ISO 9001 2000 Overview -Induction Sep07

Protection notice / Copyright notice

ISO 9001:2000Induction - Sep 2007

Page 2 Sep 2007Protection notice / Copyright notice

P&QFor Internal Use only

Contents

What is ISO?

Definition of Quality

ISO 9001:2000 Model

Quality Management Principles

Quality Manual

Quality Audits



What is ISO?What is ISO?

International Organization for Standardization (ISO)

Is a worldwide federation of national standards bodies from some 130 countries, one from each country

Say what you doDo what you say



What is ISO 9000?What is ISO 9000?

International standards for Quality Assurance Quality by focus on “process” Need for quality policy; standards and procedures Defines “whats” and not the “hows”

Focus on: Documented quality system covering all ISO

requirements Functioning in compliance to the documented quality

system



Definition of QualityDefinition of Quality

QUALITY is “FIT for USE

Customer’s perspective of Quality

QUALITY is “CONFORMANCE to REQUIREMENTS”

Producer’s perspective of Quality



ISO 9000:2000 ModelISO 9000:2000 Model



YEAR 2000 STANDARDSYEAR 2000 STANDARDS

ISO Core standards

ISO 9000:2000 - Quality Management Systems – Fundamentals and vocabulary

ISO 9001:2000 - Quality Management Systems – Requirements

ISO 9004:2000 - Quality Management Systems – Guidelines for performance improvements



Continual Improvement - Quality Management SystemContinual Improvement - Quality Management System

The ISO 9001:2000 ModelThe ISO 9001:2000 Model



Benefits of a Process ModelBenefits of a Process Model

Provides a structure to address all aspects of an Organization

Applies to any size or type of Organization

Directs Management attention to both people and products

Highlights process ownership and responsibility



PDCA Cycle & the Process Approach

ACTHow to

improve next time?

PLANWhat to do?

How to do it?

DODo what was

planned

CHECKDid things

happen according to

plan?

Establish the objectives and processes necessary to deliver results in accordance with customer requirements and the organization’s policies

Implement the processes

Monitor and measure processes and product against policies, objectives and requirements for the product and report the results

Take actions to continually improve process performance



Quality Management PrinciplesQuality Management Principles



Eight Principles are used by senior management as a framework to guide their organization towards improved performance. The ISO model is based on these principles.

Customer Focus Leadership Involvement of People The Process Approach A System approach to Management Continual Improvement Factual approach to decision making Mutually beneficial Supplier Relationship





1. Focus on your customers Understanding customer needs and expectations Measuring customer satisfaction and acting on results

2 Provide leadership Being proactive and leading by example Establishing a clear vision of the organization’s future

3 Involve your people Accepting ownership and responsibility to solve problems Actively seeking opportunities to make improvements

4 Use a process approach Defining processes needed to achieve desired results Identifying and measuring inputs and outputs Evaluating risk and its impact




5 Take a systems approach Structuring the system in most efficient way. Understanding interdependencies of processes in the system

6 Encourage continual improvement Continual improvement of processes, systems and products Periodic assessment against established criteria Promoting prevention based activities

7. Get the facts before you decide Measuring and collecting data & Information Analyse data and information Make decisions and take actions based on analysis

8. Work with your suppliers Identifying and selecting key suppliers Establishing relationships that balance short term gains and long term

considerations



Compliance with ISO 9001:2000Compliance with ISO 9001:2000

Operate a Quality Management System that is:

Documented DemonstrableEffectiveMaintained

Achieve certification and maintain it



Quiz

Q1 The PDCA cycle provides a framework for:

a) Improvement of software

b) improvement of a process or system

c) Improvement of testing cycle

Q2 The Quality Management Principle that creates a sense of belonging and pride to be

part of the organization is:

a) Customer Focused Organization

b) Process Approach

c) Involvement of People

Q3 The qualities of a good leader are:

a) Being proactive and leading by example

b) Establishing a clear vision of the organization’s future

c) Both the above



Quality Manual & AuditsQuality Manual & Audits



The Quality ManualThe Quality Manual

The Quality Manual is :

The superior document Contains a written description of your operational practices An explanation of how you comply with ISO 9000 Represents ACTUAL practices of the registering unit Communicates policy Defines the organization and responsibilities Lists exceptions Provides a basis for assessment



SISL Quality PolicySISL Quality Policy

SISL shall endeavour to deliver high quality solutions and services to its customers on time and in a consistent manner. This shall be achieved through a documented Quality Management System that supports continual levels of improvement across all business processes. SISL shall ensure customer delight by working and partnering closely with them; while striving to develop competencies and improve employee satisfaction.



Internal Quality AuditInternal Quality Audit

Ensures Quality Management System is maintained

Must be documented, demonstrable, effective, and maintained

Opportunity to assess system for opportunities for improvement

Required by ISO 9001 ( clause 8.2.2 )



Audit ObjectivesAudit Objectives

Add value

Verify effectiveness of the implementation

Establish the degree of compliance

Identify areas for corrective action

Find opportunities for continuous improvement

The findings are against project/process/function and not against an individual



Audit RequirementsAudit Requirements

The audit must :

Be described in the Quality Manual

Follow a documented process

Be done by trained auditors

Be reviewed by senior management

Feed directly into a Corrective Action Process

Result in a written internal audit report



Corrective Action ProcessCorrective Action Process

The corrective action process should :

Be documented and approved

Be capable of eliminating deficiencies

Be used to evaluate the effectiveness of the quality management system on a continual basis

Have wide ownership, rather then be owned by the quality department alone

Have a clearly defined escalation process

Be accessible to all those who directly affect quality



TerminologyTerminology

Correction

Action taken to eliminate a detected nonconformity

Corrective Action (Reactive)

Action taken to eliminate the cause of a detected

nonconformity or other undesirable situation

Preventive Action (Proactive)

Action taken to eliminate the cause of a potential

nonconformity or other potentially undesirable situation



Non ComplianceNon Compliance

Minor non-compliance is an isolated non-fulfillment of a specific requirement which has a negligible effect on quality i.e. it does not, on its own indicate a breakdown in the QMS eg. Document numbering is not as per project /quality plan.

Major non-compliance refers to a significant failure to comply with a specified requirement or a breakdown of a quality system element (which can be indicated by a pattern of minor non-compliance) eg. No. of projects without a contract or review procedure in place, absence of a project/quality plan.

Observation refers to a potential non-conformance or suggestion for improvement

In case of any dispute Lead Auditor would moderate the findings



Quiz

Q4 Preventive Action is:a) Proactive, where a cause of potential nonconformity is

removedb) Reactive and done in fire-fighting modec) A corrective action on a defective software

Q5 The Internal Quality Audit aims ata) Ensuring Quality Management System is maintainedb) QMS is documented, demonstrable and effectivec) Both the above

Q6 Quality is defined as :a) Fitness for Useb) Conformance to requirementsc) Both the above



Recap…

What is ISO?

Definition of Quality

ISO 9001:2000 Model

Quality Management Principles

Quality Manual

Quality Audits



Any Questions?



Thank You!

Documents

ISO 9001 2000 Overview -Induction Sep07