ISO 9001:2015 Questions

R

rfoley14411

Hi! I am very familiar with ISO13485 - the version before current & knew the really old ISO9002. A few starting questions on the new ISO 9001:

-Can you still 'grandfather' the old ways - understanding you need compliant documentation, need to stake the sand by date & do it right going forward?
-Design & Development: I have no prior knowledge so am trying to get going on understanding this.
-We make our own 'standard' parts that we have been making forever, have controlled datasheet that customers order from & we control changes to them - will I need to do anything for D & D on this?
-We also make 'custom' parts that are generated from initial customer inquiry with their specs - we figure it out, spec & control on our end & get their approval before starting - is this acceptable or is something further needed?

Thank you in advance!!
 

yodon

Leader
Super Moderator
-Can you still 'grandfather' the old ways - understanding you need compliant documentation, need to stake the sand by date & do it right going forward?

You'd have to provide more information on what processes you're talking about; regardless, you have to demonstrate compliance so if the 'old ways' are not compliant then, no, that would not be acceptable.

-Design & Development: I have no prior knowledge so am trying to get going on understanding this.

You mention you're familiar with 13485 so the D/D part isn't all that different (more controls for medical devices so the 9001 part should be readily understood).

-We make our own 'standard' parts that we have been making forever, have controlled datasheet that customers order from & we control changes to them - will I need to do anything for D & D on this?

When you say you "control changes to them" is this design changes? If so, then, yes, these activities would be under the D/D processes.

-We also make 'custom' parts that are generated from initial customer inquiry with their specs - we figure it out, spec & control on our end & get their approval before starting - is this acceptable or is something further needed

Sounds like D/D work... so you'd need to be compliant with those requirements. This also backs up into 8.2, requirements for products and services.

If you don't have a copy of the standard, you should get one, map your current processes onto the requirements in the standard, then do a gap analysis to determine what needs to be shored up.
 
R

rfoley14411

Thanks for the comments.

For D & D, if in the past you did not do a Design Review, i.e. had no such records but write your procedure today to require & start doing it per procedure - can you 'grandfather' the old designs for the review portion? We would make any changes per proper control system, etc. It's just in the 'olden' days you could pretty much grandfather everything & I just wasn't sure if the new version still permitted that. Thank you!
 

somashekar

Leader
Admin
Thanks for the comments.

For D & D, if in the past you did not do a Design Review, i.e. had no such records but write your procedure today to require & start doing it per procedure - can you 'grandfather' the old designs for the review portion? We would make any changes per proper control system, etc. It's just in the 'olden' days you could pretty much grandfather everything & I just wasn't sure if the new version still permitted that. Thank you!
The new version does not stop you from doing any needed things. Your design may be old, but your design documentation always remains current until changed. As a new version input, your grandfathering can now be part of the 7.1.6 Organizational Knowledge.
 
Top Bottom