Overview of Global ISO Standards Cem Onus, RSM November 14, 2008

Presentation Objectives Overview of Various Standards. Utilization of standards in sectors. International acceptance. Cost of Quality / Benefits of Certification. Medical Standards i.e. ISO 13485. CE Marking, Testing, and Product Certification by Pierre Salle.

Overview of Various Standards.

Utilization of standards in sectors.

International acceptance.

Cost of Quality / Benefits of Certification.

Medical Standards i.e. ISO 13485.

CE Marking, Testing, and Product Certification by Pierre Salle.

KEMA Company Overview Established in 1927 as the Dutch industries test house for all things electrical. Owned by the Dutch utilities. Global expansion after ’92 EU formation. 1,500 employees around the world Major Scope of business: Consulting, Non-Destructive Testing, and Certification .

Established in 1927 as the Dutch industries test house for all things electrical. Owned by the Dutch utilities. Global expansion after ’92 EU formation.

1,500 employees around the world

Major Scope of business: Consulting, Non-Destructive Testing, and Certification .

Where do we operate? Brazil Colombia Australia

Global Standards ISO 9001:2000 ISO 14001:2004 (environmental) AS 9100B (aerospace) TL 9000 R4.0 (telecommunications) TS 16949 (automotive) NBS Certification (National Biosolids) ESD S20.20 (electrostatic discharge) ISO 13485 – Medical device CE Marking OSHAS 18001 or Z10 ISO 14064 (greenhouse gas emission) LEED Certification (green building)

ISO 9001:2000

ISO 14001:2004 (environmental)

AS 9100B (aerospace)

TL 9000 R4.0 (telecommunications)

TS 16949 (automotive)

NBS Certification (National Biosolids)

ESD S20.20 (electrostatic discharge)

ISO 13485 – Medical device

CE Marking

OSHAS 18001 or Z10

ISO 14064 (greenhouse gas emission)

LEED Certification (green building)

What is ISO ? International Organization for Standardization. ISO is a network of the national standards institutes of 157 countries , one member per country, with a Central Secretariat in Geneva, Switzerland, that coordinates the system. Standards ensure desirable characteristics of products and services such as quality, environmental friendliness, safety, reliability, efficiency and interchangeability. When standards are absent, we soon notice. Certificates Issued Worldwide as of Dec. ’07* ISO 9000 : 951,486 6% increase ISO 13485 : 12,985 62% increase ISO 14001 : 154,572 21% increase *The ISO Survey - 2007

International Organization for Standardization.

ISO is a network of the national standards institutes of 157 countries , one member per country, with a Central Secretariat in Geneva, Switzerland, that coordinates the system. Standards ensure desirable characteristics of products and services such as quality, environmental friendliness, safety, reliability, efficiency and interchangeability.

When standards are absent, we soon notice.

Certificates Issued Worldwide as of Dec. ’07*

ISO 9000 : 951,486 6% increase

ISO 13485 : 12,985 62% increase

ISO 14001 : 154,572 21% increase

*The ISO Survey - 2007

Utilization of Standards Traditional view... Customer driven Confidence in Global Trade Consistency Modernized view... Management Tool Financial benefits.... “green is green” Cost of Quality

Traditional view...

Customer driven

Confidence in Global Trade

Consistency

Modernized view...

Management Tool

Financial benefits.... “green is green”

Cost of Quality

What are the costs of quality? Preventive Costs Inspection Costs Internal and External Failure Costs

Preventive Costs

Inspection Costs

Internal and External Failure Costs

Various Industry Sectors ISO 9001 & 14001 Generic Standards. AS9100B utilized by global aerospace community. TS 16949 utilized by automotive industry. TL 9000 Telecommunication industry. ISO 13485 – Medical device manufacturing.

ISO 9001 & 14001 Generic Standards.

AS9100B utilized by global aerospace community.

TS 16949 utilized by automotive industry.

TL 9000 Telecommunication industry.

ISO 13485 – Medical device manufacturing.

Benefits of Certification To improve business processes and $ave money!! . Most companies implementing ISO 9000 certification report increases in business process efficiencies, reductions in waste, and improved product quality. To qualify for new customers. Many corporations see ISO 9000 Certification as an essential requirement for conducting business with a new vendor. To enter global markets. Some ISO standards are required in many countries. i.e. ISO 13485 To help control Cost of Quality at Prevention and Assessment to reduce the potential for product failure.

To improve business processes and $ave money!! .

Most companies implementing ISO 9000 certification report increases in business process efficiencies, reductions in waste, and improved product quality.

To qualify for new customers.

Many corporations see ISO 9000 Certification as an essential requirement for conducting business with a new vendor.

To enter global markets.

Some ISO standards are required in many countries. i.e. ISO 13485

To help control Cost of Quality at Prevention and Assessment to reduce the potential for product failure.

List of KEMA Clientele