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Quality Management System

ISO 9001:2008

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Quality

Quality

Fitness for use

Least Variability

Loss to society

Conformance to specifications/requirements

Customer Satisfaction/Interested PartiesSatisfaction

Degree to which inherent characteristics of aproduct or service meets requirements

Ability to fulfill stated and implied needs

Cost of poor quality

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Quality Management Principles

QualityManagement

Principles

Customer Focus

Leadership

Involvement of People

Continual Improvement

Facts based Decisions

Mutually Beneficial Supplier Relationship

Process Approach

System Approach

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Process Perspectives for QMS

PROCESSset of interrelated or

interacting activitieswhich transformsinputs into outputs

INPUT OUTPUT

RESOURCES

CONTROLS

PRODUCT

AdjustmentsMeasurements

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Process Approach

Process

A

ProcessD

ProcessB

Process

C

InputOutput

Controls

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QMS Documentation

Policy

Processes

Procedures

Forms/ Data/ Records/

Information

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ISO 9001 QMS model

CUSTOMERS

CUSTOM

ERS

Managementresponsibility

Resourcemanagement

Measurement, analysis,improvement

Service/Product

Product/ Servicerealisation

Continual Improvement of theQuality Management System

Requir

ements

Sa

tisfacti

on

InputOutput

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Improvements

Ground Fruits

Low Hanging Fruits

Bulk Fruits

Sweet Fruits

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Maturity Levels of Implementation

Level5Optimized

Level4Quantitatively

Managed

Level 3Defined

Level 2Some How Managed

Level 1Chaos/ Uncertain

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4.0 Quality Management System

Processes

Technical Processes

Commercial Process

Quality SystemsProcess

OutsourcedProcesses

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4.0 Quality Management System

Procedures

Documents Control

Record Control

Auditing

Handling Non Conforming Situations

Solving Problems Occurred to avoidre-occurrence

Solving Anticipated Problems to avoidoccurrence

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4.0 Quality Management System

Procedures, as required byindustry/ customers/ Law/

Management

Planning

Marketing

Design

Purchase

Production

Packing

Finished Goods/ Other Stores

Dispatch

Services

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4.0 Quality Management System

Quality Manual

Scope

Exclusions

Processes Description

Procedures Reference

Any other information, asnecessary

Quality ManagementApproach

Quality Policy

Objectives

Organization Chart

Strengths/ Capability

Market

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4.0 Quality Management System

Departmental Manual

Departmental Activities

Departmental Objectives

Processes Description/Flow Charts

Procedures/ SOPs/ SampleFormats

Any other information, asnecessary

List of Documents

List of Records/ Softwares

List ofEquipments/Instruments

Organization Chart/Responsibilities

List of Suppliers/ ServiceProviders

Audit Checklist

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4.0 Quality Management System

DocumentControl

Approval

Review

Update

Reapprove

Changes identification

Revision Status identification

Available at point of use

Legible Documents

Readily identifiable

External Origin Documents identification

External Origin Documents Distribution

Prevention of misuse of obsolete documents

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4.0 Quality Management System

Records Controls

Records ofConformity

Records ofEffectiveness

Hard Copy/Electronic Records

Identification

Legibility

Storage

Protection

Retrieval

Retention

Disposition

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4.0 Quality Management System

Records

Management ReviewsCompetence RelatedProduct Requirements Review

Design RelatedSuppliers evaluation

TraceabilityCustomers Property related Communications

CalibrationAuditsNon Conforming Products

Corrective ActionsPreventive Actions

Reports

Quality Objectives AchievementData Analysis

Complaint ReportsProcess Performance

Maintenance ReportsService Reports

Test ReportsCustomer Satisfaction

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5.0 Management ResponsibilityCommitment

Customer Focus

Quality Policy

Objectives

Planning for Achievement

Managing Changes

Responsibility & Authorities Management Representative

Internal Communication

Management Review

Process

Inputs

Outputs

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5.0 Management Responsibility

Management Commitment forQMS

Development

Implementation

Continual Improvement

ManagementCommitment

by

Communication for meetingrequirements

Quality Policy

Objectives

Management Reviews

Resources

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5.0 Management Reviews

ManagementReviews

Top ManagementInvolvement

Planned (not equal)intervals

Review of QMS

Suitability

Adequacy

Effectiveness

ImprovementOpportunity

Need for Changes

Quality Policy

Quality Objectives

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5.0 Management Reviews

ManagementReviews

Inputs

Audits

Customer Feedback

Process Performance

Product Conformity

Actions Status

Corrective

Preventive

Previous ActionsChanges Expected

Recommendations forImprovement

Outputs

Improvement in QMS

Improvements in Processes

Improvement in Product

Resources Needs

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6.0 Resource Management

Resources

Human Resources

Allocation

CompetenceImprovement

Training

Plan

Do

CheckEffectiveness

Take ActionsAwareness

Infrastructure

Machines

Equipments

Buildings

Communication

Software

Hardware

WorkEnvironment

Physical Factors

Human Factors

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7.0 Product RealizationPlanning Process

Process Planning

Process Development

Planning considerations

Product Requirements

New/ Changed Processes

Criteria of Acceptance

Quality Objectives

Documents

Resources

Verification

Validation

Monitoring

Measurement

Inspection

Testing

Quality Plan

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7.0 Product Realization

Product/ ServiceRequirements

DetermineRequirements

Specified

Implied

Statutory

Management

Review Requirements

Any ambiguities

resolved

Capability Assessment

Agreement

Verbal RequirementsConfirmation

Changed RequirementsManagement

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7.0 Product Realization

CustomerCommunication

Product Information

Enquiry Handling

Contracts Handling

Amendments Handling

Feedback

Complaints

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7.0 Product Realization

Design andDevelopment

Planning

Inputs

Reviews

Verification

Validation

Outputs

Changes

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7.0 Product Realization

Purchase Considerations

Purchase Requirements

Control over supplier

Control over purchased product

Criteria and Process for

Evaluation of Suppliers

Selection of Suppliers

Re-evaluation of Suppliers

Accurate Purchase Information

Arrangements of Verification ofPurchased Products

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7.0 Product Realization

Production andService Provision

ControlledConditions

Specifications

Work Instruction

Suitable Equipments

Monitoring and Measurement

Release/ Delivery and PostDelivery

Validation ofProcesses

Qualifying processes toguarantee required outcome

Revalidation

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7.0 Product Realization

Production and ServiceProvision

Product Identification

Product Status Identification

Traceability

Customer Property Control

Lost

Damaged

Unsuitable

Preservation

Packing

Storage

Handling

Delivery

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7.0 Product Realization

Measuring Instruments/Systems Control

Measuring Instrument

Selection

Calibration

Calibration Statusidentification

Instruments Handling

Instruments Maintenance

Instruments Storage

Validation of Softwaresupporting monitoring

activities

Evaluate situation wheninstruments are found out of

calibration

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8.0 Measurement, Analysis and

Improvement

Measurement

Plan

Statistical Techniques

Customer Satisfaction

Direct Methods

Indirect Methods

Internal Audit

Plan

Do

Follow-up

Action CompletionProcess Monitoring

Product Monitoring

Product Release

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8.0 Measurement, Analysis and

Improvement

Non ConformingProduct/ Complaints/

Returns/ Penalties

Identification

Control to avoid mix-up

Decide for

Acceptance onConcession

Rework & Re-inspection

Re-grade for differentapplication

Scrap

What to do if alreadydelivered

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8.0 Measurement, Analysis and

Improvement

Continual Improvement using

Analysis of Data

Internal Audits

Management reviews

Quality Policy

Quality Objectives

Corrective Actions (No Repetition ofProblems)

Preventive Actions (Right First Time)

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