Steve ISO requires that you follow your own procedures. What do your internal procedures require? You will probably find that the ISO requirements are less stringent than the restrictions from internal specifications that were written to satisfy the ISO requirements. ISO9001-1994 merely requires documented procedures defining the manner of production, installation, and servicing, where the absence of such procedures could adversely affect quality (4.9 (a)) ISO 9001-2000 requires the availability of work instructions, as necessary (7.5.1 (b)) This leads to the obivous question of "What's a work instruction?" The answer is that it is the instructions needed to perform the function properly. Work instructions can take the form of formal step-by-step instructions, flow charts, pictures, prints, or who knows what. In other words, it's up to you to define and justify what is necessary to ensure quality to comply with ISO requirements. Keep in mind that specific customer or regulatory agency requirements may place additional restrictions on your freedom of choice. Just my opinion. I'm sure others will offer variations or contradictory advice. In the end it's up to each organization to define the processes and procedures needed to achieve customer satisfaction. Documents like ISO provide an outline of the elements of an effective quality system. For the most part, they don't dictate the particulars of how the elements must be implemented. Don Vischulis -----Original Message----- From: TechNet [mailto:[log in to unmask]]On Behalf Of Steve Gregory Sent: Tuesday, June 03, 2003 8:08 PM To: [log in to unmask] Subject: [TN] ISO and prototypes.... just curious...how do you deal with ISO and prototypes? Do you do full-blown work instructions? Try to run things through normal production processes, so that you have traceability? Or do you you treat it as it is, a prototype? Going through some stuff here...thinking that we put more stuff into prototypes than we need to...just curious what everybody else does...I have my past experience, but that's not good enough. Like to hear from everybody else... -Steve Gregory- --------------------------------------------------- --------------------------------------------------- Technet Mail List provided as a free service by IPC using LISTSERV 1.8e To unsubscribe, send a message to [log in to unmask] with following text in the BODY (NOT the subject field): SIGNOFF Technet To temporarily halt or (re-start) delivery of Technet send e-mail to [log in to unmask]: SET Technet NOMAIL or (MAIL) To receive ONE mailing per day of all the posts: send e-mail to [log in to unmask]: SET Technet Digest Search the archives of previous posts at: http://listserv.ipc.org/archives Please visit IPC web site http://www.ipc.org/html/forum.htm for additional information, or contact Keach Sasamori at [log in to unmask] or 847-509-9700 ext.5315 -----------------------------------------------------