ISO 9000 STANDARDS

QUALITY SYSTEMS

ISO 9000 STANDARDS

ISO 9000

1)ISO 9001

2)ISO 9002

3)ISO 9003

ISO 9001

Design, Development, Production, Installation & Servicing

ISO 9002

Production, Installation & Servicing

ISO 9003

Inspection & Testing

ISO 9004

Provides guidelines on the technical, administrative and human factors affecting the product or services.

BENEFITS OF ISO 9000 STANDARDS :

Ø  Achievement of international standard of quality.

Ø  Value for money.

Ø  Customer satisfaction.

Ø  Higher productivity.

Ø  Increased profitability

Ø  Improved corporate image

Ø  Access to global market

Ø  Growth of the organization

Ø  Higher morale of employees

CLAUSES (ELEMENTS) OF ISO 9000 (During the year 1987)

Management Responsibility

Ø   Adequate resources for the verification activities

Ø   Need for trained personnel

Ø   Work and verification activities including audits

Ø   A Management Representative to be identified

Ø   Review the Quality System performance and customer complaints periodically

·     Quality System

·     Contract review

·     Design Control

·     Documents Control

·     Purchasing

·     Purchaser – Supplied Product

·     Product Identification and Traceability

·     Process Control

·     Inspection and Testing

·     Inspection Measuring and Test Equipment

·     Inspection and Test Status

·        Control of Non – Conforming Product

·     Corrective Action

·     Handling, Storage, Packaging and Delivery

·     Quality Records

·     Internal Quality Audits

·     Training

·     Servicing

·     Statistical Techniques

CLAUSES (ELEMENTS) OF ISO 9000 (During the year 2000)

1.       Scope

2.       Normative Reference

3.       Terms and Definitions

4.       Quality Management System (QMS)

General Requirements

Documentation

5.       Management Responsibility

Management Commitment

Customer Focus

Quality Policy Planning

Responsibility, Authority and

Communication Management Review

6.       Resource Management

Provision of Resources Human Resources Infrastructure

Work Environment

7. Product Realization Planning of Product Realization Customer related processes Design and Development Purchasing

Production and Service Provision

Control of Monitoring and Measuring devices

8.       Monitoring and Measurement General

Monitoring and Measurement

Control of Non-Conforming Product

Analysis of Data

Improvement

IMPLEMENTATION OF QUALITY MANAGEMENT SYSTEM :

1.                 Top Management Commitment

2.                 Appoint the Management Representative

3.                 Awareness

4.                 Appoint an Implementation Team

5.                 Training

6.                 Time Schedule

7.                 Select Element Owners

8.                 Review the Present System

9.                 Write the Documents

10.            Install the New System

11.            Internal Audit

12.            Management Review

13.            Pre-assessment

14.            Registration

PITFALLS OF SUCCESSFUL IMPLEMENTATION :

1.                 Using a generic documentation program or another organization’s documentation program

2.                 Over-documentation or documentation that is too complex

3.                 Using External Consultants without involvement

4.                 Neglecting to obtain top management’s involvement

5.                 Developing a system that does not represent what actually occurs

DOCUMENTATION

In every organization, the quality system must be documented properly. The documentation of the system can be seen as a hierarchical format as shown.

QUALITY AUDITING

The term Audit refers to a regular examination and checking of accounts or financial records, settlement or adjustment of accounts.

It also refers to checking, inspection and examination of Production Processes.

PURPOSE OF QUALITY AUDIT :

Ø    To establish the adequacy of the system.

Ø    To determine the effectiveness of the system.

Ø    To afford opportunities for system analysis.

Ø    To help in problem solving.

Ø    To make decision making easier etc.

TYPES OF QUALITY AUDIT :

1.                 First – Party Audit.

 2.                 Second – Party Audit.

3.                 Third – Party Audit.

Quality audit can also be classified on the basis of the area taken into account for the audit such as

Ø    System Audit.

Ø    Process Audit.

Ø    Product Audit.

Ø    Adequacy Audit.

Ø    Compliance Audit.