Quality Management System Assessment for ISO 13485 / AS9100 Certification
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Example: "We have a one-page quality policy statement signed by the CEO, but no formal quality manual."
Example: "Documents are stored on a shared network drive. The department head emails out new versions when ready."
Example: "Paper records are filed in cabinets in the quality office. We keep them for 7 years."
Example: "Quarterly management meetings, but minutes not always taken. Responsibilities generally understood but not documented."
Example: "On-the-job training by supervisors. No formal training records. Equipment calibrated annually by external service."
Example: "Sales team takes orders via email. We review purchase orders before accepting."
Example: "Engineering uses CAD software. We have design reviews, but process not formally documented."
Example: "We use a list of approved suppliers. We visually inspect incoming materials."
Example: "Work instructions for key assembly steps. Each product has serial number tracked on spreadsheet."
Example: "We perform final inspection on 100% of products before shipping."
Example: "Defective parts put in red bin. Production manager decides whether to rework or scrap."
Example: "No, we have never performed an internal audit."
Example: "When customer complains, we replace product. No formal root cause analysis process."
Example: "Required by major customer, entry into new market, improve overall quality system"