External Validation of Quality

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

• In the past, ISO had three standards: ISO 9001:1994, ISO

9002:1994, and ISO 9003:1994. Now there's only one standard: ISO
9001:2000! ISO 9002 and ISO 9003 have been dropped.
• So, if you are currently ISO 9002:1994 or ISO 9003:1994 certified,
you will now need to become ISO 9001:2000 certified.
• And if you're now ISO 9001 certified, you're going to have to
update your quality system in order to meet the new ISO
9001:2000 requirements.
New Structure

• When you compare ISO 9001:1994 and ISO

9001:2000 you’ll notice that ISO has abandoned
the 20-clause structure of the old standard.
Instead of 20 sections, the new standard now has
5 sections.
• It time to write some new manuals!
ISO 9001 Requirements (old
structure):
• Management responsibility
• Quality system
• Contract review
• Design control
• Document and data control
• Purchasing
• Control of customer - supplied product
• Product identification and traceability
• Process control
• Inspection and testing
• Control of inspection, measuring, and test equipment
• Inspection and test status
• Control of nonconforming products
• Corrective and preventive action
• Handling, storage, packaging, preservation, and delivery
• Control of quality records
• Internal quality audits
• Training
• Servicing
• Statistical techniques
New Definitions ISO 9000-2000

• Suppliers are now organizations.

• The term supplier now refers to the organization’s supplier.
• Old standard products: software, hardware, services, and
processed materials.
• New standard: ISO seems to take a more abstract
approach. ISO now refers to these four items as generic
elements, not types of products.
New Emphasis

• New standard is more customer-oriented. More specifically,

ISO 9001 now expects you to identify and meet customer
needs and expectations. Plus it expects you to
communicate with customers and to measure and monitor
customer satisfaction.
• In addition, the new standard emphasizes the need to make
improvements.
New Requirements (old clause numbers)

 Communicate with customers (7.2.3).

 Identify customer needs and expectations (5.2, 7.2.1).
 Meet customer needs and expectations (5.2).
 Measure and monitor customer satisfaction (8.2.1).
 Meet regulatory requirements (5.1, 5.2).
 Meet legal requirements (5.1, 5.2).
 Support internal communication (5.5.4).
 Provide quality facilities (6.3).
 Provide a quality work environment (6.4).
 Evaluate the effectiveness of training (6.2.2).
 Measure and monitor realization processes (8.2.3).
 Evaluate the effectiveness and suitability of quality system (8.4).
 Identify quality management system improvements (5.1, 8.4).
 Improve quality management system (5.1, 8.5).
New Flexibility

• Under the new ISO 9001:2000 standard, you may ignore or

exclude some requirements.
• Requirements that may be ignored under special
circumstances are known as permissible exclusions.
• According to ISO, you may ignore or exclude any of the
requirements found in Section 7 Product realization if you
meet certain conditions.
A Process Approach

• 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

•
21. Continual Improvement Process
Process Inputs and Outputs

• 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

Size of audit team

Fees, terms,
Audit style
and conditions

Contact the ASQC for more information on ISO 9000/ASQ90

Historical Problems with ISO 9000

• Some maintain that ISO 9000:

– is mainly for exporting firms
– is a barrier to trade
– is time consuming
– is costly
– is difficult for small firms to afford
– eats up human resources
– discourages free thinking and employee empowerment
– is limited because not all countries are accepting of all ISO registrars
– registrars are poorly regulated
– is a symptom of standard proliferation