Inspection QC TQC Quality Assurance Quality Management System ISO9000 TQM TQM TQM TQM TQM TQM TQM TQM TQM TQM TQM TQM TQM TQM TQM TQM TQM TQM TQM TQM TQM TQM TQM TQM TQM TQM TQM TQM ISO14001 OHSAS18001 HSEQ IMS QC ISO/TS 29001 ISO/TS16949 IMS QA HACCP QM ISO22000 ISMS AS9000 I TL9000 ISO9001 RF9000 TQC QA QC ISO17025 SAFETY HEALTH SYSTEM ENVIRONMENT PLAN INSPECTION PROCESS QA PLAN DO CHECK ACT SCOPE QUALITY PLAN AUDIT TQC

CERTIFICATION APPROVED VERIFY CONTROL ASSESSMENT TRAINING RESPONSIBILITY RECORDS FORMS

Quality Management System

Based on ISO9000 Standard

Mar 2015

S.Nasser Mirfassihi

Quality racing has no end

Add

ress

: #6

07, 2

004,

Ful

lerto

n A

ve.,

Nor

th V

anco

uver

Cel

l Pho

ne: +

1 60

4-71

9-24

34

E

-mai

l: m

irfas

sihi

@ya

hoo.

com

or m

irfas

ihi@

gmai

l.com

Sayed Nasser Mirfassihi

Page 2

ISO9001:2008 Implementation Project

The duration of this project differs from each company to another. But generally I show a schedule for knowing the phases and sequences.

What are standards?

International Standards make things work. They give world-class specifications for products, services and systems, to ensure quality, safety and efficiency. They are instrumental in facilitating international trade.

ISO has published more than 19 500 International Standards covering almost every industry, from technology, to food safety, to agriculture and healthcare. ISO International Standards impact everyone, everywhere.

Benefits of International Standards

International Standards bring technological, economic and societal benefits. They help to harmonize technical specifications of products and services making industry more efficient and breaking down barriers to international trade. Conformity to International Standards helps reassure consumers that products are safe, efficient and good for the environment. Benefits of standards: the ISO Materials

ISO has developed materials describing the economic and social benefits of standards, the ISO Materials. They are intended to be shared with decision makers and stakeholders as concrete examples of the value of standards. Facts and figures about the benefits of standards

The repository of studies on economic and social benefits of standards provides an insight of the approaches and results of the studies undertaken by different authors, such as national and international standards bodies, research institutes, universities and other international agencies.

Row Phase Month 1 2 3 4 5 6 7 8 9 10 11 12 1 Assessment 1 2 Development 3 3 Implementation 3 4 Verification 1 5 Certification 1 * Sum 7

Quality racing has no end

Add

ress

: #6

07, 2

004,

Ful

lerto

n A

ve.,

Nor

th V

anco

uver

Cel

l Pho

ne: +

1 60

4-71

9-24

34

E

-mai

l: m

irfas

sihi

@ya

hoo.

com

or m

irfas

ihi@

gmai

l.com

Sayed Nasser Mirfassihi

Page 3

Benefits of International Standards

For business

International Standards are strategic tools and guidelines to help companies tackle some of the most demanding challenges of modern business. They ensure that business operations are as efficient as possible, increase productivity and help companies access new markets.

Benefits include:

• Cost savings - International Standards help optimize operations and therefore improve the bottom line

• Enhanced customer satisfaction - International Standards help improve quality, enhance customer satisfaction and increase sales

• Access to new markets - International Standards help prevent trade barriers and open up global markets

• Increased market share - International Standards help increase productivity and competitive advantage

• Environmental benefits - International Standards help reduce negative impacts on the environment

For Society

ISO has over 19 500 standards touching almost all aspects of daily life.

When products and services conform to International Standards consumers can have confidence that they are safe, reliable and of good quality. For example, ISO's standards on road safety, toy safety and secure medical packaging are just a selection of those that help make the world a safer place. International Standards on air, water and soil quality, on emissions of gases and radiation and environmental aspects of products contribute to efforts to preserve the environment and the health of citizens.

For government

ISO standards draw on international expertise and experience and are therefore a vital resource for governments when developing public policy.

National governments can use ISO standards to support public policy, for example, by referencing ISO standards in regulations. This has a number of benefits, including:

• Expert opinion - ISO standards are developed by experts. By integrating an ISO standard into national regulation, governments can benefit from the opinion of experts without having to call on their services directly.

• Opening up world trade - ISO standards are international and adopted by many governments. By integrating ISO standards into national regulation, governments help to ensure that requirements for imports and exports are the same the world over, therefore facilitating the movement of goods, services and technologies from country to country.

Quality racing has no end

Add

ress

: #6

07, 2

004,

Ful

lerto

n A

ve.,

Nor

th V

anco

uver

Cel

l Pho

ne: +

1 60

4-71

9-24

34

E

-mai

l: m

irfas

sihi

@ya

hoo.

com

or m

irfas

ihi@

gmai

l.com

Sayed Nasser Mirfassihi

Page 4

1- Assessment phase

1-1- Fundamental Training • The ISO Quality definition: "The totality of features and characteristics of a

product or service that bear on its ability to satisfy stated or implied

• ISO9000 history

needs". (ISO9000:2008)

• The ISO story began in 1946 when delegates from 25 countries met at the Institute of Civil Engineers in London and decided to create a new international organization ‘to facilitate the international coordination and unification of industrial standards’. In February 1947 the new organization, ISO, officially began operations.

• Because 'International Organization for Standardization' would have different acronyms in different languages (IOS in English, OIN in French for Organisation internationale de normalisation), our founders decided to give it the short form ISO. ISO is derived from the Greek isos, meaning equal. Whatever the country, whatever the language, we are always ISO.

• ISO (International Organization for Standardization) is an independent, non-governmental membership organization and the world's largest developer of voluntary International Standards. It is based in Geneva, Switzerland.

• Product and System Standard?

1937/ Final Inspection

Systems

1960/ TQC

1979/ ISO TC176

1980/ TQM

1987/1994/ ISO9000

2000/ 2008

TQM

QM

QA

TQC

QC

Insp.

Quality racing has no end

Add

ress

: #6

07, 2

004,

Ful

lerto

n A

ve.,

Nor

th V

anco

uver

Cel

l Pho

ne: +

1 60

4-71

9-24

34

E

-mai

l: m

irfas

sihi

@ya

hoo.

com

or m

irfas

ihi@

gmai

l.com

Sayed Nasser Mirfassihi

Page 5

• Internal & External Customers

• ISO9000 Standards

1994 2000 2008

Guidance Executive Guidance Executive Guidance Executive ISO8402 ISO9000 1SO9004 ISO10011

ISO9001 ISO9002 ISO9003

ISO9000 ISO9001 ISO9000 ISO9001

ISO14001 OHSAS18001 IMS

ISOTS29001 AS9000

ISOTS16949 ISO10006

ISO22000 HACCP

ISO17025 ISMS

RF9000 TL9000

ISO

• Standards • Dos & Don'ts • 163Countries • 230 Committees

Consultant • Training • Consulting

CBs • Auditing • Certifying

•Product •Service

Supplier •Product •Service

Producer •Product •Service Customer

Continual Improvement

Plan

Do

Check

Act

D

c A

P

D

c A

P

D

c A

P

Client

Quality racing has no end

Add

ress

: #6

07, 2

004,

Ful

lerto

n A

ve.,

Nor

th V

anco

uver

Cel

l Pho

ne: +

1 60

4-71

9-24

34

E

-mai

l: m

irfas

sihi

@ya

hoo.

com

or m

irfas

ihi@

gmai

l.com

Sayed Nasser Mirfassihi

Page 6

• Quality management 8 principles

1- Customer Focus 5- System approach to management 2- Leadership 6- Continual improvement 3- Involvement of People 7- Factual approach to decision making 4- Process approach 8- Mutually beneficial supplier relationship

1-2- Assessment

2-

Development phase

2-1- Documentation Training 1) Purpose 2) Descriptions 3) Scope 4) Responsibilities

(A-Preparing & Establishing, B-Executing) 5) Description of operation 6) Records 7) References 8) Attachments

ISO9001:2008 Requirements

Your Quality System

Final Quality System

Quality racing has no end

Add

ress

: #6

07, 2

004,

Ful

lerto

n A

ve.,

Nor

th V

anco

uver

Cel

l Pho

ne: +

1 60

4-71

9-24

34

E

-mai

l: m

irfas

sihi

@ya

hoo.

com

or m

irfas

ihi@

gmai

l.com

Sayed Nasser Mirfassihi

Page 7

2-2- Preparing Quality Documents

Quality Policy (1 page)

Quality Manual (20-30 pages)

Quality Procedures (10 pages/Each)

Working Instructions (5-10 pages/Each)

Job Descriptions, Forms, Records

Prepared by Approved by Verified by

Quality racing has no end

Add

ress

: #6

07, 2

004,

Ful

lerto

n A

ve.,

Nor

th V

anco

uver

Cel

l Pho

ne: +

1 60

4-71

9-24

34

E

-mai

l: m

irfas

sihi

@ya

hoo.

com

or m

irfas

ihi@

gmai

l.com

Sayed Nasser Mirfassihi

Page 8

3-

Implementing of all verified quality documents .Doing works based on new approved quality documents and making records.

Implementation phase

4-

Verification phase

4-1- Internal Auditing Training

4-2- Internal Auditing

Documents

Do

Audit

Auditing is not Inspection

Quality racing has no end

Add

ress

: #6

07, 2

004,

Ful

lerto

n A

ve.,

Nor

th V

anco

uver

Cel

l Pho

ne: +

1 60

4-71

9-24

34

E

-mai

l: m

irfas

sihi

@ya

hoo.

com

or m

irfas

ihi@

gmai

l.com

Sayed Nasser Mirfassihi

Page 9

5- Certification phase

5-1- CB Contract • Client’s work scope • Market, Customers • Contract duration; 3 years

SGS TUV BSI DQS QMI

DNV PWC MIC IMQ DAS

5-2- External Auditing • Audit team (Lead Auditor and Auditors) • Opening and Closing meeting • Non-Conformity (Major and Minor) • Actions • Certification • Annual Audits • Validity until 3 years