The development of new products is covered under the ISO 9001:2008 standard as design control. The implementation of design control may be dreaded by your engineering department but it is one of the easiest areas to implement a new system Our Turnkey Quality Management System includes everything you need to create a usable and effective design control process.

Design control requires the company to maintain quality record of how the product was specified, developed, tested, validated, and verified. In many small engineering intensive companies, this is the bane of the engineering department. The engineers like structure but hate the thought of additional paperwork. A good design control procedure does not require significant additional paperwork but does put in place structure that will improve the quality of new products. It does this by defining the interface between marketing (with their ever changing requirements) and engineering, called a product specification. By forcing approvals and revision control on a totally defined product (or project) specification, the ISO 9001:2008 standard requires detailed a project scope that is usually not well defined in non-ISO companies.

An effectively design control process will reduce the chances that a product is released without a proper market or proper testing to meet that market. Control of the "product specification" is the key to the success of the product and project. The reference resources listed here explain the concept of design control and the sample procedure is an example of the simplest system for maintaining design control. If you work with the engineering department so they have buy in, this simple system works perfectly. The system revolves around the creation of a design notebook that includes all the documentation required to properly target a market, design a product, test the product and support the product.


ISO 9001:2000 Design Control Procedure
This is a sample ISO 9001:20000 design control procedure.

ISO 9001:2000 Design Control Summary
This article is a summary of the ISO 9001 requirements for design control.