The Elsmar Cove Wiki More Free Files The Elsmar Cove Forums Discussion Thread Index Post Attachments Listing Failure Modes Services and Solutions to Problems Elsmar cove Forums Main Page Elsmar Cove Home Page
Go Back   The Elsmar Cove Forum > Medical Devices, Medical Information Technology, Medical Software and Health Informatics > Medical Device Related Standards > ISO 13485 and ISO 14969 - Medical Devices - Quality Management Systems
Forum Username

Search the Elsmar Cove
Custom Search
Monitor the Elsmar Forum
Follow Marc & Elsmar
Elsmar Cove Forum RSS Feed  Marc Smith's Google+ Page  Marc Smith's Linked In Page   Marc Smith's Elsmar Cove YouTube Page  Marc Smith's Facebook Page  Elsmar Cove Twitter Feed
Elsmar Cove Groups
Elsmar Cove Google+ Group  Elsmar Cove LinkedIn Group  Elsmar Cove Facebook Group
Donate and $ Contributor Forum Access

Courtesy Quick Links

Links that Elsmar Cove visitors will find useful in your quest for knowledge:

Howard's
International Quality Services
Marcelo Antunes'
SQR Consulting
Bob Doering's
Correct SPC - Precision Machining

NIST's Engineering Statistics Handbook
IRCA - International Register of Certified Auditors
SAE - Society of Automotive Engineers
Quality Digest Portal
IEST - Institute of Environmental Sciences and Technology
ASQ - American Society for Quality

Related Topic Tags
iso 13485 - medical device qms, iso 14969 (medical devices - application of iso 13485)
Reply
 
Thread Tools Search this Thread Rate Thread Content Display Modes
  #1  
Old 27th May 2011, 03:03 PM
Marcelo Antunes's Avatar
Marcelo Antunes Marcelo Antunes is online now
Addicted to standards

 
Registration Date: Mar 2006
Location: São Paulo, SP, Brazil
 
Posts: 2,406
Thanks Given to Others: 344
Thanked 1,809 Times in 967 Posts
Karma Power: 302
Karma: 13802
Marcelo Antunes is appreciated, and has over 1700 Karma points.Marcelo Antunes is appreciated, and has over 1700 Karma points.Marcelo Antunes is appreciated, and has over 1700 Karma points.Marcelo Antunes is appreciated, and has over 1700 Karma points.
Marcelo Antunes is appreciated, and has over 1700 Karma points.Marcelo Antunes is appreciated, and has over 1700 Karma points.Marcelo Antunes is appreciated, and has over 1700 Karma points.Marcelo Antunes is appreciated, and has over 1700 Karma points.Marcelo Antunes is appreciated, and has over 1700 Karma points.Marcelo Antunes is appreciated, and has over 1700 Karma points.Marcelo Antunes is appreciated, and has over 1700 Karma points.Marcelo Antunes is appreciated, and has over 1700 Karma points.Marcelo Antunes is appreciated, and has over 1700 Karma points.Marcelo Antunes is appreciated, and has over 1700 Karma points.Marcelo Antunes is appreciated, and has over 1700 Karma points.Marcelo Antunes is appreciated, and has over 1700 Karma points.
Send a message via ICQ to Marcelo Antunes Send a message via MSN to Marcelo Antunes Send a message via Skype™ to Marcelo Antunes
Look! ISO 13485 Revision - User Requirements Survey for ISO 13485 revision

As i mentioned some time ago, it was decided to revise ISO 13485.

The below information was distributed to members of ISO TC 210 WG 1:

"Below is a link to a survey that is to be completed by existing users and/or potential users of ISO 13485 2003 and users of other Medical Device Quality Management Systems. The purpose of this questionnaire is to determine the need for modification or updating of the ISO 13485:2003 requirements standard and the ISO/TR 14969:2004 guidance document.

Please complete the following survey by 31 August 2011:

ISO TC210 WG 1 ISO 13485 Revision User Requirements Survey

Please feel free to forward the survey to any medical device firms, government agencies, competent authorities, registrars, industrial organizations and consultants that are appropriate. The survey should take approximately 30 minutes to complete and the deadline is 31 August 2011."

__________________

I'm a moderator on the medical device forums, so if you need help with something, feel free to ask!
Thank You to Marcelo Antunes for your informative Post and/or Attachment!

Sponsored Links
  #2  
Old 4th November 2011, 11:57 AM
JohnM's Avatar
JohnM JohnM is offline
Involved in Discussions

 
Registration Date: Nov 2006
Location: New York
 
Posts: 25
Thanks Given to Others: 6
Thanked 31 Times in 4 Posts
Karma Power: 34
Karma: 225
JohnM is appreciated, and has over 200 Karma points.JohnM is appreciated, and has over 200 Karma points.JohnM is appreciated, and has over 200 Karma points.
Re: ISO 13485 Revision - User Requirements Survey for ISO 13485 revision

Has this August 31st deadline been extended? I thought it had.

__________________

John Minier
Sponsored Links

  #3  
Old 4th November 2011, 09:31 PM
Marcelo Antunes's Avatar
Marcelo Antunes Marcelo Antunes is online now
Addicted to standards

 
Registration Date: Mar 2006
Location: São Paulo, SP, Brazil
 
Posts: 2,406
Thanks Given to Others: 344
Thanked 1,809 Times in 967 Posts
Karma Power: 302
Karma: 13802
Marcelo Antunes is appreciated, and has over 1700 Karma points.Marcelo Antunes is appreciated, and has over 1700 Karma points.Marcelo Antunes is appreciated, and has over 1700 Karma points.Marcelo Antunes is appreciated, and has over 1700 Karma points.
Marcelo Antunes is appreciated, and has over 1700 Karma points.Marcelo Antunes is appreciated, and has over 1700 Karma points.Marcelo Antunes is appreciated, and has over 1700 Karma points.Marcelo Antunes is appreciated, and has over 1700 Karma points.Marcelo Antunes is appreciated, and has over 1700 Karma points.Marcelo Antunes is appreciated, and has over 1700 Karma points.Marcelo Antunes is appreciated, and has over 1700 Karma points.Marcelo Antunes is appreciated, and has over 1700 Karma points.Marcelo Antunes is appreciated, and has over 1700 Karma points.Marcelo Antunes is appreciated, and has over 1700 Karma points.Marcelo Antunes is appreciated, and has over 1700 Karma points.Marcelo Antunes is appreciated, and has over 1700 Karma points.
Send a message via ICQ to Marcelo Antunes Send a message via MSN to Marcelo Antunes Send a message via Skype™ to Marcelo Antunes
Re: ISO 13485 Revision - User Requirements Survey for ISO 13485 revision

Not really extended...but it's been reopened until january 2012 - on this link: http://www.zoomerang.com/Survey/WEB22CB9ZPRRSP

__________________

I'm a moderator on the medical device forums, so if you need help with something, feel free to ask!

Last edited by howste; 6th November 2011 at 10:10 AM. Reason: Fixed web link.
  #4  
Old 21st June 2012, 08:04 AM
Asiah Asiah is offline
Getting Involved (6 to 9 Posts)

 
Registration Date: Nov 2011
Location: Asia
 
Posts: 6
Thanks Given to Others: 2
Thanked 0 Times in 0 Posts
Karma Power: 12
Karma: 10
Asiah has less than 100 Karma points so far.
Re: ISO 13485 Revision - User Requirements Survey for ISO 13485 revision

Hi!
Thanks for sharing. I tried clicking on the link but
the survey is closed.

Newbie,
Asiah
  #5  
Old 21st June 2012, 08:05 AM
Marcelo Antunes's Avatar
Marcelo Antunes Marcelo Antunes is online now
Addicted to standards

 
Registration Date: Mar 2006
Location: São Paulo, SP, Brazil
 
Posts: 2,406
Thanks Given to Others: 344
Thanked 1,809 Times in 967 Posts
Karma Power: 302
Karma: 13802
Marcelo Antunes is appreciated, and has over 1700 Karma points.Marcelo Antunes is appreciated, and has over 1700 Karma points.Marcelo Antunes is appreciated, and has over 1700 Karma points.Marcelo Antunes is appreciated, and has over 1700 Karma points.
Marcelo Antunes is appreciated, and has over 1700 Karma points.Marcelo Antunes is appreciated, and has over 1700 Karma points.Marcelo Antunes is appreciated, and has over 1700 Karma points.Marcelo Antunes is appreciated, and has over 1700 Karma points.Marcelo Antunes is appreciated, and has over 1700 Karma points.Marcelo Antunes is appreciated, and has over 1700 Karma points.Marcelo Antunes is appreciated, and has over 1700 Karma points.Marcelo Antunes is appreciated, and has over 1700 Karma points.Marcelo Antunes is appreciated, and has over 1700 Karma points.Marcelo Antunes is appreciated, and has over 1700 Karma points.Marcelo Antunes is appreciated, and has over 1700 Karma points.Marcelo Antunes is appreciated, and has over 1700 Karma points.
Send a message via ICQ to Marcelo Antunes Send a message via MSN to Marcelo Antunes Send a message via Skype™ to Marcelo Antunes
Re: ISO 13485 Revision - User Requirements Survey for ISO 13485 revision

Quote:
Hi!
Thanks for sharing. I tried clicking on the link but
the survey is closed.

Newbie,
Asiah
Hello, Asiah, the survey closed on January 2012.

__________________

I'm a moderator on the medical device forums, so if you need help with something, feel free to ask!
  #6  
Old 21st June 2012, 08:08 AM
Asiah Asiah is offline
Getting Involved (6 to 9 Posts)

 
Registration Date: Nov 2011
Location: Asia
 
Posts: 6
Thanks Given to Others: 2
Thanked 0 Times in 0 Posts
Karma Power: 12
Karma: 10
Asiah has less than 100 Karma points so far.
Re: ISO 13485 Revision - User Requirements Survey for ISO 13485 revision

Yess.. did not read the text carefully.
How about the ISO 9000:2005 when is the next
upgrade? Any info.

Thanks
  #7  
Old 21st June 2012, 08:20 AM
Marcelo Antunes's Avatar
Marcelo Antunes Marcelo Antunes is online now
Addicted to standards

 
Registration Date: Mar 2006
Location: São Paulo, SP, Brazil
 
Posts: 2,406
Thanks Given to Others: 344
Thanked 1,809 Times in 967 Posts
Karma Power: 302
Karma: 13802
Marcelo Antunes is appreciated, and has over 1700 Karma points.Marcelo Antunes is appreciated, and has over 1700 Karma points.Marcelo Antunes is appreciated, and has over 1700 Karma points.Marcelo Antunes is appreciated, and has over 1700 Karma points.
Marcelo Antunes is appreciated, and has over 1700 Karma points.Marcelo Antunes is appreciated, and has over 1700 Karma points.Marcelo Antunes is appreciated, and has over 1700 Karma points.Marcelo Antunes is appreciated, and has over 1700 Karma points.Marcelo Antunes is appreciated, and has over 1700 Karma points.Marcelo Antunes is appreciated, and has over 1700 Karma points.Marcelo Antunes is appreciated, and has over 1700 Karma points.Marcelo Antunes is appreciated, and has over 1700 Karma points.Marcelo Antunes is appreciated, and has over 1700 Karma points.Marcelo Antunes is appreciated, and has over 1700 Karma points.Marcelo Antunes is appreciated, and has over 1700 Karma points.Marcelo Antunes is appreciated, and has over 1700 Karma points.
Send a message via ICQ to Marcelo Antunes Send a message via MSN to Marcelo Antunes Send a message via Skype™ to Marcelo Antunes
Re: ISO 13485 Revision - User Requirements Survey for ISO 13485 revision

Quote:
Yess.. did not read the text carefully.
How about the ISO 9000:2005 when is the next
upgrade? Any info.
There's a discussion thread on the revision of ISO 9001 here: http://elsmar.com/Forums/showthread.php?t=30496

__________________

I'm a moderator on the medical device forums, so if you need help with something, feel free to ask!
Thanks to Marcelo Antunes for your informative Post and/or Attachment!
  #8  
Old 21st June 2012, 09:23 AM
Asiah Asiah is offline
Getting Involved (6 to 9 Posts)

 
Registration Date: Nov 2011
Location: Asia
 
Posts: 6
Thanks Given to Others: 2
Thanked 0 Times in 0 Posts
Karma Power: 12
Karma: 10
Asiah has less than 100 Karma points so far.
Re: ISO 13485 Revision - User Requirements Survey for ISO 13485 revision

Thanks..
Reply

Lower Navigation Bar
Go Back   The Elsmar Cove Forum > Medical Devices, Medical Information Technology, Medical Software and Health Informatics > Medical Device Related Standards > ISO 13485 and ISO 14969 - Medical Devices - Quality Management Systems

Do you find this discussion thread helpful and informational?


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
Smilies 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
ISO 13485:2016 Pre-Release News and Discussion Marcelo Antunes ISO 13485 and ISO 14969 - Medical Devices - Quality Management Systems 129 12th September 2014 07:47 PM
Revision to ISO 13485: 2003 .... ? somashekar ISO 13485 and ISO 14969 - Medical Devices - Quality Management Systems 2 18th February 2010 02:31 AM
Upgrading of QMS from ISO 9001 to ISO 13485 - Quality Manual Revision Tiffany ISO 13485 and ISO 14969 - Medical Devices - Quality Management Systems 5 22nd January 2009 10:54 AM
When is ISO 13485:2003 Scheduled for Revision? Tiffany ISO 13485 and ISO 14969 - Medical Devices - Quality Management Systems 13 21st January 2008 06:51 PM
ISO 13485:2003 Quality Policy Controlled with a Revision date and number? lisar ISO 13485 and ISO 14969 - Medical Devices - Quality Management Systems 5 15th December 2005 10:53 AM



The time now is 03:33 PM. All times are GMT -4.
Your time zone can be changed in your UserCP --> Options.


   


Marc Timothy Smith - Elsmar.com
8466 LeSourdsville-West Chester Road, Olde West Chester, Ohio 45069-1929
513 341-6272
NOTE: This forum uses "cookies".