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IEC 62366 - Medical Device Usability Engineering Process Maps, Process Mapping and Turtle DiagramsĪssessing Hazard-Related Use Scenarios where control measures exist through standards
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Interesting Discussion Where Does Marketing/ Advertisement of Products fit in to ISO 9001? Where does IATF 16949 address Process mapping? Gage R&R (GR&R) and MSA (Measurement Systems Analysis) Gage R&R - Where am I going wrong? Part of a FAIR submission (Aerospace) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards Records where apply and stop recording everything? Where to find Guidance Class II AmendmentĮN 301 489-1 and EN 301 489-17 - Where do we get the information of the Published versions? Other Medical Device Regulations World-Wide
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Where to find Regulations for Reprocessing and Reuse of Single-Use Devices Where to acquire EN 868-5 required dye (Amaranth red)? Where to place the what/when/how/who/where procedures in a multi-regulation AS9110C organisationĪS9100, IAQG, NADCAP and Aerospace related Standards and Requirements Where to draw the line for "sufficient evidence" to verify safety/performance of a device?ĬE Marking (Conformité Européene) / CB Scheme
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Quality Manual - Where does Revision History Section go?ĭocument Control Systems, Procedures, Forms and Templates Other ISO and International Standards and European Regulations Where do l get calibration standards to run a calibration lab? Where to buy Template / sample SCSMS Manual, checklist Travel - Hotels, Motels, Planes and Trains When Travel is allowed - Where are you going? Where does a coatings and paint company fall in IATF? Where is the definition of a critical supplier? Job Openings, Consulting and Employment Opportunities MDR requirement where unit of use packaging is too small for UDI carrierĭesign and Development of Products and ProcessesĪSQ, ANAB, UKAS, IAF, IRCA, Exemplar Global and Related OrganizationsĪny recommendations on where to find experienced quality hires in Chicago area? Question regarding where "validations" fit according to ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems IATF 16949 - Automotive Quality Systems Standardĭeviations - Where in ISO 13485 deviations are covered? Where do the definitions of the types of processes come from? Where do you place Human Factors report in a 510(k) application? Please take all my heavy talk with a big grin. Tell them to purchase their your own copy, it is part of the cost of doing business. When questioned on an issue, the answer to the question can be: What does the standard say about this? If the answer is vague, ask: From which paragraph in the standard did they get their data? If it is admitted that they were trying to make your product to a standard of which they have no copy, and thus no direct knowledge of your requirements, you win by pointing out their incompetence, but only if you own the standard, and, oh-by-the-way, you cannot give them a copy because it is copyrighted. It took some phone calls, but I did eventually get the whole thing printed, but I will not do that again.įifth, owning and knowing the standard will give you an upper hand in any quality debate. I later went back to the standard to print the whole file for my data records and was prohibited from doing so.
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Immediately upon receiving the download I printed the one page so I could finish my task. A real life example: I purchased a standard because I urgently needed to read one page. Basically you can only view the standard on the computer to which it was downloaded, and you can only print one copy of the standard. Again, the cost of the standard is minimal compared to the hidden costs of avoiding the purchase.įourth, I have been purchasing standards one at a time and I am finding that the copyright protection on the downloaded standards is getting very good. Third, and this almost never happens, but violation of copyright law can be costly.:mg: It is best for any company who needs a standard to just purchase the standard. Second, if your company has the design responsibility for a product and you specify compliance to a standard, you should own the standard.
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Your employer would be much better served to purchase the standard for the minimal charge, than to pay you for hours of internet searching to avoid the cost. The cost of supplying the data now is mostly from fees for purchase. Years past, the standards were compiled at taxpayer expense. First, the reason that the standards cost something to own is that then only the people who need to see the standard are paying for the privilege of having the technical data provided in such a concise manor.