INSIGHT REPORT
Vol 6 No. 2
March
2003

INSIGHT REPORT

I

N

S

I

G

H

T

Insight Report Vol. 6  No.2

What is the difference between ISO 9000:1994 and ISO 9000:2000?

The frustrations that we usually see on your face when we start to explain that there is a yet another change to a “Standard” — whether it is the FDA, QSR or the ISO — is understandable. There never seems to be an end to this ongoing “Standard Abuse” that the industry is subject to.

Keeping this in mind, let’s look at the next change that you will have to learn about and deal with – ISO 9001:2000.

We hope that the following information will make this change a little easier to comprehend and also help clarify any confusion. As always, when the bureaucrats (in this case the International Organization of Standardization - ISO) come out with the new family of ISO 9001 requirements, it may not be clear as to what the differences are between this new standard and the old one.

We have grouped the differences into three categories: philosophical, requirements, and structural.

Philosophical differences

• Focus on business processes – the new standard focuses on identifying the key business processes that exist within an organization and ensuring that meeting customer requirements is embedded into those processes. The old standard was procedurally based – it identified the individual procedures required to meet customer requirements. The process approach ensures that handoffs between procedures doesn’t create problems in meeting customer requirements
• Focus on product and services – the original standard was meant to cover both products and services but many companies complained that it was truly focused on product companies. The new standard has been generalized to include both product and service companies
• Focus on business results – the new standard takes a stronger position of ensuring that meeting customer requirements assists in helping business performance. The process based approach, increased emphasis on continual improvement as well as the release of a new standard, ISO 9004:2000, which is focused on Business Performance Improvement all lend to ISO’s efforts to tie the standards to business performance

Requirement differences  (This is a partial list, it includes the major changes)

• Responsibility of resources – management has now more flexibility in identifying what resources are responsible for different activities     
• Management communication- management is now responsible for communicating the customer requirements throughout the organization     
• Customer requirements – further emphasis has been put on identifying the customer requirement inputs and outputs during the design phase of a product or service     
• Supplier vs. Subcontractor – the term subcontractor has been removed and combined under the word supplier     
• Work process validation – organizations must now consider how they validate processes where resulting output cannot be verified with subsequent measuring or testing     
• Corrective Action / Preventive Action – there is a greater emphasis on management’s responsibility to ensure that continuous improvement is occurring. Also, there is increased documentation of corrective actions and preventive actions. In particular, the new ISO is looking for actions not just status.
• Competence vs. Qualification – the new ISO suggests that employees need to be competent to do a function, not just qualified. It requires management to define what competency is and how it will determine and train individuals to be competent.
• Measurement – the new standard requires organizations to use analysis to identify improvement areas. It also states monitoring customer perceptions is required to measure performance     
• Reduction in documentation of procedures – the only documentation of procedures that is now specifically required is in control of documents, control of records, internal audits, control of nonconforming product, corrective action and preventive actions

Structural differences

• ISO 9001, ISO 9002, and ISO 9003 are combined – the old ISO requirements were spread over three standards. The differences were meant primarily to differentiate business models. The new standard combines all three standards under the new ISO 9001:2000 standard.
• Reorganization of requirements – the old ISO standards were grouped into a number of procedures. The new standard is structured in to the following 5 areas:
  • Quality Management System – an organization needs to ensure that it has established what its processes are, how they interact with each other, what resources are required to realize the product and how the processes are measured and improved.
  • Management Responsibility – it is management’s responsibility to set policies, objectives and review the Quality Management System as well as communicate its effectiveness to the organization
  • Resource Management – the organization must identify and create a rationale for the amount of human, physical and support resources required in meeting customer requirements.
  • Product Realization – this section covers the requirements to creating and delivering a product/service. The requirements include capturing customer requirements, designing products/services that meet those requirements, purchasing materials/services required to realize the product/service, the activities of manufacturing the product/service and the delivery of the product/service.
  • Measurement Analysis and Improvement – this section includes the measurement of the products, customer satisfaction and ensuring continual improvement of the quality management systems.

Explained this way, we are confident that you will have found this not too difficult to understand. Therefore, changing your present system to this new one should less complicated that you may have initially thought.

If you have any questions on the new standard and what it will take to convert your present system to this standard, do not hesitate to contact us.

The next Insight Report – To Be Announced

If you have any comments on these INSIGHTS we hope that you let us hear them. If you have any of your own INSIGHTS that you feel would be of value to other companies, we would be pleased to hear from you and to discuss them with you and if you allow, we would even put them up on this site for others to learn from.
e-mail INSIGHT