Category A Supplier Documentation

Supplier Category

Arthrex-Designed Devices (ADD)

OEM

Private Label

Services

A

ISO 13485

ISO 13485 or ISO 9001 if certified

ISO 13485 or ISO 9001 if certified

Sterilization

ISO 13485

Analytical testing/laboratory services

ISO 13485 and/or ISO 17025

Other

ISO certificate if supplier is certified

  • Supplier Evaluation and Selection Form
  • Arthrex Supplier Quality Agreement

 

Category B Supplier Documentation

Supplier Category

Arthrex-Designed Devices (ADD)

OEM

Private Label

Services

B

ISO 13485 or ISO 9001 if certified

ISO 13485 or ISO 9001 if certified

ISO 13485 or ISO 9001 if certified

Calibration

ISO 17025 or OEM

Analytical testing/laboratory services services

ISO 13485 and/or ISO 17025

Special processes

ISO 9001

  • Supplier Evaluation and Selection Form
  • Arthrex Supplier Quality Agreement

 

Category C Supplier Documentation

Supplier Category

All Category C Suppliers

C

ISO certificate if supplier is certified

  • Vet/Distributors/Importers Quality Agreement for veterinary, translation, and literature printing companies
  • Supplier Evaluation and Selection Form
  • Curriculum vitae, professional resume, and/or other acceptable documents for consultants and other private personal entities demonstrating ability to successfully fulfill criteria established by Arthrex for the product or service requested