iso-standards-readiness

ISO Standards Readiness Evidence Preparation

Purpose

Use this skill to organize declared scope, controlled documents, implementation records, traceability, and readiness evidence for substantive human review against a named standard. It summarizes process workflows and provides deterministic local checks. It contains no clause text and performs no audit.

SKILL.md holds the boundary, lane discipline, shared evidence workflow, and CLI contract. Per-standard preparation details live in references/.

Non-negotiable boundary

This skill cannot:

• certify or accredit anything, issue or validate a certificate, accreditation schedule, or licence, or promise an audit, assessment, or inspection result;
• determine legal/regulatory applicability, device classification, reportability, conformity route, product authorization, market access, licensure, personnel qualification, or compliance;
• replace authorized management, the management representative, laboratory director, quality manager, authorized signatory, RA/QA, legal counsel, regulatory/competent authorities, a notified body, an MDSAP Auditing Organization, an accreditation body, an assessor, or a certification body;
• validate a method, compute or approve measurement uncertainty, establish metrological traceability, set risk-acceptability criteria, or judge whether a risk, decision rule, or reference interval is fit for purpose; or
• infer implementation, competence, conformity, compliance, or readiness from a template, checklist, filename, keyword, document count, percentage, or script result.

Always label outputs draft evidence-preparation material for authorized human review. Preserve unresolved decisions as blockers rather than resolving them.

ISO and IEC copyright

ISO and IEC standards are copyrighted. Obtain each standard from ISO, IEC, an ISO national member, or another authorized source. Do not retrieve, paste, reproduce, or generate clause text. Summarize the organization's own process and cite the controlled authorized copy. See ISO copyright. Accreditation-body, CAP, and scheme checklists that quote requirements are separately licensed — keep them out of shared repositories and prompts too.