On being asked to summarize the differences between two quality standards, ISO 9000 and Six sigma, this is

how I replied:

A. ISO 9001 is a management system standard.
B. Six-sigma is a statistical description of process performance.

A. ISO 9001 focuses organizations on their management system that governs the processes that yield
products. At the system level ISO 9001 is inviting organizations to address common (system level) causes of
process variation. The process-based management systems specified by ISO 9001 can be used to assure
product quality and manage continual improvement (to add value faster and prevent loss sooner).

B. Six-sigma is a continual improvement methodology. Most organizations run at two or three sigma. Six-
sigma focuses on designing products so they can be made with fewer defects and on running projects to
progressively remove the most costly assignable causes of process variation. Many organizations mistakenly
focus their six-sigma efforts on manufacturing before product design. Six-sigma literally means 3.4 defects per
one million products. I understand that US airlines with the FAA run their safety processes at about 7-sigma.

So, A and B are designed to work together. Most text books do not mention the 10 to 20 year investment that
Motorola, Allied Signal and other six sigma leaders made in developing their management systems before
investing in six-sigma. Consequently, perhaps, many organizations using these books have neglected their
systems and waste money on their six-sigma efforts because they are let down by inadequate management
systems.

To summarize, ISO 9001 specifies a process-based management system which could include its six sigma
improvement process. So, both are compatible and many would say that you should first put in place the
organizations process-based management before investing in six sigma training to turbo-charge the systems
improvement process.

In conclusion, develop your process-based management system first. Run it to assure quality and prevent
pollution for a few years. Then invest in six sigma to supercharge your continual improvement process to yield
even more cost savings from design, production and delivery.

Please note that certification is not necessary for this but may provide marketing benefits.