©2024 by the American Board for Certification in Orthotics, Prosthetics & Pedorthics, Inc. All rights reserved.
No part of this document may be produced in any form without written permission of the American Board for Certification in Orthotics, Prosthetics & Pedorthics, Inc.
October 2023
The Warranty and Recall Standards address
written policies and procedures related to
warranties, item/device failures and product
recalls. You must have written policies to identify
incidents such as failures and product recalls.
These policies must include the ability to identify
and notify all customers affected by a recall. You must also have procedures for the disclosure of
request information related to an item/device
failure. You must document and disclose the
addition of any used components and that items/
devices were obtained without fraud or deceit.
The business has established written policies and procedures that address item/device failures and product recalls.
Tip–Failures and Recalls
You must have a policy in place for investigating and documenting incidents such as failures and product recalls. The investigation documents should include all relevant information, your conclusions and whether or not you will be making changes to protocols or procedures because of the incident.
The business has established written policies and procedures related to the disclosure of information requested as part of an investigation by the customer involving item/ device failure.
Tip–Information Requests
In the event that a customer reports an item/ device failure, your written policy will detail your response and follow up actions.
The business has written policies and procedures to collect data related to item/ device failures and to respond to product recalls.
Tip–Collecting Data
Data can be compiled from customer feedback and recorded in a complaint log, failure log or other tracking system. Data may also be obtained from customer work orders, complaints, visual defects or employee feedback. Your policy needs to include how you will identify and notify all customers affected by the recall.
The business provides its customers with warranty information on items/devices that it fabricates.
Tip–Warranty Information
The business shall verify that its supplied items were obtained without fraud or deceit.
Tip–Verification of Purchase
You must have documentation that shows items were purchased from a known, reputable source. This can be documented through purchase orders, invoices or packing slips.
The business shall document and disclose to the customer the incorporation of any used components, not supplied by the customer, on items/devices that it fabricates.
Tip–Disclosure of Used Components
Disclosure may be through labeling on the item/device or direct communication with the customer. You need to document any instance of fabrication with used components.