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Last updated: 25 Feb 2005

ISO 9001:2000 explained

The most crucial part of ISO 9000 family is the ISO 9001:2000, named Quality Management Systems – Requirements. As stated in the title, its objective is to present the requirements for a quality management system. It does not say how these requirements should be approached or implemented. It’s up to each company to decide the best way of fulfilling the requirements. There are certain things that standard does not require. Read more about that...

T he standard is organized into major sections, as follow:

Section 1 – Scope

Section 2 – References

Section 3 – Terms and definitions

Section 4 – Quality Management System

Section 5 – Management Responsibility

Section 6 – Resource Management

Section 7 – Product Realization

Section 8 – Monitoring and Measurement

F irst three sections deals with the scope of the standard (for companies that wants to prove to their customers the capability of supplying products which meet their requirements and to increase customer satisfaction by applying the system in an effective manner, when is possible to apply exclusions from standard requirements – only within section 7), what references are used (ISO 9000:2000) and definitions of terms supplier, organization and client.

I mportant clauses of the standard are 4, 5, 6, 7 and 8, which will be detailed below. For an overview of basic requirements, click here ...

Section 4 - Quality Management System

4.1 General requirements

4.2 Documentation requirements

4.2.1 General

4.2.2 Quality manual

4.2.3 Control of documents

4.2.4 Control of records

Section 5 – Management responsibility

5.1 Management commitment

5.2 Customer focus

5.3 Quality policy

5.4 Planning

5.4.1 Quality objectives

5.4.2 Quality management system planning

5.5 Responsibility, authority & communication

5.5.1 Responsibility & authority

5.5.2 Management representative

5.5.3 Internal communication

5.6 Management review

5.6.1 General

5.6.2 Review input

5.6.3 Review output

Section 6 – Resource management

6.1 Provision of resources

6.2 Human resources

6.2.1 General

6.2.2 Competence, awareness & training

6.3 Infrastructure

6.4 Work environment

Section 7 – Product realization

7.1 Planning of product realization

7.2 Customer-related processes

7.2.1 Determination of requirements related to the product

7.2.2 Review of requirements related to the product

7.2.3 Customer communication

7.3 Design & development

7.3.1 Planning of design and development

7.3.2 Inputs for of design and development

7.3.3 Outputs from of design and development

7.3.4 Review of design and development

7.3.5 Verification of design and development

7.3.6 Validation of design and development

7.3.7 Changes to design and development

7.4 Purchasing

7.4.1 Purchasing control

7.4.2 Purchasing information

7.4.3 Verification of purchased product

7.5 Production and service provision

7.5.1 Control of production & service provision

7.5.2 Validation of processes for production & service provision

7.5.3 Identification and traceability

7.5.4 Customer property

7.5.5 Preservation of product

7.6 Control of monitoring and measuring devices

Section 8 – Measurement, analysis and improvement

8.1 General

8.2 Monitoring and measurement

8.2.1 Customer satisfaction

8.2.2 Internal audit

8.2.3 Measuring & monitoring of processes

8.2.4 Measurement & monitoring of product

8.3 Control of nonconformity

8.4 Analysis of data

8.5 Improvement

8.5.1 Continual improvement
8.5.2 Corrective action
8.5.3 Preventive action

R emember that according to section 1.2 Application, the only possible exclusions to standard requirements can be made within clause 7. No exclusion is possible under sections 4, 5, 6, and 8. Exclusions decided for section 7 has to be very well sustained.