这些信息来自收录时的来源分析，可能滞后；使用前请核对最新来源文件。
来源内容
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...
相关技能
OpenClaw
10-of-my-most-popular-text-to-image-series-prompts-78b0897e
generate a bunch of images, then you curate the results to handpick the best ones
☆ 0查看技能
OpenClaw
13-Day Sprint Method
Productivity system based on Maya calendar with 13 natural tones for project management and personal development
☆ 0查看技能
OpenClaw
1password
Set up and use 1Password CLI (op). Use when installing the CLI, enabling desktop app integration, signing in (single or multi-account), or reading/injecting/running secrets via op.
☆ 0查看技能