SAMPLE COMPANY                                       Page 1 of 6
SOP # 04-3  Revision: 0               Prepared by:             _
Effective Date:                       Approved by:             _



Title:         Engineering Change/Document Change Control

Policy:   The Control of changes to devices, processes and the
          associated master records is one of the most important
          elements of a quality assurance system.  Therefore, it
          is company policy that all changes MUST be made
          according to approved Engineering Change/Document
          Change Control Notices.

Purpose:  The purpose of this procedure is to outline the steps
          and responsibilities to request changes to products or
          processes and the implementation of those changes to
          assure an orderly, controlled and a 100% effective
          change to all aspects of the manufacture of a device
          and all related documentation.

Scope:    This procedure applies to all manufacturing processes
          and products manufactured by the Company.
          Specifically, Change Control applies to: components,
          including software; labeling and packaging; devices;
          processes; production equipment; manufacturing
          materials; and all associated documentation such as
          standard operating and quality assurance procedures,
          data forms and product-specific documentation.  These
          documents constitute the Device Master Record.
          Therefore much of the discussion herein is centered
          around the Device Master Record.

          These procedures are to be followed From the time the
          master record is first released for production of a
          device for all changes to the in-process device or the
          associated manufacturing processes through
          implementation of changes to all appropriate
          documents.

          Significance:  Change Control is a Complex process.
          However, failure to have an adequate change control
          system can have equally "Complex" results.  Inadequate
          change control can expose the Company to product
          liability actions, result in product recalls, cause
          confusion internally and to customers and is a serious
          violation of the Good Manufacturing Practices
          regulation.
ENGINEERING CHANGE/DOCUMENT CHANGE CONTROL           Page 2 of 6


Procedures:

1.0  Request for Design and/or Process Changes

1.1  All personnel in the Company are encouraged to be involved
     in product and process improvement. To facilitate this
     process and to allow management to assign priorities to
     various tasks, a Request for Engineering Action (REA) form
     (Exhibit 1) should be used for all intended or desired
     changes.

1.2  The REA form should be completed by the originator with as
     much detail as necessary to adequately describe the reason
     for request and proposed recommendations.  Additional
     documentation can be attached to provide increased clarity
     or further information.

1.3  The REA will then be forwarded to Engineering, where a
     sequential REA # will be assigned for tracking purposes.
     Engineering and the Company's President will be responsible
     for evaluating the viability of the request.

1.4  A meeting will be set to review, evaluate and determine the
     proposed plan for implementation or resolution of the REA.
     The following functional areas will be evaluated for the
     impact of the REA.

     A.   Product Management - Product Management shall be
          evaluated to determine the effect of changes on
          marketability, field information, catalogs, price
          lists, data sheets, and gross profit margin.  Product
          Management must verify the suitability of each change
          in the international as well as the domestic
          marketplace.

     B.   Field Service - Field Service shall be evaluated to
          determine the: time required to implement the change
          in the field; availability of components and
          assemblies for retrofit; impact of the change on
          service manuals; and adjustments to service stock.
          Field Service will make the changes in the areas under
          their jurisdiction and pass other defined tasks to
          appropriate departments.

     C.   Quality Assurance - Quality Assurance shall be
          evaluated to determine the effect of all changes on
          test requirements and on overall quality of our
          products plus compliance with customer, corporate and
          regulatory agency requirements.
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     D.   Manufacturing - Manufacturing shall be evaluated to
          determine component and raw material availability,
          break-in point, effect on material-on-order, material-
          in-process and material-in-stock.  Manufacturing shall
          determine total cost to the Manufacturing Department
          of implementing each change.

     E.   Engineering - Engineering is responsible for making
          certain that the change is technically feasible and
          complies with appropriate company and customer
          specifications and with accepted standards.  Every
          major change must be fully tested and the results
          documented by Engineering before it becomes a change
          order.  A change may be tried in Manufacturing on a
          limited pilot production basis before final approval
          and implementation in full-scale production.  None of
          the trial units may be shipped until the change has
          received final approval.  If, as the result of such
          trial production, the change is altered or modified
          before final approval, all of the trial units must be
          changed to the final form before shipment.

     F.   Finance - Finance shall be evaluated to make certain
          that all financial aspects have been considered.

1.5  For minor product/process changes and/or changes in
     documentation only, the REA process may be skipped and the
     change implemented by the ECN and DCC procedures of this
     SOP.

2.0  Engineering Change Notice and Document Change Control

2.1  Upon successful evaluation design, development, testing and
     authorization of a change, an ECN (Exhibit 2) will be
     completed to "order" the change and begin implementation.

2.2  Part I of the ECN will be completed, authorized and
     assigned a sequential number for tracking, logging, and
     filing purposes.

2.3  To implement a change and ensure that all related
     documentation is updated, the Document Change Control (Part
     II) must be completed.  The Engineering documentation
     section shall have overall responsibility for coordinating,
     scheduling and executing documentation changes.

2.4  When updating documentation the designated individuals will
     also be responsible for purging all originals and working
     copies of the obsolete documentation to avoid any confusion
     or misuse of the wrong document.  A copy of the obsolete
     document will be retained and stored as appropriate for
     archive files.