Review the operating evidence behind your medical device quality system—not just whether a procedure exists. Mark each area, record where evidence lives, and turn the result into an internal audit worklist.
Check whether processes are implemented, not merely documented.
Inputs stay locally in your browser and never call an API.
Verify findings against licensed and official source materials.
Assess implementation and objective evidence for each area. Your notes stay in this browser and are never sent to an API.
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Evidence to sample: Quality manual, scope statement, site/process map, regulatory-role matrix, exclusion rationale.
Evidence to sample: Document master list, approval history, change records, retention matrix, access controls, sampled records.
Evidence to sample: Objectives/KPIs, organization chart, management-review inputs and outputs, action tracking, resource decisions.
Evidence to sample: Regulatory matrix, market approvals, standards list, change-assessment process, reporting and retention requirements.
Evidence to sample: Risk-management procedure/file, process-risk criteria, change records, complaint/CAPA links, risk acceptability decisions.
Evidence to sample: Design plan, trace matrix, review minutes, V&V protocols/reports, transfer checklist, change history, design file.
Evidence to sample: Approved supplier list, evaluations, quality agreements, scorecards, audit reports, purchasing specifications, incoming controls.
Evidence to sample: Travelers/batch records, work instructions, environmental logs, acceptance records, release authorization, service records.
Evidence to sample: Validation master plan, IQ/OQ/PQ or equivalent evidence, software validation, acceptance criteria, revalidation decisions.
Evidence to sample: Bioburden/cleanroom controls, sterilization validation, cycle records, packaging validation, release records, traceability.
Evidence to sample: Equipment register, calibration certificates, status labels, traceability, out-of-tolerance impact assessments.
Evidence to sample: Complaint files, investigation rationale, trend reports, vigilance decisions/submissions, feedback inputs, escalation records.
Evidence to sample: NCRs, concessions, segregation/status controls, rework instructions, re-verification, post-delivery actions.
Evidence to sample: CAPA files, root-cause evidence, implementation records, effectiveness criteria/results, risk-file updates, trend data.
Evidence to sample: Risk-based audit schedule, auditor competence/independence, reports, findings, corrections, follow-up and closure evidence.
The score summarizes reviewed items only. It is not an audit grade or certification prediction.
Sample records across products, sites, shifts, and time periods. Look for consistent execution, traceability between connected processes, competent decision makers, and evidence that actions were effective.
Use every partial or gap result as a work item with an owner, target date, containment where needed, root-cause depth proportionate to risk, and an effectiveness check. Revisit the assessment after changes are implemented.
No. It is an independent readiness tool with paraphrased process prompts. It does not reproduce the standard and does not replace a licensed copy of ISO 13485 or certification-body criteria.
No. Certification can only be issued through the applicable accredited certification process. This tool helps organize an internal gap assessment.
Applicable areas should have implemented, consistent, and objective evidence. A documented procedure alone may not demonstrate effective implementation.
Your selections and notes are stored only in this browser. They are not uploaded to Pure Global AI. Download the summary if you need a portable worklist.
