Guide · Agent skill
How to use the ISO Standards Readiness Evidence Prep agent skill
Updated · written with AI from the project's own documentation and checked against our catalogue data
The iso-standards-readiness skill is an add-on for an AI coding or chat agent that helps organize a company's own documents, scope statements, traceability links, CAPA records and supplier controls for ISO management-system and laboratory-competence standards such as ISO 13485, ISO 14971, ISO/IEC 17025 and ISO 15189. After this guide you will know what the skill does, how to install it, how to ask for it in plain language, and what its limits are. It prepares draft material for qualified people to review; it does not decide compliance, certification or accreditation.
ISO Standards Readiness Evidence PrepK-Dense-AI/scientific-agent-skills · MIT Download the skill Quick start
- 1Download and unzip. Download the skill ZIP from the directory page and unzip it into ~/.claude/skills/ or a project's .claude/skills/ folder.
- 2Or upload in the Claude apps. In the Claude apps, open Settings, go to Capabilities, then Skills, and upload the skill.
- 3Get the standard from an authorized source. Obtain the ISO or IEC standard from ISO, IEC, an ISO national member or another authorized source. The skill does not supply clause text.
- 4Copy the matching template. Pick the intake template for your standard and copy it outside the skill folder so the distributed original stays unchanged.
- 5Complete it with controlled evidence. Fill in the copy with your organization's own controlled documents, owners and scope statements, leaving undetermined items as blockers.
- 6Run the scope check. Run the bundled validate_scope_intake.py script with your file and --standard option, then review any HUMAN_DECISION_REQUIRED messages.
- 7Route the draft to authorized reviewers. Give the draft evidence pack to qualified people such as the quality manager, RA/QA or the laboratory director for substantive review.
What the skill makes the agent do
An agent skill is a folder of instructions, templates and reference notes that an agent reads when a request matches the skill's description. This one covers readiness evidence for four standards: ISO 13485 (medical device quality management), ISO 14971 (device risk management), ISO/IEC 17025 (testing and calibration laboratories) and ISO 15189 (medical laboratories).
The skill helps the agent organize declared scope, controlled documents, risk-management files, scope of accreditation, traceability, CAPA, external-provider controls and local evidence manifests. It can also explain how certification, laboratory accreditation, FDA QMSR inspection, CLIA certification, MDSAP and EU MDR/IVDR evidence differ. It can run small local checks that verify files are structured correctly.
- Uses bundled templates such as a document register, CAPA record, traceability matrix, supplier controls and evidence manifest.
- Uses bundled procedure and quality manual working templates, all marked as drafts.
- Does not decide whether anything complies, is certified or is accredited.
- Contains no ISO or IEC clause text. You must obtain the standards from ISO, IEC or another authorized source.
Install the skill in Claude
Download the ZIP for the skill from the directory page. Then choose one of two routes. For a personal setup, unzip it into ~/.claude/skills/. For a single project, unzip it into the project's .claude/skills/ folder.
You can also upload the skill in the Claude apps under Settings → Capabilities → Skills. Use this route if you work in the apps rather than in a local project folder.
- Personal: unzip into ~/.claude/skills/.
- Project only: unzip into .claude/skills/ inside the project.
- Claude apps: Settings → Capabilities → Skills, then upload.
Ask for it with natural requests
You do not need a special command. Describe the task in plain words that match the skill's purpose. Name the standard and the kind of evidence you need, and say that you want a draft for human review.
Good requests name the standard, the lane you are working in and the artifact you want. State the lane as a fact you already know, because the skill treats the lane as an input, not something it infers.
- Organize our controlled document register for ISO 13485 and flag missing owners.
- Build a traceability matrix template for our ISO 14971 risk controls.
- Help me draft a CAPA record structure for ISO 13485 with approval roles left as pending.
- Prepare a scope-of-accreditation intake for our ISO/IEC 17025 calibration lab.
- Explain the difference between ISO 15189 accreditation and CLIA certification for our lab.
Run the bundled scope check
The skill's readiness workflow starts by declaring the standard, purpose and owners. A bundled script checks your scope intake file. Each distributed template is designed to fail closed, so copy it outside the skill folder and complete it with your organization's controlled evidence before running the check.
The --standard option defaults to iso-13485. Use the matching template for your standard. For ISO 13485 and ISO 14971 use the scope intake template; for ISO/IEC 17025 use the laboratory scope intake template; for ISO 15189 use the medical laboratory scope intake template. If applicability is undetermined, the check raises HUMAN_DECISION_REQUIRED. Leave that item as a blocker for a person to resolve.
- Python 3.11 or later is needed for the bundled checks.
- The checks use only the Python standard library.
- Do not resolve HUMAN_DECISION_REQUIRED items yourself.
PYTHONDONTWRITEBYTECODE=1 python3 scripts/validate_scope_intake.py assets/templates/scope-intake-template.json --standard iso-13485Safety notes: scripts and network
The skill runs scripts, but it does not use the network and needs no API keys, accounts or credentials. The bundled checks work on local JSON and Markdown files. Because the skill allows the agent to run commands, review any script before you run it, and keep your working copies of templates in a controlled location.
A passing script result is not evidence of conformity. Templates carry draft status banners that say they are not approved and make no compliance claim. Keep those banners until your authorized roles have approved the controlled version.
- Network access: none.
- Credentials: none required.
- Do not paste copyrighted ISO text or accreditation-body checklists that quote requirements into prompts or shared repositories.
- Keep the draft status until authorized approvers sign off.
What people use it for
- A quality manager builds a document register and CAPA record structure before an internal readiness discussion.
- A regulatory or QA team creates a traceability matrix linking risk controls to design records for human review.
- A laboratory prepares a scope-of-accreditation intake draft for ISO/IEC 17025 before a conversation with its accreditation body.
- A student compares ISO certification with laboratory accreditation and the FDA QMSR, CLIA and MDSAP boundaries.
Frequently asked questions
Is the ISO Standards Readiness skill free to use?
The skill is published under the MIT licence, as stated on the directory page. Check the licence file included with the download for the full terms.
What do I need to run the iso-standards-readiness skill?
You need Python 3.11 or later for the bundled command-line checks, which use only the standard library. No API keys, accounts or credentials are needed, but you must obtain the ISO or IEC standards yourself from an authorized source.
Does the skill certify my company or accredit my lab?
No. The skill cannot certify, accredit, issue certificates or predict an audit or assessment result. It prepares draft evidence for authorized human review.
Does the skill include the text of ISO 13485 or ISO/IEC 17025?
No. It deliberately contains no clause text, and it asks you to get standards from ISO or another authorized source and to keep copyrighted text out of prompts and shared repositories.
Why does my scope check show HUMAN_DECISION_REQUIRED?
The check raises this flag when applicability is undetermined. Leave the item as a blocker and have the authorized owner decide it. Do not fill it in to make the check pass.
How is this different from hiring a consultant or using another ISO tool?
This skill only organizes your own documents and runs local structural checks inside an agent. It does not set risk criteria, validate methods, compute measurement uncertainty or judge compliance, so a consultant or the authorized people in your organization still need to do those jobs.
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Our verdict
Use this skill if you are a quality manager, regulatory or QA specialist, or a student who needs organized draft templates and structural checks before a human-led review. Pick something else if you expect a compliance, certification or accreditation decision, need the actual standard text, or need help setting risk-acceptability criteria, validating methods or computing measurement uncertainty.
Download the skill