Iso13485 Audit Prep
Iso13485 Audit Prep: Prepare a traceable compliance or quality review. Review the current framework, system boundary, controls, and evidence and produce a requirement-to-evidence matrix with prioritized gaps.
--- name: compliance-os-iso13485-audit-prep description: Use for iso13485 audit prep when asked to prepare a traceable compliance or quality review; produce a requirement-to-evidence matrix with prioritized gaps. license: MIT metadata: author: Thrive category: compliance-os --- # Iso13485 Audit Prep ## When to use Use this skill for iso13485 audit prep when you need to prepare a traceable compliance or quality review. The expected result is a requirement-to-evidence matrix with prioritized gaps. ## Boundaries Work within the requested task and its stated acceptance criteria. Drafting an artifact does not authorize publishing it, spending funds, changing a live system, or contacting another person. Identify any such action separately before taking it. ## Inputs Inspect the current framework, system boundary, controls, and evidence. Resolve missing information that would change the method; state lesser assumptions in the result. ## Method 1. **Diagnose.** Identify the current framework version, scoped systems, data flows, control owners, and existing evidence. 2. **Decide.** Map each requirement to evidence, an owner, and an unresolved gap. 3. **Produce.** Build a requirement-to-evidence matrix with prioritized gaps from the inspected material; keep assumptions distinguishable from observed facts. ## Decision rules - Separate policy language from operational control performance. Prioritize gaps with no owner or no evidence. - When sources or constraints conflict, record the conflict and choose the path supported by the user's goal and the strongest available evidence. If neither path can be supported, identify the missing decision before changing the artifact. ## Domain rules - Map each requirement to a control, owner, evidence item, and gap. - Check the current authoritative requirement and reserve final interpretation for qualified review. ## Verification Verify requirements against current primary sources and flag qualified review. Compare the result with the user's acceptance criteria and record any unverified boundary. Return a control matrix with exact evidence request, affected scope, remediation owner, and review date. ## Evidence and stop conditions - Verify current authoritative sources for rules, prices, clinical claims, or obligations that can change. Distinguish fact, interpretation, and assumption. - Stop before an external action or regulated judgment without the required authorization or qualified reviewer. - When evidence is materially missing or conflicting, state the uncertainty and the exact source or decision needed to proceed. ## Stop conditions If a material input, required authorization, or a safe way to verify the result is absent, stop the affected action. Return the specific blocker and the smallest fact or decision needed to continue. Do not report an unrun check as passed. ## Output Provide a requirement-to-evidence matrix with prioritized gaps. Include the decisive evidence and actual verification result. Name any artifact location and unresolved issue that affects its use. <!-- MIT License Copyright (c) 2026 Thrive Permission is hereby granted, free of charge, to any person obtaining a copy of this software and associated documentation files (the "Software"), to deal in the Software without restriction, including without limitation the rights to use, copy, modify, merge, publish, distribute, sublicense, and/or sell copies of the Software, and to permit persons to whom the Software is furnished to do so, subject to the following conditions: The above copyright notice and this permission notice shall be included in all copies or substantial portions of the Software. THE SOFTWARE IS PROVIDED "AS IS", WITHOUT WARRANTY OF ANY KIND, EXPRESS OR IMPLIED, INCLUDING BUT NOT LIMITED TO THE WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE AND NONINFRINGEMENT. IN NO EVENT SHALL THE AUTHORS OR COPYRIGHT HOLDERS BE LIABLE FOR ANY CLAIM, DAMAGES OR OTHER LIABILITY, WHETHER IN AN ACTION OF CONTRACT, TORT OR OTHERWISE, ARISING FROM, OUT OF OR IN CONNECTION WITH THE SOFTWARE OR THE USE OR OTHER DEALINGS IN THE SOFTWARE. -->