ISO 9001:2015
I know this is a loaded question, with a long answer. I was wondering if anyone had any insight, or any direction on where to begin a self audit to get the ball rolling on an ISO 9001:2015 certification?
3 Replies
Trish Borzon
637 Posts
Hi Brian Winchester‍ - While I'm not an expert on this...there are a lot of discussion on the topic here.  Here's a quick search https://my.asq.org/search?query=ISO+Audit and https://my.asq.org/search?query=ISO+9001
Also - we have a quite a few members who have expertise in this area.  Amanda Foster‍, Duke Okes‍ might be able to provide some insights as well.  
Good luck :D 
Trish
Duke Okes
133 Posts
You're right ... this could be a very long answer.  However, based on how you've phrased the question I'm going to assume that you are basically talking about a gap assessment to determine what will need to be done in order to prepare for an initial certification audit.

The major issues are:

1) do you have someone who is well versed in the 9001 requirements who could do the assessment?  If not, either you need to find someone or need to develop someone (either by taking a course, or reading books, or having a coach, ...)

2) the assessment itself will be impacted by how sophisticated the organization and its QMS is, and whether or not it is well documented.  If there is a quality manual and procedures someone knowledgeable can simply review them and get a rough idea of major gaps, and then perform an actual assessment thru interviews and looking at records to see whether the policies & procedures are being followed.  If the QMS is not very well developed then the assessment becomes sort of a rough training effort whereby key members of the organization learn what is expected

3) the assessor(s) can then write a report detailing the major gaps, and can probably give a rough estimate of the amount of work and resources required in order to become compliant

Of course in order for this to have any legitimacy it must be championed by the leadership team, who will need to commit time not only to the assessment, but also to implementation if they decide to go forward.

 
Thank you, for your response. Our issue, honestly, is that we had no quality department until I recently moved into this role. However, I am new to quality myself. Long story short, we had no systems in place to go by, I am afraid I am completely starting from scratch, and may need to look into the thought of hiring an outside company to walk us through the process?