As part of the Arthrex supplier monitoring program, Arthrex suppliers may be subject to routine quality system audits. In addition, Arthrex may conduct for-cause audits in circumstances that warrant additional activity. See the information below for which supplier types and categories correspond to audit types and frequencies. Supplier types not listed below do not require routine quality system audits.
|
Supplier Classification |
Audit Information |
||||
|
Type |
Description |
Category |
ISO Certification |
Audit Type |
Audit Frequency |
|
Arthrex-Designed Device (ADD) |
Contract manufacturer (High risk) |
A |
ISO 13485 |
On-site audit |
3 years |
|
Contract manufacturer (Moderate risk) |
B |
ISO 13485 or ISO 9001 |
On-site or desktop audit |
4 years |
|
|
Contract manufacturer (Low risk) |
C |
ISO certificate if Supplier is certified |
Desktop audit and/or ISO certificate |
5 years |
|
|
Packaging (Sterile barrier) |
A |
ISO 13485 |
On-site audit |
3 years |
|
|
Veterinary |
C |
ISO certificate if Supplier is certified |
Desktop audit and/or ISO certificate |
5 years |
|
|
OEM |
Externally manufactured devices |
A |
ISO 13485 or ISO 9001 if certified |
Desktop audit |
3 years |
|
OEM |
Externally manufactured devices |
B |
ISO 13485 or ISO 9001 if certified |
Desktop audit |
4 years |
|
Private Label |
Externally manufactured devices |
A |
ISO 13485 or ISO 9001 if certified |
Desktop audit |
3 years |
|
Externally manufactured devices |
B |
ISO 13485 or ISO 9001 if certified |
Desktop audit |
4 years |
|
|
Services |
Sterilization |
A |
ISO 13485 |
On-site audit |
3 years |
|
Analytical testing/Laboratory services – Product release |
A |
ISO 13485 and/or ISO 17025 |
On-site audit |
3 years |
|
|
Analytical testing/Laboratory services – Non-product release |
B |
ISO 13485 and/or ISO 17025 |
On-site audit or certificate |
4 years |
|
|
Services |
Device design |
A |
ISO certificate if Supplier is certified |
On-site audit or desktop |
3 years |
|
Calibration |
B |
ISO 17025 or OEM |
On-site audit or certificate/OEM |
4 years |
|
Packaging = sterile barrier material, pouches, trays, lids, etc.
Externally Manufactured Devices includes suppliers that are manufacturers of OEM/private label products distributed by Arthrex and/or off-the-shelf components that may be included in an assembly or kit.