The Cove Business Standards Discussion Forums More Free Files Forum Discussion Thread Post Attachments Listing Cove Discussion Forums Main Page
ISO 13485 - Medical Device Quality Management System Standard
UL - Underwriters Laboratories - Health Sciences
ISO 13485 - Medical Device Quality Management System Standard
ISO 13485 - Medical Device Quality Management System Standard
ISO 13485 - Medical Device Quality Management System Standard
ISO 13485 - Medical Device Quality Management System Standard
ISO 13485 - Medical Device Quality Management System Standard
ISO 13485 - Medical Device Quality Management System Standard
ISO 13485 - Medical Device Quality Management System Standard
ISO 13485 - Medical Device Quality Management System Standard
ISO 13485 - Medical Device Quality Management System Standard
Go Back   The Elsmar Cove Business Systems and Standards Discussion Forums > > >
Forum Username

Elsmar Cove Forum Visitor Notice(s)

Wooden Line

ISO 13485 - Medical Device Quality Management System Standard


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
cdsco (central drugs standard control organization), india, iso 13485 - medical device qms, singapore health sciences authority (hsa), medical devices
Reply
 
Thread Tools Search this Thread Rate Thread Content Display Modes
  Post Number #1  
Old 12th April 2010, 08:34 AM
Marc's Avatar
Marc

 
 
Total Posts: 25,861
Read This! ISO 13485 - Medical Device Quality Management System Standard

Standard Title: ISO 13485:2003 - Medical devices - Quality management systems - Requirements for regulatory purposes

ISO 13485:2003 is a Quality Management System for medical devices, specifically for regulatory purposes. It is based on ISO 9001:2000 with some modifications. The standard includes a process model similar to that of ISO 9001:2000 but requires more documented procedures that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services.

The ISO 13485:2003 standard is an update and compilation of the older ISO 13485:1996 & ISO 13488:1996 standards. This update was in response to the publication of ISO 9001:2000.

The ISO 13485:2003 standard does not reference the requirements of ISO 9001 but does provide medical device manufacturers with a standalone standard for quality management systems that need to demonstrate compliance to regulatory requirements.

Updates and additions/corrections welcomed by posting in this thread.

Sponsored Links
  Post Number #2  
Old 12th April 2010, 09:48 AM
Sidney Vianna's Avatar
Sidney Vianna

 
 
Total Posts: 8,797
Read This! Re: ISO 13485 - Medical Devices Standard

Quote:
In Reply to Parent Post by Marc View Post

The ISO 13485:2003 standard does not reference the requirements of ISO 9001 but does provide medical device manufacturers with a standalone standard for quality management systems that need to demonstrate compliance to regulatory requirements.

Updates and additions/corrections welcomed by posting in this thread.
For the uninitiated, that could be a little confusing. ISO 13485:2003 does not reference the requirements of ISO 9001, like the previous version of ISO 13485 used to. It does, however, includes MOST of the requirements from ISO 9001 in it's body, though.

Last edited by Sidney Vianna; 12th April 2010 at 09:55 AM.
Sponsored Links

  Post Number #3  
Old 12th April 2010, 12:08 PM
Wes Bucey's Avatar
Wes Bucey

 
 
Total Posts: 11,075
I Say... Re: ISO 13485 - Medical Devices Standard

The notable exception being it specfically excludes "continual improvement." The primary concept here for medical device maufacturers is that many countries have chosen to "harmonize" their regulations for medical devices by requiring manufacturers to become registered to ISO 13485 as an entry into doing business in their country. Most countries, like Canada, for example, do not allow grandfathering - every manufacturer must qualify! Most countries also have very short lists of registrars they consider qualified to issue a certificate of registration to ISO13485.

The advantage for manufacturers is they only have one set of rules to follow (in addition to the USA FDA) instead of uneven rules in multiple countries where they opt to sell products.
  Post Number #4  
Old 12th April 2010, 12:50 PM
Sidney Vianna's Avatar
Sidney Vianna

 
 
Total Posts: 8,797
Re: ISO 13485 - Medical Devices Standard

Quote:
In Reply to Parent Post by Wes Bucey View Post

The notable exception being it specfically excludes "continual improvement."
In my opinion, the most notable difference is the missing monitoring of customer satisfaction requirement. Apparently the regulatory stakeholders behind the development of ISO 13485 believe that focus on customer satisfaction and continual improvement would detract from the goal of regulatory compliance.

As there are many medical device manufacturers that are dually certified to both ISO 9001 and 13485, the requirements associated with customer satisfaction and continual improvement don't impede regulatory compliance.

For those interested in learning more about the application of ISO 13485, they should read ISO/TR 14969:2004 - Medical devices -- Quality management systems -- Guidance on the application of ISO 13485: 2003
Thanks to Sidney Vianna for your informative Post and/or Attachment!
  Post Number #5  
Old 12th April 2010, 05:25 PM
Marcelo Antunes's Avatar
Marcelo Antunes

 
 
Total Posts: 3,075
Re: ISO 13485 - Medical Devices Standard

There´s a technical corrigendum which was publisheds in 2009 and which links the standard to the 2000 version of ISO 9001 (instead of the 2008 version).

ISO 13485:2003/Cor 1:2009
  Post Number #6  
Old 12th April 2010, 05:28 PM
Marcelo Antunes's Avatar
Marcelo Antunes

 
 
Total Posts: 3,075
Re: ISO 13485 - Medical Devices Standard

Quote:
Apparently the regulatory stakeholders behind the development of ISO 13485 believe that focus on customer satisfaction and continual improvement would detract from the goal of regulatory compliance.
I think the main problem here is that the standard is to be used by manufacturers, and the regulations deal with safety of the patients and end users.

So, costumer satisfaction and continual improvement (of the manufacturer) could mean that the safety of the patient and user could be compromised.
  Post Number #7  
Old 12th April 2010, 07:12 PM
Sidney Vianna's Avatar
Sidney Vianna

 
 
Total Posts: 8,797
Re: ISO 13485 - Medical Devices Standard

Quote:
In Reply to Parent Post by mmantunes View Post

So, costumer satisfaction and continual improvement (of the manufacturer) could mean that the safety of the patient and user could be compromised.
Sorry, Marcelo, but I don't understand. The device designer and manufacturer has to balance product safety with all other expectations, such as cost reduction (via improvement) and customer satisfaction. Automakers do it, aircraft manufacturers do it, toy manufacturers do it. I don't understand what is so special about the medical device industry where a QMS should not be concerned with customer satisfaction and continual improvement. I don't see how a responsible medical device manufacturer would overlook patient safety in order to please a hospital or a doctor.

If you have a concrete example of how these would conflict, can you share?
  Post Number #8  
Old 12th April 2010, 07:40 PM
Marcelo Antunes's Avatar
Marcelo Antunes

 
 
Total Posts: 3,075
Re: ISO 13485 - Medical Devices Standard

Quote:
The device designer and manufacturer has to balance product safety with all other expectations, such as cost reduction (via improvement) and customer satisfaction...... I don't see how a responsible medical device manufacturer would overlook patient safety in order to please a hospital or a doctor.
Sidney, you are totally right in your statements, but i was thinking about the practical application of the standard; i can see that a manufacturer, for example, could be pushed by an auditor in fullfilling improvement and satisfaction requirements and thus forget this balance just to "pass the audit".

Please note that this is just my own opinion; the main justification of the writers of the standardon removing these requirements was that continuous improvement and customer satisfaction were too broad a requirement toincluding in regulations, and as the standard was made to harmonize with medical devices regulations, they would create problems in the harmonization should they be required.
Thanks to Marcelo Antunes for your informative Post and/or Attachment!
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
ISO 13485 IAF Medical Device Conformity Assessment System IAF-MDCAS gramaley ISO 13485:2016 - Medical Device Quality Management Systems 10 3rd October 2011 07:39 AM
Training on the Basics of a QMS (Quality Management System) for ISO 13485 YellowQCPro Training - Internal, External, Online and Distance Learning 4 5th July 2010 08:15 PM
Developing an ISO 13485 System - New Small Medical Device Company zkoulou ISO 13485:2016 - Medical Device Quality Management Systems 11 29th May 2009 05:22 PM
Medical Device Component Suppliers - Require ISO 13485 system? Cathy ISO 13485:2016 - Medical Device Quality Management Systems 10 16th April 2004 02:36 PM



The time now is 12:50 PM. All times are GMT -4.
Your time zone can be changed in your UserCP --> Options.


 
 
 


NOTE: This forum uses "Cookies"