When ISO 9001 Fails

Why the standard has regulations about handling defective materials and nonconforming product

Failure can have many root causes, even with great products and methods. Photo by Julien L on Unsplash

Wed, 10/23/2024 - 12:03

You’ve finally gotten ISO 9001 certification. Congratulations! You’ve built your quality management system, written your procedures, trained your staff, sweated through internal and external audits, and your registrar sent you a certificate suitable for framing. Now, at long last, all of your problems are over, right? 

ADVERTISEMENT

If only. 

The ISO 9001 standard isn’t magic, and it won’t make all your headaches disappear. It’s a powerful tool—don’t get me wrong. But like any tool, it’s good for some jobs but not others, and you have to use it the right way. (A hammer is great for driving nails, but not so good for sweeping floors.) So it’s helpful to understand what ISO 9001 can’t do, and also how it can go wrong if you misuse it. 

 …

Want to continue?
Log in or create a FREE account.
By logging in you agree to receive communication from Quality Digest. Privacy Policy.

Comments

Submitted by Rick Fehlau (not verified) on Wed, 10/23/2024 - 09:31

An ISO 9001 based QMS MUST be a living system. When managers. in particular, care about what the system can and can't do, and are not afraid to alter the system to make it work and be beneficial to the company, then it is indeed a direct contributer to the bottom line.

Submitted by Dr. Susan O. Schall (not verified) on Wed, 10/23/2024 - 10:08

Spot on!  I've seen all failure modes and the effects in multiple industries from manufacturing to education.  Why go through all that work if you are going to ignore it, never change it or mis-size it ?  An auditor and/or your customers will figure it out sooner or later.

While these are all true and I do not dispute them. What is not said here is the most important part. While compliance to standards is necessary in the modern age of manufacturing quality, it is not sufficient to ensure delivered quality outcomes to customers, and that a new approach and mindset is necessary that brings compliance back into its proper perspective of the effort-value calculus.

Lets say the obvious, a quality system, no matter how simple or complex, small or large is flawed and that flaw is based on one thing, People. A new mindset of Embedded Quality with a focus on Delivered Quality that digitizes everything necessary to achieve quality outcomes that customers can see and feel is the most important thing quality can do to bring competitive advantage to their companies. Compliance is necessary but not sufficient and we should view it through that lens.

Add new comment