Publicatie van de Maand: Juni 2000

Tekst overgenomen met toestemming van:
ISO-BULLETIN, juni 2000 (COMMENT)

Geschreven door: John L. Donaldson, Chairman CASCO (ISO Committee on Conformity Assessment)



Incorporating conformity assessment considerations in standards development

Do you participate in any of the 187 technical committees of ISO? Did you contribute to the development of any of the 12524 standards published by ISO? Are suppliers of products, processes, services, or systems expected to use the standard you have helped to develop? Will these suppliers or their customers want to be able to confirm that what the customers are receiving meets "your' 'standard? In other words, are conformity assessment procedures likely to be associated with the use of "your' ' standard?

If your answer to these questions is "yes", then this comment is intended for you. There are two ways in which you as a standards developer may be interested in conformity assessment, i.e. the process whereby conformance with a standard is demonstrated. First, a standard needs to be suitable to serve as a basis for conformity assessment applications. You may also need to specify conditions for conformity assessment procedures that relate uniquely to the use of your standard within your specific industrial sector. For both of these concerns, ISO has guidance for technical committees on how to incorporate conformity assessment considerations in standards development.

ISO procedures for standards development, namely, the ISO/IEC Directives, anticipate that standards developers may not know as much about conformity assessment as might be useful to them, The Directives establish that CASCO, the ISO Conformity Assessment Committee, has a responsibility to ensure that committees have the help they need to address conformity assessment aspects of standards development knowledgeably.

You are the standards developer. CASCO conformity assessment experts cannot and do not tell you how to write your standards, but they can and do offer you suggestions of what to take into account if you want to produce a technical standard that is more likely to be suitable for conformity assessment applications, This guidance has been documented in ISO/IEC Guide 7:1994, Guidelines for drafting of standards suitable for use for conformity assessment.

CASCO is responsible for the development of general conformity assessment standards. Your technical committees, however, may develop conformity assessment standards when they are sector specific, i.e. their application is strictly Iimited to narrowly defined fields whose unique requirements justify the special development. When this situation arises, the Directives state that the technical committee should consult with CASCO in the development of its sector specific standard, and CASCO is expected to provide consultative advice in response.

The consultative process ensures, that ISO provides documentation that is robust and consistent Committee participants may not always be fully aware of all of CASCO documents and their content. If technical committees are to issue sector specific conformity assessment standards, ISO wishes to ensure these are not redundant with what is already available from CASCO. There needs to be some unique aged requiring the separate standard. In addition, the sector specific standards are expected to rely as much as possible on the existing CASCO generic documents and should cite them, as appropriate, among the specifications contained in the sector specific standard. CASCO is responsible for enabling technical committees to accomplish this requirement.

As a standards developer, you may well have realized that you are becoming increasingly involved with conformity assessment aspects in your standards development work Certainly CASCO is hearing from many more of you. As this workload intensifies, we realize that we must be better prepared to respond. As a result we have established a group to revise Guide 7 to improve its content, we are also considering how we might improve our responsiveness to requests with regard to proposals for sector specific schemes. We hope to have these available in the near future so we can better assist you. If you have suggestions for how we might accomplish this, please let us know.