THE ISO 9000 FAMILY

Agenda
The ISO 9000 Family Why Companies Implement ISO 9000 Impact on Business Results The Engineers Role in ISO 9000

What is The ISO 9000 Family?

Three Core International Standards Associate standards, technical supports and guides

What is The ISO 9000 Family?

The family consists of
ISO 9000 Quality Management Systems Fundamentals and vocabulary ISO 9001 Quality Management Systems Requirements ISO 9004 Quality Management Systems Guidelines for performance improvement

What is The ISO 9000 Family?

Associated with the family are
ISO/TR 1017 Guidance on statistical techniques IEC 60300-1 Dependability management ISO 10006 Guidelines to quality in project management ISO Guidelines for configuration management

The Meaning of ISO

International Organization for Standardization
Worldwide federation of national standards bodies from 130 countries Over 11,000 standards Over 97 categories

ISO 9001
Key standard in the family Contains quality management system requirements Requirements applicable to any kind of organization Does not dictate how requirements should be achieved

ISO 9001
Organized by key business processes
Quality management system Management Resources Product realization Measurement, analysis and improvement

ISO 9001
Over 250 requirements summarized as
Determine needs and expectations of interested parties Establish policies, objectives and work environment to satisfy needs of interested parties Design, resource and manage numerous interconnect processes to meet objectives and policy Measure and analyze effectiveness of each process in meeting its purpose and objectives Pursue continual improvement of the system through on-going evaluation of system performance

ISO 9000
Quality Management Fundamentals
Role of top management Auditing the quality management system Role of statistical techniques

Vocabulary
Quality planning Customer satisfaction Continual improvement

ISO 9004
ISO 9001 = Effectiveness ISO 9004 = Efficiency Not a guide to implement ISO 9001

What the ISO 9000 Family is not

A family of product standards A guarantee of product quality A method to rescue a troubled company

Why Companies Implement ISO 9000

Meet customer requirements Meet regulatory requirements Improve quality Increase profitability

Impact on Business Results

ISO 9001 promotes
Not entering into commitments that the organization cannot meet Identification and management of resources needed to meet organizational objectives Processes designed to meet organizational objectives Reduction in waste Continual improvement of the quality management system Satisfied customers

ISO 9000
Companies may elect to obtain
Registration to ISO 9001
Third party initial and on-going evaluation Over 70,000 registrations in North America

Compliance to ISO 9001

Internal effort

Registration is only possible to ISO 9001

ISO 9000
Registration and compliance require audit of the quality management system Auditors interview personnel and assess objective evidence throughout the company Auditors ask four basic questions
Is the process identified and defined? Are responsibilities assigned? Are procedures implemented and maintained? Is the process effective in achieving the required results?

The Engineers Role in ISO 9000

Engineers working in quality management may be responsible for implementation of the entire standard
Project management task

ISO 9001 Processes operated / managed by technical personnel may include

Design and development Planning of product realization Infrastructure Work environment Monitoring and measurement of product and processes

The Engineers Role in ISO 9000

ISO 9000 does not prescribe a specific approach
Organization can design the process as efficient or inefficient as desired

ISO 9000 does require 21 categories of records be maintained

Design review Design validation Management review Internal quality audit

The Engineers Role in ISO 9000

Clause 7.3.1- Design and Development Planning During design and development planning, the organization shall determine
Design and development stages Review, verification, validation that are appropriate to each design phase Responsibilities and authorities for design and development

The Engineers Role in ISO 9000

Clause 7.3.5- Design and Development Verification Verification shall be performed in accordance with planned arrangements (7.3.1) to ensure that the design and development outputs have met the design and development input requirements Records of the results of the verification and any necessary actions shall be maintained

Additional Information
Further information regarding the ISO 9000 standards can be obtained at:
www.iso.ch

Summary
Thank you for your attention Any Questions?