BD iso-13485-certification
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) developing required procedures and work instructions, (4) preparing Medical Device Files, (5) understanding ISO 13485 requirements, or (6) identifying missing documentation for medical device certification. Also use when users mention medical device regulations, QMS certification, FDA QMSR, EU MDR, or need help with quality system documentation.
Comprehensive toolkit for preparing ISO 13485 certification documentation for medical device Quality Management Systems.
As a process D 38/100 · Unfinished process — weak spots: result and completion, when it triggers, inputs and preconditions
How to improve
- The SKILL.md body is over 5,000 tokens: move reference detail into references/ and load it when needed.
- Your own cases (evals/evals.json, 4–6 real requests with expected answers): the full check would then run those instead of a model-drafted suite.
- A spec.yaml with trigger phrases and assertions — a behaviour contract for CI; `skilltest init` writes a template.
Guard findings · 0
✓ No critical or high findings
Files scanned: 9. Evidence is masked. Grey chips explain why severity was lowered.
Against the Agent Skills spec
- warning
body-longSKILL.md body ≈ 5626 tokens (recommended < 5000); move details to references/
Process rating: all ten parameters 38/100
- 0Result and completion. Does not say what the result is
- 0Inputs and preconditions. Does not say what the process needs to start
- 0Failures and branches. Linear process with no failure handling
- 20When it triggers. No condition that starts the skill
- 30Running it twice. 23 mutating operations with no state check
- 60Tools and files. Uses tools (bash) that frontmatter does not declare
- 60Steps. 432 steps, 4 vague phrases
- 70Execution cost. Instruction body is 5626 tokens
- 100Consistency. Name and required fields are in place
- 100Progress reporting. Reports progress
Everything here is measured from the skill text rather than judged by a model, so the numbers are checkable. A parameter weighs more when it is a more common reason for the process to stall.
Quality signals
- +5Description has no quoted example phrases that should trigger the skill
- +4Description does not say when NOT to use the skill (false activations)
- +3Output format is not stated: the model decides each time
- +2Single-language instructions
- +3Description length 626: enough signal without eating the budget
- +4Structure: 30 headings
- +3Step-by-step instructions: 432 items
- +4Has examples (1 code blocks)
- +4Reference files are cited in the instructions (4 of 4)
- +3All 1 scripts are documented
- +1License stated
Quality base 70; lint remarks subtract, signals add up to 100. Result: 82.