ISO 9001 Clause 7.3 - Design & Development - Requirements help wanted

Hi everyone:

Need help as above mentioned!
My company is registered as ISO9001:2008. During certification, we declared that we don't have design department, but acutally is not.
Now we are going to anounce that we will include R&D which is clause 7.3 - Design & development.
Can someone instruct me that what procedures need to write. what kind of records need to control. and how to control the input and outputs?

Would appreciate for your help

Re: Need help for ISO 9001 Clause 7.3 - Design & Development

delia628 said:

Hi everyone:

Need help as above mentioned!
My company is registered as ISO9001:2008. During certification, we declared that we don't have design department, but acutally is not.
Now we are going to anounce that we will include R&D which is clause 7.3 - Design & development.
Can someone instruct me that what procedures need to write. what kind of records need to control. and how to control the input and outputs?

Would appreciate for your help

Click to expand...

What do you produce? What's your product?

Here are a couple things to help you start thinking about designing your system.

Re: Need help for ISO 9001 Clause 7.3 - Design & Development

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The most obvious statement is that you need to read and understand clause 7.3 and it will tell you which records etc are required.

I would pay particular attention to the 'design inputs' and find out which inputs are applicable e.g. customer requirements, industry standards, regulatory requirements, etc as it is against these that you will need to verify and validate your designs.

I suspect that you have many of the requirements already covered but perhaps not formally and not in the words of ISO 9001.

Perhaps you could produce a flowchart of some type that would outline your existing design process and post it for us to look at and comment on.

delia628 said:

.............. Can someone instruct me that what procedures need to write. what kind of records need to control. and how to control the input and outputs?

Would appreciate for your help

Click to expand...

Sounds like you had a handle on the subject but isn't sure of how to write a procedure. Why not have a look at some of the procedures that others used (can be found in the post attachments list) and come back if you have further questions.

You don't need to worry about writing procedures before you know exactly how you will do R&D and/or product design.

If you read ISO 7.3 all the way through, it will give you a pretty good idea what is required.

If one person knows about product design and sets up the system, writing the procedures should be fairly easy. Setting up an R&D department/process/area is a big assignment. Writing the procedures and defining the requiremetns for audit should not be real difficult if the first part is done correctly.

It's not impossible for one person to do it all, but the process must be understood and set up before you go to writing procedures.

Hi Colin, Thx for your precious opinions! you made point! As we always declare that our exclusion is Clause 7.3 in our Quality Manual during 3rd party audit, and R&D dept is not under ISO control. therefore, R&D Dept has itself control method and process flow. According to ISO requirements, records which generated during D&D must be reviewed and approved by an authorized party before use, and we dont have fomally records control process.

I am thinking that to write a design review procedure, and then try to revise some of forms based on Document control procedure, besides, need to systematically control their records. Like Colin San said, we do have records to cover ISO, but not under good control.

will post here for discussion and opinions.

Glad to have been of help . Of course you don't have to have a written procedure for design control, but I must be honest that I always do, it seems too important a process to rely on other methods of control.

I suggest you talk with the people involved in design and ask them what type of procedure they would prefer e.g. text based or a flowchart and ask them to tell you what they do. You then draft that out in procedure/flowchart form and ask them to comment - don't worry if you haven't got it right - that is why we are doing this.

When you have got it close to what everyone thinks is right, compare it against clause 7,3 ad make sure it satisfies each element. I know 7.3 can be a bit daunting but it isn't too bad once you get to know it. I think is important to do it this way round rather than writing it around the clause and then trying to 'shoe horn' it into your department.

Once it is done, implement it i.e. run with it for a while then, when it has had chance to work and produce some records, conduct an internal audit.

yes I know procedure for D&D is not mandatory in ISO 9001:2008 requirements, but an approved procedure is easier for people to follow and understand. Till now I still found, when I deal with external party auditors, they still ask for reviewing formal procedures and work instructions.

I roughly know about our company design process flow, but what I trying to do is gather much more information from R&D dept, from Sales contract to customer evaluation result, what forms and records they are using, how do they control records. I don't want to change their control system, but I will do some amendments based on current system to meet ISO requirements. Meanwhile, I will standardize forms number for critical forms, centralize control the records, update masterlist including retention period and index method.

That's all what I can do now, as in my company culture, especially R&D dept, they really not pay so much attention to documentation job and ISO activities. But anyway, I will try my best to complete the task.

Thanks a lot Colin!