Creating a QMS - Starting from scratch

Hi ASQ Community! I am the quality manager for a group within a division of a large company. To my knowledge, I am the only quality related role within the entire company. I have several questions, but first, let me explain my intentions and what I am hoping you can help me with.

Developing a QMS is my ultimate goal, however, I need to determine the scope of the QMS. It is my belief that I can do this, meeting ISO 9001:2015 requirements, within the smaller group tied to the division I work in and not the whole division. (Correct me if I'm wrong)

I have started writing the quality manual, policy, etc. but I am at a standstill without “top management” support. I think hiring a consultant to help me through this process is the way to go, but I don't want to if it isn't necessary. Any advice here would be greatly appreciated.

Lastly, I'm strongly considering an eQMS solution, BPA Solutions, to house all relevant documents and data to manage the QMS. If anyone has experience with BPA, I would like to hear from you. We need a tool that works well with MS365 and possibly Dynamics. BPA seems to meet those requirements.

Thank you in advance!

31 Replies
Trish Borzon
1465 Posts

@Chris Deardorff - thanks for posting.

We've had a few discussions on this topic. Although I don't remember BPA Solutions being mentioned, but eQMS is. Recently there was discussion on using SharePoint.

SharePoint as Document Control? - myASQ

QMS software for small businesses - myASQ

Search myASQ - myASQ

Hope this helps!

Trish

@Trish Borzon , thank you. I have read both of those threads before I posted. They were helpful, however, I haven't yet found anything related to actually creating a complete QMS, using a consultant to do so, or the actual process of implementing QMS software. I'm hoping the community can provide some insight on those topics. Truthfully, I've spent the past several weeks searching ASQ and still cannot find a comprehensive, step-by-step resource for creating and implementing a QMS from scratch. I have the standard (ISO 9001:2015), I've read everything that is relevant to ISO 9001 available on the ASQ website and I have utilized google extensively. I feel pretty confident that I have the tools I need but still had this notion that either there are additional resources I have yet to find, or someone could suggest a consulting firm with a strong reputation within the ASQ community. I'm at the point where I must take action and move from education to execution. Thanks again!

Hi Chris, sounds like a challenge! My advice for starting planning the QMS is to get top management commitment. Otherwise your attempt can fail. Involve them in the high level tasks like developing the quality policy and objectives. You could host a brainstorming session of CTQ (critical-to-quality) characteristics of products/services the company provides and then choose with them the most important 4 or 5. With those CTQ you can develop the quality policy and later, of course, the objectives. The key is to keep them involved. Hope this helps you to start!

Trish Borzon
1465 Posts

Tagging a few people to get their perspective.

@Duke Okes , @Grace Duffy , @Janet Lentz , @Lance Coleman, @Jerry Rice, @Jd Marhevko , @Ellen Quinn - any suggestions?

thanks

Trish

Anastasis, Thank you for those tips! That gives me a great starting point.

@Chris Deardorff - hopefully helpful tip: the March 2022 member gift was all about implementing and optimizing a QMS. You'll find ebooks, videos, and articles all about how to implement a QMS. In my experience these can be quite helpful!

Grace Duffy
109 Posts

I am surprised that there is not a “how to implement a QMS” text by Jack West and Charles Cianfrani in the Quality Press catalog. Their now out of print “Unlocking the Power of your QMS” is one of the best QMS improvement books I have ever read. If you are not looking to register with ISO, you could simply use the 7 Quality Management Principles and use an initial assessment like the BEST-Quick Scan to find what previous commenters have suggested for addressing the biggest gaps first and working to integrate your local department processes. 2022 4 13 updated BEST-Quick-Scan.xlsx. The Quick Scan tool is described 2022 1 27 The Best tool for Continuous Improvement Orlando Duffy.pptx. An ISO advocate may not see this as a true QMS. It depends on your perspective and the results you wish to achieve. The Quick Scan works core process by core process, then puts the improved processes together to meet the 7 Quality Management Principles.

Janet Lentz
119 Posts

Chris,

I have created an ISO 9001 compliant QMS from scratch. It’s easier than you think. If you would like to discuss it more in depth I’d be happy to help. I can be contacted a little easier at jlentz@memberleader.asq.org.

Regards,

Janet

Wow, thank you all for your excellent tips and insights! I've dug around and looked at several of the March member gift contents and have found most of it useful. Grace, thank you for sharing those tools, I will certainly look at them. Janet, I'll contact you! Thank you again!

I, too, have created several QMS systems from scratch. Grace Duffy mentions some solid resources. If you'd like to talk thru the basics, join me on LI and we can set up a time to help to you sketch an outline. Jd Marhevko

Currently I am at the starting point of doing the same: create a quality system. My problem is a slightly different one. I have to dismantle or defuse 2 existing dysfunctional quality systems (one of them being ISO9001) and create a working, workable one. Merging is not an option.

On top of the various replies, I want to add my view here. I strongly recommend you NOT to finish writing up a quality manual before top management engagement. That is exactly the situation I am brought into: the previous manager prepared all documentations, got certification and let the system fall apart at everyone's disappointment.

Engaging top management is, by and large, similar to engaging subordinates. Numerous great reference materials are available (in ASQ that I have bought and downloaded) and some of them free. But sorry I don't have the links at hand.

I recommend you do the basic groundwork, process management, corrective and preventive actions etc. Then engage top management by asking them to decide, name or pinpoint the organizational vision (on quality) or direction based on the paperwork. If that works, incorportate that (corporate quality statement) in the paperwork (quality manual) and everythings else are textbook items. Go back to them every time after adding something into the system so that they can visualize their vision coming true. It is my way of engaging top management from bottom up. All I need is the A3 rule.

My two cents.

Chris … I will somewhat echo the responses of others. Without top management support, you're wasting your time. The first issue that caught my attention was that you work for a “large” company and you're the only quality-related person there. That tells me something about the awareness of quality systems by your top management. Even though we as quality professionals understand the value (and negative issues) related to these system standards, it doesn't sound like your top executives are.

Before I dove into implementing a quality system, I would learn about the quality-related priorities of your company's top managers, and work on those. Those priorities may be “baby steps” toward a full system.

Hi Chris,

No need to complicate things. Sometimes simple and pragmatic is the way to go. If your organization has a robust IT group, then your best bet may be to go with a simple file share structure where permissions can be applied for ease of access and secure file storage. I suggest keeping it simple by providing root documents in Word or PDF, if you'd rather, with tables of contents and hyperlinks to semi-automate your QMS. There is so much you can do without having to purchase off-the-shelf programs. I always recommend a homegrown QMS based whereby ISO 9001 is integrated into your QMS. Homegrown, verses off-the-self or ERP-based systems are a bit difficult to make your own. You want your QMS to be your own, which if done right, will be embraced by the organization and will be simple to use. Believe me, the best QMS is the one that is used! If this is helpful and you have questions or need assistance, please don't hesitate to reach out.

Don Brecken, ASQ Fellow

Grace Duffy:

I am surprised that there is not a “how to implement a QMS” text by Jack West and Charles Cianfrani in the Quality Press catalog. Their now out of print “Unlocking the Power of your QMS” is one of the best QMS improvement books I have ever read. If you are not looking to register with ISO, you could simply use the 7 Quality Management Principles and use an initial assessment like the BEST-Quick Scan to find what previous commenters have suggested for addressing the biggest gaps first and working to integrate your local department processes. 2022 4 13 updated BEST-Quick-Scan.xlsx. The Quick Scan tool is described 2022 1 27 The Best tool for Continuous Improvement Orlando Duffy.pptx. An ISO advocate may not see this as a true QMS. It depends on your perspective and the results you wish to achieve. The Quick Scan works core process by core process, then puts the improved processes together to meet the 7 Quality Management Principles.

Thank you Grace!


This is a fantastic guiding material, in my opinion (does encourage the user to think out-of-the-ISO-box, which means rather of the actual process and how well it is established and maintained)!

Regards,
Alexander Kholodov
ASQ CQE

I would not recommend selecting the consulting option, the system needs to be developed by the people that lead the departments responsible or are the key contact for the process. Your fist step is to assign process champions or key contacts. You cannot own the system, the personnel responsible for the process must own the system and if they are involved from the start, they will actively participate going forward. Then you need to meet with them and their team and develop a diagram showing who is involved, what is used to conduct the process; inputs to the process; how the process is controlled and where the gaps are at this time, the outputs etc. You should also review the section on Interested parties to ensure your scope is accurately reflected.

I agree with the other responses about needing top management support. I was in a similar situation many years ago and without the support of the owners of the company, it would have failed.

Given the support, I had to bring in individuals that had experience that was nonexistent at the company to create a framework and educate/train people on what a quality systems looked like. It has developed and evolved over the years, but it started with a strong foundation.

I would be happy to share information on the system if you would like - Drop me an email and I will share some files. mike.kedanis@altec.com.

Hi @Chris Deardorff, you may want to approach the effort as solving little problems, one at the time, but I strongly recommend to start with the main “gears” (internal audit - management review - nonconformity and corrective action); attached is a model I've being using for awhile to develop management systems, hope it helps. model.pdf

Attached files
Aimee Baer
2 Posts

In relation to the esolution, since you use O365 I would highly recommend utilizing SharePoint as your document control tool. With the extensive capabilities beyond document storage using their workflows, you can manage document control, approval, notifications, etc. You can tie in through email or Teams or both. We have had great success and I'm seeing a lot of potential the more I learn about it. We also use Dynamics and have written custom reports, downloaded data, and other things that also tie in with our company-wide SharePoint usage.

Now, the consulting question. I will start by saying that I have been a quality systems consultant for over 20 years in addition to managing the inspection aspect of our business. Using a consultant can be a good or bad thing, depending on who you use. I would only suggest that if you do decide to go that route, choose someone that focuses on your business and not an “out of the box” solution. You want a partner to work with you or you will not be successful.

And, I agree that top management support is necessary. You just might have to find a reason that they can buy into to get things rolling.

Good luck! (if you would like to discuss any of this, please get in touch: aimee.baer@benchmark-usa.com)

You have nearly everybody in this discussion chain telling you to get MGT buy in first, & I agree, otherwise, you'll et called out for wasting their/your time

That being said, I'd set up a few items that will get your company off to a ‘Quality’ start regardless. It's not hard to create an NCR reporting system --my company does it w/in MS-TREAMS. Also depending on what your company does, do you have an Returned Goods scheme? This is where your NCR system could begin…

AS NCR's beget CAR's, next you could create a Corrective & Preventive action scheme. As things go aand your mgt starts to buy into the QMS idea, now you are able be ahead of the game a bit, and show them why it is good.

Chris,

I did very similar project on the past

Let's talk over the phone or Teams meeting

my email is rangelf@gmail.com

phone 619 948 8044