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


Elsmar Cove Forum Sidebar
Custom Search
Monitor the Elsmar Forum
Monitor New Forum Posts
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 Groups
Elsmar Cove Google+ Group  Elsmar Cove LinkedIn Group  Elsmar Cove Facebook Group
Sponsor Links







Donate and $ Contributor Forum Access
Sponsored Links
Courtesy Quick Links

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


Howard's
International Quality Services

Atul's
Symphony Technologies

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

Reply
 
Thread Tools Search this Thread Rate Thread Content Display Modes
  #1  
Old 5th April 2007, 02:49 PM
Doug Tropf Doug Tropf is offline
Appreciated Member

 
Registration Date: Apr 2005
Location: USA - Missouri
Age: 60
 
Posts: 366
Thanks Given to Others: 1,100
Thanked 163 Times in 110 Posts
Karma Power: 72
Karma: 1089
Doug Tropf is appreciated, and has over 900 Karma points.Doug Tropf is appreciated, and has over 900 Karma points.Doug Tropf is appreciated, and has over 900 Karma points.Doug Tropf is appreciated, and has over 900 Karma points.Doug Tropf is appreciated, and has over 900 Karma points.Doug Tropf is appreciated, and has over 900 Karma points.Doug Tropf is appreciated, and has over 900 Karma points.Doug Tropf is appreciated, and has over 900 Karma points.
I Say... We completed our first annual ISO 13485 Continuing Assessment Audit

We just completed our first annual 13485 Continuing Assessment Audit. We had one minor nonconformity in that the annual re-training records for one of our staff members was not available for audit (this individual seems to feel he's above some of the annual training requirements).

We also had two "opportunities for improvement" relating to some of the forms we use.
__________________
Things turn out best for those who make the best of the way things turn out. Jack Buck

Sponsored Links
  #2  
Old 5th April 2007, 03:28 PM
SteelMaiden's Avatar
SteelMaiden SteelMaiden is offline
Super Moderator

 
Registration Date: Jan 2001
Location: NC, USA
 
Posts: 4,192
Thanks Given to Others: 574
Thanked 1,371 Times in 845 Posts
Karma Power: 492
Karma: 11374
SteelMaiden is appreciated, and has over 1700 Karma points.SteelMaiden is appreciated, and has over 1700 Karma points.SteelMaiden is appreciated, and has over 1700 Karma points.
SteelMaiden is appreciated, and has over 1700 Karma points.SteelMaiden is appreciated, and has over 1700 Karma points.SteelMaiden is appreciated, and has over 1700 Karma points.SteelMaiden is appreciated, and has over 1700 Karma points.SteelMaiden is appreciated, and has over 1700 Karma points.SteelMaiden is appreciated, and has over 1700 Karma points.SteelMaiden is appreciated, and has over 1700 Karma points.SteelMaiden is appreciated, and has over 1700 Karma points.SteelMaiden is appreciated, and has over 1700 Karma points.SteelMaiden is appreciated, and has over 1700 Karma points.SteelMaiden is appreciated, and has over 1700 Karma points.SteelMaiden is appreciated, and has over 1700 Karma points.SteelMaiden is appreciated, and has over 1700 Karma points.
Re: Continuing Assessment Visit

there is always one, isn't there? Is this a member of management?

anyway, good job.
__________________
"It's fun to have fun, but you have to know how", Dr. Seuss
Man may have invented fire, it took a woman to learn how to play with it.
Sponsored Links

  #3  
Old 5th April 2007, 03:38 PM
GStough's Avatar
GStough GStough is offline
Super Moderator

 
Registration Date: Aug 2006
Location: Manassas, VA, USA
Age: 49
 
Posts: 1,091
Thanks Given to Others: 1,195
Thanked 420 Times in 287 Posts
Karma Power: 144
Karma: 3931
GStough is appreciated, and has over 1700 Karma points.
GStough is appreciated, and has over 1700 Karma points.GStough is appreciated, and has over 1700 Karma points.GStough is appreciated, and has over 1700 Karma points.GStough is appreciated, and has over 1700 Karma points.GStough is appreciated, and has over 1700 Karma points.GStough is appreciated, and has over 1700 Karma points.GStough is appreciated, and has over 1700 Karma points.GStough is appreciated, and has over 1700 Karma points.
Send a message via Yahoo to GStough Send a message via Skype™ to GStough
Re: Continuing Assessment Visit



Indeed, congratulations on a job well done!
__________________
Gidget Stough, ASQ CQA
"It's easier to do a job right than to explain why you didn't." - Martin Van Buren
  #4  
Old 5th April 2007, 03:52 PM
Doug Tropf Doug Tropf is offline
Appreciated Member

 
Registration Date: Apr 2005
Location: USA - Missouri
Age: 60
 
Posts: 366
Thanks Given to Others: 1,100
Thanked 163 Times in 110 Posts
Karma Power: 72
Karma: 1089
Doug Tropf is appreciated, and has over 900 Karma points.Doug Tropf is appreciated, and has over 900 Karma points.Doug Tropf is appreciated, and has over 900 Karma points.Doug Tropf is appreciated, and has over 900 Karma points.Doug Tropf is appreciated, and has over 900 Karma points.Doug Tropf is appreciated, and has over 900 Karma points.Doug Tropf is appreciated, and has over 900 Karma points.Doug Tropf is appreciated, and has over 900 Karma points.
Re: Continuing Assessment Visit

Thanks for the congratulations!

The individual is our staff engineer who manages the validation / calibration side of the business.

Not that it applies to this person - but the auditor stated that we might want to include a statement in our training procedures to the effect that individuals that write procedures or conduct the actual training will be considered trained due to the research / preparation for such activities.
__________________
Things turn out best for those who make the best of the way things turn out. Jack Buck
  #5  
Old 6th April 2007, 03:48 AM
Gert Sorensen's Avatar
Gert Sorensen Gert Sorensen is offline
Forum Moderator

 
Registration Date: Apr 2006
Location: Denmark
Age: 45
 
Posts: 1,232
Thanks Given to Others: 687
Thanked 478 Times in 297 Posts
Karma Power: 160
Karma: 3771
Gert Sorensen is appreciated, and has over 1700 Karma points.
Gert Sorensen is appreciated, and has over 1700 Karma points.Gert Sorensen is appreciated, and has over 1700 Karma points.Gert Sorensen is appreciated, and has over 1700 Karma points.Gert Sorensen is appreciated, and has over 1700 Karma points.Gert Sorensen is appreciated, and has over 1700 Karma points.Gert Sorensen is appreciated, and has over 1700 Karma points.Gert Sorensen is appreciated, and has over 1700 Karma points.
Re: We completed our first annual ISO 13485 Continuing Assessment Audit

Congratulations. It is always nice to "survive" an audit with this few NCīs. I hope that it reflects the state of your QMS
__________________
Beetle Bailey Rules! :)
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
General ISO 13485 Certification Assessment Audit Question jbdominguez ISO 13485 and ISO 14969 - Medical Devices - Quality Management Systems 1 10th December 2011 12:35 AM
ISO 9001 Implementation moving forward - Completed pre-assessment audit jsn80 ISO 9000, ISO 9001, and ISO 9004 - Questions and Discussions 13 7th October 2010 11:30 AM
Annual Internal Audit effectiveness - ISO 13485 Medical Devices richroland - 2009 Internal Auditing 7 3rd April 2009 12:14 AM
Continuing Assessment Audit - Recommended for continued registration 13485:2003 Doug Tropf ISO 13485 and ISO 14969 - Medical Devices - Quality Management Systems 4 4th April 2008 09:07 AM
Do you need to have a supplier assessment completed prior to the audit? mikeb Supplier Quality Assurance and other Supplier Issues 3 7th November 2005 07:02 PM



The time now is 11:40 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