It’s Too Late: Quality Management System (QMS) Optimization Will Have to Wait

I got a call from a perspective client recently (Jan 17th). The perspective client was the site Quality Manager for a medium size manufacturing organization. The site maintained an ISO 9001:2008 QMS certificate and needed to prepare for transition to ISO 9001:2015 this year. 

As part of the transition the Quality Manager wanted to optimize the site’s QMS documentation which, she admitted, hadn’t been updated in years. 

My immediate feedback was: It’s too Late.

With a certification audit scheduled for June (5 months away), I recommended focusing solely on updating existing documentation and leaving any plans to optimize or update their QMS documentation until after the transition to ISO 9001:2015 was completed. 

This was not what the client wanted to hear.

I explained that to meet the requirements of the new standard, the organization had to first train personnel to the new standard, perform a gap assessment, close those gaps, conduct an internal audit, and hold a management review incorporating the new requirements and covering the preparation for certification to ISO 9001:2015.  

This process, I explained, for most manufacturing sites of their size normally takes 9 – 12 months depending on resource availability. They would need to condense this into 5 months. Thus, there was simply no time for anything else. 

What I didn’t mention was most organization that planned to optimize their QMS documents prior to certification, started that effort over a year ago.    

A dose of reality is sometimes difficult to swallow. She thanked me for my time and inputs and said they had other candidates they would consider. 

I hung up the phone thankful I missed this opportunity.

About the author: Shawn Rogers is a Certified Quality Management Lead Auditor (ISO9001 and IATF 16949) with more than 35 years’ experience in high-technology manufacturing and product development. He has extensive experience in technology startups, engineering, and business management and quality systems development in both small and large organizations. He has worked in all areas of the electronics industry, including: semiconductor wafer fabrication, semiconductor assembly operations, printed circuit board (PCB) manufacturing, and multi-factory manufacturing logistics. He has degrees in electrical engineering and business administration.