TQM SYSTEMS INDIA (PVT ) LTD

ISO/ 9001-2000

ISO/9001-
2000

TQM SYSYTEM INDIA (PVT ) LTD

B2/ 2A LAWRENCE ROAD
DELHI 1110035
Presented by
PHONE: 91-11-27189498
FAX 91-11-27189498 A S CHANDRASEKARAN
Email: as.chandru4@gmail.com

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 Internal/external interface between a organization and a
customer

This is a process
ORGANIZATION •An interface organization/external
environment input (I)

I •An interface organization/external

environment output (o)

Continual Improvement of the Quality

Management System

Customers Management Customers

Responsibility

Measurement,
Resource
analysis and Satisfaction
management
improvement

INPUT Product OUTPUT

Requirements Product
realization

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 4. Quality Management System

QUALITY MANGEMENT PRINCIPLES

1. CUSTOMER FOCUS
2. LEADERSHIP
3. INVOLVEMENT OF PEOPLE
4. PROCESS APPROACH
5. SYSTEM APPROACH TO MANAGEMENT
6. CONTINUAL IMPROVEMENT
7. FACTUAL APPROACH TO DECISION MAKING
8. MUTUALLY BENEFICIAL SUPPLIER
RELATIONSHIPS

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 4. Quality Management System

4.1 General Requirements

Establish, document, implement & maintain a QMS and
continually improve its effectiveness
Implement QMS by
Identifying processes needed for the QMS throughout
organization
Determining sequence and interaction between these
processes
Determining criteria & methods required to ensure that both
operation and control of these processes are effective
Ensuring the availability of resources & information necessary
for operation & monitoring of processes

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 4. Quality Management System

4.1 General Requirements (Contd.)

Implement QMS by (Contd.)
monitoring, measuring and analyzing these processes,
and
implementing actions necessary to achieve planned
results and Continual Improvement of these
processes

Identify and control outsource processes

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 4. Quality Management System

4.2 Documentation Requirements

4.2.1
documented Statement of Quality Policy & Quality Objectives

a Quality Manual

documented procedures required in this standard

documents needed by organization to ensure effective planning,

operation and control of its processes

quality records required by this standard (see 4.2.4)

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 4. Quality Management System

4.2 Documentation Requirements

(Contd.)
4.2.2 Quality Manual
Establish & maintain Quality Manual that includes
the scope of QMS, including details of, and justification
for any exclusions referred at 1.2,
documented procedures established for QMS or their
reference
a description of the interaction between the processes
of QMS

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 4. Quality Management System

4.2.3 Control of Documents

Establish a procedure defining the
controls

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 4. Quality Management System

4.2.4 Control of Quality Records

Establish a Procedure defining Control of
Records. Controls to include:
Identification, Storage
Protection , Retrieval
Retention Time & Disposition
including (Disposal)

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 5.0 Management Responsibility

5.1 MANAGEMENT COMMITMENT –

Top management to demonstrate commitment to QMS & continually

improving its effectiveness by

Communicating to organization the importance of meeting

customer and statutory / regulatory requirements
Establishing Quality Policy & Quality Objectives
Conducting Management Reviews; &
Ensuring the availability of necessary resources

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 5.0 Management Responsibility

5.2 CUSTOMER FOCUS

Aim to enhance customer satisfaction

5.3 Quality Policy

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 5.0 Management Responsibility
5.4 Planning
5.4.1 Quality Objectives
Shall be for meeting the requirements of
products
Established at relevant functions and levels
Shall be measurable and consistent with Quality
Policy

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 5.0 Management Responsibility

5.4.2 Quality Management System Planning

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 5.0 Management Responsibility

5.5 Responsibility, Authority &

Communication
5.5.1 Responsibility & Authority

Top Management to ensure that :

Responsibilities & authorities and their inter-relations are
defined and communicated within the organization.

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 5.0 Management Responsibility

5.5.2 Management Representative

Appoint member of the Management as
Management Representative (MR). He is
responsible for :
Promotion of awareness of customer
requirements throughout the organization

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 5.0 Management Responsibility

5.5.3 Internal Communication

Top Management to ensure that
communication processes are established
between various levels and functions and
takes place regarding effectiveness of QMS.

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 5.0 Management Responsibility
5.6 Management Review
Management Review to include
• all elements of QMS and
• its performance trends,
• Quality Objectives and Cost of poor quality.

Management Review result to provide

evidence of achievement of
• Quality Policy Objectives,
• Business Plan Objectives and
• Customer Satisfaction

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 5.0 Management Responsibility

5.6 Management Review (Contd.)

Review Input
Shall include information on
Audit Results;
Customer feedback;
Process performance and product conformity;
Status of preventive and corrective actions;
Follow up actions of previous management reviews;
Planned changes that could affect QMS and
Recommendations for improvement

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 5.0 Management Responsibility

5.6 Management Review (Contd.)

5.6.3 Review Output
To include any decisions and actions related to
improvement of the effectiveness of QMS and its
processes; improvement of product related to customer
requirements and resource needs

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5.0 Management Responsibility

Business
plan

Policy

Objectives

Planning

Employee understanding / Involvement

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 6 Resource Management

6.1 Provision of Resources

Determine and provide resources
needed :
to implement, maintain and continually improve
effectiveness of QMS and
to enhance customer satisfaction by meeting
customer requirement

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 6 Resource Management

6.2 Human Resources

6.2.1 General
6.2.2 Competence, Awareness and
Training
6.3 Infrastructure
6.4 Work Environment

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 7. Product Realization

7.1 Planning of Product Realization

7.2.1 Determination of Requirements Related
to the Product

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 7. Product Realization

7.1 Planning of Product Realization

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 7.2 Customer Related Processes

7.2.1 Determination of Requirements Related to

the Product

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 7.2 Customer Related Processes

7.2.2 Review of Requirements Related to Product

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 7.2 Customer Related Processes

7.2.2 Review of Requirements Related to Product

When the product requirements change ensure
Updation of affected documents
Provide information about the change to the
concerned personnel

NOTE 1: In some situations such as internet sales,

a formal review is impractical for each order.
Instead, the review can cover relevant product
information such as catalogues or advertising
material
.

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 7.2 Customer Related Processes

7.2.3 Customer Communication

Determine and implement effective arrangements for

communicating about,
Product information
Enquiry, contract / order handling including
amendments
Customer feedback and customer complaints

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 7.3 Design & Development

7.3 Design and Development

7.3.1 Design and Development Planning

7.3.2 Design and Development Inputs

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 7.3 Design & Development

7.3.3 Design and Development Output

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

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 7.4 Purchasing

7.4 Purchasing

7.4.1 Purchasing Process

7.4.2 Purchasing Information

7.4.3 Verification of Purchased Product

7.4.3.1 Incoming Product Quality

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 7.5 Production & Service Provision

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 & Measuring Devices

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 7.6 Control of Monitoring & Measuring Devices

7.6 Control of Monitoring & Measuring

Devices

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 8. Measurement Analysis & Improvement

8.1 General

8.1.1 Identification of Statistical Tools

8.1.2 Knowledge of Basic Statistical Concepts

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 8. Measurement Analysis & Improvement

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 Non-Conforming Product

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 8. Measurement Analysis & Improvement

8.4 Analysis of Data

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 8. Measurement Analysis & Improvement

8.5 Improvement
8.5.1 Continual Improvement
Continually improve the effectiveness of QMS
Facilitate Continual Improvement through use of
Quality Policy
Quality Objectives
Audit (Internal & External) Results
Analysis of Data
Corrective and Preventive Action and
Management Review

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 8. Measurement Analysis & Improvement

8.5 Improvement (Contd.)

8.5.2 Corrective Action
8.5.3 Preventive Action

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