|STEREOTAXIS, INC. filed this Form S-1/A on 05/12/2004|
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4. QUALITY REQUIREMENTS
4.1 CERTIFICATIONS AND ACCEPTANCE TESTS
Supplier agrees to certify that Items have passed all production acceptance
tests and configuration requirements as specified by Stereotaxis and to provide
to Stereotaxis, if required, raw materials certifications for all magnet
materials used in Items, a Certificate of Conformance and documentary evidence
of passing any specified Acceptance Test Procedures.
4.2 QUALITY REQUIREMENTS DOCUMENT
Stereotaxis will develop a quality requirements document for each Item pursuant
to this Agreement, defining all quality requirements and including all
applicable elements of the Item (a "Quality Requirements Document"). Supplier
will provide reasonable assistance to Stereotaxis in its development of a
Quality Requirements Document. Supplier agrees to comply with all quality
requirements defined by such Quality Requirements Document.
4.3 QUALITY SYSTEM
Supplier's quality system must be in compliance with ISO 9000. Certification to
ISO 9000 is desired.
4.4 QUALITY PROBLEMS
Should Stereotaxis identify a quality issue or problem on a component or
subassembly and request Supplier to implement containment action on the part
failure, Supplier shall, within 3 business days after receipt of Stereotaxis'
request, deliver to Stereotaxis a documented containment plan. Stereotaxis will
review the proposed plan and will promptly notify Supplier of acceptance or
revisions to the plan. Upon acceptance of the containment plan Supplier shall
commence implementation of plan and diligently proceed with implementation of
plan to completion. Supplier will substantiate this containment plan with a
closed loop corrective action identifying a permanent fix. Additionally,
Supplier will implement a preventative action plan, as necessary, to prevent the
occurrence of a quality issue or problem on a component or subassembly.
4.5 SUPPLIER AUDITS
At its option, Stereotaxis may conduct audits to ensure a high level of quality
of parts and assemblies purchased from Supplier. Such audit may include product,
process and/or system audits.
4.6 SOURCE INSPECTION
All Items purchased under this Agreement may be subject to source inspection and
test by Stereotaxis at Supplier's facilities at any time, including during the
period of manufacture and anytime prior to Stereotaxis' final acceptance.
Supplier will provide all reasonable facilities and assistance for the safety
and convenience of Stereotaxis' inspectors at no charge to Stereotaxis. The
parties may agree to conduct source inspection and test at an alternate
location. No preliminary inspection or test shall constitute acceptance. Records
of all inspection work shall be kept complete and available to Stereotaxis
during performance under this Agreement and for such further period as
Stereotaxis may determine. Performance of source inspection does not constitute
acceptance of the Items nor waive Supplier's responsibility for any defects that
might subsequently be identified by Stereotaxis or its customers.
4.7 SUB-TIER SUPPLIER QUALITY CONTROL
Supplier agrees to provide Stereotaxis with a quality plan for the selection,
control and maintenance of its sub-tier suppliers (which shall include special
process suppliers). The quality plan will include requirements for Supplier to
conduct periodic quality testing of sub-tier supplier parts and to validate
compliance with Stereotaxis' Specifications. Supplier shall demonstrate
compliance to its quality plan by (i) establishing and maintaining an approved
supplier list of sub-tier suppliers that have passed an on-site quality audit
and (ii) confirming that there are no open corrective actions resulting from
Supplier's audit of sub-tier suppliers. Supplier will, upon Stereotaxis'
request, provide evidence that Supplier quality representatives have conducted
periodic sub-tier supplier on-site audits and have confirmed with sub-tier
suppliers that all sub-tier supplier corrective actions resulting from Supplier
quality audits are closed in a timely manner. At
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