WHAT IS ISO 9000

It is a set of written standards laying down a quality system. It defines the basic elements of the system through documentation.

It creates a quality system rooted in your customers requirements.

It ensures uniform systems that are universally recognized It create the discipline required for a total quality process.

What are ISO 9000 Standards?

ISO 9000 Standards
Define the required elements of an effective quality management system Can be applied to any company Adopted by the United States as the ANSI/ASQC Q90 series.

Revised 2000 wider applicability

ISO 9000

Who created the standards?

International Organization for Standardization - Geneva ISO tech committee - TC 176 started in 1979 Standards created in 1987
To eliminate country to country differences To eliminate terminology confusion To increase quality awareness
ISO 9000

How did ISO get started?

1906 - International Electro-technical Commission 1926 - International Federation of the National Standardizing Associations (ISA) 1946 London - delegates from 25 countries decided to create a new international organization "the object of which would be to facilitate the international coordination and unification of industrial standards 1947 - ISO began to officially function 1951 - The first ISO standard was published
"Standard reference temperature for industrial length measurement".

ISO 9000

ISO Organization
General Assembly
Policy Development Committees Council Technical Management Board Technical Advisory Groups Technical Committees Technical Committees Technical Committees Technical Committees

ISO 9000

What has ISO Accomplished?

ISO film speed code Standard format for telephone and banking cards ISO 9000 which provides a framework for quality management and quality assurance ISO 14000 series provides a similar framework for environmental management Internationally standardized freight containers Standardized paper sizes. Automobile control symbols ISO international codes for country names, currencies and languages
ISO 9000

REVIEW OF ISO 9000

ISO 9000 quality management and assurance standards used to determine which of three quality systems standards best applies to an organization. ISO 9001 quality systems a 20 element model used for quality assurance in design/ development, production, installing & servicing. ISO 9002 quality systems a 18 element model for quality assurance in production & installation.

ISO 9003 quality systems a 12 element model for quality assurance in final inspection and test. ISO 9004 quality management and quality systems elements guidelines for internal quality improvement.

TANGIBLE BENEFITS
High perceived quality Improved customer satisfaction Competitive Edge Reduced customer quality audit 33% 26% 21% 8.5%

Increase in market share

Quick time to market response

4.5%
0.5%

INTANGIBLE BENEFITS
Better Documentation Greater quality assurance Positive Cultural Change Increased operative efficiency 32.4% 25.8% 15% 9%

Enhanced computer communication

Reduced scrap work

7.3%
5%

MOTIVATION FOR ISO 9000

REACTIVE Customer demand PROACTIVE Market leadership

Competitive pressures Quality benefits Corporate mandate Part of a larger strategy Reduction in production cost

Requirements from regulations

Why is ISO 9000 important?

European Union directive
ISO 9000 certification required by suppliers of Regulated Products
health, safety, and the environment

EC has strict corporate liability legislation protecting consumers

Globalization impact

ISO 9000

Why adopt ISO 9000?

To comply with customers who require ISO 9000 To sell in the European Union market To compete in domestic markets To improve the quality system To minimize repetitive auditing by similar and different customers To improve subcontractors performance
ISO 9000

ISO 9000:2000 Consists of 3 Areas

ISO 9000:2000 Quality Management Systems: fundamentals and vocabulary ISO 9001:2000 Quality Management Systems Requirements (required for certification) Management responsibility Resource management Product/service realization Measurement, analysis, improvement ISO 9004-2000 Quality Management Systems Guidelines for performance improvement
ISO 9000

ISO 9000 Family of Standards

ISO 8402 - QA and Quality management vocabulary ISO 9000-2 - Generic guidelines for applying ISO 9001, ISO 9002, and ISO 9003 ISO 9000-3 - Guidelines for applying ISO 9001 to the development, supply, and maintenance of software ISO 9000-4 Application for dependability management ISO 9004-2 Guidelines for services ISO 9004-3 Guidelines for processed material ISO 9004-4 Guidelines for quality improvement ISO 9004-5 Guidelines for quality plans ISO 9004-6 Guidelines for configuration management
ISO 9000

What are the elements of the standards?

Management responsibility Resource management Quality System Contract Review Design Control Document Control Purchasing Purchaser-Supplied Product Product Identification and Traceability Process Control Inspection and Testing Inspection, Measuring and Test Equipment Inspection and Test Status Control of Non-conforming product Corrective Action Quality Records Internal Quality Audit Training Servicing Statistical Techniques

ISO 9000

Element Standard: Management Responsibility

Management must have a written policy statement of their commitment to quality. This policy must be communicated to and understood by all employees. Management must clearly define quality-related organizational responsibilities and interrelationships. A management representative must be assigned to oversee the implementation and continuous improvement of the quality system. Senior management must continually review the system.
ISO 9000

Element Standard: Process Control

The company must identify all processes that directly affect the quality of the product or service and ensure that these processes are carried out under controlled conditions, including:
Formal approval of process design and equipment. Documented work instructions. Development of quality plans describing how the process is to be monitored. A suitable working environment. Documented quality criteria.
ISO 9000

Third party registration

ASQC
Accreditors (RAB in US) Registrars

Supplier Companies
ISO 9000

Steps Towards ISO - 9000 Certification

Set up a steering group
Review current status relative to ISO-9001, 9002 or 9003 Identify action items Establish a program Define and implement new procedures.

 Compile quality manual

Meet with assessment body Submit manual for approval

Assessment visit

ISO Awareness Campaign Nominate ISO representative Implementation teams + Planning Quality Manuals Write II Tier

Document III Tier

Monitor Implementation Process

First Internal Audits Clear Non-Con- Formalities Pre Registration Audit Quality Training/ On- Going Compliance Audit Clear Discrepancies Registration

Estimated ISO Implementation Schedule

Ten Steps to ISO Registration

10. Registration! 9. Final assessment by registrar

8. Take corrective actions

7. Pre-assessment by registrar 6. Submit quality manual for approval 5. Perform self-analysis audit 4. Select a third-party registrar and apply 3. Develop and implement the quality system 2. Select the appropriate standard 1. Set the registration objective
ISO 9000

Six Essential Elements of a Successful Registration Effort

Senior Management Commitment to the Effort
Appropriate ISO 9000 Training An Effective Management Review Process Documentation of the Quality System An Effective Internal Auditing System An Effective Corrective Action Process

ISO 9000

ISO 9000:2000: Quality management Principles The Quality management system standards of the revised ISO 9000:2000 series are based on eight quality management principles. Senior management can use these principles as a framework to guide their organization toward improved performance. The standardized description of the principles as they appear in ISO 9000:2000 and the benefits derived from their use are as follows:

Principle 1- Customer focus Organization depands on their customers and therefore should understand current and future customer needs, should meet customer requirement and strive to exceed customer expectations. Benefits: Increased revenue and market share obtained through flexible and fast response to market opportunities Increased effectiveness in the use of the organizations resources to enhance customer satisfaction Improved customer loyalty leading to repeat business

Principle 2- Leadership Leaders establish unity of purpose and direction of the organization. They should create and maintain the internal environment in which people can become fully involved in achieving the organizations objectives. Benefits: People will understand and be motivated towards the organizations goals and objectives Activities are evaluated, aligned and implemented in a unified way. Miscommunication between levels of an organization will be minimized.

Principle 3 Involvement of people People at all levels are the essence of an organization and their full involvement enables their abilities to be used for the organizations benefit. Benefits: Motivated, committed and involved people within the organization Innovation and creativity in furthering organizations objectives. People being accountable for their own performance. People eager to participate in and contribute to continual improvement.

Principle 4 Process approach A desired result achieved more efficiently when activities and related resources are managed as a process. Benefits: Lower costs and shorter cycle times through effective use of resources. Improved, consistent and predictable results. Focused and prioritized improvement opportunities.

Principle 5 System approach to management Identifying, understanding and managing interrelated processes as a system contribution to the organizations effectiveness and efficiency in achieving its objectives. Benefits: Integration and alignment of the processes that will best achieve the desired results. Ability to focus effort on the key processes. Providing confidence to interested parties as to the consistency, effectiveness and efficiency of the organization.

Principle 6 Continual Improvement Continual improvement of the organizations overall performance should be a permanent objective of the organization. Benefits: Performance advantage through improved organizational capabilities. Alignment of improvement activities at all levels to an organization strategic intent. Flexibility to reach quickly to opportunities.

Principle 7 factual approach to decision making Effective decisions are based on the analysis of data and information. Benefits: Informed decision An increased ability demonstrate the effectiveness of past decision through reference to factual records. Increased ability to review, challenge and change opinion and decisions.

Principle 8 Mutually beneficial supplier relationship An organization and its suppliers are interdependent and a mutually beneficial relationship enhances the ability of both to create value Benefits: Increased ability to create value for both parties. Flexibility and speed of joint responses to changing market or customer needs and expectations. Optimization of costs and resources.