MCS documentation (manuals, procedu

MCS documentation (manuals, procedures, work instructions and records), and reviews/audits. Risk level (as was significance with ISO 14001) is and will remain a very subjective subject and is sure to be the cause of much discussion.
An example of the interaction between key activities and risk is the
following:

334 MATERIAL COMPLIANCE SYSTEMS

Key activity—Export of radioisotopes from the United States.
Risk—Significant risk as the goods are covered by EAR as they may be
used for other purposes.
Objective—To ensure all shipments of radioisotopes are screened for both
end use and end users.
Documentation—Requirement to create a customer profile (as per BIS
EMS Guideline, Appendix A—Customer guidance) and procedures for conducting screening of transactions (as per BIS EMS Guideline—Screening Elements).

Summaries of both the BIS EMS Customer Guidance and Screening Elements are presented in Section 9.4.4 of this chapter.


9.3.2 Legal and Other Requirements
Both ISO 14001 (Section 4.3.2—Legal and Other Requirements) and BIS
Export Management System Guidelines (Screening Elements) require com- panies to have a procedure(s) in place to identify and access all legislation related to ensuring compliance. The "Legal and Other Requirement" has no equivalent within ISO 9001. QS-9000, Section 4.6—Purchasing, contains addi- tional requirements (not required by ISO 9001) relating to "All materials used in part manufacture shall satisfy current governmental and safety constraints on restricted, toxic and hazardous materials; as well as environmental, electri- cal and electromagnetic considerations applicable to the country of manufac-
ture and sale."
ISO 14001 also requires companies to have a procedure(s) for identifying information on other requirements to which it subscribes. This is especially important when operating in jurisdictions in which there may not be ample legislation and hence guidance is required via company's own best manage- ment practices or industry association standards.
We are proposing that the concepts put forward in the ISO 14001 be adapted in a MCS. Based upon our experience in reviewing organizations,
those that operate effectively employ procedures that:

• List the sources from which the legislation (all legislation, not just for U.S.
facilities) is obtained on an ongoing manner (e.g., U.S. Export Adminis- tration Bulletin updates and Federal Register notices identifying parties'
added/deleted from the Denied Persons List)
• Frequency of update
• Name of individual(s) responsible for review and assessment of potential
impact on the organization
• Method of communicating said changes in legislation and corresponding
impact to appropriate personnel within the organization