Summary of Changes in ISO 9001:2000



Changes to ISO 9001:2000

I seek to obtain advice pertaining to the any significant changes in the revision of ISO 9001:2000 in the following areas :-
1) Involvement of top management
2) Measurement of customer satisfaction and dissatisfaction
3) Continual improvement

Thanks and Best Regards


Andy Bassett

Ill avoid the specifics, but tell you my take on the three points mentioned.

1) Involvement of top management.
I beleive that the new standard strengthens the requirements for management involvement. I understand that they now have to set clear targets for the system and measure them and follow them. Before you could of scraped by with a Quality Policy.
2) Measurement of customer satisfaction and dissatisfaction.
I now understnad that this is a requirement.
3) Continual improvement.
This should automatically come about becuase you are required to measure your processes.

The general discussion is that all this SHOULD have been done before. This is true, but i beleive many companies with the certificate were not doing this.

Andy B


Fully vaccinated are you?
Some thoughts:

From: ISO Standards Discussion
Date: Mon, 9 Oct 2000 13:21:07 -0500
Subject: Re: Q: ISO 9000:1994 Vs. ISO 90002000 /van Putten/Paten

From: "Mike Paten"


I have used Figure 1 of ISO 9001:2000 (the "Process-Based Quality Management System") to depict how the new standard focuses on both "compliance" and "improvement". The following narrative explains:

Assuming that what you "Say You Do" meets the intent of the standards, both the 1994 and 2000 versions require you to "Do What you Say" (implement) and "Prove It" (demonstrate compliance).

The biggest change for 2000 is that you also must "Improve It".

In order to improve you must have "baseline" measures to gage improvement against. Therefore we must develop at least one key performance measure for each of the key QMS processes (or elements) - then we must gather our baseline data and set goals or objectives for improvement based on current performance - then we must take action to improve the processes most in need of improvement - then we must take a look at measureable results to see if actions taken achieved the desired results. Classic stuff.

I advocate that at least two key measures be easily established for each QMS process or element: 1) at least one measure of (in)effectiveness - i.e. something that measures whether (or not) you achieved the overall objective or desired outcome of a particular process; and 2) at least one measure of (in)efficiency - i.e. something that measures how well (or poorly) resources were utilized to achieve the results measured in 1). For example

Clause 6.2.2: Training Processes: Key measures of effectiveness: % employees fully trained and qualified and/or % corrective actions resulting from a lack of training. Key measures of efficiency: % of training completed rated by attendees as marginally satisfactory or worse.

Clause 7.2: Customer Related Processes. Key measures of effectiveness: % customer satisfacation and/or the # of customer complaints. Key measures of efficency: resources dedicated to customer related processes and/or resources devoted to investigating/resolving customer complaints.

Clause 7.3: Design Control Processes. Key measure(s) of effectiveness: Product/Service Performance Measures. Key measures of efficiency: resources devoted to design function and/or resources devoted to design changes resulting from product failures reported from the field.

Clause 7.4: Purchasing Control Processes: Key measures of effectiveness: Supplier performance measures and/or the # corrective actions resulting from incorrect, misidentified or poor quality purhased material. Key measures of efficiency: Resources involved in processing returns and/or supplier corrective actions.

Clause 7.5: Operations Control Processes: Key measures of effectiveness: Product / Service Quality Measures. Key measures of efficiency: defect rate, % scrap, rework, equipment downtime; inventory accuracy, % operations where work instructions or automated process controls are in place.

In any case, these measures should be easy to come up and track. Like most of what ISO has always required - it's not rocket science - just good, down to earth common sense stuff.

Best of luck in the "Move from Conformance to Performance"

Mike Paten
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