1. Company Confidential 1 9104/1 Status Mike Roberts 14 Sept. 2010

2. Company Confidential Status: 9/14/2010

3. Company Confidential 9104/1 Tentative Schedule (Part 1)

4. Company Confidential 9104/1 Tentative Schedule (Part 2)

5. Company Confidential Executive Decisions IAQG LT / SWG Sanctioned ‘Special Team’ To Define “Sites” and Auditor Day Requirements –Five Categories of Site ‘Certification Structures’ »Single Site »Multiple Site »Campus »Several Site »Complex –Table 2 from Previous Ballot Remains the Same –Table 6 from Previous Ballot Remains the Same

6. Company Confidential Executive Decisions (Continued) 9104/1 Book Bosses Sent to the 9104/1 TL, the Reviewed Comments for All 29 Sections and Chapters of the Standard. –Many comments implemented –Several comments rejected »Example: Did not change 8 hour Audit Day Still Working to Integrate the 18 Page Document Incorporating the New Requirements from the ‘Special Team’. –Causing some document structure changes »Table 2 becomes Table 3

7. Company Confidential Executive Decisions (Continued) 9104/1 TL, OPMT Chair, and Sect. 8 Book Boss decided to simplify Section 8.2.2.h (multiple certifications, additional certifications) –Removed confusion in calculating audit days. –Removed examples / tables that raised questions –Added simplified audit day calculation »Table[Total # employees] + 20% –May add examples

8. Company Confidential Executive Decisions (Continued) Time for filling out forms is not included in Audit Day Table (8.2.2.c), but we added: –“Note: The entry of data on the 9101 Obective Evidence Record (OER) during on site audit time is acceptable.” “Audit calculations shall round up to the nearest ½ day.” “Audit activity shall never be less than 1 audit day per site.”

9. Company Confidential Issues and Comments We have reduced auditor days for organizations with “no design”. But we also have a number of organizations with “no manufacturing”. Should we consider “no manufacturing” be an “or” criteria for the “no design” reduced audit day table column? There is nothing in the requirements that an AEA must close out a corrective action / finding. Should this be added to the upcoming 9104/1 draft? Notified that there may be some conflict between what 9101D and draft 9104/1 says about the certificate transfer process. (Comment referenced 4.3.6 and Special Audit Transfer / Pre-transfer review.

10. Company Confidential That’s All, Folks