Is there a summary of changes from a withdrawn ISO standard to the current version

[Ethan Loh]

Hi everyone,

I would like to ask is there a summary of change(s) between a new ISO standard that is published and the withdrawn ISO standard.

The problem I am facing now is, there is a list of ISO standards quoted in my company Technical files for our CE marking medical devices.

So when a new standard is published, I will need to perform a gap analysis and try to find out what the new standard call for. That mean I got to read from page 1 to the last page of the standard.

After that I will pass the information to the design team or engineer team and try to ensure my company can comply with this standard before we quote in the ER checklist.

Any help is deeply appreciated.

Ethan

 

[Stijloor]

Re: Is there a summary of changes from a withdraw ISO standard to the current version

Hi everyone,

I would like to ask is there a summary of change(s) between a new ISO standard that is published and the withdrawn ISO standard.

The problem I am facing now is, there is a list of ISO standards quoted in my company Technical files for our CE marking medical devices.

So when a new standard is published, I will need to perform a gap analysis and try to find out what the new standard call for. That mean I got to read from page 1 to the last page of the standard.

After that I will pass the information to the design team or engineer team and try to ensure my company can comply with this standard before we quote in the ER checklist.

Any help is deeply appreciated.

Ethan

Can someone help Ethan?

Thank you!!

Stijloor.

 

[Paul Simpson]

Re: Is there a summary of changes from a withdraw ISO standard to the current version

Despite there being a requirement in ISO 9001 for:

c) to ensure that changes and the current revision status of documents are identified,

ISO doesn't follow that principle for its own standards. Your best bet is to get onto the relevant Technical Committee web site. So for example Medical Devices is TC 210 and they list standards covered here. All other TCs are mentioned in the relevant standard and you can do a search on ISO's web site.

Generally when a new standard is launched there is information on the change on the ISO web site and on those of the National Standards Body selling (!) the ISO. Here in the UK BSI normally gives a good overview of changes for the more noteworthy standards. There is an example here.

It's not easy but you just have to track some stuff. Alternatively there are plenty of consultants who can keep track on your behalf.

 

[Bill Mitchell]

Re: Is there a summary of changes from a withdraw ISO standard to the current version

Ethan:

Being on the consulting side of Quality Management I have the benefit of working with many of the Registrars. I have on file a great breakout of what you are looking for looking for. It takes you line by line throught the standard. This is 16 pages long and cannot be posted. If you provide me a email address I will be happy to forward this to you.

 

[Ethan Loh]

Re: Is there a summary of changes from a withdraw ISO standard to the current version

Dear Bill,

My email address is as follow: [email protected]

Thank you so much for your help.

 

[Stijloor]

Re: Is there a summary of changes from a withdraw ISO standard to the current version

Ethan:

Being on the consulting side of Quality Management I have the benefit of working with many of the Registrars. I have on file a great breakout of what you are looking for looking for. It takes you line by line through the standard. This is 16 pages long and cannot be posted. If you provide me a email address I will be happy to forward this to you.

Bill, any chance you can post or link this document for the benefit of all our Members?

Stijloor.