After Enron, holding CEOs' feet to the ISO fire

ISO certification has long been the requisite first step for entrance into specialized markets of automotive and medical device manufacturing.

Now it could also help processors comply with the Sarbanes Oxley Act.

Now in addition to its importance to OEMs from those industries, the rigorous auditing and record keeping ISO requires could fulfill another purpose for U.S. companies that undertake it, according to Lewis Yasenchak, business development manager for Orion Registrar, a third-party auditing firm that helps companies attain ISO certification.

"Section 404 of the Sarbanes Oxley Act requires the operational manager, which is the CEO or the highest-ranking person on the operational level, to record customer complaints, rejects, rework, and to have corrective actions in place to prevent reoccurrence of these," Yasenchak explains.

Held accountable

Passed in the wake of various corporate accounting scandals that exploded in 2001 and 2002, the Sarbanes Oxley Act, passed by the U.S. Congress, seeks to mitigate fraud by having executives of publicly traded companies sign off on all bookkeeping. But Yasenchak says that because of the strenuous accounting Sarbane''s demands, public companies can also use ISO to keep better track of items like customer complaints, plant safety, accidents, machinery maintenance, and shipping, to name a few, since all ultimately affect the bottom line.

In light of this change, and the new ISO 9001 addendum for automotive, QS 9000/TS 16949, and medical devices, ISO 13485, Yasenchak is working with processors to help them become compliant with the new standards.

He assists companies with assessments of their quality program, if they have one, or lays the groundwork to implement one if they don''t. The first step is to complete a comprehensive, six-page questionnaire that addresses several areas including the organization and philosophy of the quality plan if one exists, the quality plan''s documentation procedures, customer requirements, document control, inspection, and testing.

Beyond that, Yasenchak provides a nine-step quality management system (QMS) program that includes management orientation, assembly of a stakeholder team, flow charts for existing QMS, identification of ISO 9001 standards, process streamlining, procedure implementation, internal compliance audits, findings review, and strategizing.

Yasenchak says that many companies today that are forced to add ISO to their capabilities attempt to meet the standard by sending a quality control manager to a five-day course and then implement a "canned" program, which may or may not be detailed enough for the particular standards of plastics processing.

He is now working along with Orion Registrar, which is registered with the Food and Drug Administration (FDA) to perform third-party auditing of medical device manufacturers. Yasenchak has been with them since July 2004, promoting third party plastics registration, following 30 years in the industry at Johnson & Johnson and Hoechst-Celanese.

Getting specific

"The ISO 9001 2000 requires industry-specific information-plastics professionals talking to plastics professionals," Yasenchak says. "I want to steer the course to the owners of a company, because the standards require top management involvement and that''s not occurring."

Yasenchak strongly recommends executive involvement in any ISO program, and he cites several clients as success stories to reinforce this assertion. In 2003, he helped American Eagle Instruments Inc. (Missoula, MT), a dental instrument manufacturer, attain ISO 9001 and FDA dental/medical requirements in nine months. In the process, rework dropped by 12% and rejects fell 3%, according to Allen Dekmar, quality assurance manager and ISO coordinator for American Eagle.

From Section 404 of the Sarbanes Oxley Act, a portion of the new financial reporting requirements:

A statement of management''s responsibility for establishing and maintaining adequate internal control over financial reporting for the companyA statement identifying the framework used by management to conduct the required evaluation of the effectiveness of the company''s internal control over financial reportingManagement''s assessment of the effectiveness of the company''s internal control over financial reporting as of the end of the company''s most recent fiscal year, including a statement as to whether or not the company''s internal control over financial reporting is effectiveA statement that the registered public accounting firm that audited the financial statements included in the annual report has issued an attestation report on management''s assessment of the registrant''s internal control over financial reporting. Tony Deligio [email protected] Contact information
Orion Registrar Inc.   www.orion4value.com