GP-010 Purchases and suppliers

Procedure flowchart

Purpose

To describe a systematic procedure in the purchasing process, as well as for the evaluation and reevaluation (periodical and planned) of suppliers.

Scope

All the purchasing processes and suppliers whose performance may directly or indirectly affect the quality of the products we develope.

Inputs

• Need to purchase products or services.
• Suppliers offers.

Outputs

• T-010-001 Supplier evaluation

Procedure

Record of suppliers

The evaluation is carried out following the template T-010-001 Suppliers evaluation. The verification and record of approved suppliers is also recorded following the template T-010-001 Suppliers evaluation. The record shows whether the supplier meets the approval criteria.

Types of supplier

To understand the classification of suppliers, there are two dimensions to consider:

1. Whether the supplier has an impact on the quality of the device (its safety or its performance) and whether or not the risk of that impact is fully controlled
2. Whether or not the supplier offers a commercial and standardised product

The proposed taxonomy categorizes suppliers into 6 distinct classes, as the following matrix shows:

	No impact to quality	Impacts quality, but it's controlled	Impacts quality and is not controlled
Commercial and fully standardised	Non-Impact Vendor (NIV)	Controlled Impact Vendor (CIV)	High-Risk Impact Vendor (HRIV)
Non-commercial nor fully standardised	Non-Impact Subcontractor (NIS)	Controlled Impact Subcontractor (CIS)	High-Risk Impact Subcontractor (HRIS)

This taxonomy is grounded in the principle of risk management, by differentiating suppliers based on their potential impact and the degree of risk control, we ensure compliance with regulatory requirements, and most importantly, uphold the safety and efficacy of their devices

Keep in mind

The classification of a supplier depends not only on what the supplier does but on what ways to mitigate the risk. For example, if we have two simultaneous suppliers so that one is a backup to the other, a supplier that might be one type would be another type. As you can see, this has nothing to do with the supplier itself. The same if we have signed a contract with one SLA or another: the same provider would be one type or another, depending on the SLA.

Supplier Evaluation

Supplier scorecard

Facet	Min score	Max score
Quality of services	0	2
QMS Certification	0	2
ISMS Certification	0	2
Affordable price	0	2
Experience	0	2
Technical capacity	0	2
International reach	0	2

Minimum required score

Supplier type	Required score
Non-Impact Vendor (NIV)	≥6
Controlled Impact Vendor (CIV)	≥8
Controlled Impact Subcontractor (CIS), Non-Impact Subcontractor (NIS)	≥9
High-Risk Impact Vendor (HRIV) or Subcontractor (HRIS)	Can't be approved