HPDC Approved Preparer
Introduction
The HPDC Third Party Verification (TPV) Program has been established to manage the credentialing and methodology for independent review and verification of completed Health Product Declarations (HPDs) under the HPD 2.0 Standard. The program also recognizes HPDC Approved Preparers which a manufacturer may choose to engage for support in developing HPDs.
The requirements for approval of Preparers are designed to identify those organizations with sufficient knowledge, experience, resources, and demonstrated business practices to effectively execute preparation projects. These requirements include:
- HPDC General Membership
- 5 Years Relevant Experience
- Resources to handle all work in-house
- Adherence to ISO 17065 Requirements for Bodies Certifying Products, Processes and Services.
- Annual audits of the verifying organization to maintain approval
You will be asked to provide an explanation of how you will demonstrate that you meet each of the above requirements and what additional documentation you’ll use to support each explanation. You then have the option of attaching that documentation to the application for submittal. If the documents or systems are too large to attach, or if you would prefer not to attach them, make sure that you reference the appropriate supporting documents or system and we will review them in a follow-up Application Audit meeting in a conference call that will allow us to review the documents in real time.
Registration
The Health Product Declaration® (HPD) Collaborative Third Party Approved Preparer Program requires registration to complete the online application. Having an account allows users to create, edit, and submit the application form with the ability to save and return to complete it in multiple sessions. To create an account, register using the form below. Once you’ve begun your application, it will be visible on your profile page for editing. Please note that all edits must be manually saved by clicking the “Save Draft” button at the bottom of the form. You will also be able to view your application on your profile page once it has been submitted.
To help you prepare the application, you may also download a digital copy of the form (in MS Word format) by clicking here. This will allow you to review the application offline and collect the required data before proceeding online to complete the application. This online application is, however, the only way to complete a valid HPDC Third Party Preparer application.
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