The Cove Business Standards Discussion Forums
ISO 31000 vs. ISO 14971 - Differences and similarities
UL - Underwriters Laboratories - Health Sciences
ISO 31000 vs. ISO 14971 - Differences and similarities
ISO 31000 vs. ISO 14971 - Differences and similarities
ISO 31000 vs. ISO 14971 - Differences and similarities
ISO 31000 vs. ISO 14971 - Differences and similarities
ISO 31000 vs. ISO 14971 - Differences and similarities
ISO 31000 vs. ISO 14971 - Differences and similarities
ISO 31000 vs. ISO 14971 - Differences and similarities
ISO 31000 vs. ISO 14971 - Differences and similarities
ISO 31000 vs. ISO 14971 - Differences and similarities
Go Back   The Elsmar Cove Business Systems and Standards Discussion Forums > >
Forum Username

Elsmar Cove Forum Visitor Notice(s)

Wooden Line

ISO 31000 vs. ISO 14971 - Differences and similarities


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

AIAG - Automotive Industry Action Group

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
iso 14971 - medical device risk management, iso 27001 - information security management system (isms), iso 27002 - information technology security techniques, iso 27799 - health informatics using iso/iec 27002, iso 31000 - risk management, medical device company or industry
Reply
 
Thread Tools Search this Thread Rate Thread Content Display Modes
  Post Number #1  
Old 8th December 2009, 07:43 AM
Paul22

 
 
Total Posts: 12
Please Help! ISO 31000 vs. ISO 14971 - Differences and similarities

Does anyone know if there is any similarity between ISO 31000 and ISO 14971? Are these standards able to co-exist within a medical device industry? Will ISO 31000 be applicable for all MD manufacturers, next to ISO 14971?

Sponsored Links
  Post Number #2  
Old 8th December 2009, 08:15 AM
Marc's Avatar
Marc

 
 
Total Posts: 26,502
Re: ISO 31000 vs. ISO 14971 - Differences and similarities

FYI Summary:

ISO 31000:2009 provides principles and generic guidelines on risk management.

ISO 31000:2009 can be used by any public, private or community enterprise, association, group or individual. Therefore, ISO 31000:2009 is not specific to any industry or sector.

ISO 31000:2009 can be applied throughout the life of an organization, and to a wide range of activities, including strategies and decisions, operations, processes, functions, projects, products, services and assets.

ISO 31000:2009 can be applied to any type of risk, whatever its nature, whether having positive or negative consequences.

Although ISO 31000:2009 provides generic guidelines, it is not intended to promote uniformity of risk management across organizations. The design and implementation of risk management plans and frameworks will need to take into account the varying needs of a specific organization, its particular objectives, context, structure, operations, processes, functions, projects, products, services, or assets and specific practices employed.

It is intended that ISO 31000:2009 be utilized to harmonize risk management processes in existing and future standards. It provides a common approach in support of standards dealing with specific risks and/or sectors, and does not replace those standards.

ISO 31000:2009 is not intended for the purpose of certification.

ISO 14971:2007 specifies a process for a manufacturer to identify the hazards associated with medical devices, including in vitro diagnostic (IVD) medical devices, to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls.

The requirements of ISO 14971:2007 are applicable to all stages of the life-cycle of a medical device.
Thank You to Marc for your informative Post and/or Attachment!
  Post Number #3  
Old 9th December 2009, 02:53 AM
Marc's Avatar
Marc

 
 
Total Posts: 26,502
Look! Re: ISO 31000 vs. ISO 14971 - Differences and similarities

Quote:
In Reply to Parent Post by Paul22 View Post

Does anyone know if there is any similarity between ISO 31000 and ISO 14971? Are these standards able to co-exist within a medical device industry? Will ISO 31000 be applicable for all MD manufacturers, next to ISO 14971?
If anyone has anything to share with respect to this post, Please give a hand. My appreciation in advance!
  Post Number #4  
Old 10th December 2009, 10:28 AM
Marcelo Antunes's Avatar
Marcelo Antunes

 
 
Total Posts: 3,211
Re: ISO 31000 vs. ISO 14971 - Differences and similarities

I have some info, sorry for not answering before, just a little busy here :-)

Quote:
Does anyone know if there is any similarity between ISO 31000 and ISO 14971? Are these standards able to co-exist within a medical device industry? Will ISO 31000 be applicable for all MD manufacturers, next to ISO 14971?
ISO 31000 is being developed as THE standard on risk management in ISO (following an strategy of ISO on having general management systems standards).

The problem here is that ISO 31000 is for business risk (it details a general enterprise risk management process applicable to all enterprises). ISO 14971, on the contrary, is for product risks. Their similarities, then, are only a few.

Tehy might be able to co-exist because they deal with different things, but the main concern is that, as 31000 is being published to be the general risk management standard on ISO, it will be "forced" into other risk manbagement standards. ISO TC 210, JWG 1, which is the originator of ISO 14971, has been aware of this for some time and is studying possible situations around this scenario.
Thank You to Marcelo Antunes for your informative Post and/or Attachment!
  Post Number #5  
Old 10th December 2009, 10:58 AM
Sidney Vianna's Avatar
Sidney Vianna

 
 
Total Posts: 9,315
Re: ISO 31000 vs. ISO 14971 - Differences and similarities

ISO has just released ISO 31010:2009. Risk management -- Risk assessment techniques
Thanks to Sidney Vianna for your informative Post and/or Attachment!
  Post Number #6  
Old 10th December 2009, 11:00 AM
Marcelo Antunes's Avatar
Marcelo Antunes

 
 
Total Posts: 3,211
Re: ISO 31000 vs. ISO 14971 - Differences and similarities

Quote:
ISO has just released ISO 31010:2009. Risk management -- Risk assessment techniques
Yep...in fact there´s planning to develop more standards in the ISO 31000 series...just like what happens to other management standards such as ISO 9000.
  Post Number #7  
Old 24th April 2018, 03:10 AM
Mandy

 
 
Total Posts: 45
Re: ISO 31000 vs. ISO 14971 - Differences and similarities

Quote:
In Reply to Parent Post by Marcelo Antunes View Post

I have some info, sorry for not answering before, just a little busy here :-)



ISO 31000 is being developed as THE standard on risk management in ISO (following an strategy of ISO on having general management systems standards).

The problem here is that ISO 31000 is for business risk (it details a general enterprise risk management process applicable to all enterprises). ISO 14971, on the contrary, is for product risks. Their similarities, then, are only a few.

Tehy might be able to co-exist because they deal with different things, but the main concern is that, as 31000 is being published to be the general risk management standard on ISO, it will be "forced" into other risk manbagement standards. ISO TC 210, JWG 1, which is the originator of ISO 14971, has been aware of this for some time and is studying possible situations around this scenario.
Hi

We are ISO 13485 certified, and aligned ourselves to the 14971 standard.

Now our CEO wants us to become ISO 27001 and ISO 27799 certified. Both these standards talk about the 31000 risk management standard.

The question is whether we can keep using ISO 14971 to manage the risk of ISO 27001 and ISO 27799 (with adaptations of course).

Would appreiciate any advice.
Thanks

Mandy
  Post Number #8  
Old 24th April 2018, 10:25 AM
Marcelo Antunes's Avatar
Marcelo Antunes

 
 
Total Posts: 3,211
Re: ISO 31000 vs. ISO 14971 - Differences and similarities

Quote:
In Reply to Parent Post by Mandy View Post

Hi

We are ISO 13485 certified, and aligned ourselves to the 14971 standard.

Now our CEO wants us to become ISO 27001 and ISO 27799 certified. Both these standards talk about the 31000 risk management standard.

The question is whether we can keep using ISO 14971 to manage the risk of ISO 27001 and ISO 27799 (with adaptations of course).

Would appreiciate any advice.
Thanks

Mandy
ISO 24971 was created to deal with the risk posed by medical devices to the patient/user/etc, so it was not created to any other end. To prevent problems, my suggestion would be to keep ISO 14971 only for that end.

Then you can use ISO 31000 or any other risk management process to deal with other risks.
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
Similarities and Differences between EU & US GMPs (Good Manufacturng Processes) vsankar Document Control Systems, Procedures, Forms and Templates 8 6th October 2011 07:48 PM
ISO 14971:2003 vs. 14971:2007 - Major differences nick lekanides ISO 14971 - Medical Device Risk Management 5 7th March 2009 05:27 AM
Key Differences and Similarities between Environmental and Quality Management Systems Amelia80 Environmental Related Standards 1 13th February 2008 07:56 AM
AS9100 vs. QS9000 vs. ISO-TS16949 - Similarities and Differences Ivo Schaefer AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 3 28th July 2006 02:03 PM
Differences and similarities between ISO 17025 and A2LA certification? Craig H. ISO 17025 related Discussions 2 22nd January 2003 03:29 PM



The time now is 10:53 AM. All times are GMT -4.
Your time zone can be changed in your UserCP --> Options.



Misc. Internal Links


NOTE: This forum uses "Cookies"