Title Page
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Site conducted
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Audit Number
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Conducted on
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Auditor
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Auditee
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The scope of this internal audit to check the effectiveness of the quality system to the standards ISO9001 & ISO 13485. This includes our own internal procedures and the clauses represented in the above standards. This audit is looking at the controls and process of the purchasing function and supplier controls.
Purchase Requirements
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What triggers the requirement to purchase an item?
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Does the system give you the option to see supplier lead times?
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How do you know what specification of material to order?
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How do you know how much to order?
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Does this include all requirements for that specific item / material?
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Is this the same process for both raw materials and bought in parts?
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Do you request a quote for the items being ordered?
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Do you ever purchase without a quote?
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Do you use a price list on the system for any items?
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How is the price list kept up to date?
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How would you order a new part that is not on the system?
Supplier Control
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If there is more than one supplier for the item? how do you choose where to order it from?
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Can you tell if the supplier is approved?
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Can you order items if the supplier is not approved?
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Can you see a list of approved suppliers?
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What do you do if you need to use a supplier that either not approved or on the list?
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How are new suppliers added to the system?
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How are suppliers approved?
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Can you see why a supplier is not approved?
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Can you order from a supplier that has not been used for a long time?
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Would you do anything different if ordering from a supplier that not been used for a while?
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Are suppliers highlighted as key suppliers?
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How is this identified within the system?
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Can you see what has been ordered on a supplier?
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Is supplier performance monitored?
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What is used for measuring supplier performance?
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What actions are taken if the suppliers performance is poor?
Processing an order
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How would you raise an order to a specific supplier?
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Can this be done from both an RFQ or just purchase order?
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What is the normal method?
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Do you have to add the prices or does the system provide them?
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How is the purchase order sent to the supplier?
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Do you acknowledge the expected delivery date?
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Can you see what should be delivered on any specific day?
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Does the system highlight if a delivery is late?
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Do we add any extra details or requirements on the purchase order?
Booking in Items
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How are raw materials checked when they are received on site?
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What information is required to enable them to be booked in?
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How do you check that what was delivered matches the purchase order?
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How are these identified once booked in?
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Where are these stored once booked in?
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How are bought in parts received onsite?
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What checks if any are made on the items?
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What information is required to book these in?
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Should certain items be fully inspected?
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How are these identified once booked in?
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Where are these stored?
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What do you do if the items are incorrect or poor quality?
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Can you see what has been rejected?
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How are these returned to the supplier?
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How are returned items booked back into stock?
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Do rejected items change the suppliers performance?
ISO 13485 - Requirements / Clauses
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Once audit has been completed review the above findings and complete the following sections
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ISO 13485 - 4.1.5 General Requirements
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ISO 13485 - 7.1 Planning of product realisation
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ISO 13485 - 7.4.1 Purchasing process
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ISO 13485 - 7.4.2 Purchasing information
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ISO 13485 - 7.4.3 Verification of purchased product
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ISO 13485 - 7.5.8 Identification
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ISO 13485 - 7.5.9 Traceability
ISO 9001 - Requirements / Clauses
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ISO 9001 - 4.4 Quality management system and its processes
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ISO 9001 - 8.4 Control of externally provided processes, products and services
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ISO 9001 - 8.1 Operational planning and control
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ISO 9001 - 8.4.1 General - Control of externally provided processes, products and services
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ISO 9001 - 8.4.2 Type and extent of control
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ISO 9001 - 8.4.3 Information for external providers
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ISO 9001 - 8.6 Release of products and services
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ISO 9001 - Identification and traceability
