Parts 8 & 9 have to do with quality control procedures and testing. I'm not really sure how to answer these questions. For folks that have been through this before, if you need to write up manufacturing test procedures, how extensive do they need to be? Are there any samples floating around so I could get an idea of what is required?
Code:
8.1 Attach, and identify as attachments to Part 8, samples
of documents that describe, specify, or relate to procedures or tests used to
ensure compliance of your reported product with the standard, including
compliance with all performance, labeling, and informational requirements.
These may include:
( ) specification controls for critical components,
( ) manufacturing and assembly control procedures,
( ) inspection and test control procedures,
( ) assembly and test traveler forms,
( ) inspection and test reports and checklists, and/or
( ) other(s) (specify):
8.2 If formal quality control and testing procedures have not been implemented or are not sufficient to assure that your product(s) will comply with the standard, explain how you assure that your products comply and submit supporting documentation.
NOTE: Section 1010.2(c) REQUIRES THAT CERTIFICATION BE BASED
ON A TEST, IN ACCORDANCE WITH THE STANDARD, OF EACH UNIT OR ON A PROGRAM
IN ACCORDANCE WITH GOOD MANUFACTURING PRACTICES. Failure to maintain an
adequate testing program may result in disapproval of the program by CDRH.
Thanks,
Mike