If you want to establish a holistic and functional quality management system from scratch, ISO 9001:2015 is the perfect place to begin. ISO 9001 lays out the core fundamentals of the modern QMS, and the key ingredients for providing products and services that consistently meet the requirements of your customers.
By itself, ISO 9001 compliance won’t provide the niche life science quality management requirements needed for a medical device, pharmaceutical or therapeutic business. But it will give you the foundational groundwork upon which all your QMS activity is built. Crack ISO 9001, and your business is empowered to move onto any other quality standard – and be recognized as an established, quality-conscious organization as you do so.