Quality Management System - What Is Expected?



Need input and feedback on the following:
What is expected from QMS - merely getting the ISO certification?
What are some successful initiative that drives the employee (organization) in achieving ISO9000 certification?. Any articles on implementing successful Quality System?
Of all the 21 elements, which top 5 element is regarded as critical or favorites element for auditor (in general)?


Quite Involved in Discussions
Top five for most N/Cs: 4.5, 9, 10, 11, 6
Articles: try Quality Progress,Quality Digest, Quality Magazine
Successful Initiative: generally customer driven, marketing, reduce ppms.
Certification is the base (min.) how far you go with it is up to leadership. The new standard suggest a scenario: Registration, 9004,
MBNQA, Excellence


ISO for Real?

Johnnybegood asks:
“What is expected from QMS - merely getting the ISO certification?”

When I am working with a company, I insist their intent is to have a system that “works” for them. I am less interested in the paper brag of registration than having a QMS that achieves results. I encourage customers to select some meaningful metrics (I refer to them as their “isometrics”) to determine the impact of the QMS. They should also have certain triggers to automatically schedule supplemental management review and internal audits.

The worst thing that can happen is for upper management to drop a folder on the Quality Manager’s desk and say: “This is your baby, get it done.”

Dave B (the other Dave)


Thanks for great inputs. Now that we know what are the failure and the Top 5 NC, it would be of great help to how to be a good QMS representative. How would you approach an organization of 2000 employee getting them excited over this ISO. Taking up the QMS role is a real challenge. I had recently talk with my new team member about thier experience. And guessed what, they told me about the frustration and energy just to get the doc. originators to update the document, form and record are not proper filled or timely by the operators. I don't really blame them cos the record are not even being review or verified by their supervisor. Should I use the 'cane' approach? I am more for the soft approach making it as a culture rather then using cane. But if we don't cane then the form and doc. would not be attended. I am running out of ideas. There is just too many follow-up and running around to do. You know what, recently we found a station was not calibrated as avidence by the cal sticker. The maintenenace told us that cal was performed but they have forgotten to replace the cal sticker. What they did was immediately get the sticker replaced and that was it. I was not satisfied cos I don't think the issue is closed but the maintenance think otherwise. Pls. advise.

David Mullins

Originally posted by johnnybegood
I was not satisfied cos I don't think the issue is closed but the maintenance think otherwise. Pls. advise.

You have to strike while the iron is hot on these issues. Did they have objective evidence that the calibration was performed? If not, then it clearly didn't happen, but don't make a big issue of that as people will become even more defensive in the future.
By now they could have manufactured some evidence so it may be too late.

1. Do they understand it? "NO": train them. "YES": go to 2.
2. Do they use it? "NO": Show them how, or if they know how, find out why they don't and make some improvements. "YES": audit them.

(Believe me training is a powerful tool. Staff will do whatever you want to avoid going through any more quality training)


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Johnny B. I believe the rep should be a member of top management, be someone who is quality focused, honest and has a genuine concern for the customer. If the rep has an attitude of "screw the customer", then s/he should not be a rep and not be employeed by the company. All industry must realize that do not work for their employer but the customer and should base decisions on the customer point of view. BE PREPARED FOR SOME HELL!!! Please do not cane anyone. ISO is not a police action!! If the cane approach is used the QMS is in Vain. Many companies are not ready for ISO or the future.



Can I put it that it's norm for a QMS rep. to go round 'chasing' and ensuring compliance? I agreed that we should continue to communicate, train the people but if disciplin is not there then it won't work. I am running out of patience. We have done plant wide training, we have carried out audit, we have communicate thru townhall briefing we have pratically done what most other company will do. Yet people are not keen and excited. I dont see the energy in the employee. Form are not recorded, cal are not done, ppl are defensive. I salute those who took this QMS job and still continue to pursue this journey. How do you guys manage the stress. I wonder.
Our company focus much on the customer. Total Customer Satisfaction is in fact our quality policy. But as we are in manufacturing most of our employee don't deal directly to end customer. I guess this may be one reason of not meeting achieveing 100% compliance. They don't really see the importance of ISO9000 and when they don't see they don't take-up the responsibility. And when there is no ownership, very likely things are not done accordingly just like the doc. update and filling of the forms. There will be lots of policing and follow-up. I am a strong believer in Quality and I have the same opinion that ISO is a way of continuos improvement regardless whether customer ask for it.

David Mullins

a few random thoughts - there are many possible solutions

at the lower level:
Audit the crap out of them.
Aks them why they don't followed the prescribed method.
Then use a lot of what ifs.

at the higher level:
Is management commited?
Make them prove it.
Are you certified/registered?
If so, or persuing it, Why?
Yes the managers and supervisors need to start hurting for not complying. Ask your senior managers how they think the culture can be changed.

Before you perform any support activity, ask yourself who are the people/person you're doing this for, then go to them and ask them if they really want it done. If so, ask them what you get in return. It's a 2 way street. We have to work together, not master and (quality) slave relationship.

Eat lunch with the supervisors all the time. Go and sit in their offices and find out what they're doing. Go and watch and talk to the 'operators'. Make yourself a physical visible presence in their working lives.

You have 2 choices:
Change them, or
let them change you.

You figure it out.


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Originally posted by johnnybegood

How do you guys manage the stress. I wonder.
After a few years, you get so addicted to being stressed you don't know what to do with yourself when you hit a period of relative calm.:biglaugh:

Seriously, spend lots of time with people on a one to one basis like DM says. If you can show the people that you are on their side, trying to make their life (easier, more efficient, more effective) better you will gain a lot of support. And I have found that even though your management needs to be fully committed, sometimes that only happens when the managers see that the hourly guys and gals see a value in the program.

Zoloft helps too. It doesn't leave you with a hangover.:bonk:
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