The ISO 9001:2000 Quality Management System

publication date 14.10.2007

Process oriented organization according to ISO 9001: 2000

The ISO 9001:2000 standard defines the requirements on the quality management system. It is this very standard that directs certifications of quality systems. The fundamental benefit of this standard is its process-orientated approach.  

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ISO Standards

ISO is the International Organization for Standardization. It is a worldwide federation of the national standard institutions. ISO publishes international standards usually prepared by ISO technical committees. At least 75 % of voting members is needed to publish the standard.

ISO 9001:2000 is already the third edition which superseded the second edition from 1994. Three standards of the second edition are focused on the whole quality management system – ISO 9001, the standard describing a quality management system where design and development were excluded – ISO 9002,A test and an inspection system described in ISO 9003 were superseded by one standard ISO 9001:2000 standard.

Members of ISO 9000 standards family are the basic manual for each and every quality management system consultant.

ISO 9001:2000 Quality management system - requirements

ISO 9001 urges management to have the quality management system as a strategic decision.

The system allows:

  • easiest introduction of newcomers
  • simple and easy modeling of upcoming changes
  • costs optimization
  • efficiency of material and products flows
  • etc.

The system can oblige continual changes of targets, products, management requirements and interested parties with its flexibility.

Process approach

ISO 9001 emphasizes process approach of the system, which is a baseline for its flexibility. An objective of the process approach is to increase customer satisfaction (see picture). Only Customer satisfaction keeps current customers and attracts new customers.

Process is defined as an activity using resources and controlled in order to change inputs to outputs. Application, identification and mutual processes control and activities are considered as process approach. Process approach emphasizes:

  • understanding and fulfillment of customers & interested parties’ requirements, 
  • added value of processes and activities within the company
  • continual improvement of processes’ efficiency and effectiveness
  • continual improvement of processes based on the metrics measurement

PDCA model for continual improvement is firmly confirmed in the ISO standard.

ISO 9001 is addressed to companies intended to:

  • demonstrate ability to constantly deliver products according to customer requirements
  • continually increase customer satisfaction

Content of ISO 9001:2000 standard

The following chapters which define all process quality management system requirements can be found in the standard:

1. Scope

 2. Normative reference

 3. Terms and definitions

 4. Quality management system

 5. Management responsibility

 6. Resource management

 7. Product realization

 8. Measurement, analysis and improvement

These 8 chapters replaced original 20 chapters, see bellow, of the ISO 9001 standard seconds edition:

4.1 Management responsibility

4.2 Quality system

4.3 Contract review

4.4 Design control

4.5 Document and data control

4.6 Purchasing

4.7 Control of customer-supplied product

4.8 Product identification and traceability

4.9 Process control

4.10 Inspection and testing

4.11 Control of inspection, measuring and test equipment

4.12 Inspection and test status

4.13 Control of nonconforming product

4.14 Corrective and preventive action

4.15 Handling, storage, packaging, preservation & delivery

4.16 Control of quality records

4.17 Internal quality audits

4.18 Training

4.19 Servicing

4.20 Statistical techniques

Resource: The ISO 9001:2000 Quality Management System

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„If our fate is on the line, we know how to effectively change our routine.“ more >>

Jiří Střelec Jiří Střelec

How many times you have heard that people do not change. Yet they do, and we ourselves have changed. When we wanted our first computer, we got some seasonal job. When we wanted to win favour of a girl of our dreams, we were ready to memorize a poem or even to write one. As parents, we want and know how to protect our own children. For their smile is worth it. People who are interested in nothing and do not want to change are very few. Often enough, it is just that we do not know how to break an established routine. Managers sometimes do not know how to effect a change, or, as the case may be, are afraid the change they are going to effect might have some unpleasant repercussions. They do not feel like resolving unpleasant situations.

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