QMS Roll out with guidance from ISO 9001

[Adehanks]

Hi Everyone,

Has anyone had experience rolling out a QMS? I was wondering if there is a logical order to rolling out a QMS while also becoming compliant with ISO 9001. For instance, start with 4 - Context of organization, then hit 5 leadership, etc. I'm trying to structure a logical project pan for the QMS roll out and wondered if anyone has any feedback TIA.

 

[Tagin]

I think what you want to do is to 'work from what you have outwards', so to speak. By that, I mean:

• Think of what you currently do as a subset of what the standard requires. E.g., like a Venn diagram with one circle inside the other.
• Document (maybe in flow charts, paragraphs, or outline format, etc.) what your organization already has and does.
• Then see where and how well those pieces fit with the standard.
• Where there is a deficiency, then modify or add as needed to flesh out your processes and systems to meet the standard.

This way, how your organization actually works becomes the core of your QMS. I found out the hard way years ago that starting from the standard and trying to wrap our processes around the standard was clumsy, difficult, and did not serve us well.

 

[Mike S.]

Do you have anything at all in place now as far as procedures, work instructions, etc. or is this a brand-new entity with nothing in place?

 

[Adehanks]

I think what you want to do is to 'work from what you have outwards', so to speak. By that, I mean:

• Think of what you currently do as a subset of what the standard requires. E.g., like a Venn diagram with one circle inside the other.
• Document (maybe in flow charts, paragraphs, or outline format, etc.) what your organization already has and does.
• Then see where and how well those pieces fit with the standard.
• Where there is a deficiency, then modify or add as needed to flesh out your processes and systems to meet the standard.

This way, how your organization actually works becomes the core of your QMS. I found out the hard way years ago that starting from the standard and trying to wrap our processes around the standard was clumsy, difficult, and did not serve us well.

Great feedback. Thank you. I found a gap analysis spreadsheet from a previous life that I may tailor to my needs. That way, I can understand our current state.

 

[Adehanks]

Do you have anything at all in place now as far as procedures, work instructions, etc. or is this a brand-new entity with nothing in place?

We have a lot of documentation but none of it is controlled. I'm currently setting up a project plan to spin all of our needed documents to a standard template and under revision control using SharePoint. As far as everything else, I was just going to conduct a gap assessment to understand our current state and action it from there. Just wondering if there is a logical method.

 

[Mike S.]

Sounds like you have a reasonable plan, but consider dropping the "I" for "we". Don't try to do this all yourself, that's a bad idea for many reasons. Build a team with your co-workers.

 

[Golfman25]

We have a lot of documentation but none of it is controlled. I'm currently setting up a project plan to spin all of our needed documents to a standard template and under revision control using SharePoint. As far as everything else, I was just going to conduct a gap assessment to understand our current state and action it from there. Just wondering if there is a logical method.

The logical method is to start with what you have and start at the core of your business. So if you make something, start with production and work from there. Leave the ancillary stuff. like "context of organization" until the end.

 

[Sidney Vianna]

This all comes down to the proper understanding of what a quality system is. Anyone who gravely mistakenly attempts to “plug-in” a quality system external to and disconnected from the ALREADY EXISTING business processes is destined to fail. With a few exceptions, most organizations have all the business processes impacted by ISO 9001. The key is to understand the bits and pieces of such processes that affect product conformity and customer satisfaction and ensure the business process owners are involved and committed to the organization’s goal of conforming to 9001 in a business savvy manner. Anyone who is hired to “implement” 9001 and struggle to have access to top management and process owners is destined to fail, miserably and painfully.

 

[Peter Fraser]

Your system exists now, whether or not it is defined anywhere - it is what you do. I suspect that you are talking about what documentation you have in place. That is different! Do you mean "how do we define and communicate how we work"?