The Cove Business Standards Discussion Forums More Free Files Forum Discussion Thread Post Attachments Listing Cove Discussion Forums Main Page
UL - Underwriters Laboratories - Health Sciences
Go Back   The Elsmar Cove Business Systems and Standards Discussion Forums > National and International Business System Standards > ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards
Forum Username

Elsmar Cove Forum Visitor Notice(s)

Wooden Line

ISO 9001 vs. 13485 - What are the differences between ISO 9001 and ISO 13485


Elsmar XML RSS Feed
Elsmar Cove Forum RSS Feed

Monitor the Elsmar Forum
Sponsor Links




Courtesy Quick Links


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

International Standards Bodies - World Wide Standards Bodies

ASQ - American Society for Quality

International Standards Organization - ISO Standards and Information

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


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


Related Topic Tags
iso 13485 - medical device qms, iso 9001 - quality management systems, differences (general)
Reply
 
Thread Tools Search this Thread Rate Thread Content Display Modes
  Post Number #1  
Old 12th September 2010, 01:14 PM
QE's Avatar
QE

 
 
Total Posts: 248
Question ISO 9001 vs. 13485 - What are the differences between ISO 9001 and ISO 13485

Dear Coves

At work we are told by management that the quality systems will be changing in the near future. From ISO 13485 to a process based ISO 9000.

Can some one point out the pros and cons between the two ?

-QE

Sponsored Links
  Post Number #2  
Old 12th September 2010, 02:50 PM
Randy's Avatar
Randy

 
 
Total Posts: 8,443
Re: ISO 9001 vs. 13485 - What are the differences between ISO 9001 and ISO 13485

If you are under 13485 you already meet 9001

13485 is more stringent and specifically for medical device just as TS 16969 is for automotive and AS 9100 is for aerospace...basically all the same and you don't have to do anything special or different to conform to 9001, it's a done deal
Thanks to Randy for your informative Post and/or Attachment!
Sponsored Links

  Post Number #3  
Old 12th September 2010, 03:45 PM
Marc's Avatar
Marc

 
 
Total Posts: 25,335
Re: ISO 9001 vs. 13485 - What are the differences between ISO 9001 and ISO 13485

Also see this oldie but goodie:

Differences - ISO 13485 - Requirements in Addition to ISO 9001
  Post Number #4  
Old 12th September 2010, 05:06 PM
Sidney Vianna's Avatar
Sidney Vianna

 
 
Total Posts: 8,384
Re: ISO 9001 vs. 13485 - What are the differences between ISO 9001 and ISO 13485

There are a couple of requirements in ISO 9001 that are not included in ISO 13485: monitoring of customer satisfaction and continual improvement. So, strictly speaking, conformance to ISO 13485 makes you very close to ISO 9001, but not 100%.

Last edited by Marc; 12th September 2010 at 08:16 PM. Reason: Add emphasis.
Thank You to Sidney Vianna for your informative Post and/or Attachment!
  Post Number #5  
Old 12th September 2010, 05:24 PM
DannyK

 
 
Total Posts: 659
Re: ISO 9001 vs. 13485 - What are the differences between ISO 9001 and ISO 13485

There are many more requirements for documented procedures with ISO 13485:2003. Since you are dealing with medical devices, there are expectations that your system will be more robust.
Regulatory requirements play a major role with ISO 13485:2003.

Last edited by Marc; 12th September 2010 at 08:11 PM. Reason: Hi-lited a significant point.
Thanks to DannyK for your informative Post and/or Attachment!
  Post Number #6  
Old 12th September 2010, 05:40 PM
AndyN's Avatar
AndyN

 
 
Total Posts: 8,459
Thumbs up Re: ISO 9001 vs. 13485 - What are the differences between ISO 9001 and ISO 13485

Quote:
In Reply to Parent Post by Sidney Vianna View Post

There are a couple of requirements in ISO 9001 that are not included in ISO 13485: monitoring of customer satisfaction and continual improvement. So, strictly speaking, conformance to ISO 13485 makes you very close to ISO 9001, but not 100%.
Thanks for that very salient, and often overlooked, point, Sidney!
  Post Number #7  
Old 12th September 2010, 08:15 PM
Marc's Avatar
Marc

 
 
Total Posts: 25,335
Re: ISO 9001 vs. 13485 - What are the differences between ISO 9001 and ISO 13485

Quote:
In Reply to Parent Post by DannyK View Post

<snip> Regulatory requirements play a major role with ISO 13485 <snip>
Can you be more specific?
  Post Number #8  
Old 13th September 2010, 12:46 AM
somashekar's Avatar
somashekar

 
 
Total Posts: 5,148
Re: ISO 9001 vs. 13485 - What are the differences between ISO 9001 and ISO 13485

Quote:
In Reply to Parent Post by Marc View Post

Can you be more specific?
Just pitching in, while DannyK would write back ...
By your 13485 QMS if you are to respect
FDA requirement (your medical devices may be getting into USA) or
MDD / IVD requirements (your medical devices may be getting into EU) or
CMDR requirements (your medical devices may be geting into Canada) or
the respective regions regulatory requirements wherever your medical devices will be entering the market
These requirements becomes a part of your QMS activities, and they get to be mentioned in your QMS documentation, and addressed accordingly. These will be audited by you in internal audits and by the CB or NB etc etc.
Reply

Lower Navigation Bar
Go Back   The Elsmar Cove Business Systems and Standards Discussion Forums > National and International Business System Standards > ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards

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
ICH Q10 vs. ISO 9001 vs. ISO 13485 and FDA 210-211 - Differences v9991 US Food and Drug Administration (FDA) 9 21st January 2011 10:16 PM
EN ISO 13485 vs ISO 13485 Certification - EN vs EN ISO Differences icare2much ISO 13485:2016 - Medical Device Quality Management Systems 12 14th December 2009 01:40 PM
Differences - ISO 13485 - Requirements in Addition to ISO 9001:2000 Jimmy Olson ISO 13485:2016 - Medical Device Quality Management Systems 25 29th April 2009 10:26 PM
ISO 13485:2003 documentation vs. ISO 9001:2000 documentation - Differences Izatul ISO 13485:2016 - Medical Device Quality Management Systems 4 13th February 2007 11:33 AM
What are the major differences between ISO 13485:1996 and ISO 13485:2003? senna ISO 13485:2016 - Medical Device Quality Management Systems 8 19th October 2005 12:08 PM



The time now is 10:42 AM. All times are GMT -4.
Your time zone can be changed in your UserCP --> Options.


 
 


NOTE: This forum uses "Cookies" - A Peachfarm Internet Property