ISO 13485 · Basic · 13 min lesson
Purchasing information, verification of purchased product and supplier quality agreements
ISO 13485:2016 clauses 7.4.2 and 7.4.3: purchasing information, change notification, incoming verification
What you will learn
- Write purchasing information that satisfies clause 7.4.2, including the written agreement on notification of changes.
- Plan verification of purchased product under clause 7.4.3 with an extent that follows supplier evaluation and risk.
- Draft the key terms of a supplier quality agreement and recognise a weak record.
Key takeaways
- Clause 7.4.2: purchasing information describes the product, is checked for adequacy before sending and is kept as records.
- The written agreement must require the supplier to notify changes before implementing them.
- Clause 7.4.3: verification activities are established, and their extent follows supplier evaluation results and risk.
- A certificate supports verification only when a recorded basis for trusting it exists.
- If verification is planned at the supplier, state the arrangements and release method in the purchasing information.
Free practice question
Halden Films changed its resin supplier in April. Lumora's purchase orders for the film list only part number and quantity. Lumora learned of the change in June, after seal failures. There is no signed agreement between the companies about changes.
Which requirement is not met?
Clause 7.4.2: purchasing information must include a written agreement on notification of changes.
Correct. Clause 7.4.2 requires the written agreement that the supplier notifies changes before implementation, and none exists.
Clause 7.5.6: validation of the supplier's extruder.
Not quite. Clause 7.5.6 covers production process validation, and the described gap concerns purchasing information instead.
Clause 8.5.2: corrective action by Halden.
Not quite. Corrective action is a response, while the root gap is the missing agreement required by clause 7.4.2.
None: suppliers have no duty to tell customers about changes.
Not quite. Clause 7.4.2 requires the manufacturer to secure that duty in a written agreement, so a gap exists.
Key terms
- purchasing information: The description of the purchased product and its requirements, including specifications, acceptance requirements and the change notification agreement.
- quality agreement: A written agreement defining responsibilities, specifications, change notification, audit access and nonconformity handling between manufacturer and supplier.
- certificate of conformity: A supplier statement that a lot meets specified requirements, supported by measured results.
- verification of purchased product: Inspection or other activity confirming that purchased product meets the purchasing information, proportionate to risk.
- change notification: The supplier's duty to inform the manufacturer before implementing changes that affect the ability to meet requirements.
- skip-lot inspection: A reduced inspection frequency allowed after proven supplier performance and a documented rationale.
Official sources
- ISO 13485:2016 Medical devices - Quality management systems - Requirements for regulatory purposes
- Advisera: How can ISO 13485 clause 7.4 Purchasing enhance procurement
- Hardcore QMS: Verifying purchased product according to ISO 13485 7.4.3
Go further
The full lesson has narrated slides, more scenario questions with explained answers and a simulation.
Open the AcademyWatch on YouTubeIllustrative example. Educational only, not legal advice.