ISO 9001 StandardQuality Management System

Overview

Vipul Gupta06/05/2013 – NTL Lemnis

ISO & ISO 9000 StandardISO : International Organization for Standardization

ISO 9000 : Quality Management System standardThe ISO 9000 family of standards is related to quality management systems and designed to help organizations ensure that they meet the needs of customers and other stakeholders while meeting statutory and regulatory requirements related to the product and services.

Evolution of ISO 9000 standard• 1987 version : Emphasized on conformance to procedures rather than overall process of

management which was likely the actual intent --- was based on following standards• MIL-Q-9858 : 1959• BS 5179 : 1974 & BS 5750 : 1979

• 1994 version : Emphasized Quality assurance via preventive measures, instead of just checking the final product, and continued to require compliance with documented procedures.

• 2000 version : a) Made a radical change by placing the Process Management the central theme. b) Design and Development procedures were required only if a company was engaged in creation of new product.

• 2008 version : Essentially same as 2000 version with clarifications to existing requirements - Design & Development exclusion requires a formal justification now.

No. of certifications as on 2011 – World : 11 Lac plus; China : 3 Lac plus; India : 0.35 Lac

Guiding Principles – Foundation of QMS

CUSTOMER

CUSTOMER

Management responsibility

Resourcemanagement

Measurement, analysis,improvement

ProductProductrealisation

Requirements

Satisfaction

InputOutput

Quality Management SystemContinual Improvement

The QMS Model

World’s Top Business / Quality Excellence Model

What is more important !

• First ---- “ Doing Right Things ”

“ Doing Right Things ” or “ Doing Things Right ”

• Next ---- “ Doing Things Right”

• Finally ---- “ Doing Right Things Right First Time”

Assurance vs. Control

Assurance :

aims to assure that Work and Deliverables will be built in before work is done (Doing Right Things)

Control :

aims to determine that Work and Deliverables did occur after work is done (Doing Things Right)

PROCESS“set of interrelated or interacting activities

which transforms inputs into outputs

INPUT OUTPUT

RESOURCES

CONTROLS

PRODUCT

PROCESS EFFECTIVENESSExtent to which planned

activities are realized and planned results achieved

PROCESS EFFICIENCYRelationship between the result achieved and the resources used

A desired result is achieved more efficiently when activities and related resources are managed as a process

ISO 9001 Process Approach

Turtle Diagram for Management Process Monitoring

• Main QMS requirements :

• Quality Management System• Management Responsibility• Resources Management• Product Realization• Measurement, Analysis & Improvement

• Clause 4– QMS requirements

• Process approach

• Documentation requirements

• Clause 5– Management responsibility

• Commitment, Customer focus

• Policy, Objectives, Planning,

Communication

• Clause 6– Resource Management

• Human resources

• Infrastructure

• Work Environment

• Clause 7– Product Realization

• Planning

• Marketing, selling, design, production, purchase…

• Clause 8– Measurement, Analysis & Improvement

• Measure, Analyze and improve…

ISO 9001 : 2008 QMS Requirements

Scope :Design, Development

Manufacturing, Installation & Servicing

Gap Analysis Matrix – Quality of Service

Managing CustomersExpectations & PerceptionsIt is said that beauty is in eye of the beholder.

Nowhere is this statement truer than in the field of measuring service quality

It is not how good you think you are that matter. It is not even how good you actually are that matters. What really matters is how good your client perceives you to be.

Improving our processes, systems, products and services are all important element is driving up customer satisfaction. But vital ingredient that really makes difference is how you behave when you are dealing with our customers.

The basic rule is simple – be friendly, really listen, show you understand, give customer the benefit of the doubt, don’t be afraid to say you are sorry, do not leave the customer in dark, don’t blame the other part of company, take responsibility, agree what happens next and always keep your promise.

Meaning of Quality & ExcellenceQuality means Excellence

excellence in what ever we do

“Excellence” is never an accident,

it is always the result of high intentions, sincere efforts,

intelligent direction and

skilful execution,

it represents the wise choice of many alternatives.

Thank You

Vipul Gupta 06/05/2013 : NTL Lemnis