Are We Ready for a QMS?

#1
Hi there - new to the board and I need some outside opinions.

My company is less than 10 years old and we operate in an industry that is in its infancy for Quality (HVAC manufacturing). Our strategic business partner indicated last year that they wanted to see a greater commitment to organizational quality this year. Our ears heard QMS! and we began laying plans to start building an ISO 9001 compliant QMS this year. In the last few weeks it has become apparent that the company may not actually be ready for this step. We conducted a Quality Maturity Assessment today and didn't score above a Level 2 in any category. On 'Leadership Support' we were at a Level 1.

My question is, if the industry isn't demanding ISO certification, how do you know when a QMS is the next logical step? We're doing a lot of good work right now building enterprise-level processes and procedures, but it feels like we have a lot of education and consensus building ahead of us in order to get the type of organizational support that will ensure a successful launch of a QMS.

Thoughts?
 
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Randy

Super Moderator
#2
Just sit back and do a simple cost - benefit analysis taking into consideration the pro's and con's. If the costs outweigh your perceived benefits don't waste your time. Regardless of advertising, hype and everything else if down in your gut you see no good reason then just continue to march because it'll become nothing more than an Albatross around your neck. In the end, you'll only get out that which you put in and you'll spend time accomplishing nothing more than an extended game of buzz word bingo.

I've seen it too many times, a MS put into place to be stylish and look good without real expectation.

Now on the other hand, if you can make a good business case and you take a good, honest hard look at what you are currently doing against what a QMS requires you might actually find you've already got in place a good majority of a functioning system requiring little effort into formalizing the process. Look honestly at what you have, stay away from the bogus BS and changes people will say that you need and base your decision on that. Nothing, not one thing is required to be complicated or mandates that you flush what you are presently doing and create a QMS from scratch.

Simply put, get a copy of the quality system document in question, change everything from "the organization shall" to "Do we?" and honestly answer each question and be able to support your answers with proof (evidence)...Write it all down and for everything that gets a "No" turn it into a "Yes" if you can, with the understanding that based on your specific needs, operations and a couple other factors some things might not be applicable to you, and if so support the reasoning with evidence as to "Why".

I tend to over simplify, but that's it in a nutshell....... $1,000 or more of consulting for free.
 
Last edited:

Mike S.

Happy to be Alive
Trusted Information Resource
#3
Hi there - new to the board and I need some outside opinions.

My company is less than 10 years old and we operate in an industry that is in its infancy for Quality (HVAC manufacturing). Our strategic business partner indicated last year that they wanted to see a greater commitment to organizational quality this year. Our ears heard QMS! and we began laying plans to start building an ISO 9001 compliant QMS this year. In the last few weeks it has become apparent that the company may not actually be ready for this step. We conducted a Quality Maturity Assessment today and didn't score above a Level 2 in any category. On 'Leadership Support' we were at a Level 1.

My question is, if the industry isn't demanding ISO certification, how do you know when a QMS is the next logical step? We're doing a lot of good work right now building enterprise-level processes and procedures, but it feels like we have a lot of education and consensus building ahead of us in order to get the type of organizational support that will ensure a successful launch of a QMS.

Thoughts?
I like your name. ;) Great piece of equipment that is.

Randy, as usual, gave good advice. I would add, get some more info to clarify what your strategic business partner meant by "a greater commitment to organizational quality". IF he/she really meant they want to see ISO9001 implemented, that may be one step in getting the top management commitment that will be critical in that pursuit.
 

Ed Panek

QA RA Small Med Dev Company
Trusted Information Resource
#4
I stopped reading after you listed your Leadership Support number at a 1. This almost sounds like they are actively against a QMS implementation. I would consider talking to Sales for their perspective on how would having ISO 9001 would help sales. If sales doesnt care I dunno.


Maybe take a look at customer complaints to see if that's an argument.


I also second what Randy above said.
 
#5
All,

Thank you for your opinion. Some additional information:

Our customer is not looking for ISO certification and within this industry it doesn't make sense today. We had planned on writing the Quality Manual to ISO 9001, but not going for certification.

The customer IS looking for structure and PDCA approach in the way we do business, but they have also told us explicitly that they don't want to be the bad guy that forces it on us. They essentially want us to realize it's the right step forward on our own.

Most of our management grew up within the company and have zero exposure to QMS or ISO so the only internal advocates are within Quality and so far, that message isn't getting through. My question is really about whether now is the right time to force it or do we 'backdoor' many of the elements in the short term (18-24 months)?
 

jmech

Trusted Information Resource
#6
Most of our management grew up within the company and have zero exposure to QMS or ISO so the only internal advocates are within Quality and so far, that message isn't getting through. My question is really about whether now is the right time to force it or do we 'backdoor' many of the elements in the short term (18-24 months)?
Don't add any elements just to conform to ISO 9001 - more QMS requirements do not necessarily mean higher quality and are not always good for the company.

Only add elements that will clearly increase profits / reduce risk / help achieve important business goals (such as keeping your customer who wants structure happy, if that is sufficiently important to your business to justify associated costs).

Any elements that you add, focus on maximizing their value for your company and minimizing their cost, not on satisfying a possible future auditor.
 

Tagin

Trusted Information Resource
#7
All,

Thank you for your opinion. Some additional information:

Our customer is not looking for ISO certification and within this industry it doesn't make sense today. We had planned on writing the Quality Manual to ISO 9001, but not going for certification.

The customer IS looking for structure and PDCA approach in the way we do business, but they have also told us explicitly that they don't want to be the bad guy that forces it on us. They essentially want us to realize it's the right step forward on our own.

Most of our management grew up within the company and have zero exposure to QMS or ISO so the only internal advocates are within Quality and so far, that message isn't getting through. My question is really about whether now is the right time to force it or do we 'backdoor' many of the elements in the short term (18-24 months)?
  • ISO 9001 no longer requires a quality manual. Instead of a manual that gets ignored, I'd focus on getting some concise consensus statement, kind of like a 'mission statement' with quality overtones, which leadership can agree on and believes in. That can become the mantra/slogan that quality gets focused around.
  • Unless you know of an urgent problem area, I'd start first with applying PDCA to your main service you provide. Essentially, working from the center outwards, and hopefully providing the biggest ROI. Call it PDCA, 'feedback loop', 'improvement spiral', whatever makes sense to the company culture, for people to 'get it'.
  • If the above is successful, leadership may then see the value in applying PDCA elsewhere.
  • Management-level PDCA can take the form of monthly or quarterly 'state-of-the-business' meetings, which really are your KPI, mgmt review, etc. meetings.
  • Low-friction changes to processes will be best: people don't want burdensome TPS reports to fill out "just so quality can do their job."
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#8
Our strategic business partner indicated last year that they wanted to see a greater commitment to organizational quality this year. Our ears heard QMS.
Thoughts?
Typically your business partner makes a comment like that after some quality “issues”. Zoom in what the issues were and focus on that. I am sure your business partner could give a rodent’s derrière if your top management is performing structured reviews or if you have an internal audit program. Their feedback and your “understanding” of what they want might be at odds. The way I read it and based on my experience, organizational quality is an expectation that you don’t let the same repeat mistakes happen. Focus on that and make it your first step on the journey for a structured system.
 
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