Re: [PSES] ISO 13485-2016
Thanks everyone! On Wednesday, January 18, 2017 10:20 AM, Stephen Whalen wrote: All,I am helping a client with medical device manufacturing QMS. ISO 13485 - 2016 has been released however 2016 version is not listed as harmonized with EU. Does anyone know if 2016 version is acceptable now for CE approval?https://ec.europa.eu/growth/single-market/european-standards/harmonised-standards/medical-devices_en Regards,Stephen - This message is from the IEEE Product Safety Engineering Society emc-pstc discussion list. To post a message to the list, send your e-mail to All emc-pstc postings are archived and searchable on the web at:http://www.ieee-pses.org/emc-pstc.htmlAttachments are not permitted but the IEEE PSES Online Communities site at http://product-compliance.oc.ieee.org/ can be used for graphics (in well-used formats), large files, etc.Website: http://www.ieee-pses.org/ Instructions: http://www.ieee-pses.org/list.html (including how to unsubscribe) List rules: http://www.ieee-pses.org/listrules.htmlFor help, send mail to the list administrators: Scott Douglas Mike Cantwell For policy questions, send mail to: Jim Bacher David Heald - This message is from the IEEE Product Safety Engineering Society emc-pstc discussion list. To post a message to the list, send your e-mail to All emc-pstc postings are archived and searchable on the web at: http://www.ieee-pses.org/emc-pstc.html Attachments are not permitted but the IEEE PSES Online Communities site at http://product-compliance.oc.ieee.org/ can be used for graphics (in well-used formats), large files, etc. Website: http://www.ieee-pses.org/ Instructions: http://www.ieee-pses.org/list.html (including how to unsubscribe) List rules: http://www.ieee-pses.org/listrules.html For help, send mail to the list administrators: Scott Douglas Mike Cantwell For policy questions, send mail to: Jim Bacher: David Heald:
Re: [PSES] ISO 13485-2016
These OJ list updates are often long delayed. In fact, a 2016 standard might not yet have completed the endorsement process in CEN. With best wishes DESIGN IT IN! OOO – Own Opinions Only <http://www.jmwa.demon.co.uk/> www.jmwa.demon.co.uk J M Woodgate and Associates Rayleigh England Sylvae in aeternum manent. From: Stephen Whalen [mailto:scwha...@bellsouth.net] Sent: Wednesday, January 18, 2017 3:17 PM To: EMC-PSTC@LISTSERV.IEEE.ORG Subject: [PSES] ISO 13485-2016 All, I am helping a client with medical device manufacturing QMS. ISO 13485 - 2016 has been released however 2016 version is not listed as harmonized with EU. Does anyone know if 2016 version is acceptable now for CE approval? https://ec.europa.eu/growth/single-market/european-standards/harmonised-standards/medical-devices_en Regards, Stephen - This message is from the IEEE Product Safety Engineering Society emc-pstc discussion list. To post a message to the list, send your e-mail to mailto:emc-p...@ieee.org> > All emc-pstc postings are archived and searchable on the web at: http://www.ieee-pses.org/emc-pstc.html Attachments are not permitted but the IEEE PSES Online Communities site at http://product-compliance.oc.ieee.org/ can be used for graphics (in well-used formats), large files, etc. Website: http://www.ieee-pses.org/ Instructions: http://www.ieee-pses.org/list.html (including how to unsubscribe) <http://www.ieee-pses.org/list.html> List rules: http://www.ieee-pses.org/listrules.html For help, send mail to the list administrators: Scott Douglas mailto:sdoug...@ieee.org> > Mike Cantwell mailto:mcantw...@ieee.org> > For policy questions, send mail to: Jim Bacher mailto:j.bac...@ieee.org> > David Heald mailto:dhe...@gmail.com> > - This message is from the IEEE Product Safety Engineering Society emc-pstc discussion list. To post a message to the list, send your e-mail to All emc-pstc postings are archived and searchable on the web at: http://www.ieee-pses.org/emc-pstc.html Attachments are not permitted but the IEEE PSES Online Communities site at http://product-compliance.oc.ieee.org/ can be used for graphics (in well-used formats), large files, etc. Website: http://www.ieee-pses.org/ Instructions: http://www.ieee-pses.org/list.html (including how to unsubscribe) List rules: http://www.ieee-pses.org/listrules.html For help, send mail to the list administrators: Scott Douglas Mike Cantwell For policy questions, send mail to: Jim Bacher: David Heald:
Re: [PSES] ISO 13485-2016
All hail the Goddess of Search. March 2019 per https://standards.cen.eu/dyn/www/fp=204:110:0FSP_PROJECT,FSP_ORG_ID:37957,581003&cs=10ED77AEC2D379A0A511B4BB99F861487 Brian From: Stephen Whalen [mailto:scwha...@bellsouth.net] Sent: Wednesday, January 18, 2017 7:17 AM To: EMC-PSTC@LISTSERV.IEEE.ORG Subject: [PSES] ISO 13485-2016 All, I am helping a client with medical device manufacturing QMS. ISO 13485 - 2016 has been released however 2016 version is not listed as harmonized with EU. Does anyone know if 2016 version is acceptable now for CE approval? https://ec.europa.eu/growth/single-market/european-standards/harmonised-standards/medical-devices_en Regards, Stephen - This message is from the IEEE Product Safety Engineering Society emc-pstc discussion list. To post a message to the list, send your e-mail to All emc-pstc postings are archived and searchable on the web at: http://www.ieee-pses.org/emc-pstc.html Attachments are not permitted but the IEEE PSES Online Communities site at http://product-compliance.oc.ieee.org/ can be used for graphics (in well-used formats), large files, etc. Website: http://www.ieee-pses.org/ Instructions: http://www.ieee-pses.org/list.html (including how to unsubscribe) List rules: http://www.ieee-pses.org/listrules.html For help, send mail to the list administrators: Scott Douglas Mike Cantwell For policy questions, send mail to: Jim Bacher: David Heald:
Re: [PSES] ISO 13485-2016
Stephen, At this stage, the version of ISO 13485 required for approval to the Medical Devices Directive is EN ISO 13485:2012. The body of this standard is identical to ISO 13485:2003, and there are some additional EU appendices. I have heard from at least one Notified Body that they will not be accredited to audit to ISO 13485:2016 until the start of 2018, so at the moment you can't claim compliance to this standard alone. However, the solution is quite simple. You prepare the quality manual and procedures to ISO 13485:2016 and operate the quality system according to its requirements. You also make sure that the quality system is also compliant with ISO 13485:2003 and EN ISO 13485:2012. That's shouldn't be difficult, as the differences are minor. Then, in the scope section of the Quality Manual, you state that the quality system is intended to comply with ISO 13485:2003, EN ISO 13485:2012 and ISO 13485:2016, together with whatever other regulatory requirements you need. Regards, Jon Griver http://www.601help.com The Medical Device Designer's Guide to IEC 60601-1 From: Stephen Whalen [mailto:scwha...@bellsouth.net] Sent: 18 January 2017 17:17 To: EMC-PSTC@LISTSERV.IEEE.ORG Subject: [PSES] ISO 13485-2016 All, I am helping a client with medical device manufacturing QMS. ISO 13485 - 2016 has been released however 2016 version is not listed as harmonized with EU. Does anyone know if 2016 version is acceptable now for CE approval? https://ec.europa.eu/growth/single-market/european-standards/harmonised-standards/medical-devices_en Regards, Stephen - This message is from the IEEE Product Safety Engineering Society emc-pstc discussion list. To post a message to the list, send your e-mail to mailto:emc-p...@ieee.org> > All emc-pstc postings are archived and searchable on the web at: http://www.ieee-pses.org/emc-pstc.html Attachments are not permitted but the IEEE PSES Online Communities site at http://product-compliance.oc.ieee.org/ can be used for graphics (in well-used formats), large files, etc. Website: http://www.ieee-pses.org/ Instructions: http://www.ieee-pses.org/list.html (including how to unsubscribe) <http://www.ieee-pses.org/list.html> List rules: http://www.ieee-pses.org/listrules.html For help, send mail to the list administrators: Scott Douglas mailto:sdoug...@ieee.org> > Mike Cantwell mailto:mcantw...@ieee.org> > For policy questions, send mail to: Jim Bacher mailto:j.bac...@ieee.org> > David Heald mailto:dhe...@gmail.com> > - This message is from the IEEE Product Safety Engineering Society emc-pstc discussion list. To post a message to the list, send your e-mail to All emc-pstc postings are archived and searchable on the web at: http://www.ieee-pses.org/emc-pstc.html Attachments are not permitted but the IEEE PSES Online Communities site at http://product-compliance.oc.ieee.org/ can be used for graphics (in well-used formats), large files, etc. Website: http://www.ieee-pses.org/ Instructions: http://www.ieee-pses.org/list.html (including how to unsubscribe) List rules: http://www.ieee-pses.org/listrules.html For help, send mail to the list administrators: Scott Douglas Mike Cantwell For policy questions, send mail to: Jim Bacher: David Heald:
Re: [PSES] ISO 13485-2016
Forgot to say that, while the 2016 edition can be used now, accreditation and reports per 2016 edition dependent on your particular registrar update schedule, lunar phase, and planetary alignments relative to the Klingon Home-world. https://standards.cen.eu/dyn/www/f?p=204:110:0FSP_PROJECT:37957&cs=1B04E3A6EA841FF02235DCA86690F765D Brian -Original Message- From: Brian O'Connell Sent: Wednesday, January 18, 2017 8:27 AM To: 'Stephen Whalen'; EMC-PSTC@LISTSERV.IEEE.ORG Subject: RE: [PSES] ISO 13485-2016 All hail the Goddess of Search. March 2019 per https://standards.cen.eu/dyn/www/fp=204:110:0FSP_PROJECT,FSP_ORG_ID:37957,581003&cs=10ED77AEC2D379A0A511B4BB99F861487 Brian From: Stephen Whalen [mailto:scwha...@bellsouth.net] Sent: Wednesday, January 18, 2017 7:17 AM To: EMC-PSTC@LISTSERV.IEEE.ORG Subject: [PSES] ISO 13485-2016 All, I am helping a client with medical device manufacturing QMS. ISO 13485 - 2016 has been released however 2016 version is not listed as harmonized with EU. Does anyone know if 2016 version is acceptable now for CE approval? https://ec.europa.eu/growth/single-market/european-standards/harmonised-standards/medical-devices_en Regards, Stephen - This message is from the IEEE Product Safety Engineering Society emc-pstc discussion list. To post a message to the list, send your e-mail to All emc-pstc postings are archived and searchable on the web at: http://www.ieee-pses.org/emc-pstc.html Attachments are not permitted but the IEEE PSES Online Communities site at http://product-compliance.oc.ieee.org/ can be used for graphics (in well-used formats), large files, etc. Website: http://www.ieee-pses.org/ Instructions: http://www.ieee-pses.org/list.html (including how to unsubscribe) List rules: http://www.ieee-pses.org/listrules.html For help, send mail to the list administrators: Scott Douglas Mike Cantwell For policy questions, send mail to: Jim Bacher: David Heald:
[PSES] ISO 13485-2016
All,I am helping a client with medical device manufacturing QMS. ISO 13485 - 2016 has been released however 2016 version is not listed as harmonized with EU. Does anyone know if 2016 version is acceptable now for CE approval?https://ec.europa.eu/growth/single-market/european-standards/harmonised-standards/medical-devices_en Regards,Stephen - This message is from the IEEE Product Safety Engineering Society emc-pstc discussion list. To post a message to the list, send your e-mail to All emc-pstc postings are archived and searchable on the web at: http://www.ieee-pses.org/emc-pstc.html Attachments are not permitted but the IEEE PSES Online Communities site at http://product-compliance.oc.ieee.org/ can be used for graphics (in well-used formats), large files, etc. Website: http://www.ieee-pses.org/ Instructions: http://www.ieee-pses.org/list.html (including how to unsubscribe) List rules: http://www.ieee-pses.org/listrules.html For help, send mail to the list administrators: Scott Douglas Mike Cantwell For policy questions, send mail to: Jim Bacher: David Heald:
