Planning for Success with Clause 8.3 Design and Development of Products and Services within ISO 9001:2015

Clause 8.3 Design and Development of Products and Services within ISO 9001:2015 is often the most dreaded for many clients. This is especially true for those clients who find themselves doing varying levels of design work. Sure, Clause 8.3 makes a ton of sense for truly novel designs intended for mass production, but what about the rest of the design world?

During many of our ISO 9001 implementations, we have heard, "Well, we do true design sometimes, but most of the time we are only changing a few minor design details. Do we need two different design processes? Do we have to apply our design requirements to all projects?" Unfortunately, the answer to this question is not always clear. However, in general, we recommend writing one high-level process for all designs with more focus on the design planning phase of the process.

8.3.2 Design and Development Planning specifically states "in determining the stages and controls for design and development, the organization shall consider (a) the nature, duration, and complexity of the design and development activities" which is green-lighting the idea that the stages and controls needed for each design need not be the same. We have found that a good design plan, even a short one, is a great way to augment the generic design process to increase control and achieve compliance while maintaining the appropriate level of flexibility. So rather than write a complicated one-size-fits-all design process, focus more on a generic high-level process and allow a design plan to fill in the gaps.

Lastly, we suggest that design plans should be seen as a living document to be managed and updated as needed, not looked at once and forgotten.  Good design plans demonstrate a level of controlled flexibility, which is essential for thriving in today's fast pace and high demand design environments.  As a Quality and Professional Engineering consulting firm, Simplicit Engineering attests that good design plans can work wonders for an organization.