qms iqa[1]. tr

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GENERAL INTRODUCTIONGENERAL INTRODUCTION

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ISO Means...International Organization for Standardization

A Worldwide Federation of National Standards Bodies

Represented by almost 170 Countries.

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When? ISO 9001 Established in 1987

(i.e. ISO 9001 : 1987).Latest version is ISO 9001 : 2008

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Both ISO 9001 and ISO 14001 concern the way an organization goes about its work.

They are not product standards.

They are not service standards.

They are process standards.

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Quality Means... Performance Goodness Safety Freedom Fineness Appearance Meeting Specifications Maintainability...

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Quality Management Means... ISO 9001 is for quality

management. Quality refers to all those features

of a product (or service) which are required by the customer.

Quality management means what the organization does to

ensure that its products or services satisfy the customer's quality requirements and

comply with any regulations applicable to those products or services.

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Quality Management Means (Cont...)

Quality management also means what the organization does to

enhance customer satisfaction, and

achieve continual improvement of its performance.

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Management System Means... To be really efficient and effective,

the organization can manage its way of doing things by systemizing it.

Everyone is clear about who is responsible for doing what, when, how, why and where.

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PURPOSE OF ISO 9001 : 2008PURPOSE OF ISO 9001 : 2008

Specifies requirements for organization to

Demonstrate its ability to consistently provide product that meets applicable requirements

Enchance customer satisfaction thru system – processes for improvement & conformity assurance

Prevent nonconformity12

ISO 9001 : 2008 Does Not Say “HOW TO DO”

It Only Says “WHAT TO

DO” 13

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QUALITY MANAGEMENT SYSTEMQUALITY MANAGEMENT SYSTEM

PRINCIPLESPRINCIPLES

Customer Focus Leadership Involvement of People Process Approach System Approach Continual Improvement Factual Approach to Decision Making Mutually Beneficial Supplier

Relationships 15

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PDCAPDCA

P – Plan D – Do C – Check

A - Act

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Deming’s wheel

(P.D.C.A.)

Deming’s wheel

(P.D.C.A.)

ISO9001

PLAN DO

ACT CHECK ContinuousImprovement

Continuous improvement ?

ISO 9001: 2008 Quality

Management System

Requirements19

General Requirements (4.2.1) Documentation Requirements (4.2.2) Reference Manual Page 26 of 98 Control of document & data control

(4.2.3) Control of recorts (4.2.4)

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Providing evidence of activities performed.

Shall be Identification, Storage Protection, Retrieval, Retention Time & Disposition

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Top Management (5.1) Customer Focus (5.2) Quality Policy (5.3) Quality management system planning

(5.4) Responispility, authority &

communication (5.5) Management Review (5.6)

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Resource Management (6.1) Human Resources (6.2) Infrastructure (6.3) Work Environment (6.4)

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A systematic independent examination to determine whether quality activities & related results comply with planned arrangements and whether these arrangements are implemented effectively and are suitable to objectives.

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First PartySecond PartyThird Party

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NC - Non-Conformance (Non Fulfill Document / Process / Product / Service)

TYPE OF NC:Major Minor

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Performance advantage through improved organizational capabilities

Alignment of improvement activities at all levels to an organization's strategic intent.

Flexibility to react quickly to opportunities.

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Continuous improvement of theQuality Management System

CLIE

NT

Product /Service

Realization

ManagementResponsibility

Measurement,Analysis andImprovement

ResourceManagement

InputData

ProductService

OutputData

Req

uire

men

ts

Satis

factio

nSystem Approach ?

Action taken to eliminate the cause of “Detected Non-Conformity”

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Action taken to eliminate the cause of “Potential Non-Conformity”

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