ISO 9000

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ISO 9000

• An Overview

2
ISO

• ISO Standards- created, published and maintained
  by the International Organization for
  Standardization
• ISO is NOT an acronym
• ISO is a root word even, equal, harmonious
• ISO 9000
• A family of standards
• Primarily concerned with quality management

3
ISO 9000

• ISO 9000
• An international consensus on good management
  practices with the aim of ensuring that the
  organization can time and time again deliver the
  product or services that meet the clients
  quality requirements.
• Appropriate and beneficial for large AND small
  businesses

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ISO 9000

• Why?
• Primary driver for compliance initiated in Europe
  during the rush for EC 92
• Many companies have realized that there are
  benefits beyond just meeting the requirements
• estimates are that between 1987 and 2000, more
  than 100,000 companies will be ISO 9001 or 9002
  certified

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ISO 9000

• Main reasons for pursuing compliance
• customer requirement
• certain opportunities or benefits if certified
• government/regulatory requirement
• certain European Market directives require
  registration to obtain the CE mark, allowing
  access to European Union marketplace
• internal benefits
• streamlined, efficient, effective processes and
  planning

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ISO 9000

• A family of standards describing three quality
  assurance models
• ISO 9001
• ISO 9002
• ISO 9003

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ISO 9000

• ISO 9001
• model for quality assurance in design,
  development, production, installation and
  servicing
• sets out the requirements for an organization
  whose business processes range all the way from
  design and development, to production,
  installation and servicing

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ISO 9000

• ISO 9002
• model for quality assurance in production,
  installation and servicing
• for an organization that does not carry out
  design and development, but otherwise has
  identical requirements to ISO 9001 its business
  processes do not require design control

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ISO 9000

• ISO 9003
• model for quality assurance in final inspection
  and testing
• for an organization whose business processes do
  not include design control, purchase control,
  purchasing or servicing, and which basically uses
  inspection and testing to ensure that final
  products and services meet specified requirements

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ISO 9001

• Scope - Applicable in situations when
• design is required and the product requirements
  are stated principally in performance terms, or
  they need to be established, and
• confidence in product conformance can be attained
  by adequate demonstration of a suppliers
  capabilities in design, development, production,
  installation, and servicing

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ISO 9001

• Definition of a Product
• the result of activities or processes
• a product may include service, hardware,
  processes, materials, software or a combination
  thereof
• for the purposes of this Standard, product
  applies to the intended product offering only and
  not to unintended by-products affecting the
  environment

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ISO 9001

• Quality System Requirements (20 in all)
• 4.1 Management Responsibility
• 4.2 Quality System
• 4.3 Contract Review
• 4.4 Design Control
• 4.5 Document and Data Control
• 4.6 Purchasing
• 4.7 Control of Customer-Supplied Product

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ISO 9001

• Quality System Requirements (cont.)
• 4.8 Product Identification and Traceability
• 4.9 Process Control
• 4.10 Inspection and Testing
• 4.11 Control of Inspection, Measuring and Test
  Equipment
• 4.12 Inspection and Test Status
• 4.13 Control of Nonconforming Product
• 4.14 Corrective and Preventive Action

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ISO 9001

• Quality System Requirements (cont.)
• 4.15 Handling, Storage, Packaging, Preservation
  and Delivery
• 4.16 Control of Quality Records
• 4.17 Internal Quality Audits
• 4.18 Training
• 4.19 Servicing
• 4.20 Statistical Techniques

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ISO 9001

• 4.2 Quality System
• 4.2.1 General
• Establish, document and maintain a quality system
  as a means of ensuring that product conforms to
  specified requirements
• Prepare a quality manual covering the
  requirements of this International Standard

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ISO 9001

• 4.2 Quality System (cont.)
• 4.2.2 Quality system procedures
• prepare documented procedures consistent with the
  requirements of this International Standard and
  the suppliers stated quality policy
• effectively implement the quality system and its
  documented procedures

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ISO 9001

• 4.4 Design Control (9 Elements)
• 4.4.1 General
• 4.4.2 Design and development planning
• 4.4.3 Organizational and technical interfaces
• 4.4.4 Design input
• 4.4.5 Design output
• 4.4.6 Design review
• .. more

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ISO 9001

• 4.4 Design Control (Elements - cont.)
• 4.4.7 Design verification
• 4.4.8 Design validation
• 4.4.9 Design changes

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ISO 9001

• 4.4 Design Control (details)
• 4.4.1 General
• establish and maintain documents and procedures
  to control and verify the design
• 4.4.2 Design and development planning
• prepare plans for each design and development
  activity
• define responsibilities for implementation
• assign activities to qualified personnel with
  adequate resources

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ISO 9001

• 4.4 Design Control (details - cont.)
• 4.4.3 Organizational and technical interfaces
• define interfaces between different groups which
  input into the design process
• 4.4.4 Design input
• input requirements (specifications) relating to
  the product shall be identified, documented, and
  reviewed

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ISO 9001

• 4.4 Design Control (details - cont.)
• 4.4.5 Design output
• documented and expressed in terms that can be
  verified and validated against design review
  requirements
• output shall
• meet design input requirements
• contain or make reference to acceptance criteria
• identify characteristics that are crucial to the
  safe and proper functioning of the product

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ISO 9001

• 4.4 Design Control (details - cont.)
• 4.4.6 Design review
• at appropriate stages of design, formal
  documented reviews of the design results shall be
  planned and conducted
• participants shall include representatives of all
  functions concerned with the design stage being
  reviewed
• records of such reviews shall be maintained

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ISO 9001

• 4.4 Design Control (details - cont.)
• 4.4.7 Design verification
• at appropriate stages of design, design
  verification shall be performed to ensure that
  the design stage output meets the design stage
  input requirements

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ISO 9001

• 4.4 Design Control (details - cont.)
• 4.4.8 Design validation
• performed to ensure that product conforms to
  defined user needs
• follows successful design verification
• normally performed under defined operating
  conditions
• normally performed on the final product
• multiple validations may be performed if there
  are different intended uses

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ISO 9001

• 4.4 Design Control (details - cont.)
• 4.4.9 Design changes
• all design changes and modifications shall be
  identified, documented, reviewed and approved by
  authorized personnel

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ISO 9001

• 4.5 Document and Data Control
• 4.5.1 General
• establish and maintain documented procedures to
  control all documents and data that relate to the
  requirements of this standard
• may include documents of external origin such as
  standards and customer drawings

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ISO 9001

• 4.5 Document and Data Control
• 4.5.2 Document and data approval and issue
• documents and data shall be reviewed and approved
  by authorized personnel prior to issue
• a master list identifying current revision status
  of documents shall be established and readily
  available
• pertinent issues of appropriate documents shall
  be available where operations essential to the
  effective functioning of the quality system are
  performed

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ISO 9000 - Summary

• ISO 9000
• A series of internationally recognized standards
  and guidelines that define an effective quality
  system
• An international consensus on good management
  practices with the aim of ensuring that the
  organization can time and time again deliver the
  product or services that meet the clients
  quality requirements.

29
ISO 9000 - Summary

• ISO 9001
• Primarily meant for organizations with the
  capability to design.
• ISO 9002
• Primarily for those who provide goods and
  services they do not design themselves
• ISO 9003
• For those when conformance is assured solely at
  final inspection and test

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Design Review
Design Review
Design Review
Design Review
Design Review
Product Development Process
After Ulrich and Eppinger, Exhibit 2-2
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End