Clause 7.3 Design and development

Recent study of world's top 500 companies suggest that they are investing less in research and development compared to previous years against their investment in marketing and promotional activities.

To remind you of importance of design and development, just look at the picture below:

Think what it could be......

........
It’s a hard disk at 1956....

..............

The Volume and Size of 5MB memory storage in 1956.
In September 1956 IBM launched the 305 RAMAC, the first computer with a hard disk drive (HDD). The HDD weighed over a ton and stored 5MB of data.
... ... .... ... ... and today you carry 4 GB pen drive and can even carry a laptop hard disc of 120 GB with USB connector in your pocket. 

Design and development has following sub clauses:

7.3.1 Design and development planning
7.3.2 Design and development input
7.3.3 Design and development output
7.3.4 Design and development review
7.3.5 Design and development verification
7.3.6 Design and development validation
7.3.7 Control of design and development changes

Design and development is excluded (as per clause 1.2) by many organizations without understanding the requirement of the standard. Even certification bodies allow this exclusion without understanding product requirements or customer requirements.

If an organization has out sourced design and development that it should be included within QMS and outsourcing controls should be determined and established. ISO/TC 176 has clarified that design and development should be applied in designing packaging for the product as well. That means if a company is making standard product as per national or international standard and does not design the product, it is at least designing its packaging to preserve the conformity of product during delivery. Click here to see ISO/TC 176 Approved Interpretation.

External Document Reference: Documentation Kit

Methodology for Product Design and Development
Design and Development Plan/Review Record