Will ISO 9001 Still Apply For the Medical Device Industry?

Concerns are resolved at meeting in Kyoto

by Joe Tsiakals

For the last 10 months International Organization for Standardization Technical Committee (ISO/TC) 210, quality management and corresponding general aspects for medical devices, has been revising ISO 13485:1996, Quality systems--Medical devices--Particular requirements for the application of ISO 9001,1 to become a standalone document independent from ISO 9001.

This work had the potential to cause the medical device quality systems requirements to diverge from the basics of ISO 9001--something that ISO directives actually do not allow for. But today this situation appears to be on the path of being reversed due to the recent successful Kyoto, Japan, meeting of ISO/TC 176, quality management and quality assurance, the ISO committee responsible for the revision of the ISO 9000 series of quality management standards.

Delegates from more than 50 nations and liaison organizations were in attendance at the ISO/TC 176 June 28 to July 9 meeting. The purpose of the meeting was to address comments received on the draft revisions of the ISO 9000 series.

During more than a week of intense sessions, ISO/TC 176 addressed more than 4,000 comments on the draft international standards (DIS) of ISO/DIS 9000:2000, ISO/DIS 9001:2000 and ISO/DIS 9004:2000. The great majority of the comments dealt with clarity issues. In fact, to most readers, actual wording changes would appear to be minor. The underlying concepts and intent of the DIS remained unchanged.

In large part because of the carefully planned consensus building process for the Kyoto meeting, ISO/TC 176 was successful in addressing the medical device concerns, along with many others. This process involved the establishment of a Consensus Facilitation Group, the circulation of interim final draft standards, a review of critical issues against the interim final drafts and the holding of an open forum meeting midway through the week.

During the final plenary session there was overwhelming endorsement of the edits. The drafts proceeded to Final Draft International Standard (FDIS) status, on track for a December 2000 release of the new ISO 9000 series.

The medical device sector's influence

As a liaison organization, ISO/TC 210 had a disproportionate level of influence at this meeting for a number of reasons:

  • Official liaisons and the longstanding presence on ISO/TC 176 of key members employed by medical device companies or by medical device regulatory agencies.
  • The recognized importance of the medical device sector as a primary user of ISO 9001 by the leadership of ISO/TC 176.
  • The desire for ISO 9001 to remain appropriate for use by a regulated industry.

Officially, three liaison members represented ISO/TC 210, each working on one of the three writing teams for ISO 9001. Included among these three were the chairman of ISO/TC 210 and the convener of the ISO/TC 210 quality systems working group responsible for ISO 13485.

In addition, a key member of the ISO/TC 176 subcommittee for definitions is also a key member of ISO/TC 210 and employed by the Canadian medical device regulatory agency. Four other long-term, influential members of ISO/TC 176 are from the medical regulated sector.

Major user of ISO 9001

The medical device sector is recognized as a major user of ISO 9001. Changes to the standard can have serious implications for manufacturers since all of the major medical device regulatory jurisdictions base elements of their quality systems regulations on ISO 9001:1994 and ISO 9002:1994, either directly or indirectly.

In the European Union (EU), for example, manufacturers often demonstrate conformance with ISO 9001 and then EN 46001 (the EU equivalent of ISO 13485) to meet requirements of the EU's Medical Device Directive.

Regulations in the United States, Canada, Australia and Japan were written to harmonize with or directly use ISO 9001 and ISO 13485. What this means from a practical standpoint is that the vast majority of medical device manufacturers worldwide must comply with ISO 9001.

Today over 300,000 organizations are certified to the requirements of ISO 9001 or ISO 9002. Many more use the standards internally without subscribing to expensive, external audits. The motivation now, in many cases and certainly in the automotive, telecommunications and aerospace industries, is customer driven.

But the regulated sectors, though small, began the groundswell of acceptance for the ISO 9000 series that occurred in the late '80s when the EU adopted these quality system standards as a means of harmonizing regulations among the member states and lowering trade barriers.

The ISO 9000 series remains a key element of CE marking. ISO is very much aware of this relationship and strongly desires to maintain it. It is important that the ISO 9000 series continues to serve its role as a foundation for regulatory compliance. ISO/TC 176 has welcomed the comments and concerns of ISO/TC 210 about the planned changes to the ISO 9000 series.

Medical device sector concerns

The ISO medical device quality management committee had previously endorsed the continued development of a standalone version of ISO 13485 and of ISO 13488 at an appropriate future date. The 1996 version of ISO 13485 incorporates all of ISO 9001:1994, adding specific medical device provisions. ISO 13488:1996 is the corresponding medical device standard aligned to ISO 9002:1994.

The work on drafting a new ISO 13485 began in November 1999 in reaction to discontent with ISO/DIS 9001:2000, which was drafted at the September 1999 meeting of ISO/TC 176.

The new medical device standards would break the alignment to the ISO 9000 series. Instead of referencing the complete requirement clauses of ISO 9001, the working draft of ISO 13485 incorporated only some of the text of ISO/DIS 9001. Elsewhere it picked out text from the older ISO 9001 standard.

This action caused considerable concern. Divorcing ISO 13485 from its foundation of ISO 9001 would mean manufacturers could be forced to maintain separate, overlapping quality systems in order to conform to both standards.

The major objections of ISO/TC 210 to ISO/DIS 9001 involved the use of the terms "customer satisfaction" and "continual improvement" and the change to only one requirements standard instead of both 9001 and 9002 (9003 is not used by this industry) that exist with the 1994 versions. Although there were numerous other comments, all agreed that these were either minor or could be dealt with in the normal drafting of an aligned ISO 13485.

Customer satisfaction

Both medical device manufacturers and regulators have expressed a tremendous amount of concern about the use of the term "customer satisfaction" in the DIS, forgetting the fact that key aspects of customer satisfaction serve as the basis for ISO 9001:1994.

The second sentence of the 1994 standard (1.0 Scope) reads: "The requirements specified are aimed primarily at achieving customer satisfaction by preventing nonconformity at all stages from design through to servicing." In a similar vein, the 1994 standard under Management Responsibility (4.1.1 Quality Policy) states: "The quality policy shall be relevant to the supplier's organizational goals and the expectations and needs of its customers."

Significantly greater focus on defining customer needs, expectations and requirements was presented in the DIS. There was also a requirement to measure customer satisfaction and/or dissatisfaction. Incidentally, all medical device manufacturers are required to manage customer complaints. ISO 13485 requires measuring customer feedback.

Working closely with liaisons from ISO/TC 210, ISO/TC 176 made changes in the FDISs that provide significant clarifications:

  • A new definition of customer satisfaction has been prepared: "customer's opinion of the degree to which the customer's requirements have been fulfilled. Note: Customer complaints are a common indicator of customer dissatisfaction with a transaction, but their absence does not necessarily imply customer satisfaction."
  • It is now clearer that customer requirements must be determined and the more abstract concepts of determining customer needs and expectations will be left to ISO 9004:2000.
  • Measurement of customer satisfaction has been changed to measuring the customer "perception of whether or not the organization has met customer requirements as one of the measures of performance of the quality management system."

Continual improvement

One of the medical device community's main objections to the proposed ISO 9001 standard is its emphasis on continual improvement. Organizations are required to "plan and manage the processes necessary for the continual improvement of the quality management system."

The standard further states that continual improvement will be facilitated through "use of the quality policy, objectives, audit results, analysis of data, corrective and preventive action, and management review." Continual improvement is also mentioned under the standard's quality objectives and quality planning clauses.

The principle source of concern was that the definition for improvement in ISO/DIS 9000:2000 embraced both the concepts of effectiveness and efficiency. Effectiveness means meeting the requirements. Efficiency means using minimum resources when meeting requirements.

All agreed with the need for corrective and preventive action, the need for meeting the requirements for the quality management system and the need for enhancing the ability of the organization to continue to meet requirements. But concern with the use of the word "efficiency" remained.

The ISO 9001 writing teams then agreed that efficiency has never been an intended requirement for compliance to ISO 9001. ISO 9001, in requiring a system of processes, laid the groundwork for achieving efficiency, but did not require it. Efficiency as a principle is embraced by ISO 9004. The definition of continual improvement was changed to reflect this.

One requirements standard

Regulatory members of ISO/TC 210 have been upset with the concept of "permissible exclusions" as described in the scope of ISO/DIS 9001:2000 and used as the mechanism for achieving one requirements standard. They viewed this as something that organizations being audited should not be permitted to do.

Furthermore, they believed removing ISO 9002 from the ISO 9000 series would eliminate ISO 13488 and would result in wholesale confusion and require revamping of their approach for regulatory compliance.

The resolution of this issue was simple, and necessary actions are completely within the authority of ISO/TC 210. It was pointed out that the scope statement in ISO 9001 is not a normative requirement of the standard. ISO 13485:1996 has a unique scope that supplants the scope of ISO 9001:1994.

For medical device quality system purposes, ISO/TC 210 should require the inclusion of all of the requirements of ISO 9001 without any exclusions. This would be for use in ISO 13485. Additionally, ISO 13488 should still be used. It would reference the new ISO 9001:2000 but exclude the design/development and serviceability requirements in a similar fashion to the old ISO 9002 and ISO 13488.

The resolving of this issue required no changes to ISO/DIS 9001:2000. Instead, ISO/TC 210 will issue a new ISO 13485 and a new ISO 13488. The first should reference the entire set of requirements of the new ISO 9001. The second should reference all of the requirements of the new ISO 9001, excluding the requirements that have been excluded all along by ISO 9002.

Next steps

ISO/TC 210 will meet in September in Toronto. The members should be able to review the FDIS, consider the changes to the DIS and begin preparation of a fully aligned ISO 13485 and 13488 with target dates of 2002.

The likelihood of ISO/TC 210's rejecting the FDIS and continuing its efforts to break away from ISO 9001:2000 seems improbable due to the cooperation and compromises achieved in Kyoto.


1. ISO 13485:1996, Quality systems--Medical devices--Particular requirements for the application of ISO 9001 (Arlington, VA: Association for the Advancement of Medical Instrumentation, 1996).

JOE TSIAKALS is senior director of corporate quality, Amgen Inc., Thousand Oaks, CA. He is a member of the ISO/TC 176 writing team for ISO 9001:2000 and served in the same role for the development of ISO 9001:1994. He is one of the founding members of ISO/TC 210 and has more than 25 years of experience in quality management and engineering in regulated industry. Tsiakals co-authored the book ISO 9001:2000 Explained (Milwaukee: ASQ Quality Press, 2000). He can be contacted at tsiakals@amgen.com.

If you would like to comment on this article, please post your remarks on the Quality Progress Discussion Board, or e-mail them to editor@asq.org.

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