Why do so many ISO 9001 Implementation Programs Fail?

C

Chance

Re: Why do many ISO 9001 implementation programs fail?

Oh, I wasn't clear on just what this review would entail - I thought it would be a review of the gap analysis or first round audit results. My bad.

How many procedures do you have?
This is annual review of our procedures. We are already ISO 9001 certified since last year. Almost done with our first surveillance.
We have 100 SOP's to review. My review agenda would be: 1) discuss identified areas that needs improvement, 2) discuss areas that has a deviation, 3) discuss procedures that has been violated
Any other areas that I should include? Appreciate your help.
 

Jen Kirley

Quality and Auditing Expert
Leader
Admin
Re: Why do many ISO 9001 implementation programs fail?

This is annual review of our procedures. We are already ISO 9001 certified since last year. Almost done with our first surveillance.
We have 100 SOP's to review. My review agenda would be: 1) discuss identified areas that needs improvement, 2) discuss areas that has a deviation, 3) discuss procedures that has been violated
Any other areas that I should include? Appreciate your help.
This sounds like an audit. Have internal audits captured these issues?
 
C

Chance

Re: Why do many ISO 9001 implementation programs fail?

This sounds like an audit. Have internal audits captured these issues?
Yes, it is taken care of during internal audits. But improvements continue to happen everyday. Please share your idea how to tackle this, so it won't be like internal audits...thanks.
 

Jen Kirley

Quality and Auditing Expert
Leader
Admin
In a thread called Audit Summary Report - Nonconformance Aging Analysis I attached an example of system performance and an audit tracking log that helps collect the data. Since we're talking about improvements and things audits have already noted, I suggest a "higher altitude" summary for managers and the CEO.

I have learned to be armed with a list of details in case I'm asked about them.
 
J

James Bright

We employed the services of a consultancy firm to help us with implementation of ISO 9001. Their approach was very simple and straight forward and ensured that the main body of staff did not get ‘bogged down’ with the ‘whys and wherefores’ of the system. Key staff members were allocated key parts of the system to manage and they in turn ensured that the staff under them were following the work instructions. In fact the staff were tasked with writing down what they do and how they thought it could be changed for the better. This was a great exercise and proved to be very beneficial in improving all of our core processes. You would be surprised what the ‘man at the sharp end’ actually knows but is to scared to say in case of ridicule or rejection. This consultants made the whole experience very interesting and as they promised very achievable and had us ready for an audit by an Accredited Certification Body in under 4 months, which we passed with flying Colours. This could have been quicker if we had of wanted.

Once you understand the ISO 9001 standard it breaks down into a few basic sections which when tackled head on amount to pure common sense and good business practice. I believe it should be implimented on a need to know basis through out any organisation ensuring all instructions are communicated in very plain and easy to consume speak. Throwing ISO speak at your staff only confuses them and they tend to fear it….what they fear they will avoid. KISS all the way. Just my humble opinion. They turned a potential nightmare into a great all round experience for us.

Thanks for listening to my ramblings

James:agree1:
 
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Stijloor

Leader
Super Moderator
We employed the services of a consultancy firm <snip>

Welcome to The Cove Forums! :bigwave: :bigwave:

I went to visit the web site of the organization that you recommended.

I read this:

<snip>Your Consultant will then carry out a 'Mock Audit' to ensure you are ready for the real thing. When, and only when, you and your consultant are satisfied that your ISO Management Systems have been successfully implemented and managed will we arrange for an Accredited Certification Body to attend your premises and carry out a totally impartial Audit of your Systems to ensure they meet the required standards for Certification.

Emphasis mine.

Just curious: Who are these "Accredited Certification Bodies?"
If this organization "arranges", how is independency of 3rd party audits assured?

Thanks.

Stijloor.
 

Marc

Fully vaccinated are you?
Leader
I think it is best if we stick to the thread topic: "Why do so many ISO 9001 implementation programs fail?"
 

suildur

Involved In Discussions
I think we can answer this question by benchmarking ISO 9001 QMS to 6 sigma.

Why is 6 sigma successful (in brief)?

1. Leadership:

6 sigma: The top management, managers and process owners join the 6 sigma teams and lead people.

ISO 9001: Most of the time, management involvement is not avaliable.

2. Participation:

6 sigma: 6 sigma teams, statistical methods and implementation of solutions make employees participate and bear responsibility in the system.

ISO 9001: Noone bears responsibility, they think QA or QMR deals with the whole stuff.

3. Implementation

6 sigma: You have measurements and analysis from the begining. You do know where, when and how to continue. You do write down what you can and will do in the documentation.

ISO 9001: Most of the time, the documentation varies between weak and exaggerated or don't suit the field in any means. What you do and you want it to be done is probably different, -also- where you have no firm and objective milestone to manage your way to the success.

4. Resources

6 sigma: The organization (well, to tell the truth, top management) reserves the required resources.

ISO 9001: :nope:

Those are the simplest things which I can think of, and, I believe they do say something about the failure.
 

howste

Thaumaturge
Trusted Information Resource
I think we can answer this question by benchmarking ISO 9001 QMS to 6 sigma...

You make some excellent points. Unfortunately I've seen 6 sigma implementations fail for exactly the same reasons. I believe that some key points for the success of any implementation are Top Management support, user involvement, and clearly stated expectations/requirements.

I was recently reading the results of a survey on projects. There were some interesting data in the report, which I believe could apply to the implementation of any project or system. Here are some of the highlights:
  • For every 100 starts, there were 94 restarts
  • Only 44% of all projects finished on time
  • On average, projects were 222% longer than planned
  • 53% of projects cost 189% of estimate
  • 70% of projects fell short of planned technical content
  • 30% of projects were canceled before they were finished
  • Percentage of projects both on-time and on-budget: 9% in large companies and 16% in small companies
Along with these statistics were also reported the top reasons for success and failure. It's not surprising that these two lists mirrored each other.

The top reported reasons that projects succeeded were:
  • User Involvement
  • Executive Management Support
  • Clear Statement of Requirements
The top reported reasons that projects failed were:
  • Lack of User Input
  • Incomplete Requirements & Specifications
  • Changing Requirements & Specifications
  • Lack of Executive Support
These factors are extremely important, and without them any implementation can fail. I personally believe that ISO 9001 is based on sound principles, and in general the principles are supported by the requirements. When organizations fail to implement a system that is based on the principles (such as Leadership, Involvement of People, and Factual Approach to Decision Making) and only base it on meeting requirements, it will never be as successful as it could be.
 
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