The document summarizes ISO 9000 quality management standards. ISO 9001 provides requirements for quality management systems to help organizations ensure customer needs are met. Over 1 million organizations are ISO 9001 certified globally. ISO 9000 deals with quality management system fundamentals while ISO 9001 specifies requirements for certification. Certification bodies independently confirm organizations meet ISO 9001 requirements. The standards are criticized by some as not useful for all organizations.
2. ISO9000
• The ISO 9000family of quality management
systems standards is designed to help organizations ensure
that they meet the needs of customers and other
stakeholders while meeting statutory and regulatory
requirements related to a product.
• ISO 9000 deals with the fundamentals of quality
management systems,including the eight management
principles upon which the family of standards is based.
• ISO 9001 deals with the requirements that organizations
wishing to meet the standard must fulfil.
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3. ISO9000
• Third-party certification bodies provide independent
confirmation that organizations meet the requirements of
ISO 9001.
• Over one million organizations worldwideare independently
certified, making ISO 9001 one of the most widely used
management tools in the world today.
• Despite widespread use, the ISO certification process has
been criticized as being wasteful and not being useful for all
organizations
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4. CONTENTS OFISO9001
• ISO 9001:2008 Quality management systems — Requirements is a
document of approximately 30 pages which is available from the national
standards organization in each country.
• It is supplemented by two other standards: ISO 9000:2005 Quality
management systems—Fundamentals and vocabulary and ISO 9004:2009
Managing for the sustained success of an organization—A quality
management approach.
• Only ISO 9001 is directly audited against for third party assessment
purposes.
• The other two standards are supplementary and contain deeper
information on how to sustain and improve quality management systems;
they are therefore not used directly during third party assessment.
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6. 5
ISO9000Series
ISO 9000
ISO 9002
ISO 9001
• Explains fundamental quality concepts
and provides guidelines for the selection
and application of each standard
• Explains fundamental quality concepts
and provides guidelines for the selection
and application of each standard
• Explains fundamental quality concepts
and provides guidelines for the selection
and application of each standard
7. 6
ISO 9004
ISO 9003 • Quality assurance in final
inspection and testing.
• Guidelines for the applications of
standards in quality management
and quality systems.
ISO 9000 and ISO 9004 are guidance standards.
They describe what is necessary to accomplish
the requirements outlined in standards 9001,
9002 or 9003.
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Advantages
Quality is maintained
ISO registration also has significant
bearing on market credibility as well.
Opportunity to compete with larger
companies
More time spent on customer focus,
Confirmation that your company is
committed to quality
May facilitate trade and increased
market opportunities
Can increase customer satisfaction and
confidence
10. CERTIFICATION
• ISO does not certify organizations itself.
• Numerous certification bodies exist, which audit organizations and, upon
success, issue ISO 9001 compliance certificates.
• Although commonly referred to as "ISO 9000" certification, the actual
standard to which an organization's quality management system can be
certified is ISO9001:2008.
• Many countries have formed accreditation bodies to authorize ("accredit")
the certificationbodies.
• Both the accreditation bodies and the certification bodies charge fees for
their services.
• An organization applying for ISO 9001 certification is audited based on an
extensive sample of its sites, functions, products, services and processes.
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11. 10
• Quality Management Clause
▫ General requirements
▫ Documentation requirement
▫ Quality manual
▫ Control of records and documents
• Management responsibility clause
▫ Customer focus
▫ Quality objective
▫ Quality policy
▫ Quality management system planning
▫ Management representative
▫ Internal communication
12. 11
• Resource management requirement clause
▫ Competence, awareness and training
▫ Infrastructure
▫ Work environment
• Product realization requirement clause
▫ Planning of product realization
▫ Customer related process
▫ Customer communication
• Measurement, analysis and improvement clause
▫ General requirements
▫ Monitoring and measurement
customer satisfaction
Internal audit
▫ Analysis of data
▫ Continual improvement