Understanding ISO 9001:2008 Quality Management System

Presentation Goals

  

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

Expectations Yesterday

SERVICE

Quality

SYSTEM

TIMELINES

Expectations Today
Good Ambience

Excellent Service

Good Quality

Any time ready to Change

One Stop Solution Price

Customer Needs & Requirement

Good Consistency

What is Change?

Change is Improvement

What to Change???

Attitude

Vision/Goals

Culture

Technology

Approach

Strategy

Procedure

Values

Speed

Perception

Our Vision

Businesses must have a vision about what 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 there is risk if we are not changing

If we dont risk anything, we risk everything

System should be adopted for changing

Quality Management System

Quality 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

Introducing ISO 9001:2008

Getting Started.

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

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

develops technical standards to contribute in making the manufacturing & supply of goods & services more efficient, safer and cleaner. 1947, ISO has published more than 15,000 standards
Since

ISO

About ISO 9001

Its

a Quality Management System Standard published in 1987

Initially 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

Point of Failure

Point of Failure

Last Improved Level Improvement Phase Consolidation Phase

Initial Level of Performance

Initial Level of Performance

Continuous Improvement

Continual Improvement

The ISO9000 Environment

Develops International Standards ISO International Organization for Standardization Non-governmental Organisation 158 member countries 2830 groups, 30000 experts ISO 9000 represents QMS family UK UKAS Holland - RvA USA - RAB Germany - DAR

Grants License to Certification agencies

Accreditation bodies

Assesses management system compliance with ISO standards

Certification Agencies

Third Party Certification Agencies

Assists organization in getting ready for certification

Consultants

NiMble Business Solutions

Entity implements and Continuously improves the QMS Organizations Client Company

Key Benefits of ISO 9000

A QMS Improves
Management control Process efficiency & productivity

How?
System based approach. Regular performance reviews. Introduction of measurable objectives and process level key performance indicators. Non conforming process and products are identified, root cause investigated, corrective & preventive action implemented and effectiveness measured.

Quality consistency

Staff morale & motivation

Documented policy & objectives provide direction & purpose. Documented processes and procedures promote clarity & understanding. Performance expectations are defined. Training needs regularly assessed.

Supplier & contractor performance International recognition & reputation Internal inter department service Monitoring levels

Defined system of evaluation for selection and performance monitoring. Third party certification to a globally recognized standard. Monitoring & measurements of inputs & outputs. Proactive feedback. Defined procedures for complaint handling.

ISO 9000 QMS & its Elements

Getting Started.

ISO 9001:2008 Quality Management System

C U S T O M E R RE Q U I RE M E N T S

C U S T O M E R

Management Responsibility

A T I S FA C T I O N

Resource Management

Measurement, Analysis, Improvement

PRODUCT

ISO 9001:2008 Main Clauses

Quality

Management System Responsibility

Management Resources Product

Management

Realization Analysis and Improvement

Measurement,

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

Focus Responsibility, Authority and communication

Resource Management
Provision Human

of Resources (in a timely manner)

Resources

Competence Awareness Training

Infrastructure Work

Environment

Product Realization
Customer-related

processes

Determination of requirements Review of requirements Customer communication

Design

and Development

Purchasing

Vendor Selection & evaluation Purchasing information Verification of purchased product

Measurement Analysis
Control of Monitoring and Measuring Monitoring and Measurement

Devices (Calibration)

Customer Satisfaction Internal Audit Analysis of Data Customer Satisfaction Conformity to product requirements Suppliers Improvement Continual improvement through policy, objectives, audit results, analysis of data, corrective/preventive actions and management reviews

ISO 9001:2008 QMS Implementation

Overview of QMS implementation project

Overview of the QMS implementation project

The project is segmented in three phases:

Phase 1

Mobilization
1.1 Gap Analysis 1.2 Definition of QMS scope, quality policy & objectives 1.3 QMS design and documentation architecture

QMS Documentation & Initial 2.1 Training Process

analysis 2.2 Preparation of QMS documentation 2.3 Delivery of ISO9001 awareness training

Phase 2

Phase 3

Phase 4

QMS Implementation 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 ISO 9001:2008 Certification Audit Support During
4.1 Document (to be carried review 4.2

out by an
t audit

independent Assessmen 3rd 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 Follow up Verification Internal Audit

Management Review Agree Corrective /Preventive action for system improvement

Certification & Surveillance Audit

Roles

Top

Management Role Representative Role

Management Function QMS

Head Role

Coordinator Role

Top Management Role

Leadership, commitment and active involvement
Define

structure, roles, responsibilities, Authorities the importance of quality to staff

Communicate Provide

necessary resources in a timely manner big/small improvement activities

Sponsor Actively Review Create

seek customer feedback and enhance customer satisfaction

the performance of the quality system objectives and competition an environment for continual improvement in everything we do

Management Representative Role

Ensuring Ensuring

the system is understood & followed appropriate control of documentation of internal audits of QMS

Coordination Providing

inputs for management review on status of QMS implementation active involvement of everyone and ensure customer focus
Coordinate Promoting

with consultants, certification body

Function Head Role

Understand Understand Ensure Train

the quality policy and objectives the role, responsibilities, authorities

alignment to quality policy and objectives

all supervisory and support staff on quality and monitor key process/product indicators and identify areas of improvement

Measure Analyze Drive Know

improvement projects

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

performance and progress

QMS Coordinator Role

the QMS requirements & role of the respective functions, support in drafting necessary procedures / process maps awareness session for the department staff on a selected topic / procedure / process / decide an action plan for QMS effective implementation
Agree Conduct Understand

Internal audits, closure of NCs related to respective functions

Coordinate

Achieving ISO 9001 is only the beginning.. Remember

Quality

Management Systems take time to mature

Rome wasnt built in a day

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

Staff

Management

involvement is critical .develop a quality Culture

feedback and process measurement should help drive continual improvement

Customer

Remember the Goal!

Customer Satisfaction Process Efficiency Profitability

THANK YOU