iso-13485-certification

Name: iso-13485-certification
Author: K-Dense-AI

31kstars3.1kforks

How to install iso-13485-certification?

k-dense-ai/scientific-agent-skills/iso-13485-certification

$npx -y skills add K-Dense-AI/scientific-agent-skills --skill iso-13485-certification

Installs into the current project.

Summary

Comprehensive toolkit for preparing ISO 13485 certification documentation for medical device Quality Management Systems. Use when users need help with ISO 13485 QMS documentation, including (1) conducting gap analysis of existing documentation, (2) creating Quality Manuals, (3) d

Files · 1

View on GitHub

SKILL.md

1	# ISO 13485 Certification Documentation Assistant
2
3	## Overview
4
5	This skill helps medical device manufacturers prepare comprehensive documentation for ISO 13485:2016 certification. It provides tools, templates, references, and guidance to create, review, and gap-analyze all required Quality Management System (QMS) documentation.
6
7	What this skill provides:
8	- Gap analysis of existing documentation
9	- Templates for all mandatory documents
10	- Comprehensive requirements guidance
11	- Step-by-step documentation creation
12	- Identification of missing documentation
13	- Compliance checklists
14
15	When to use this skill:
16	- Starting ISO 13485 certification process
17	- Conducting gap analysis against ISO 13485
18	- Creating or updating QMS documentation
19	- Preparing for certification audit
20	- Transitioning from FDA QSR to QMSR
21	- Harmonizing with EU MDR requirements
22
23	## Core Workflow
24
25	### 1. Assess Current State (Gap Analysis)
26
27	When to start here: User has existing documentation and needs to identify gaps
28
29	Process:
30
31	1. Collect existing documentation:
32	- Ask user to provide directory of current QMS documents
33	- Documents can be in any format (.txt, .md, .doc, .docx, .pdf)
34	- Include any procedures, manuals, work instructions, forms
35
36	2. Run gap analysis script:
37	```bash
38	python scripts/gap_analyzer.py --docs-dir <path_to_docs> --output gap-report.json
39	```
40
41	3. Review results:
42	- Identify which of the 31 required procedures are present
43	- Identify missing key documents (Quality Manual, MDF, etc.)
44	- Calculate compliance percentage
45	- Prioritize missing documentation
46
47	4. Present findings to user:
48	- Summarize what exists
49	- Clearly list what's missing
50	- Provide prioritized action plan
51	- Estimate effort required
52
53	Output: Comprehensive gap analysis report with prioritized action items
54
55	### 2. Understand Requirements (Reference Consultation)
56
57	When to use: User needs to understand specific ISO 13485 requirements
58
59	Available references:
60	- `references/iso-13485-requirements.md` - Complete clause-by-clause breakdown
61	- `references/mandatory-documents.md` - All 31 required procedures explained
62	- `references/gap-analysis-checklist.md` - Detailed compliance checklist
63	- `references/quality-manual-guide.md` - How to create Quality Manual
64
65	How to use:
66
67	1. For specific clause questions:
68	- Read relevant section from `iso-13485-requirements.md`
69	- Explain requirements in plain language
70	- Provide practical examples
71
72	2. For document requirements:
73	- Consult `mandatory-documents.md`
74	- Explain what must be documented
75	- Clarify when documents are applicable vs. excludable
76
77	3. For implementation guidance:
78	- Use `quality-manual-guide.md` for policy-level documents
79	- Provide step-by-step creation process
80	- Show examples of good vs. poor implementation
81
82	Key reference sections to know:
83
84	- Clause 4: QMS requirements, documentation, risk management, software validation
85	- Clause 5: Management responsibility, quality policy, objectives, management review
86	- Clause 6: Resources, competence, training, infrastructure
87	- Clause 7: Product realization, design, purchasing, production, traceability
88	- Clause 8: Measurement, audits, CAPA, complaints, data analysis
89
90	### 3. Create Documentation (Template-Based Generation)
91
92	When to use: User needs to create specific QMS documents
93
94	Available templates:
95	- Quality Manual: `assets/templates/quality-manual-template.md`
96	- CAPA Procedure: `assets/templates/procedures/CAPA-procedure-template.md`
97	- Document Control: `assets/templates/procedures/document-control-procedure-template.md`
98
99	Process for document creation:
100
101	1. Identify what needs to be created:
102	- Based on gap analysis or user request
103	- Prioritize critical documents first (Quality Manual, CAPA, Complaints, Audits)
104
105	2. Select appropriate template:
106	- Use Quality Manual template for QM
107	- Use procedure templates as examples for SOPs
108	- Adapt structure to organization's needs
109
110	3. Customize template with user-specific information:
111	- Replace all placeholder text: [COMPANY NAME], [DATE], [NAME], etc.
112	- Tailor scope to user's actual operations
113	- Add or remove sections ba

People who liked this also viewed

6 picks

Type

iso-13485-certification

31kstars3.1kforks

View on GitHub

How to install iso-13485-certification?

k-dense-ai/scientific-agent-skills/iso-13485-certification

$npx -y skills add K-Dense-AI/scientific-agent-skills --skill iso-13485-certification

Installs into the current project.

Summary

Files · 1

View on GitHub

SKILL.md

1	# ISO 13485 Certification Documentation Assistant
2
3	## Overview
4
5	This skill helps medical device manufacturers prepare comprehensive documentation for ISO 13485:2016 certification. It provides tools, templates, references, and guidance to create, review, and gap-analyze all required Quality Management System (QMS) documentation.
6
7	What this skill provides:
8	- Gap analysis of existing documentation
9	- Templates for all mandatory documents
10	- Comprehensive requirements guidance
11	- Step-by-step documentation creation
12	- Identification of missing documentation
13	- Compliance checklists
14
15	When to use this skill:
16	- Starting ISO 13485 certification process
17	- Conducting gap analysis against ISO 13485
18	- Creating or updating QMS documentation
19	- Preparing for certification audit
20	- Transitioning from FDA QSR to QMSR
21	- Harmonizing with EU MDR requirements
22
23	## Core Workflow
24
25	### 1. Assess Current State (Gap Analysis)
26
27	When to start here: User has existing documentation and needs to identify gaps
28
29	Process:
30
31	1. Collect existing documentation:
32	- Ask user to provide directory of current QMS documents
33	- Documents can be in any format (.txt, .md, .doc, .docx, .pdf)
34	- Include any procedures, manuals, work instructions, forms
35
36	2. Run gap analysis script:
37	```bash
38	python scripts/gap_analyzer.py --docs-dir <path_to_docs> --output gap-report.json
39	```
40
41	3. Review results:
42	- Identify which of the 31 required procedures are present
43	- Identify missing key documents (Quality Manual, MDF, etc.)
44	- Calculate compliance percentage
45	- Prioritize missing documentation
46
47	4. Present findings to user:
48	- Summarize what exists
49	- Clearly list what's missing
50	- Provide prioritized action plan
51	- Estimate effort required
52
53	Output: Comprehensive gap analysis report with prioritized action items
54
55	### 2. Understand Requirements (Reference Consultation)
56
57	When to use: User needs to understand specific ISO 13485 requirements
58
59	Available references:
60	- `references/iso-13485-requirements.md` - Complete clause-by-clause breakdown
61	- `references/mandatory-documents.md` - All 31 required procedures explained
62	- `references/gap-analysis-checklist.md` - Detailed compliance checklist
63	- `references/quality-manual-guide.md` - How to create Quality Manual
64
65	How to use:
66
67	1. For specific clause questions:
68	- Read relevant section from `iso-13485-requirements.md`
69	- Explain requirements in plain language
70	- Provide practical examples
71
72	2. For document requirements:
73	- Consult `mandatory-documents.md`
74	- Explain what must be documented
75	- Clarify when documents are applicable vs. excludable
76
77	3. For implementation guidance:
78	- Use `quality-manual-guide.md` for policy-level documents
79	- Provide step-by-step creation process
80	- Show examples of good vs. poor implementation
81
82	Key reference sections to know:
83
84	- Clause 4: QMS requirements, documentation, risk management, software validation
85	- Clause 5: Management responsibility, quality policy, objectives, management review
86	- Clause 6: Resources, competence, training, infrastructure
87	- Clause 7: Product realization, design, purchasing, production, traceability
88	- Clause 8: Measurement, audits, CAPA, complaints, data analysis
89
90	### 3. Create Documentation (Template-Based Generation)
91
92	When to use: User needs to create specific QMS documents
93
94	Available templates:
95	- Quality Manual: `assets/templates/quality-manual-template.md`
96	- CAPA Procedure: `assets/templates/procedures/CAPA-procedure-template.md`
97	- Document Control: `assets/templates/procedures/document-control-procedure-template.md`
98
99	Process for document creation:
100
101	1. Identify what needs to be created:
102	- Based on gap analysis or user request
103	- Prioritize critical documents first (Quality Manual, CAPA, Complaints, Audits)
104
105	2. Select appropriate template:
106	- Use Quality Manual template for QM
107	- Use procedure templates as examples for SOPs
108	- Adapt structure to organization's needs
109
110	3. Customize template with user-specific information:
111	- Replace all placeholder text: [COMPANY NAME], [DATE], [NAME], etc.
112	- Tailor scope to user's actual operations
113	- Add or remove sections ba

People who liked this also viewed

6 picks

Type