Standards

Hello, What about a small company with very little in the way of process documentation?  I fear this will present issues in going for ISO 9001:2015 initial certification.  While 2015 4.4.2 allows latitude for the organization to determine the extent of its process documentation needs, it seems like this could present problems for the auditor (and for the organization).  Any advice with regard to minimal process documentation?

Thanks,

Tony

Any advice on designing a QMS for a small organization? where there is not a lot of hierarchy, can any one share their experience with ISO 9001:2015 for small organization, how to get the most out of the standard? what to look out for? key points? any help will me much appreciated!

I'd say keep it simple.  This new standard allows for less documentation than the 2008 version did, but you should also document what you need to in order to manage the system.  I'm an auditor with a registrar so I see companies of all sizes and all types of systems.  The ones that always have me shaking my head are the ones who document everything, almost down to turning on the lights, or the ones who don't document anything.  Make it something you will use even if you aren't going for certification.  

Hi Zubin Khalfay‍, 


Perhaps this Quality Press title could help you?

ISO 9001: 2015 Handbook for Small and Medium-Sized Businesses: https://asq.org/quality-press/display-item?item=H1480


I hope that others in this forum will be able to assist you as well. 


Gretchen Peterson

I'm tagging Amanda Foster‍ - I know she took her former company through ISO.  Any suggestions Amanda Foster‍ ?

Hi Zubin Khalfay‍!


The most important thing is you get leadership commitment and buy-in. Since there is little hierarchy every person is vital.


One of the best things we did was develop a database to house all the quality information in a single place and made certain parts accessible to everyone in the company. It became an interface for all things quality. Anytime someone needed a form they could go to that database an the current revision was readily available, same with SOPs.


The other big thing is communication. You'd think communication would be easier in a small business, but not always. Larger companies develop tools to ensure everyone receives important communications, but these don't seem as necessary in smaller businesses. It's important to develop some sort of formal communication methods that both ensure communication happens and provides a records of important communications that can be used in an audit or for training purposes. One of the companies I worked for have an all hands staff meeting every 4 weeks. Formal notes were emailed after that meeting in case anyone missed the meeting. Additionally, formal staff meeting notes were developed and emailed on the two week mark. So, in a given month you would have 1 live staff meeting followed by emailed formal notes and 1 emailed formal notes in place of a meeting. There was a standard template and many of the ISO required communications could be traced through those notes. It didn't take a lot of time, but it provided a consistent and formal record.


I did use the book Gretchen recommended in the previous post and it was helpful. Let me know if you have any specific questions and I will do my best to answer them.