I think you're misunderstanding the function of the MRA's. MRA's allow non-EU states to designate testing and accreditation bodies on their own territory as Notified Bodies. Normally, in the absence of an MRA, a Notified Body has to be located on EU soil since EU Member States can only designate bodies within their own territory.
To become designated under the MRA, testing and accreditation bodies will need to be accredited by the non-EU country's national accreditation service, and as such will need to comply with the national rules for accreditation, which will in practice include a requirement for test equipment to be calibrated at appropriate intervals. MRA's do not have a great deal of relevance to most manufacturers selling goods into the EU since unless they are dealing with a type of product which requires notified body involvement or have customers who demand third party certification as a condition of sale, they can please themselves how they demonstrate compliance with the CE marking directives. Regards Nick. At 4:31 pm -0500 16/3/06, Mike Hopkins wrote: >It's my understanding that the MRA's require >that test instruments used for compliance to >European Norms be calibrated by an accredited >lab --- in the US, NVLAP, A2LA, and (another?). > >As a manfacturer, we recommend our products be >calibrated yearly. ISO 17025 includes clause >5.10.4.4, which states: "The calibration >certificate (or calibration lable) shall not >contain any recommendation on the calibration >interval except where this has been agreed with >the customer. This requirement may be superseded >by legal regulations." ISO 17025 is, of course, >the basis of accreditation to NVLAP or A2LA and >others... > >My question to the group is: Is there some >requirement under the MRA's or European Norms >that states equipment must be calibrated >periodically, and is "periodically" defined?? It >seems to me allowing the customer to decide on >when calibration is due (per ISO) can lead to >no requirement for calibrations at all, which in >turn, puts the whole accreditation issue in >questionŠ.. I find this hard to believe, but I >haven't identified a paragraph makes it clearŠ. > > > >Best Regards, > >Michael Hopkins >Manager, Customer Technical Center >Process Instruments Division >Thermo Electron Corporation >One Lowell Research Center >Lowell, MA 01852 >Tel: +1 978 275 0800 ext. 334 >Mobile: +1 603 765 3736 >[email protected] ><file://www.thermo.com/esd>www.thermo.com/esd > - This message is from the IEEE Product Safety Engineering Society emc-pstc discussion list. Website: http://www.ieee-pses.org/ To post a message to the list, send your e-mail to [email protected] Instructions: http://listserv.ieee.org/request/user-guide.html List rules: http://www.ieee-pses.org/listrules.html For help, send mail to the list administrators: Scott Douglas [email protected] Mike Cantwell [email protected] For policy questions, send mail to: Jim Bacher: [email protected] David Heald: [email protected] All emc-pstc postings are archived and searchable on the web at: http://www.ieeecommunities.org/emc-pstc
