ISO 9000 and the Law

James W. Kolka

ISO 9000 and Liability Exposure

   All products pass through preproduction, production, and postproduction phases of development. Each phase has generated liability lawsuits.

   Preproduction includes product design, risk analysis, hazards analysis, foreseeable use and misuse, human factors analysis, instructions and warnings, packaging (a specific concern of FDA and the EU for medical devices), product liability insurance considerations, and record retention. Production includes all phases of manufacturing: quality management procedures, manufacturing processes, subcontracting (including supplier management), packing, handling, storage, and delivery. Postproduction includes servicing, customer relations (including feedback and complaints), promotional materials, product warranties and contracts, accident reporting, failure analysis, and corrective action, such as product recalls.

   The phases are not discrete and, in fact, overlap. For example, while product design may examine foreseeable use and misuse, in the hands of customers products are often used in a manner not envisioned by designers. The only way to deal with this reality is a feedback system that provokes product reevaluation, redesign, and possible recall when critical safety issues are involved.

   Likewise, several products are both manufactured and serviced by the same company or different units of a parent company. Consequently, production and postproduction overlap and likely will reach back to preproduction design issues. The breakdown into three phases is derived from cases and literature discussing product liability lawsuits and decisions. Clearly, it parallels clauses of ISO 9001, including design control, contract review, purchasing, process control, inspection and testing, control of nonconforming product, corrective and preventive action, handling, storage, packaging and delivery, training, servicing, and statistical techniques. To this list could be added clauses from ISO 9004-1.

   Recordkeeping is essential. In today's legal environment, that which cannot be documented does not exist. ISO 9001 deals with data, document control, and quality records from the perspective of the quality management system. Recordkeeping, on the other hand, deals with these matters from the perspective of defending a company in the event of a lawsuit. Manufacturers must concentrate on records that would be basic to a legal defense.

   For example, a company that diligently addresses safety in product design but fails to retain records that prove it did so shoots itself in the foot. Quite often these questions arise years after the initial design. Unfortunately, several companies have learned this lesson the hard way. They retain staff counsel and/or employ law firms to defend them in suits concerning products that haven't been manufactured for years and for which they have no useful records.

What To Do?

   A company must review its ISO 9000 quality management system with an eye to the creation of a preventive law program, asking the following questions:

• What records are important?
• What steps need to be documented for product design?
• How do we prove that we control raw materials and component parts that are used in our products?
• Is product software validated? How?
• Do we have an effective feedback system that addresses product failures or inadequate warnings and instructions?
• How is marketing presenting our products to prospective customers?
• What records should we retain?

  The liability exposure is already there. The question is what to do about it before legal discovery, depositions, and a trial. It is best to follow the Boy Scout motto, "Be Prepared!"

   James W. Kolka, PhD, JD, is a senior consultant with Excel Partnership Inc. He received his BS in political science (economics/chemistry) from the University of Wisconsin–Eau Claire; JD from the University of Wisconsin's Madison Law School with a background in product liability and environmental law; and a PhD in political science and international affairs from the University of Kansas. He has been a member of the Wisconsin Bar for 35 years. His most recent book is ISO 9000: A Legal Perspective.

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