ML19242B302
| ML19242B302 | |
| Person / Time | |
|---|---|
| Site: | 07100009 |
| Issue date: | 06/25/1979 |
| From: | Dietz G ISOMEDIX, INC. |
| To: | |
| Shared Package | |
| ML19242B298 | List: |
| References | |
| NUDOCS 7908070843 | |
| Download: ML19242B302 (2) | |
Text
-
9.
Design Control a.
Design activities ( comple ted) will be carried out in a planned, controlled anc. orderly mcnner.
b.
Measures have been estzblished to correctly translate applicable regulatory r equirements and design bases into specifications, drawings, written procedures, and instructions.
(Note:
Design specifications are as outlined in para. 178.194 -- 1 through 7. )
Quality s tandards are specifie'd in the design documents, c.
and deviations and changes from these standards are controlled.
d.
The design is reviewed to assure that design characteris-tics can be controlled, inspected and tested, and inspection and test criteria are identified.
e as outlined in para c.
The design specificat 178.194-1 through 7, and d.
act require verification by Isomedix.
f.
Individuals within this organization are not designated for design verification, per para.
e.
above.
g.
Design and specification caanges, if required, will be subject to the same design controls and procedures
- able to the original design.
h.
Groups (which may be designated at a later time) responsible for design review or verification activities, with their applicable authority and responsibilities,
will be identified and controllcd by writ ten procedures.
haL
.?4 7908070f95
SUPPLEMENT #1 to Isomedi:t "QA PROGRAM FOR THE CONTROL AND SHIPMENT OF 20WC-5 SHIPPING CONTAISERS" Effective Date:
June 25, 1979 (Identified as page 5, para.
9, to basic document of May 15, 1975).
9 Concur by tr( / 9 L 6-25-79 sn'eral Manager Concur by ot4 Cf-5 0 6-25-79 Quality Assurance j
Approved by m Cw, 9 I_sa lf 6-25-79 Pre'{ident g
June 25, 1979 u (\\ l
~
. )Vs Lc