iso 9000 introduction sumant

7/31/2019 ISO 9000 Introduction Sumant

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ISO 9000: An Introduction

Presented by:

Sumant KumarDate: 05/08/2011


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ISO 9000An Introduction

Expectations:


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What we will cover:

1. Introduction to Quality & Quality

Management System2. What is ISO, ISO 9000, etc.

3. QMS Principles

4. Advantages & Benefits of ISO 9001

5. ISO 9001 Standard

6. ISO 9001; Introduction: The Process &Systems Approach


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What we will cover (continued):

7. ISO 9001: QMS Model

8. ISO 9001; Introduction: The PDCACycle

9. ISO 9001; Clause 7: Product

Realization10. ISO 9001; Clause 8: Measurement,

Analysis & Improvement


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What is Quality?

Degree to which a Product or Servicefulfills Requirements.

Quality is what a Customer wants and iswilling to pay for.


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Quality Management System

To Manage the Quality, we need a Quality ManagementSystem; also called the QMS.

It is one that ensures good business practice. For example:Set quality goals

Ensure customer requirements are understood and met

Train employees

Control your production processes

Purchase process and control to ensure quality product

Correct problems and make sure they do not happen again

What is a good QMS?


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Documented QMS: What it contains?

The Quality Management System (QMS) isdocumented in the:

Quality Policy

Quality Manual

Procedures Work Instructions

Records


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What is ISO?

What is ISO 9000ISO 9001..ISO

9001:2008..?


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What is ISO?

ISO is the International Organization ofStandardization

ISO is an organization that developsStandards for use worldwide to help

companies plug into the worldmarket.


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ISO 9000 Family

ISO

9000

ISO

9004

ISO

9001

QMSRequirementsQMSGuidelines for

Performance Improvement

QMSFundamentals

& Vocabulary


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Quality Management Principles: From ISO 9000

1. Customer Focus

2. Leadership

3. Involvement of People

4. Process Approach

5. System Approach to Management

6. Continual Improvement7. Factual Approach to Decision Making

8. Mutually Beneficial Supplier Relationships


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ISO 9001 is an outline for a QMS

ISO Standards are made by a Technical

Committee comprising of Quality Experts &

Business Leaders.

When you build your QMS based on ISO

9001:2008, it means you are building your

QMS to the Internationally recognized ISOStandard.


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Advantage of having ISO 9001

Once the quality system is in place a Registrarwill come and audit. (The Registrars areaccredited organizations.)

If all the criteria are being followed, thecompany will be

ISO 9001 Registered.

Registered companies put their Registrationmark in marketing materials.

Potential customers will know that you have agood Quality Management System in Place.


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ISO 9001:2008 Introduction

Process

Approach

Input PROCESS Output

Resources

Controls


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System Approach

PROCESS

A

PROCESS

D

PROCESS

B

PROCESS

C


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PDCA Cycle



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The ISO 9001 Standard

ISO 9001:2008 Standard

Section 1: Scope

Talks about the standard and how it applies to organisations Section 2: Normative Reference References another document that should be used along with the standard, ISO 9000:2008,

Quality Management Systems-Fundamentals and Vocabulary Section 3: Terms and Definitions Gives a few new definitions Section 4: General Requirements

Gives requirements for the overall Quality Management System Section 5: Management Responsibility

Gives requirements for Management and their role in the Quality Management System Section 6: Resource Management

Gives requirements for resources including personnel, training, the facility and workenvironment

Section 7: Product Realization

Gives requirements for the production of the product or service, including things likeplanning, customer related processes, design, purchasing and process control

Section 8: Measurement, Analysis and Improvement

Gives requirements on monitoring processes and improving those processes


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ISO 9001:2008

Input Output

C

US

T

O

ME

R

R

E

QU

I

R

E

M

E

N

T

S

Continuous Improvement of the

4. QMS

5. Management Responsibility

6. Resource

Management

8. Measurement,

Analysis, Improvement

C

US

T

O

M

E

R

S

A

T

IS

F

A

C

T

I

O

N7. Product

RealizationProduct


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Product Realization

The processes in our organization thatactually result in the product or

service that goes to our client.

ISO 9001:2008 Clause 7


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Product Realization (Contd.)

The Sections includes the following clauses:7.1 Planning for Product Realization

7.2 Customer related processes

7.3 Design and Development

7.4 Purchasing7.5 Production and Service

7.6 Control of Monitoring & Measuring Equipment

ISO 9001:2008 Clause 7


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Production and Service Provision

7.5.1 Control of Production and ServiceProvision

7.5.2 Validation of Processes for Productionand Service Provision

7.5.3 Identification & Traceability

7.5.4 Customer Property

7.5.5 Preservation of Product

ISO 9001:2008 Clause 7.5


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ISO 9001: 2008; Section 8

Sub-section 8.1 General

The organization shall plan and implement the monitoring,measurement, analysis & improvement processes needed

to demonstrate conformity to product requirements

to ensure conformity of QMS, and

to continuously improve the QMS.

This shall include determination of applicable methods, includingstatistical techniques, and the extent of their use.

Measure, Analyze and Improve


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Corrective & Preventive Action

Corrective and Preventive action systems should beused by all employees to address problems andpotential problems.

Correction: The immediate solution to a problem that has

occurred.

Corrective Action:Fix a problem that has occurred, and prevent

it from happening again.

Preventive Action:When you see something that may cause a

problem, fix it and prevent the problem from happening.


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Any Questions?

Let us keep interacting.

Best wishes.

iso 9000 introduction sumant

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