ISO 9001 Requirements
ISO 9001 Requirements Clause 8.3.1 & 8.3.2 – Design & development (DD) – general and planning
DD is a systematic approach (set of processes) for creating new (or improving existing) products and services (PS) in order to provide value to the marketplace in terms of new and better products that customers can use, to ensure the long-term growth and success of an organization.
You must establish, implement and maintain a DD process and include it your QMS scope if you contract or convey the perception that you design PS, regardless whether you buy, outsource or actually do DD.
Although not required by this standard, the requirements of this clause are equally applicable for designing and developing new (or changing existing) operational (e.g. manufacturing) processes.
You must have an overall plan for your DD project. DD activities are unique to each design project and usually non-repetitive with unpredictable outcomes. There may be several iterations required of the DD activities before you come up with a successful PS. Your DD plan must be flexible to changing requirements and circumstances as the DD project progresses. You must track progress against your plan at regular intervals or project milestones and update the plan as activity progresses. There are many tools available for DD planning ranging from a simple checklist to complex software.
This article is an extract from my eCourse “Understanding ISO 9001:2015”. The rest of the article on this clause discusses in detail the specific controls to address each of the specific requirements of clause 8.3.1 and 8.3.2.a-j.