Welcome to the Workshop on ISO 9001

8/8/2019 Welcome to the Workshop on ISO 9001

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Welcome to the Workshop

on

ISO 9001:2008

By- Raquibul H. Siddiquee

Ext:228


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Objective

At the end of this course, delegates will have gain:

An understanding of the correct use of terminology

and vocabulary as used in ISO 9001. An understanding of the purpose of quality

management systems and the eight quality

management principles upon which ISO 9000 series

is based. A detailed understanding of the standard ISO

9001:2008.


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Course Topics

Introduction-basic concepts and definitions

Evolution of Quality System Standards

Quality Management Principles

Analysis of ISO 9001:2008

Assessment/ Certification


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FlowofCourses

Day-1

Introduction-basic concepts and definitions

(30 minutes)

Evolution of Quality System Standards(20

minutes)

Quality Management Principles (60minutes)

Q&A (10minutes)


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FlowofCourses (cont)

Day-2

Analysis of ISO 9001:2008(90 minutes)

Assessment/ Certification( 10 minutes)

Q&A( 20 minutes)


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Welcome Day-1


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Introduction-basic concepts and

definitions

KeyDrivers forBusiness Success

People

ProcessTechnology


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definitions

WhatareProcesses?

A series of predictable steps- a roadmap that

helps you create a timely, high quality result.

The roadmap that you follow is called aProcess

Requirements Design Build Test


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definitions

Why weneedProcesses?

DeliverQuality

Consistently

ImproveProductivity

Reducerisks ofProjectfailure


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definitions

QMS


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definitions

Quality Manual-A document containing the

scope and any exclusions, description and

interaction of processes and reference or

inclusion of to the quality system procedures.The manual would typically include the policy,

and an organisation chart (organogram)


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definitions

Procedures- These describe the means by

which the policy is to be implemented. They

define the activity, who carries out the activity

and when it is carried out.


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definitions

Workinstruction-These detail the

requirements for individual activities and how

they are to be carried out.

Note: Procedures and work instructions can be in the form of flow

charts, pictorial diagrams or samples and do not necessarily

have to be documented in a text format.


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definitions

Records- These are the documents that are

generated as procedures are operated. For

example, Inspection Records, Purchase

Orders, Records of Calibration, ManagementReview Records etc.


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definitions

TheDeming Cycle:


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Where as an organization,

You plan the elements of the QMS in order to meet customer

requirements and enhance their satisfaction;

You implement the QMS as per the plan;

You monitor, measure and analyze the performance of the

QMS against the plan; and

You take actions to continually improve the QMS.

Y

ou will also need to apply the same philosophy whenmanaging the processes that make up the QMS


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definitions

Quality Standards Example

ISO

CMM/CMMI

PCMM


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EvolutionofQuality System Standards

Whatis ISO?

ISO is derived from the Greek word isos,

meaning "equal

International Organization for Standardizationis the network of the national standards

institutes of 170+ countries

Part of United Nations initiative - is a non-

governmental organization

Central Secretariat in Geneva, Switzerland


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Examples ofPopular ISO standards:

ISO 9000 : Quality Management Systems-

Fundamentals and Vocabulary

ISO 9001: Quality Management Systems-Requirements

ISO 9004: Quality Management Systems- Guidelines

for performance improvement

ISO 19011:2002 :Guidelines on QMS auditing

ISO 14000 : Environment Management System

ISO 20000 : IT Services Management

ISO 27001 : Security Management System


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ISO 9001

Not very old, the first standard was published in the

year 1987.

It was revised in the year 1994 Focus was on adherence to written procedures

The last version was in 2000 which is the current

used version known as ISO 9001:2000

Focus on Customer Satisfaction and QMS Effectiveness

The latest revised version known as ISO 9001:2008

However, the small changes to the standard can

dramatically impact users QMS


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Reason forchanging ISO 9001 standard

ISO 9001, like all standards is subject to

periodic review

Normally the review period is around 5-6 years

Proposed changes are more based on the

clarification of points already in the standard

rather than the inclusion of new requirements

The main purpose of was to enhance theclarity of the current version of the ISO

9001:2000 standard


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Reason forchanging ISO 9001 standard

(cont..)

To enhance its compatibly with the latest

revision of the Environmental ManagementSpecification standard, 14001:2004


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The ISO 9001 model is based on a specific

management philosophy. This philosophy

determines the structure, planning and

implementation of the standard. It is the single most

important element which is embedded within the

standard. Its called the Shewhart/Deming Cycle. It

is a simple but powerful concept. This cycle contains

four elements:

Plan > Do > Check > Act


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The ISO 9001 model is based on the Eight

Quality Management Principles. From these

principles, tangible benefits are derived.

These principles are known as the EightQuality ManagementPrinciples. It is crucial

that the QMS that you establish and

implement demonstrate these principles in

action


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Customerfocus

Leadership

Involvement of people

Processapproach

Systemsapproach to management

Continual improvement

Factual approach to decision making

Mutually beneficial supplierrelationships


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Customerfocus ~ Organizations depend on

their customers and therefore should

understand current and future customer

needs, should meet customer requirementsand strive to exceed customer expectations.


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Leadership ~ Leaders establish unity of

purpose and direction of the organization.

They should create and maintain the internal

environment in which people can becomefully involved in achieving the organizations

objectives. Involvement of people ~ People at

all levels are the essence of an organization

and their full involvement enables theirabilities to be used for the organizations

benefit


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Involvement of people~ People at all levels

are the essence of an organisation and their

full involvement enables their abilities to be

used for an organisations benefit.


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Processapproach ~ A desired result is

achieved more efficiently when activities and

related resources are managed as a process.


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Systemsapproach to management ~

Identifying, understanding and managing

interrelated processes as a system

contributes to the organizations effectivenessand efficiency in achieving its objectives


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Continual improvement ~ Continual

improvement of the organizations overall

performance should be a permanent

objective of the organization


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Factual approach to decision making ~

Effective decisions are based on the analysis

of data and information


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Mutually beneficial supplierrelationships

~ An organization and its suppliers are

interdependent and a mutually beneficial

relationship enhances the ability of both tocreate value


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Q&A


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EndofDay-1


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Welcome Day-2


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AnalysisofISO 9001:2008

1 Scope

1.1 General

1.2 Application

-generic, applicable to all organizations.

2 Normative references

- dated and undated reference

3 Terms and definitions--all that ISO 9000

apply,productservice


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4 Quality management System

4.1 General requirements

4.2 Documentation requirements

4.2.1 General

4.2.2 Quality manual

4.2.3 Control of documents

4.2.4 Control of records


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5 Management responsibility

5.1 Management commitment

5.2 Customer focus

5.3 Quality policy

5.4 Planning

5.4.1 Quality objectives

5.4.2 Quality management system

planning


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5.5 Responsibility, authority and

communication

5.5.1 Responsibility and authority

5.5.2 Management responsibility5.5.3 Internal communication

5.6 Management review

5.6.1 General

5.6.2 Review input

5.6.3 Review output


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6 Resource management

6.1 Provision of resources

6.2 Human resources

6.2.1 General

6.2.2 Competence, training and

awareness

6.3 Infrastructure

6.4 Work environment


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7 Product realization

7.1 Planning of product realization

7.2 Customer-related processes

7.2.1 Determination of requirements related to

the product

7.2.2 Review of requirements

related to the product

7.2.3

Customer communication


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7.3 Design and development

7.3.1 Design and developmentplanning

7.3.2 Design and development

inputs7.3.3 Design and development

outputs

7.3.4 Design and developmentreview

7.3.5 Design and development verification7.3.6 Design and development validation

7.3.7 Control of design and developmentchanges


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7.4 Purchasing

7.4.1 Purchasing process

7.4.2 Purchasing information

7.4.3 Verification of purchasedproduct

7.5 Product and service provision7.5.1 Control of production and service

provision

7.5.2 Validation of processes for production andservice provision

7.5.3 Identification and traceability

7.5.4 Customer property7.5.5 Preservation of product

7.6 Control of monitoring and measuringequipments


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8 Measurement, analysis and improvement

8.1 General

8.2 Monitoring and measurement

8.2.1 Customer satisfaction

8.2.2 Internal audit

8.2.3 Monitoring and measurement of processes

8.2.4 Monitoring and measurement of product

8.3 Control of nonconforming product8.4 Analysis of data


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8.5 Improvement

8.5.1 Continual improvement

8.5.2 Corrective action

8.5.3 Preventive action

** Note: See Annex B for Changes between ISO 9001:2000

and ISO 9001:2008


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Validity of certification to ISO 9001:2008

Before publication of ISO 9001:2008- no accredited

certificates to new standard allowed

November 2008-Publication of ISO 9001:2008

Up to 1 year after publication- certification/ renewal to

ISO 9001:2000 still permitted

Beginning 1 year after publication, no new certificates

to ISO 9001:2000 allowed-all audits to be conducted to

ISO 9001:2008 2 years after publication- ISO 9001:2000 certificates

will no longer be valid.


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What to do?

Clarify the doubts

Make changes accordingly

Conduct Internal audit and ManagementReview

Ask the certification body for audit


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Q&A


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Documents

Welcome to the Workshop on ISO 9001