Design & Development Input Records Requirements - ISO 9001 Clause 7.3.2

Hi Forum users,

Can someone help me to solve the below query?

1. Is there any separate formats to be maintained to records design inputs? Is it enough that if we maintain a copy of the product data sheets, specificaitons & docs. which are from customers/clients?

But as per ISO 7.3.2 is saying that the design inputs are shall be maintained as per Cl. 4.2.4.

Regards,
Kumar D.

DK2327 said:

................. But as per ISO 7.3.2 is saying that the design inputs are shall be maintained as per Cl. 4.2.4. ................

Click to expand...

You missed the key part. It says: Inputs relating to product requirements shall be determined and records maintained (4.2.4)

You identify and determine (justify if necessary) what the inputs are and keep records.

DK2327 said:

Hi Forum users,

Can someone help me to solve the below query?

1. Is there any separate formats to be maintained to records design inputs? Is it enough that if we maintain a copy of the product data sheets, specificaitons & docs. which are from customers/clients?

But as per ISO 7.3.2 is saying that the design inputs are shall be maintained as per Cl. 4.2.4.

Regards,
Kumar D.

Click to expand...

Hi Kumar ...
In 4.2.4. procedure you state that design input is an identified record.
7.3.2 says that records of design and development inputs shall be maintained.
Now maintain all your design and development inputs. (Identify, store, protect, plan for easy and quick retrieval, hold for a defined time)
These will form the required records. Do not think about any format to complicate your task.

Thanks a lot Mr.Somashekar, but one more query.

Is it required to state the name of input records to be maintained in our QA procedure (Design procedure), for eg. if our input records are Data sheets, project docs. & specs. the same to be addressed in our QAP?

Regards,
Kumar D.

DK2327 said:

Hi Forum users,

Can someone help me to solve the below query?

1. Is there any separate formats to be maintained to records design inputs? Is it enough that if we maintain a copy of the product data sheets, specificaitons & docs. which are from customers/clients?

Click to expand...

No requirement to use any particular format - it's up to you. Some organizations do use a proforma in particular to capture their review of the design inputs and any decisions that come out of that. Again it is personal preference.

DK2327 said:

But as per ISO 7.3.2 is saying that the design inputs are shall be maintained as per Cl. 4.2.4.

Regards,
Kumar D.

Click to expand...

The idea is that the organization maintains records that show what requirements the product was designed to meet. The record could be in a number of different formats including hard copy, eectronic, physical product etc.

DK2327 said:

Thanks a lot Mr.Somashekar, but one more query.

Is it required to state the name of input records to be maintained in our QA procedure (Design procedure), for eg. if our input records are Data sheets, project docs. & specs. the same to be addressed in our QAP?

Regards,
Kumar D.

Click to expand...

Typical design inputs may be stated in your procedure, however inputs to design and development will be sought from many informations, discussions, articles, etc etc., as one gets involved in the design process. One of the best inputs is perhaps learnings from previous typical design experiences.
Again the ISO 9001:2008 does not demand a documented procedure. However, in case you go ahead and make one, feel free to keep these aspects open and do not tie down yourself.

Hello
I am new at this so not quite sure how to post a new topic I am hoping someone will be able to answer my question.
Are we required to keep the same level of documentation on small project (?) changes to design as we would with a larger project. I work in a medical device environment but we do not fall under the FDA guidelines yet. We currently create a project, and complete all documentation IDR, PDC, PMP and FDR that is required but it seems excessive with small projects or changes. For Example; Increase the size of a holes diameter for smoother movement, change of color, screen prints. If the change does not affect the quality or workings of the instrument would all of the necessary documentation that would be completed on a full instrument or components development be required? Could these types of things go through and ECN instead? Can the changes be added to the original full instrument project that was created previously?
Thanks
Rebecca

7.3.7 Control of Design and Development Changes "shall be identified and records maintained", this requirement would usually be satisfied by an ECN type change process. So long as the ECN is able to be traced to the original project/component (via a designated part or project number), I would think this would cover it.