ISO9001 Standards, Details - Petts Consulting Limited

There are three ISO9000: 2000 standards that have been developed as consistent set of quality management system standards so as to complement each other. Copies of the standards can be obtained from the British Standards Institution at www.bsi-global.com

ISO 9000:2000, Quality management systems – Fundamentals and vocabulary: This brief document explains the basic terminology and approach. It does not give details on how to implement an approach or any information concerning the various points to be covered, these are laid out in 9001 and 9004

ISO 9004:2000, Quality management systems – Guidelines for performance improvements: ISO 9004:2000 guides the organization beyond the requirements of ISO 9001:2000 by focussing on performance improvements. ISO 9004:2000 recommends an evaluation of the efficiency, as well as the effectiveness of the processes.

The document provides useful guidelines on how process effectiveness and efficiency can be assessed through internal or external review. The guidelines are intended to be used for self-assessment and not for 3^rd party accreditation.

ISO 9001:2000, Quality management systems – Requirements: This standard specifies the requirements for a quality management system where an organization needs to demonstrate its ability to consistently provide product (including services) that meet both customer and regulatory requirements. The standard is structured to allow 3^rd party assessment and accreditation of the Quality Management System.

ISO 9001:2000 stresses the importance for an organization to identify, implement, manage and continually improve the effectiveness of the processes that are necessary for the quality management system, and to manage the interactions of these processes in order to achieve the organization's objectives.

The list below gives the headings of all of the requirements within the standard.

ISO9001: 2000

1 Scope

1.1 General

1.2 Application

2 Normative reference

3 Terms and definitions

4 Quality management system [title only]

4.1 General requirements

4.2 Documentation requirements [Title only]

4.2.1 General

4.2.2 Quality manual

4.2.3 Control of documents

4.2.4 Control of records

5 Management responsibility [title only]

5.1 Management commitment

5.2 Customer focus

5.3 Quality policy

5.4 Planning [title only]

5.4.1 Quality objectives

5.4.2 Quality management system planning

5.5 Responsibility, authority and communication [title only]

5.5.1 Responsibility and authority

5.5.2 Management representative

5.5.3 Internal communication

5.6 Management review [title only]

5.6.1 General

5.6.2 Review input

5.6.3 Review output

6 Resource management [title only]

6.1 Provision of resources

6.2 Human resources [title only]

6.2.1 General

6.2.2 Competence, awareness and training

6.3 Infrastructure

6.4 Work environment

7 Product realization [title only]

7.1 Planning of product realization

7.2 Customer-related processes [title only]

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 and development [title only]

7.3.1 Design and development planning

7.3.2 Design and development inputs

7.3.3 Design and development outputs

7.3.4 Design and development review

7.3.5 Design and development verification

7.3.6 Design and development validation

7.3.7 Control of design and development changes

7.4 Purchasing [title only]

7.4.1 Purchasing process

7.4.2 Purchasing information

7.4.3 Verification of purchased product

7.5 Production and service provision [title only]

7.5. 1 Control of production and service provision

7.5.2 Validation of processes for production and 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

8 Measurement, analysis and improvement [title only]

8.1 General

8.2 Monitoring and measurement [title only]

8.2.1 Customer satisfaction

8.2.2 Internal audit

8.2.3 Monitoring and measurement of processes

8.2.4 Monitoring and measurement of product

8.3 Control of nonconforming product

8.4 Analysis of data

8.5 Improvement [title only]

8.5.1 Continual improvement

8.5.2 Corrective action

8.5.3 Preventive action

ISO9000:2000 Standards - Details