Elsmar Cove Forum Header Graphic 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
Miner's MSA (Measurement Systems Analysis) Blog 
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

Wooden Line

Gap Analysis Checklist for ISO 13485:2003 2012 - Page 2

Wooden Line
Search the Elsmar Cove
Search Elsmar
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
gap analysis, iso 13485 - medical device qms
Reply
 
Thread Tools Search this Thread Rate Thread Content Display Modes
  #9  
Old 14th November 2012, 03:12 PM
ISO assistance

 
 
Posts: 2
Re: Gap Analysis Checklist for ISO 13485:2003 2012

DR RA,

Were you able to locate a Gap Analysis Checklist for ISO 13485:2003 2012; I am looking for the same thing and have not had any luck thus far.

Sponsored Links
  #10  
Old 14th November 2012, 03:14 PM
ISO assistance

 
 
Posts: 2
Re: Gap Analysis Checklist for ISO 13485:2003 2012

In search of a GAP analysis for EN ISO 13485:2003-2012. Any assistance would be greatly appreciated.

Thank you in advance.
Sponsored Links

  #11  
Old 14th November 2012, 03:21 PM
AndyN's Avatar
AndyN

 
 
Posts: 7,895
Let Me Help You Re: Gap Analysis Checklist for ISO 13485:2003 2012

Quote:
In Reply to Parent Post by ISO assistance View Post

In search of a GAP analysis for EN ISO 13485:2003-2012. Any assistance would be greatly appreciated.

Thank you in advance.
You can create one easily. Take the standard and write in front of each requirement the words, "Do we do this?"

In a spreadsheet, make a column for each requirement, then one of the answer and any explanation of something done partially, or ineffectively.
  #12  
Old 15th November 2012, 07:49 AM
Dr RA

 
 
Posts: 19
Re: Gap Analysis Checklist for ISO 13485:2003 2012

This is what I have done for the Gap Analysis: Hope u can do similar to this
In March 2012, BS EN ISO 13485:2012 was published, following European publication in February. This version will only be applicable within Europe and is expected to be harmonised by the end of summer 2012. For the rest of the world, ISO13485:2003 will remain the applicable standard.
What is the difference between EN ISO 13485:2012 and ISO 13485:2003?
The only changes to the new 2012 standard are within the forward and Annex Zís. There has been no change to the Normative Text, i.e. the requirements of the standard remain unchanged from the 2003 version.
The revision to the (informative) Annex Zís was made to provide greater clarity on the applicability and alignment of clauses of ISO 13485 with the quality systems requirements of each of the three Medical Device Directives (AIMD, MDD and IVD). The new Annex Zs each cover a different Annex (Conformity Assessment Route) within one of the Medical Directives. For example, Annex ZB of BS EN ISO 13485 shows the relationship between the Medical Device Directive 93/42/EEC Annex II, Full Quality Assurance and the clauses of EN ISO 13485.
Quality Management Standards
EN ISO 13485:2012 and ISO13485:2003, are based on the ISO9001:2000 process model approach. These standards provide a good base Quality Management Systems model for compliance with the following:
1. EU CE marking medical device directives
2. Health Canada CMDCAS
3. Taiwan Medical device Regulations
4. Other international regulatory requirements.

As there are no change to the requirements of ISO13485 standard, no amendments are required to QMS.
Thanks to Dr RA for your informative Post and/or Attachment!
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
EN ISO 13485:2012 vs. ISO 13485:2003 - Confusion? SteveK ISO 13485 and ISO 14969 - Medical Devices - Quality Management Systems 25 10th October 2012 01:39 PM
GAP Analysis for ISO 9001:2000 vs. ISO 13485:2003 SIMMO ISO 13485 and ISO 14969 - Medical Devices - Quality Management Systems 2 12th September 2008 12:43 PM
13488:1996 vs. 13485:2003 Gap Analysis Matrix Spreadsheet senna ISO 13485 and ISO 14969 - Medical Devices - Quality Management Systems 4 25th February 2008 08:18 AM
ISO 13485 Gap Analysis Checklist - Updating ISO 13485 from the 1996 standard to 2003 Charlie ISO 13485 and ISO 14969 - Medical Devices - Quality Management Systems 4 9th April 2007 04:51 PM



The time now is 12:45 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".