|The trick to ISO 9001 to interpret the standard properly while keeping quality simple. Use a process approach. Rather than changing how you view operations to meet the requirements of the standard, instead interpret the standard so it makes sense to your operations.
The process approach is basically PDCA. Understanding how PDCA applies to a QMS is important to QMS design. After applying a process approach, which itself is not a challenge, ISO 9001 is a snap. Otherwise, processes become lost among requirements and the results aren't useful.
To understand the process approach and how to apply it, consider reading this book:
"The Process Approach of ISO 9001"
Dan has over twenty years of direct experience with ISO 9001 as a quality manger, consultant, and auditor; he also holds an advanced degree in business administration. Dan offers uncommon expertise through consulting, training, writing, speaking, and coaching.