Professional Documents
Culture Documents
Programs
• ISO 9000-2000
– There is a new sheriff in town.
– This will quickly become a widely adopted world standard.
– Focus is on documenting quality systems (establishing structural
measures) and showing that they are followed.
ISO 9000 (Redford and Streisand)
• What was ISO 9000: 1994?
– A series of three standards (9001, 9002, 9003) and two guidance
documents (9000, 9004).
– The ISO documents are very cryptic and undetailed. They do not
provide a true understanding of ISO requirements. They are open
to broad interpretation.
• ISO 9000 certification is not presently required for commerce in the
EEC.
– Can act as a filter for individual companies.
New Standard 9001:2000
• 21Processes:
• 1. Quality Management Process
• 2. Resource Management Process
• 3. Regulatory Research Process
• 4. Market Research Process
• 5. Product Design Process
• 6. Purchasing Process
• 7. Production Process
• 8. Service Process
• 9. Product Protection Process
• 10. Customer Needs Assessment Process
• 11. Customer Communications Process
• 12. Internal Communications Process
• 13. Document Control Process
• 14. Record Keeping Process
• 15. Planning Process
• 16. Training Process
• 17. Internal Audit Process
• 18. Management Review Process
• 19. Measuring and Monitoring Process
• 20. Nonconformance Management Process
• types of inputs/outputs:
Products
Services
Information
Documents
Reports
Records
Results
Needs
Data
Expectations
Requirements
Complaints
Comments
Feedback
Resources
Measurements
Authorizations
Decisions
Plans
Ideas
Solutions
Proposals
Section 4
• 4 Systemic requirements
• 4.1 Develop your quality system
Design your quality management system
Implement your quality management system
• 4.2 Document your quality system
Use documents to manage your quality system
Use documents that meet your system's needs
Section 5
• 5 Management requirements
• 5.1 Support quality
Promote the importance of quality
Develop a quality management system
Improve your quality management system
• 5.2 Satisfy your customers
Identify customer needs and expectations
Turn customer needs into requirements
Meet your customers' requirements
• 5.3 Establish a quality policy
Define your organization's quality policy
Manage your organization's quality policy
• 5.4 Carry out quality planning
5.4.1 Formulate your quality objectives
5.4.2 Plan to achieve your quality objectives
• 5.5 Manage your quality system
5.5.1 Control quality management system
5.5.2 Define responsibilities and authorities
5.5.3 Appoint management representative
5.5.4 Support internal communications
5.5.5 Prepare quality system manual
5.5.6 Control quality documents
5.5.7 Maintain quality records
• 5.6 Perform management reviews
5.6.1 Review quality management system
5.6.2 Examine management review inputs
5.6.3 Generate management review outputs
Section 6
• 6 Resource requirements
• 6.1 Provide quality resources
Identify quality resource requirements
Provide quality system resources
• 6.2 Provide quality personnel
6.2.1 Assign competent personnel
6.2.2 Educate your personnel
• 6.3 Provide quality facilities
Identify facility needs
Provide needed facilities
Maintain your facilities
• 6.4 Provide quality environment
Identify work environment
Manage work environment
Section 7
• 7 Realization requirements
• 7.1 Control realization planning
Plan product realization processes
Document product realization processes
• 7.2 Control customer processes
7.2.1 Identify product requirements
7.2.2 Review product requirements
7.2.3 Communicate with customers
• 7.3 Control product development
7.3.1 Control design and development
7.3.2 Control design and development inputs
7.3.3 Control design and development outputs
7.3.4 Control design and development reviews
7.3.5 Control design and development verifications
7.3.6 Control design and development validations
7.3.7 Control design and development changes
• 7.4 Control purchasing function
7.4.1 Control purchasing processes
7.4.2 Document product purchases
7.4.3 Verify purchased products
• 7.5 Control operational activities
7.5.1 Control production and service
7.5.2 Identify and track your products
7.5.3 Protect property supplied by customers
7.5.4 Preserve your products and components
7.5.5 Validate special process operations
• 7.6 Control measurement devices
Identify measuring and monitoring needs
Use measuring and monitoring devices
Calibrate measuring and monitoring devices
Protect measuring and monitoring devices
Validate measuring and monitoring software
Section 8
• 8 Analytical requirements
• 8.1 Plan measurement activities
Define quality measuring and monitoring needs
Meet quality measuring and monitoring needs
• 8.2 Measure and monitor quality
8.2.1 Measure and monitor customer satisfaction
8.2.2 Plan and perform periodic internal audits
8.2.3 Measure and monitor realization processes
8.2.4 Measure and monitor product characteristics
• 8.3 Control nonconforming products
Control nonconforming product before delivery
Control nonconforming product after delivery
• 8.4 Analyze quality information
Collect quality management system data
Analyze quality management system data
Identify quality improvement opportunities
• 8.5 Make quality improvements
8.5.1 Plan continual improvement
8.5.2 Correct actual nonconformities
8.5.3 Prevent potential nonconformities
How To Get Registered
• Select a standard - 9001, 9002 or 9003
• Learn about ISO 9000, talk to other companies who have registered
• Establish an organizational structure
• Prepare detailed operational standards and procedures
• Implement the quality program
• Perform internal audits
• Select a registrar
• Schedule an assessment
Selecting a Registrar
• This is difficult due to the large number of companies
offering services.
• Talk to your customers.
• Some have official ties to one of the 12 EU or 7
European Free Trade Association (EFTA) countries.
• Some have a memorandum of understanding with an
EU member country registrar.
Choosing a Registrar
Industry Number of
experience orgs. certified
Standards
Surveillance experience
visits
Factors to consider
Auditor’s
background
in choosing a
registrar
References
Fees, terms,
Audit style
and conditions