RATIONALE
FOREWORD
1 SCOPE
2 REFERENCES
3 TERMS AND DEFINITIONS
4 QUALIFICATION PROCESS
5 MANDATED BODY REPRESENTATIVE REGISTRATION
6 QUALIFICATION PROCEDURE
7 QUALIFICATION ACTIVITY REPORT
8 QUALIFICATION BY ANALOGY OR GRANDFATHER PRODUCT
9 CERTIFICATION PROCEDURE
10 QUALIFIED PRODUCTS LIST
11 PRODUCT CERTIFICATION MAINTENANCE AND RENEWAL
12 MANUFACTURING CHANGE REQUEST FOR A SEALED
MANUFACTURING ROUTE
13 VALUE ADDED DISTRIBUTORS
14 QUALITY FAILURES, NONCOMPLIANCE, AND CUSTOMER
COMPLAINTS
15 NOTES
APPENDICES
APPENDIX A - ACRONYM LOG
APPENDIX B - MANDATED BODY - PRODUCT
QUALIFICATION ACTIVITY REPORT (EXAMPLE)