MDSAP Chapter 1 — Management

Chapter 1 is where the audit starts: the quality system exists, someone is accountable, and top management can show the policy, the resources and the review.

HAVGATE loads tasks 1.1 through 1.11 from the AU P0002.010 set in the product. The titles cover QMS planning and the quality manual, the management representative, quality policy and objectives, structure and resources, the extent of outsourcing, competence and training, risk-management planning, document and record controls, management review, distribution only with the right marketing authorization, and top management commitment.

An internal audit of this chapter is not a speech from the CEO. It is the manual, the org chart, the training records, the risk procedure, the controlled documents, and the last management-review minutes with the inputs ISO 13485 clause 5.6 expects. Task 1.10 is the early check that you are not shipping a device you are not allowed to ship. Task 1.5 is where outsourcing stops being a verbal claim.

HAVGATE can record the task result, the evidence note and a nonconformance. Training records for task 1.6 live in the training module when you use it. Document control for task 1.8 is the document module. Management review itself is still a meeting you hold. The software keeps the inputs you already store: open CAPA, audit findings, supplier status.

The working checklist is the full 1.1 to 1.11 set inside /mdsap-audit-checklist and in the product, not a PDF. Grades, when you assign them, are explained on the grading page. Confirm the current audit approach document before you treat a task title as the only criterion.