8/22/2019 Certificate HE 6310 2 SCHERING

1/3

Company Confidential NUMBER: 10-8503

SYSTEMS

SERVICES GregWeddle

PAGE: 1 of 3

ISSUE DATE: 9/5/00

OWNER SUPERSEDES:

Validation Support Services PROCESS New

HANDBOOK

Certificate of Conformance

This document is used to prove that Johnson Controls, Inc uses Good Business Practices in their design, manufacture, and

development of products. It also is intended to show that Johnson Controls, Inc is ISO9001 certified for design and

development, while ISO9002 certified for manufacturing and distributing the attached products (attach a product list for the

project you are submitting this Certificate of Conformance).

163240351.doc

8/22/2019 Certificate HE 6310 2 SCHERING

2/3

C e r t i f i c a t e o f C o n f o r m a n c e

It is hereby certified that the items or services listed on the following reference document comply with specific requirements

detailed on the document or described below.

Purchaser: SCHERING PLOUGH

Reference Document: REMODELACION G.M.P.ISO Certification / Quality / Life Cycle Support

Johnson Controls Products: HE6310-2 Humidity and Temperature Sensor

Operation Conditions: 0% to 100% 32 to 140F

Accurancy: @70F(21.1C) 3% RH for 5% to 95% RH

Nickel 0.34F (0.18C)

Specific Requirements:

This document is used to prove that Johnson Controls, Inc uses Good Business Practices in their design, manufacture, and

development of products.

The HE6310-2 Humidity and Temperature Sensor supplied to the referenced job have been designed to meet or exceed

generally accepted performance/reliability standards for commercial grade products. The respective facility(s) responsible

for the Design and Development processes have been certified by independent auditors to have met ISO 9001 standards. Thedesign process for both software and hardware products includes design validation, version and change controls.

The HE-6310-2 product manufactured by JCI have been subjected to various assembly, inspection, measuring, testing and

control processes in a JCI manufacturing facility certified by an independent auditor to have met ISO 9002 standards. All

HE-6310-2 Humidity and Temperature Sensor manufactured products supplied to the referenced job have been 100% tested

to meet published performance and accuracy specifications.

The measurement and test equipment used in each manufacturing process is maintained and calibrated in keeping with the

accuracy requirements of the product. Calibration standards used in these processes are traceable to the National Institute ofStandards and Technology.

Products purchased by Johnson Controls from have been subjected to various inspection and/or test processes by a JCI ISO

9002 certified facility to assure products meet applicable performance specifications.

Certified by: Signature

Name

Charles S. RothTitle

SP Quality Systems & ProcessesDate

February 23, 2000

8/22/2019 Certificate HE 6310 2 SCHERING

3/3