ISO 9001 -
For ISO 9001, no additional actions are required from the Manufacturing Partner. The order should be completed and processed as a standard order, following the usual procedures and ensuring it meets the general quality and performance expectations.
ISO 13485
For ISO 13485, which is selected for medical components, only suppliers who have signed the “Supplier Quality Agreement” are permitted to quote on these projects. Since these components carry higher risks, the following regulations and standards must be adhered to throughout the production process:
Council Directive 93/42/EEC of 14 June 1993 concerning medical devices (the “MDD”)
Medical Device Regulation (EU) 2017/745 (the “MDR”)
21 CFR Part 820, 21 CFR 58, 21 CFR 1271 (for U.S. compliance)
ISO 13485 or ISO 9001
The Supplier Quality Agreement serves as a contract that ensures the supplier’s compliance with these regulations. It encompasses key aspects, including:
Criteria for supplier audits
Retention of quality records
Change notification requirements
Production and process control measures
This agreement is critical to maintaining quality and compliance in the manufacturing of high-risk medical components.
Before suppliers can bid they are prompted by the Geomiq platform to sign this quality agreement. Once a supplier has signed this agreement, they are capable to quote and work on any project which requires ISO 13485