Medical Device & Diagnostic Industry Magazine
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Originally Published January 2000

HELP DESK

Susan B. Jacobs, CQA, a senior quality systems specialist with Medical Device Consultants Inc. (North Attleboro, MA), and program chair for the ASQ Biomedical Division, discusses upcoming changes to the ISO 9000 standards.

How will the year 2000 ISO 9000 revision affect the medical device industry?

The three current quality assurance models (ISO 9001, ISO 9002, and ISO 9003) and the quality management guideline (ISO 9004-1) will be replaced with what is being referred to as a "consistent pair" of standards. One of these will deal with quality assurance requirements and the other with the broader topic of quality management. A third document addressing quality fundamentals and vocabulary is under revision. When finished, the three documents will be:

The 20 elements we became so familiar with in the 1987 and 1994 versions of ISO—the same elements around which many companies have built their documented quality systems—will become a thing of the past. Those memorable 20 elements will be merged into a new structure that is composed of four chapter topics, referred to as the four-phase process models:

If your firm is registered to the soon-to-be- obsolete ISO 9002 or ISO 9003 standards, or to the current ISO 9001 standard, your quality system has the foundation in place to make the transition to the new ISO 9000 standard for the year 2000, according to its authors.

It is likely that a significant portion of the revised ISO 9000 standard may not be applicable to the medical device industry seeking to demonstrate compliance with the FDA quality system regulation and European medical device directives. The emphasis on continual improvement, customer satisfaction, certain concepts of the process model, and the reduction in scope make the use of the new ISO 9001 unsuitable as a regulatory tool. Through participation in the Global Harmonization Task Force, FDA has acknowledged the merits of the requirements for better quality systems but has expressed concern that difficulties may well arise when such concepts are used in a regulated environment with legal consequences for nonconformity. EN 46000 and ISO 13485/13488 will be revised in the future to cover requirements that may not have been addressed.

The revised ISO 9000 family of standards is scheduled for release by the end of the year 2000.

"Help Desk" solicits questions about the design, manufacture, regulation, and sale of medical products and refers them to appropriate experts in the field. A list of topics previously covered can be found in our Help Desk Archives. Send questions to Help Desk, MD&DI, 11444 W. Olympic Blvd., Ste. 900, Los Angeles, CA 90064, fax 310/445-4299, e-mail [email protected]. You can also use our on-line query form.

Although every effort is made to ensure the accuracy of this column, neither the experts nor the editors can guarantee the accuracy of the solutions offered. They also cannot ensure that the proposed answers will work in every situation.

Readers are also encouraged to send comments on the published questions and answers.

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