Purchasing Process for ISO 13485

One of the mandatory procedures of ISO 13485 is the Purchasing process as per Clause 7.4 of the standard which establishes criteria for evaluation, selection of suppliers who are controlled and monitored on an ongoing basis so that the purchased/received product conforms to the requirements.

This procedure covers all the raw materials, consumables, tools and machinery; and all outsourced services of the Medical Devices Industry. The process covers the following steps:

1. Vendor Identification

2. Vendor Evaluation

3. Vendor Audit

4. Vendor registration and approval in the Approved Vendor list

5. Agreements and contracts with suppliers

6. Supplier Monitoring and improvement

7. Purchasing Information

8. Verification of the purchased product

The author recommends you to Contact I 3 Consulting for further information and expert knowledge and advice on Medical devices CE marking. Contact jr@i3cglobal.com