37 / 65
6.
Performance Tested Methods
SM
Review Agreement
7.
Check List
8.
General Criteria for Independent Laboratories
9.
Independent Laboratory Contract
10.
Method Developer Agreement for Independent Testing
11.
Method Validation Study Report Format Example
12.
Package Insert Requirements
13.
Certificate
14.
Certification Mark License Agreement
15.
Annual Renewal Application Form
16.
Re-Instatement Application Form
17.
Method Modification Review Form
18.
Test Method Definitions and Modifications Guideline
19.
Performance
Tested Methods
SM
Reviewed & Recognized Application
20.
Trade Secret Non-disclosure Policy
21.
Policy and Procedure on Volunteer Conflict of Interest
22.
Anti-Trust Policy Statement and Guidelines
23.
Flow Charts
Form Flowchart 1: Program Overview
Flowchart 2: Consulting Procedures
Flowchart 3: PTM Application Review
Flowchart 4: Independent Test Site Procedures
Flowchart 5: Validation Study Report Review
Flowchart 6: Post Certification Process Flowchart