8 Replies


Posted by Ashley Wood on Aug 19, 2019 2:47 pm

Hi Everyone,

I've been in a quality management role for close to five years now.  I work for a small business (around 40 employees) in the medical devices industry. 

I would have to say that my biggest challenge in this role has been to try and promote the idea that the processes put in place for our QMS are not just "bureaucracy."  When I started in my current role, I was tasked with implementing a QMS and gaining our certification to ISO 9001:2015.  I quickly learned that the hardest part of these tasks would be trying to change the culture of the company.  Processes that seemed to me to be commonsense needs of a thriving QMS would be shot down as being unnecessary, too much paperwork, etc.  To employees and even some members of the management team, anything that was done related to the QMS was done "for ISO."  People preferred to do the bare minimum; they wanted to only do what would meet the minimum requirements of our registrar so we could have the certificate on the wall. 

I am happy to say that our culture has significantly changed in the last five years.  We just recently finished our re-certification audit to start our fourth year as a company certified to ISO 9001:2015. However, we still have to work to continually improve company culture in regard to quality every day.   I've learned that you can implement processes all day, but if employees don't believe in them, then truly they do just become bureaucracy.

I'm looking forward to learning from my peers in the ASQ community!

Re: Introduction

Posted by Trish Borzon on Aug 19, 2019 3:45 pm

Hi Ashley, Welcome to myASQ!  Culture is definitely a hard one to overcome.  Glad to hear you've made improvements - slow & steady.  You'll get there. 
good luck & Thanks for being a member!

Re: Introduction

Posted by Amanda Foster on Aug 20, 2019 7:33 am

Welcome Ashley Wood‍!

I have performed a similar role in a different industry. I had more than 8 years of Quality Management experience with the company I recently left and my experience was similar. I particularly found it difficult to convince them that they needed to track and measure things, not just for ISO but for their own benefit in operational excellence and improvement efforts. They weren't hostile, but I felt the way you describe, as though common sense suggestions were rejected out of hand without determining their overall value.

This month I began a similar job for a new company in a related industry and am again finding similar trends. It seems that people associate ISO with extra work and extra paperwork  but don't recognize the  value these "extra" steps bring to overall efficiency.
Amanda Foster, ASQ CQA

Re: Introduction

Posted by Ashley Wood on Aug 20, 2019 9:57 am

Thanks, Trish Borzon‍!

Thanks, Amanda Foster‍!  I'm sure it's a common occurrence, unfortunately.  I've been focused on trying to show the value of QMS processes in hopes that it increases buy-in.  Showing people that one extra step might make a customer more likely to buy from us or help us with monitoring and measuring down the road sometimes does the trick.  I'm still working on it though!

Re: Introduction

Posted by Trish Borzon on Aug 20, 2019 10:16 am

It's so hard to convince people that change can be good! lol 

Re: Introduction

Posted by Luigi Sille on Aug 23, 2019 9:58 am

Hi Ashley Wood‍ , I have seen this. But I can tell you it will take time.
I have been working in the same organization for more than 18 years.
T o change a culture it will take time. But management must believe in quality and in change! 
It took us here like 8 years to change. After 8 years we had a amazing culture change, everyone, And I can tell you everyone is committed !
But again it will take time, and MANAGEMENT must be ROLE models, if not..... It will be so difficult to see any changes in your organization.


Re: Introduction

Posted by Ashley Wood on Aug 23, 2019 10:35 am

Hi Luigi Sille‍, you are definitely right about that!  Culture changes only happen from the top down. 

Re: Introduction

Posted by Gretchen Peterson on Sep 5, 2019 12:30 pm


I'm a little late to this thread but I'm posting a few resources that might be helpful to those trying to demonstrate the impact and value of quality to decision makers in organizations. 

First, a great Quality Progress column by author Govind Ramu:

And, another article, based on some extensive research, published in Quality Progress

Enjoy and good luck!

Gretchen Peterson MLIS Research Librarian

Re: Introduction

Posted by Ashley Wood on Sep 5, 2019 1:26 pm

Thank you, Gretchen Peterson‍!  I will definitely take a look at those.