MDSAP Chapter 7 — Purchasing

Chapter 7 asks how you choose and watch the companies that supply product or process, and how you know what arrived is what you ordered.

HAVGATE loads tasks 7.1 through 7.12. They cover planning of purchased product and outsourced processes, picking a supplier file to audit, the control procedure, the extent of control and the criteria for selection and re-evaluation, selection based on ability, evaluation records, effective controls, purchasing information and change-notification agreements, documented requirements, verification of what was purchased, purchasing data as an input to measurement and improvement, and management commitment.

The supplier-quality module is where approved suppliers, risk and re-evaluation live. Incoming acceptance can raise a nonconformance. The commercial bill sits in bookkeeping. Those are three records. The product does not yet join an invoice to the approved-supplier file. The bookkeeping page says that in one place so this chapter does not imply a link that is not shipped.

Outsourcing in task 1.5 and purchasing here are related. If a contract manufacturer builds the device, both chapters will be in the audit plan.

The working checklist is the full 7.1 to 7.12 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.