understanding iso 9001 2008

Understanding ISO 9001:2008 Quality Management System

A presentationfor

ATOSCO

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Strategic management consulting

Operational improvement and cost effectiveness

New initiative:

Project management

Quality Management Systems Consulting

Business Process Reengineering

IT services: Design – RFP – Vendor selection – Contract Award

HR management

Educational 3M tool

eLearning C of E: Varsity – Institutional – Continuous Education

Knowledge management

Training and learning organization

Feasibility study Business plan Implementation plan


Before We Start…

Your participation is KEY to success…..

If in doubt, stop & clarify any time….Share your thoughts any time….

Get involved….Participate, and

Contribute to make this program successful


Presentation Goals

To introduce ISO 9001 : 2008 QMS & its benefits. To outline ISO9000 implementation plan. Roles


Expectations Yesterday

SERVICE

SYSTEM

Quality

TIMELINES


Expectations Today

Any time ready to Change

Good Ambience

Good Quality

PriceGood

Consistency

Customer Needs &

Requirement

One Stop Solution

Excellent Service


What is Change?

Change is Improvement


What to Change???

Attitude Vision/Goals

Technology

Culture

Approach Strategy

Procedure Values Speed Perception


Our Vision

“…Businesses must have a vision aboutwhat they exist for, which is shared by

everyone in the company.”Moon and Bonny in the

Introduction of Business Ethics: facing up to the issues.


There is no risk in changing, but thereis risk if we are not changing…

If we don’t risk anything, we riskeverything…

System should be adopted for changing


Quality Management SystemQuality

• Fitness for purpose• Excellence• Meeting Customer Expectations not just needs

Management

• Planning, Organizing, Directing, Controlling, Structuring

System

• Work culture• Framework• Policies & procedures


Cost of Poor Quality Service

Hidden Costs of Poor Quality©All Rights Reserved - NiMble Business Solutions

Introducing ISO 9001:2008

Getting Started…….


What is ISO?

ISO is the International Organization for Standardization based in Geneva, Switzerland. On 23 Feb 1947, ISO began operations.

ISO member organizations: National standards institutes from countries large & small from all regions of the world

ISO develops technical standards to contribute in making the manufacturing & supply of goods & services more efficient, safer and cleaner.

Since 1947, ISO has published more than 15,000 standards


About ISO 9001

It’s a Quality Management System Standard

Initially published in 1987

First revision in 1994, Second revision in 2000

ISO 9001:2008 is the latest version released in 14 Nov 2008

Strong emphasis on Customer Satisfaction and Continual Improvement


Continuous v/s Continual Improvement


Continuous Improvement

Initial Level of Performance

Point of Failure

Continual Improvement

Point of Failure

Last Improved Level

Improvement PhaseConsolidation Phase

Initial Level of Performance

The ISO9000 Environment


Develops International

Standards

ISOInternational

Organization for Standardization

•Non-governmental Organisation

158 member countries•2830 groups, 30000 experts

•ISO 9000 represents QMS family

Grants License to Certification

agencies

Accreditation bodies

•UK – UKAS•Holland - RvA

•USA - RAB•Germany - DAR

Assesses management

system compliance with

ISO standards

Certification Agencies

Third Party Certification

Agencies

Assists organizationin getting ready for

certificationConsulta

ntsNiMble

Business Solutions

Entity implements andContinuously improves

the QMSOrganiza

tionsClient

Company

Key Benefits of ISO 9000 for ATOSCO


A QMS Improves How?Management control System based approach. Regular performance reviews.

Process efficiency & productivity Introduction of measurable objectives and process level keyperformance indicators.

Quality consistency Non conforming process and products are identified, rootcause investigated, corrective & preventive actionimplemented and effectiveness measured.

Staff morale & motivation Documented policy & objectives provide direction &purpose. Documented processes and procedures promoteclarity & understanding. Performance expectations aredefined. Training needs regularly assessed.

Supplier & contractor performance Defined system of evaluation for selection and performancemonitoring.

International recognition &reputation

Third party certification to a globally recognized standard.

Internal inter‐department service Monitoring levels Monitoring& measurements of inputs & outputs. Proactivefeedback. Defined procedures for complaint handling.

ISO 9000 QMS & its Elements

Getting Started…….


ISO 9001:2008 Quality Management System


Management

Responsibility

Measurement,

Analysis, Improve

ment

Resource

Management

C

U

S

T

O

M

E

R

REQU I REMENT

S

AT I S FAC T I ON

PRODUCT

C

U

S

T

O

M

E

R

ISO 9001:2008 Main Clauses

Quality Management System

Management Responsibility

Resources Management

Product Realization

Measurement, Analysis and Improvement©All Rights Reserved - NiMble Business Solutions

Management Responsibilities

Management Commitment

Establish policy and objectives (SMART) Communicate importance of meeting customer and regulatory Requirements Conducting Management Reviews Ensuring availability of resources

Customer FocusResponsibility, Authority and communication


Resource Management

Provision of Resources (in a timely manner)

Human Resources

CompetenceAwarenessTraining

Infrastructure

Work Environment


Product Realization

Customer-related processes

Determination of requirementsReview of requirementsCustomer communication

Design and Development

Purchasing

Vendor Selection & evaluationPurchasing informationVerification of purchased product


Measurement Analysis

Control of Monitoring and Measuring Devices (Calibration)Monitoring and Measurement

Customer SatisfactionInternal Audit

Analysis of DataCustomer SatisfactionConformity to product requirements

SuppliersImprovementContinual improvement through policy, objectives, audit results, analysisof data, corrective/preventive actions and management reviews


ISO 9001:2008 QMS Implementation

Overview of QMS implementation project……


Overview of the QMS implementation project


2.1 Process analysis

2.2Preparation of QMS documentation

2.3Delivery of ISO9001 awareness training

MobilizationPhase 1

3.1 Internal auditor training

3.2 Commencement of internal quality auditing of the QMS

3.3 Verification of corrective & preventive action

3.4 Management review meeting

3.5 Selection of a certification body

Phase 2 Phase 3

The project is segmented in three phases:

QMS Documentation & Initial

Training

QMS Implementation1.1 Gap Analysis

1.2Definition of QMS scope, quality policy & objectives

1.3 QMS design and documentation architecture

Phase 4

Support During

4.1 Document review

4.2 Assessment audit

ISO 9001:2008

Certificatio

nAudit(to be carried

out by anindependen

t3rd party)

ISO 9001:2008 QMS Implementation – Key Steps


Process Review & Preparation of QMS documentation

Document review & signoff

Implementation of the QMS

Customer Feedback

Product & Process measurement

Internal Audit

Management Review

Agree Corrective /Preventive action for system improvement

Certification & Surveillance Audit

Follow up Verification

Top Management Role“Leadership, commitment and active involvement “

Define structure, roles, responsibilities, Authorities

Communicate the importance of quality to staff

Provide necessary resources in a timely manner

Sponsor big/small improvement activities

Actively seek customer feedback and enhance customer satisfaction

Review the performance of the quality system objectives and competition

Create an environment for continual improvement in everything we do


Management Representative Role

Ensuring the system is understood & followed

Ensuring appropriate control of documentation

Coordination of internal audits of QMS

Providing inputs for management review on status of QMS implementation

Promoting active involvement of everyone and ensure customer focus

Coordinate with consultants, certification body


Function Head RoleUnderstand the quality policy and objectives

Understand the role, responsibilities, authorities

Ensure alignment to quality policy and objectives

Train all supervisory and support staff on quality

Measure and monitor key process/product indicators

Analyze and identify areas of improvement

Drive improvement projects

Know what customer thinks about our services and communicate it down the line.

Review performance and progress


QMS Coordinator Role

Understand the QMS requirements & role of the respective functions, support in drafting necessary procedures / process maps

Conduct awareness session for the department staff on a selected topic / procedure / process

Agree / decide an action plan for QMS effective implementation

Coordinate Internal audits, closure of NCs related to respective functions


Achieving ISO 9001 is only the beginning…..

“Remember”

Quality Management Systems take time to mature…‘Rome wasn’t built in a day’

Management commitment is absolutely essential (& a requirement of the standard)

Staff involvement is critical ….develop a quality Culture

Customer feedback and process measurement should help drive continual improvement


Remember the Goal!

Customer Satisfaction

Process EfficiencyProfitability


THANK YOU


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