Auditing clause 7.3 of the design and development section of ISO 9001 can be a challenge for the auditor and the auditee. Unlike purchasing, manufacturing, shipping or order processing, it’s rarely carried out on a regular or consistent schedule. The level of activity ranges from the highly frenetic in a fast-paced, cutting-edge industry to the relatively static in an organization that has a mature and stable product.

In many organizations, the steps vary with the project. Time tables are forever in flux. The most predictable characteristic of plans is the constant change. Because there’s not always a customer order pending, resources may get drawn away from the design team and assigned to what are perceived as more urgent tasks. Keeping the design plans—complete with milestones, deliverables and scheduled reviews—is a daunting chore. Maintaining the integrity of the design process in this kind of environment requires vigilance to ensure control of specifications, documentation, traceability, communications, approvals, revisions and inclusion of all relevant parties.

 …