ISO 9000 QUALITY SYSTEM….

Quality is a critical factor for business success in today’s highly competitive market. Companies must demonstrate that they can provide quality products and services. But first, they must have a well-managed, properly designed and certified quality system in place. Seeking ISO certification is the best way to set up such a system.
The International Standard Organisation, ISO standards is a series of international standards on quality management developed by the Geneva-based ISO in 1987. It was develop and implement to assist companies' design, develop and implement effective quality management system.
The ISO is a worldwide federation of national standards body with 120 member countries, which subscribe to ISO standards. The ISO 9000 is a series of standards, which specify requirements and recommendations for the design, and assessment of a management system. It seeks to ensure that suppliers provide products and services, which satisfy these requirements. ISO 9000 is not, however, a product standard. It does not contain any performance requirements or assessment criteria with which a product or service can comply.

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ISO Quality System

 

ISO 9000

Quality management and quality assurance standards - guidelines for selection and use. This section explains fundamental quality concepts, defines key terms and provides guidelines on selecting and using ISO 9001, 9002 and 9003. It provides the road map to use the other parts of the series.

 

ISO 9001

Quality systems - model for quality assurance in design/development, production, installation and servicing.

This is the most comprehensive standard covering 20 elements and those listed in the ISO 9002 and 9003. It specifies quality assurance in design, installation and servicing. It also covers the broad spectrum of design, development, production, installation and servicing.

 

ISO 9002

Quality systems - model for quality assurance in production, installation and servicing.

This section contains 19 elements, which address the prevention, detection and correction of problem that occur during production, installation and servicing.

 

ISO 9003

Quality systems - model for quality assurance in final inspection and testing. This section contains 16 elements and focuses on detection and correction of problems that occur during final inspection and testing.

 

ISO 9004

Quality management and quality system elements - guidelines.

This provides for overall quality management and the quality system within ISO 9000 series.

 

 

 

 

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The 20 elements

Clause title in ISO 9001

ISO 9001

ISO 9002

ISO 9003

 

4.1

Management responsibility

Y

Y

O

 

4.2

Quality system

Y

Y

O

 

4.3

Contract review

Y

Y

Y

 

4.4

Design control

Y

N

N

 

4.5

Document and data control

Y

Y

Y

 

4.6

Purchasing

Y

Y

N

 

4.7

Control of customer-supplied product

Y

Y

Y

 

4.8

Product identification and traceability

Y

Y

O

 

4.9

Process control

Y

Y

N

 

4.10

Inspection and testing

Y

Y

O

 

4.11

Control of inspection, measuring and test equipment

Y

Y

Y

 

4.12

Inspection and test status

Y

Y

Y

 

4.13

Control of nonconforming product

Y

Y

O

 

4.14

Corrective and preventive action

Y

Y

O

 

4.15

Handling, storage, packing, preservation and delivery

Y

Y

Y

 

4.16

Control of quality records

Y

Y

O

 

4.17

Internal quality audits

Y

Y

O

 

4.18

Training

Y

Y

O

 

4.19

Servicing

Y

Y

N

 

4.20

Statistic techniques

Y

Y

O

 

Key:

Y = Comprehensive requirement

O = Less-comprehensive requirement than ISO 9001 & ISO 9002

N = Element not present

 

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