Is it necessary for you to include Design and Development in your Quality Management System? Being a huge fan of keeping things as simple as possible, I would encourage you to closely look at your processes and see if you truly must include Design and Development in your quality system.
Look at your product. Do you truly design it, or do you produce items based on customer drawings and specifications? Or are you a sales organization or a distributor, with no manufacturing or design processes?
Don’t let an ISO consultant or anyone else tell you that you should include Design and Development in your QMS, just because they think you should. I’ve met a couple of people in the ISO world who just can’t believe than anyone would want to exclude Design and Development from their quality management system. These people strangely believe that just about any company has some design processes, and therefore should include this in their manual and procedures. Don’t let them bully you into this.
The question about desing and deveopment is always asked. May I have more on how to address this clause in a manufacturing facility where some of the products are actually copied from the market with slight changes on them that means they are designed in accordance with customers requirments after they, may be, failed in their present form. Please send me more highlights on theis subject.
Regards
Philip.