December 10

Awareness of
ISO 9001 : 2008 (QMS) STANDARD

Prepared By:
Ashraf S. Youssef, Ph. D.
QA & Ind. Methods Manager
S.M. ASQ, L.A. BSI, M. ELI, M. EMS

‫اﻟﺘﻮﻋﻴﺔ ﺑﻨﻈﺎم إدارة اﻟﺠﻮدة واﻟﻤﻮاﺻﻔﺔ اﻟﻘﻴﺎﺳﻴﺔ اﻟﺪوﻟﻴﺔ‬

ISO 9001 : 2008

June 27
27,, 2009

Training Approach

• Focus on Basics
• Interactive
• Exercises
• Case Studies
• Role Plays
• Have Fun !

Learning Objectives

• Learn about Quality

Management and How it
Applies to EEIC
• Become Familiar with ISO
R
Requirements
i
• Design your own QMS
• Realize the Benefits of ISO at
EEIC

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 December 10

Agenda

1. Introduction to Total Quality

Management
2. QMS Principles & ISO 9001 Model
3. ISO 9001 Model & Clauses
4. Key Quality Tools
5. ISO 9001 Certification Realization
Process

Why should my organization implement ISO

9001::2008 ?
9001

9 To keep Customer coming again to you

9 To keep them satisfied for your product
9 Provide consistent direction to employee
p y awareness of q
9 Increase employee quality
y
9 Opportunity for continuous improvement
9 And that means consistently customer
satisfaction & a Growing Organization

Exercise: What is Quality?

• Use the Japanese brainstorming

technique to answer the question.

• After the exercise, each group reads out

their ideas
ideas.

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 December 10

Dictionary Definitions

• “the degree of excellence which a

thing possesses”
• “the feature that makes something
what
h t it is”
i ”
• “superiority in kind”

Classical Definitions

• “fitness for use” (Juran)

• “conformance to requirements”
(Crosby)
• “the totalityy of features and
characteristics of a product or
service that bear on its ability to
satisfy given needs” (ASQ)

Quality Dimensions

• Meaning of quality cannot be

captured in a simple short
statement
• Let us define some dimensions
of quality for Product

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 December 10

Quality Dimensions -- Product

Conformance Durability
Reliability Serviceability
Features Aesthetic
Performance Perceived
Quality
Product

Source: Total quality and organization development by Lindsay and Petrick

What is ISO 9000:2008 QMS?

• ISO = International Organization for

Standards
• 9000 = code to denote QMS Family
• 2008 = year of last revision
• Is a family of standards for implementing a
Quality Management System (QMS)

What is a QMS?

• System for managing quality -

‰System: a set of logically related processes that turn
input into output
‰Managing: administering activities and resources to
achieve
hi an objective
bj ti
‰Quality: customer/user satisfaction

Input Process Output

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 December 10

ISO is not ...

• a product label
• a product guarantee
• assessed by the ISO organization, but
by an independent auditor

Timeline

• 1945 NATO 6-49

• 1959 MIL-Q-9858A
• 1975 BS 5179
• 1980s TC 176 formed byy ISO
• 1987 ISO 9000
• 1994 revised ISO 9000:1994
• 2000 revised ISO 9000:2000
• 2008 revised ISO 9000:2008

ISO 9000 Family

„ ISO 9000 - fundamentals,

vocabulary
„ ISO 9001 - requirements
„ ISO 9004 - continual
improvement guidelines
„ ISO 19011 - auditing guidelines

only ISO 9001 can be used for

certification purposes

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 December 10

Summary of all ISO guidelines

Say what you Do
Document what you Say
Do what you Document
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Why ISO QMS?

• Competitors have it
• Required by customers
• Helps manage company records
• Clarifies authority & responsibilities
• Improves performance
• Can cut costs
• Global acceptance

ISO 9001:2008 QMS Principles

1. Customer focus
2. Leadership
3. Involvement of people
4. Process approach
5
5. System approach to management
6. Continual improvement
7. Factual approach to decision
making
8. Mutually beneficial supplier’s
relationship
ISO 9000:
9000:2008

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 December 10

QMS Principles & ISO 9001 Model

Continual Improvement of the QMS
CUSTOMER REQUIREMENTS

SFACTION
info. flow management
responsibility QMS

CUSTOMER SATIS
resource meas., analysis info. flow
management improvement

Input product Output

realization product
value adding value
activities adding activities

1. Customer Focus

• Organizations depend on their customers;

therefore they should
CUSTOMER REQUIIREMENTS

SFACTION

‰Know their current and future needs

‰Meet their requirements
CUSTOMER SATIS

‰Exceed their expectations

‰Get their feedback

2. Leadership
management
• Leaders create common purpose responsibility

and direction; therefore they

should
‰Maintain a healthy internal
environment
‰Inspire workforce to excel

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 December 10

3. Involvement of People
resource
• People are the essence of an management
organization; therefore
‰They should be fully involved
‰Their abilities should be used for
organization benefits

4. Process Approach

„ Manage activities and related

resources as a PROCESS

Review Purchase Design Make Deliver

Order Product

4. Process Approach
EQUIREMENTS

ATISFACTION
CUSTOMER SA
CUSTOMER RE

Input product Output

realization product
value adding
value
activities
adding
activities

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 December 10

5. System Approach to Management

• Managing interrelated processes as a system

helps the organization in achieving its
objectives in an effective and efficient manner

5. System Approach
QUIREMENTS

TISFACTION

management
responsibility
CUSTOMER SAT
CUSTOMER REQ

resource meas., analysis

management improvement

Input product Output

realization product
value adding
value
activities
adding
activities

6. Continual Improvement

• A permanent objective of an organization

should be to grow and improve over time

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 December 10

6. Continual Improvement: PDCA Cycle

Continual Improvement of the QMS

management
responsibility
Plan Act

resource meas., analysis

management improvement

Do Check
product
realization

7. Factual Approach to Decision-Making

• Effective decisions are based on the

analysis of data and information
CUSTOMER REQUIREMENTS

SFACTION

info. flow management

responsibility
CUSTOMER SATIS

meas., analysis info. flow

improvement

product
realization

8. Mutually Beneficial Supplier Relationship

• Interrelated
• Win-Win
product
Supplier realization

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 December 10

ISO 9001 Model & Clauses

Continual Improvement of the QMS
QUIREMENTS

clause 4

TISFACTION
info. flow management
responsibility QMS
clause 5
clause 6 clause 8

CUSTOMER SAT
CUSTOMER REQ

resource meas., analysis info. flow

management improvement

clause 7
Input product Output
realization product
value adding
value
activities
adding
activities

Clauses/Requirements

Clause 4. Quality Management System

Clause 5. Management Responsibility
Clause 6. Resource Management
Clause 7.
7 Product Realization
Clause 8. Measurement, Analysis and
Improvement

Count the number of requirement categories.

Clause 4: Quality Management System

4.1 General requirements

4.2 Documentation requirements
1. General
2. Quality manual
3. Control of documents
4. Control of records

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Clause 5: Management Responsibility

5.1 Management commitment

5.2 Customer focus
5.3 Quality policy
5.4 Planning
1. Quality objectives
2. QMS planning

Clause 5: Management Responsibility (Cont.)

5.5 Responsibility, authority and

communication
1. Responsibility and authority
2. Management representative
3. Internal communication
5.6 Management review
1. General
2. Review input
3. Review output

Clause 6: Resource Management

6.1 Provision of resources

6.2 Human resources
1. General
2. Competence, awareness and training
6.3 Infrastructure
6.4 Work environment

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 December 10

Clause 7: Product Realization

7.1 Planning of product realization

7.2 Customer-related processes
1. Determination of requirements related to
the product
2. Review of requirements related to the
product
3. Customer communication

Clause 7: Product Realization (Cont.)

7.3 Design and development

1. Design and development planning
2. Design and development inputs
3. Design and development outputs
4 Design and development review
4.
5. Design and development verification
6. Design and development validation
7. Control of design and development changes

Clause 7: Product Realization (Cont.)

7.4 Purchasing
1. Purchasing process
2. Purchasing information
3. Verification of p
purchased p
product

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 December 10

Clause 7: Product Realization (Cont.)

7.5 Production and service provision

1. Control of production and service provision
2. Validation of processes for production and
service provision
3. Identification and traceability
4. Customer property
5. Preservation of product
7.6 Control of monitoring and measuring devices

Clause 8: Measurement, Analysis, and Improvement

8.1 General
8.2 Monitoring and measurement
1. Customer satisfaction
2. Internal audit
3 Monitoring and measurement of
3.
processes
4. Monitoring and measurement of product

Clause 8: Measurement, Analysis, and

Improvement (Cont.)

8.3 Control of nonconforming product

8.4 Analysis of data
8.5 Improvement
1. Co
Continual
ua improvement
po e e
2. Corrective action
3. Preventive action

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 December 10

Key Quality Tools

Documentation Auditing

Why Document?

Document for ARCA:

Accuracy
Repeatability
Consistency
Accountability

From Standards to Quality Manual

ISO 9001
Organization Quality
Standard
Manual

shall
shall
shall
shall
shall shall

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 December 10

ISO 9001 Documentation Structure

Policies
The Quality
Manual
Procedures
((Department)
p )

Work Instructions
(Job/Task)

Quality Records
External Documents

ISO 9001 Documentation Cross Referencing

Level
Policies I

Level
Procedures II
((Department)
p )

Level
Work Instructions III
(Job/Task)

Quality Records Level

External Documents IV

Why Audit?
The organization shall continually
improve the effectiveness of the
QMS through the use of the:
‰quality policy and objectives
‰ dit results
‰audit lt
‰analysis of data
‰corrective and preventive actions
‰management review
Clause 8.5.1

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 December 10

Types of Audits

„ 1st party - audit within your organization

„ 2nd party - auditing your suppliers

„ 3rd party - audit by regulators &

registrars

ISO 9001 Certificate Realization Process

Identify Plan
Document
Gap

QM

Implement

Evidence

Register Certificate

Gap Analysis
Identify
Gap

Organization ISO 9001

Standard

shall
shall
shall
shall
shall shall

Plan

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 December 10

Identify
From Standards to Quality Manual Gap

Document

Organization ISO 9001 Quality

Standard Manual

shall
shall
shall
shall
shall shall

Identify
Implementing Documentation Gap

Document
Document

Implement

Organization
g ISO 9001 Implementing
St d d
Standard Quality Manual

shall
shall
shall
shall
shall shall

Identify
Document
Document
Getting the Certificate Gap

Implement
Organization ISO 9001 Implementing
Standard Quality Manual
Register
shall
shall
shall
shall
shall shall

Certificate

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 December 10

ISO 9001:
9001:2008
is not a System for
Documentation!
ISO is a Documented System
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ً‫ﺷ ﻜﺮا‬
‫ﺷــــﻜﺮا‬
٥٦

١٩