ISO 9001 new certification advice request - Develop a QMS from scratch

[ochem]

I am in line for a Quality Manager position. The company is setup as a parent company that opens subsidiaries depending on the product lines/markets that their uniquely made products (chemical in nature) are developed for. The initial focus for this position will be to develop a QMS from scratch and get ISO 9001 certification for one of their subsidiaries. They currently have 2 manufacturing facilities, but will likely be opening several more over the next few years. Their thoughts were to get the one facility that I will be based at certified, then move onto the next facility, and so on.

The problem is I feel like there may be a better way to do this and I was hoping to get some opinions. The company is small for now, but I suspect it will grow considerably over the next few years, and on into the future, not just opening new manufacturing facilities, but new subsidiaries as markets open up for new products. If I set up the base of the QMS properly, it could make it vastly easier to deploy/branch it out to other facilities and subsidiaries as it grows. Maybe I'm overthinking it, I've got a strong ISO background, but have never implemented from scratch, so I want to do it right, and make the best impression I can. Would it be better to certify the parent company, then add subsidiary facilities to the certificate? It gets more complicated in that all three arms currently occupy the same building, and people (quality and production) folks go back and forth between the companies to do work and testing, so competency/training requirements will be difficult to keep straight.

Sorry if long winded, this is a huge opportunity for me, and want to guide them the right way.

 

[Sidney Vianna]

Your QMS must be clear in terms of what processes/responsibilities happen at the corporate and site levels.

it also must be scalable and replicable, allowing for the expected growth.

 

[indubioush]

If everyone is in the same building and works for all three companies, it makes sense for everyone to be under that one quality system. Include all branches from the start. My advice to you is to keep your quality system incredibly simple and lean so it is easier to understand and follow. It will evolve in time.

 

[malasuerte]

You need to determine the scope of the QMS. You can certify the parent company at not the subsidiaries, or vice versa.

Firstly, what is the expectation from customers? Do they expect their product manf. in a ISO registered location?

Now, if I read btw. the line on what you have said, my inclination would be to just get the whole organization set up. It would seem to me you would want everyone doing things the same, making it easier to manage quality, etc.

Would really need a lot more info to make a complete suggestion.

 

[Bill Levinson]

I agree with indubioush. If all three arms occupy the same building, and the same people go back and forth between them, this suggests (correct me if I am wrong) that you have processes with handoffs across organizational boundaries, and handoffs are a major source of trouble because none of the processes are explicitly responsible for them (unless otherwise specified).


On the other hand, you almost never build a QMS from scratch. If you have processes, there are almost certainly instructions and flowcharts for them, assignments of responsibilities, process controls, quality checks, and most of the other activities required by ISO 9001. It now becomes a question of matching what you already do to the standard's requirements, and then adding whatever you need to take care of anything that is missing. You almost certainly have a corrective and preventive action (CAPA) process in place, as well as processes for ensuring that supplied products meet your requirements.

Here is an article I wrote on transitioning from ISO 9001:2008 to ISO 9001:2015. Using a Conformity Matrix to Align Processes to ISO 9001:2015 | Quality Digest "No need to rewrite procedures; simply demonstrate how they meet the standard’s provisions."

 

[tony s]

I've got a strong ISO background, but have never implemented from scratch, so I want to do it right,

Use your strong background. Bill is right. You don't build a QMS from scratch. Carry out a preliminary assessment against the standard. Identify what your organization already have, what needs adjustment and those that are still lacking. Discuss the results of the assessment with your top management and colleagues and develop a work plan to initiate QMS activities and to address the gaps. Monitor the progress of your organization's efforts in establishing an ISO 9001-certifiable QMS through your management meetings. Once you complete the actions listed in your work plan, perform a readiness assessment. If your organization and top management deem they are ready, proceed to stage 1 audit by your chosen certifying body.

 

[ochem]

It's true, it's not quite from scratch. They have some form of production planning. A general idea of what testing needs to be done, some written test methods. Little in the way of control of measurement devices. No DMS to speak of (using MS teams with in conjunction with sharepoint). Obviously none of the ISO required things like internal audits, management review, etc...No change management, etc.... Got my work cut out for me, for sure.

 

[John Broomfield]

Keep the scope of your inititial system development project consistent with the scope of the responsibility and authority of the keenest top manager.

Study the business management system that already exists. Show respect for this means of converting the needs of customers into cash in the bank. Learn how the system already adds value. After all you will need everyone’s help with the few new processes too in making them a reality.

Do not assume you are starting from scratch or without you no one cares about quality. Engage the leaders in showing their commitment to this system and its improvement.

After all ISO 9001 and the QMS depends on the business management system to deliver services and products that fulfill customer needs.

 

[John Broomfield]

If everyone is in the same building and works for all three companies, it makes sense for everyone to be under that one quality system. Include all branches from the start. My advice to you is to keep your quality system incredibly simple and lean so it is easier to understand and follow. It will evolve in time.

This is great advice. Enable the system to grow muscle where needed. Do not burden the system with fat from the get-go.

 

[Randy]

You've probably got over 75% of what you need already, so if it works don't change it because some knucklehead says you need to so it'll look pretty.

Take a good hard look at what you really need to make it happen, keep out the fluff and garbage, toss and smoke and mirrors and don't do a stinking thing to try and make some jack legged auditor (like me) happy. As long as minimal meets the requirements, minimal is good.