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.