The Cove Business Standards Discussion Forums More Free Files Forum Discussion Thread Post Attachments Listing Cove Discussion Forums Main Page
EN ISO 13485:2016 or just ISO 13485:2016 without the "EN" as a prefix?
UL - Underwriters Laboratories - Health Sciences
EN ISO 13485:2016 or just ISO 13485:2016 without the "EN" as a prefix?
EN ISO 13485:2016 or just ISO 13485:2016 without the "EN" as a prefix?
EN ISO 13485:2016 or just ISO 13485:2016 without the "EN" as a prefix?
EN ISO 13485:2016 or just ISO 13485:2016 without the "EN" as a prefix?
EN ISO 13485:2016 or just ISO 13485:2016 without the "EN" as a prefix?
EN ISO 13485:2016 or just ISO 13485:2016 without the "EN" as a prefix?
EN ISO 13485:2016 or just ISO 13485:2016 without the "EN" as a prefix?
EN ISO 13485:2016 or just ISO 13485:2016 without the "EN" as a prefix?
EN ISO 13485:2016 or just ISO 13485:2016 without the "EN" as a prefix?
Go Back   The Elsmar Cove Business Systems and Standards Discussion Forums > > >
Forum Username

Elsmar Cove Forum Visitor Notice(s)

Wooden Line

EN ISO 13485:2016 or just ISO 13485:2016 without the "EN" as a prefix?


Elsmar XML RSS Feed
Elsmar Cove Forum RSS Feed

Monitor the Elsmar Forum
Sponsor Links




Courtesy Quick Links


Links Elsmar Cove visitors will find useful in the quest for knowledge and support:

Jennifer Kirley's
Conway Business Services


Howard's
International Quality Services


Marcelo Antunes'
SQR Consulting, and
Medical Devices Expert Forum


Bob Doering
Bob Doering's Blogs and,
Correct SPC - Precision Machining


Ajit Basrur
Claritas Consulting, LLC



International Standards Bodies - World Wide Standards Bodies

ASQ - American Society for Quality

International Organization for Standardization - ISO Standards and Information

NIST's Engineering Statistics Handbook

IRCA - International Register of Certified Auditors

SAE - Society of Automotive Engineers

Quality Digest

IEST - Institute of Environmental Sciences and Technology


Some Related Topic Tags
certification audits, certification certificate (content), en iso 13485:2012, iso 13485:2016
Reply
 
Thread Tools Search this Thread Rate Thread Content Display Modes
  Post Number #1  
Old 16th July 2017, 12:00 PM
SGquality

 
 
Total Posts: 257
Question EN ISO 13485:2016 or just ISO 13485:2016 without the "EN" as a prefix?

Hello,

We have EN ISO 13485:2012 certification and migrating to ISO 13485:2016 standard.

When I see references else where, I just see "ISO 13485:2016" without the "EN" as a prefix. So would the standard be referred as :

EN ISO 13485:2016 or just ISO 13485:2016 ?

Thanks

Sponsored Links
  Post Number #2  
Old 17th July 2017, 12:13 AM
somashekar's Avatar
somashekar

 
 
Total Posts: 5,262
Re: EN ISO 13485:2016 or just ISO 13485:2016 without the "EN" as a prefix?

ISO 13485: 2016 is an ISO standard
EN ISO 13485: 2016 is an European standard (see CENELEC)
This is published and date of publication is 2016-09-30
See THIS
Thanks to somashekar for your informative Post and/or Attachment!
Sponsored Links

  Post Number #3  
Old 17th July 2017, 05:57 AM
Ronen E

 
 
Total Posts: 3,526
Re: EN ISO 13485:2016 or just ISO 13485:2016 without the "EN" as a prefix?

Normative contents are identical.
You still need the 2012 EN version, though, for presumption of conformity with the MDD.
Thank You to Ronen E for your informative Post and/or Attachment!
  Post Number #4  
Old 17th July 2017, 06:32 AM
somashekar's Avatar
somashekar

 
 
Total Posts: 5,262
Re: EN ISO 13485:2016 or just ISO 13485:2016 without the "EN" as a prefix?

One has to know their requirements well and work with reputed CB to know what thay are going to get post a successful audit. There are many european NB who offer the 13485, and if you, as a customer do not know, you will end up with an EN ISO certification and not an ISO. Same is the case with the 9001, 14001, where you can get an EN ISO 9001 or an EN ISO 14001
  Post Number #5  
Old 18th July 2017, 07:41 PM
Randy's Avatar
Randy

 
 
Total Posts: 8,585
Re: EN ISO 13485:2016 or just ISO 13485:2016 without the "EN" as a prefix?

Quote:
In Reply to Parent Post by SGquality View Post

Hello,

We have EN ISO 13485:2012 certification and migrating to ISO 13485:2016 standard.

When I see references else where, I just see "ISO 13485:2016" without the "EN" as a prefix. So would the standard be referred as :

EN ISO 13485:2016 or just ISO 13485:2016 ?

Thanks
Just use the plain ISO standard, the "EN" is probably one of the reasons many of our ancestors came over here on leaky boats
  Post Number #6  
Old 19th July 2017, 09:45 AM
paulag

 
 
Total Posts: 65
Re: EN ISO 13485:2016 or just ISO 13485:2016 without the "EN" as a prefix?

Please consider that there might have been a reason for getting certified acc. EN ISO... If you are the legal manufacturer of a CE-marked medical device for the EU market, plain ISO is not enough
Reply

Lower Navigation Bar
Go Back   The Elsmar Cove Business Systems and Standards Discussion Forums > > >

Bookmarks



Visitors Currently Viewing this Thread: 1 (0 Registered Visitors (Members) and 1 Unregistered Guest Visitors)
 
Thread Tools Search this Thread
Search this Thread:

Advanced Forum Search
Display Modes Rate Thread Content
Rate Thread Content:

Forum Posting Settings
You may not post new threads
You may not post replies
You may not post attachments
You may not edit your posts

BB code is On
Emoticons are On
[IMG] code is On
HTML code is Off


Similar Discussion Threads
Discussion Thread Title Thread Starter Forum Replies Last Post or Poll Vote
EN ISO 13485:2016 vs. ISO 13485:2016 - Unannounced MDD Audit yesterday Shamann2 ISO 13485:2016 - Medical Device Quality Management Systems 4 2nd February 2017 12:13 AM
ISO 13485:2003 vs. ISO 13485:2016 Differences Comparison al40 ISO 13485:2016 - Medical Device Quality Management Systems 3 27th January 2017 04:22 PM
Migration (Transition) to ISO 13485:2016 from ISO 13485:2003 sriramsl ISO 13485:2016 - Medical Device Quality Management Systems 1 27th October 2016 02:46 PM
TGA Transition to ISO 13485:2016 Marcelo Antunes ISO 13485:2016 - Medical Device Quality Management Systems 0 8th August 2016 09:16 PM
Do I need to certify to ISO 13485:2016? mscottf ISO 13485:2016 - Medical Device Quality Management Systems 5 19th May 2016 08:40 AM



The time now is 10:29 PM. All times are GMT -4.
Your time zone can be changed in your UserCP --> Options.


 
 
 


NOTE: This forum uses "Cookies"