Introduction To ISO 9000

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Introduction To ISO 9000

• Cheng, Jing
• (2/01/04)
• Software School,Hunan University

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Objectives

• To introduce the Quality Management
• System (QMS)
• To introduce the ISO and ISO 9000
• The Standard Quagmire
• ISO 9000 History
• Comparing ISO 9001 and CMM
• ISO - Based SPI

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The Quality Management System

• The first consideration in designing a system or
  a process is to
• produce a specific desired result. In addition to
  the basic
• process that creates the output, the following
  four factors
• need to be designed into all systems and
  processes
• Ways to prevent errors
• Ways to segregate good items from bad items
• Ways to correct bad items
• Ways to prevent errors from recurring

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QMS Impacts All Areas at an Organization
Personnel System Q M S
Safety System Q M S
Environmental System Q M S
Security System Q M S
Production System Q M S
Financial System Q M S
Information System Q M S
Development System Q M S
Procurement System Q M S
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TQM And QMS of ISO
Dr. Armand, V. Feigenbaum, 1950
TQM
CMM
QMS
SEI, 1986
ISO, 1987
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What is ISO?
ISO is the International Organization for
Standardization. Because the name of the
organization would have different Abbreviations
(IOS in English, OIN in French), it was Decided
to use a word derived from Greek isos, meaning
equal. Therefore, the short form of the
Organizations Name is always ISO. ISO is made
up of national standards Institutes from
countries large and small, industrialized
and Developing, in all regions of the world. It
develops voluntary Technical standards which add
value to all types of business Operations. ISOs
web site is http//www.iso.org
ISO is pronounced Eye-So .
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What is ISO?

• Geneva-based consortium formed in 1946 comprised
  of standards-setting bodies from 110 nations.
• USA is represented by the American National
  Standards Institute (ANSI).
• Published the first internationally recognized
  Quality System standard in 1987, revised in 1994.
  Latest version is known as ISO 90002000

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ISO Certificates Highest Growth
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Highest Number of Certificates By Industrial
Sector
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IT ISO 9000 Certificate Trend
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Examples of ISO 9000 In IT Use

• A computer software developer serving a niche
  market recognized that as their user base
  expanded they would be faced with issues
  concerning product management and configuration
  control. Changes to base products, user hardware
  and regulatory requirements were compounding
  customer service issues. ISO 90042000 provided
  the guidance they needed to establish documented
  procedures to control process change and
  improvement. ISO 100061997 and ISO 100071995
  provided additional assistance as they managed
  the project and prepared procedures for
  configuration management. They later acquired
  another software developer and were able to use
  their quality management system to integrate the
  acquisition into their own structure very quickly
  with a minimum of disruption to customers.

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Examples of ISO 9000 In IT Use

• A bank decided to implement a quality management
  system for its on-line Internet banking services.
  They ensured that their quality manual made clear
  that their other conventional banking services
  were not included in their quality management
  system. While adopting the requirements of ISO
  90012000, the bank obtained guidance from ISO
  90002000 to interpret words and phrases used in
  the standard for their application. They applied
  all the requirements of Clause 7, recognizing
  that design and development is an important part
  of creating new service processes. The bank used
  ISO 100131995 to prepare their documentation,
  which they posted on their internal computer
  network to ensure current procedures are
  available to their staff

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Advantages Of a Good QMS

• Managements expectations are clearly
  communicated to the employees.
• The organization performance much more
  predictably.
• There is international acceptance of the
  organizations QMS.
• It provides a base for all the organizations
  improvement activities.
• It minimizes the number of errors that occur
  because work instructions are not documented.
• It reduces the time required to train a
  reassigned employee.
• It is required by many organizations as part of
  their contract with their suppliers and/or
  subcontractors.
• It saves time because they procedures are
  documented, eliminating the need to reinvent the
  wheel each time.
• Third-party registration reduces the number of
  second-party audits.
• It provides a base that ensures that improvement
  gains are captured and internalized.

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ISO 9000 Prevents Losing Ground
ISO
Improvement
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Generic Management System Standards

• The vast majority of ISO standards are highly
  specific to a particular product, material, or
  process. However, both ISO 9000 is known as one
  of the generic management system standards.
• Generic means that the same standards can be
  applied to any organization, large or small,
  whatever its product including whether its
  "product" is actually a service in any sector
  of activity, and whether it is a business
  enterprise, a public administration, or a
  government department.
• Management system refers to what the organization
  does to manage its processes, or activities. In a
  very small organization, there is probably no
  "system", as such, just "our way of doing
  things", and "our way" is probably not written
  down, but all in the manager's or owner's head.
  The larger the organization, and the more people
  involved, the more the likelihood that there are
  some written procedures, instructions, forms or
  records. These help ensure that everyone is not
  just "doing his or her thing", and that there is
  a minimum of order in the way the organization
  goes about its business, so that time, money and
  other resources are utilized efficiently.

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Generic Management System Standards

• To be really efficient and effective, the
  organization can manage its way of doing things
  by systemizing it. This ensures that nothing
  important is left out and that everyone is clear
  about who is responsible for doing what, when,
  how, why and where.
• Management system standards provide the
  organization with a model to follow in setting up
  and operating the management system. This model
  incorporates the features which experts in the
  field have agreed upon as representing the state
  of the art. A management system which follows the
  model or "conforms to the standard" is built
  on a firm foundation of state-of-the-art
  practices.
• Large organizations, or ones with complicated
  processes, could not function well without
  management systems although they may have been
  called by some other name. Companies in such
  fields as aerospace, automobiles, defence, or
  health products have been operating management
  systems for years.
• ISO's management system standards now make these
  successful practices available for all
  organizations.

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ISO 9000 in Plain Language

• "ISO 9000 is actually families of standards
  which are referred to under these generic titles
  for convenience. Both families consist of
  standards and guidelines relating to management
  systems, and related supporting standards on
  terminology and specific tools, such as auditing
  (the process of checking that the management
  system conforms to the standard).
• ISO 9000 is primarily concerned with "quality
  management". Like "beauty", everyone may have his
  or her idea of what "quality" is. In plain
  language, the standardized definition of
  "quality" in ISO 9000 refers to all those
  features of a product (or service) which are
  required by the customer. "Quality management"
  means what the organization does to ensure that
  its products conform to the customer's
  requirements.

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ISO 9000 One-Two-Three'

• ISO 9001 sets out the requirements for an
  organization whose business processes range all
  the way from design and development, to
  production, installation and servicing
• for an organization which does not carry out
  design and development, ISO 9002 is the
  appropriate standard, since it does not include
  the design control requirements of ISO 9001
  otherwise, its requirements are identical
• ISO 9003 is the appropriate standard for an
  organization whose business processes do not
  include design control, process control,
  purchasing or servicing, and which basically uses
  inspection and testing to ensure that final
  products and services meet specified
  requirements.
• So, an organization chooses that its quality
  system be certified against ISO 9001, ISO 9002 or
  ISO 9003 according to the business processes
  covered by the quality system. There is no
  difference of quality ranking between the three
  standards.

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The Standard Quagmire
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ISO 9000 History I

• World War II problems with welds on boats
  Solution QC inspection in factories
• 1959 US developed Mil-Q-9558a Quality Program
  Requirements
• 1962 the NASA space program developed its
  Quality System Requirements
• 1979 BS 5750 Guidelines for Quality Assurance
• 1987 BS 5750 became ISO 9000 1987
• 1992 DoD has been considering dropping
  Mil-Q-9558a in favor of ISO 9000

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ISO 9000 History II

• 1994 ISO 9000 1987 revised
• 2000 ISO 9000 1994 revised
• Promote a theory of control, not a better theory
  of management
• ISO 9000 87 94 a way of managing for
  conformance
• (Action or behavior in agreement with
  current customers, rules, principles, )
• You comply or we wont buy
• ISO 90012000 aims to enhance customer
  satisfaction

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The future evolution of ISO 9000

• In order for the ISO 9000 family to maintain its
  effectiveness, the standards are periodically
  reviewed in order to benefit from new
  developments in the quality management field and
  also from user feedback. ISO/TC 176, which is
  made up of experts from businesses and other
  organizations around the world, monitors the use
  of the standards to determine how they can be
  improved to meet user needs and expectations when
  the next revisions are due in approximately five
  years' time.
• ISO/TC 176 will continue to integrate quality
  assurance, quality management, sector specific
  initiatives and various quality awards within the
  ISO 9000 family.
• ISO's commitment to sustaining the ISO 9000
  momentum through reviews, improvement and
  streamlining of the standards guarantees that
  your investment in ISO 9000 today will continue
  to provide effective management solutions well
  into the future.

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Quality Journey
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What is Quality?

• Conforms to requirements.
• User-dependent.
• Fitness for use.
• Good quality does not necessarily mean high
  quality... It means a predictable degree of
  uniformity and dependability at a cost suitable
  for its purpose.

A man who ships bad product is worse than a
thief
-Dr. Genichi Taguchi
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An ordered set of related parts and methods
working together to meet a common goal.
What is System?
Requirements
Effectiveness
Intent
Design
Production
Implementation
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Quality System The organizational structure,
responsibilities, procedures, and resources for
error detection, correction, and prevention.
Quality System Model
Detect, Correct, Prevent Errors
Effectiveness
Intent
Procedures and Methods
Workplace Activities
Implementation
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ISO 9000 Quality Standards
ISO STANDARD DESIGNATION TITLE
ISO 9000
ISO 9000-1 Quality management and quality assurance standards, Part 1 Guidelines for selection and use
ISO 9000-2 Quality management and quality assurance standards, Part 2 Generic Guideline for the application of ISO 9001, 9002, and 9003.
ISO 9000-3 Quality management and quality assurance standards, Part 3 Guidelines for the application of ISO 9001 to development, supply, and maintenance of software.
ISO 9000-4 Quality management and quality assurance standards, Part 4 Guide to development, production, installation, and servicing
ISO 9001 Quality systems Model for quality assurance in design, development, production, installation, and servicing
ISO 9002 Quality systems Model for quality assurance in production, installation, and servicing
ISO 9003 Quality systems Model for quality assurance in final inspection and test.
STANDARD DESCRIPTION
This standard provides Guidelines on application and use of the 9001, 9002, and 9003 standards, and is divided into the following four parts
There are the three forms of the quality systems standards
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ISO 9000 Standards Structure
ISO 9001
ISO 9002
ISO 9003
Three Quality Management System Models
ISO 8402
ISO 9000-1
The Organizations Quality Management System
Selection and Use of the Standards
Definition of Concepts
ISO 9004-1
Quality Management Quality System Guidelines
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ISO 90011994 Structure
4.1 Management Responsibility
4.2 Quality System
4.14 Corrective Prev. Action
4.9 Process Control
4.17 Internal Quality Audits
4.3 Contract Review
4.4 Design Control
4.5 Document Data Control 4.8 Product ID and
Traceability 4.13 Control of Nonconforming
Prod. 4.16 Control of Quality Records 4.18 Traini
ng 4.20 Statistical Techniques
4.6 Purchasing 4.7 Control of Customer-Supd
Prod.
4.10 Inspection and Testing 4.11 Control of
Inspect Test Equip 4.12 Inspection and Test
Status
4.15 Handling, Storage, Packaging
4.19 Servicing
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4.1 Management Responsibility

• Management is responsible for establishing a
  Quality policy and quality objectives for the
  organization that are understood, accessible, and
  implemented.
• Defined responsibilities and authority.
• Qualified personnel and resources.
• Management representation.
• Periodic management reviews.

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4.2 Quality System

• Establish, document, and implement a quality
  system that meets the intent of ISO 9001, that is
  fully implemented, and that is effectively
  detecting and preventing errors.
• Requirements
• A Quality Manual including the quality policy and
  goals.
• Plans for how you will achieve the quality goals.
• A documented quality system, including
  procedures and work instructions.

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4.3 Contract Review

• Documented procedures for ensuring that what is
  expected from YOU is
• adequately defined and documented,
• that you have the capability to satisfy the
  requirements,
• Documented procedures for amending the contracted
  requirements.

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4.4 Design Control

• Documented procedures to control the design of a
  product/service to ensure it will meet its
  requirements.
• Design and development planning.
• Inputs to the design, including group interfaces.
• Acceptance criteria/outputs from the completed
  design.
• Design standards, tools, and techniques.
• Design review and verification procedures.
• Design change management.

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4.5 Document and Data Control

• You must have documented procedures to control
  all documents and data, including procedures for
• Review and approval.
• Proper marking and nomenclature.
• Publishing and distribution.
• Amending, archiving, and destroying.
• Assuring accessibility.
• Maintaining a master list.

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ISO 9000 Documentation Hierarchy
1. Corporate Quality Manual 2. Policy and
Procedures 3. Work Instructions 4. Quality
Records
1
2
3
4
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4.6 Purchasing

• There must be documented procedures to ensure
  that parts and services obtained from external
  sources used in production meet their specified
  requirements.
• This includes procedures for verifying
  third-party products and procedures for selecting
  and managing subcontractors.

Contract with XYZ Corp.
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4.7 Control of Customer Supplied Product

• There must be procedures for the proper handling,
  storage, and maintenance of customer-supplied
  products.
• Treat your customers property as you would like
  your property treated.

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4.8 Product Identification and Traceability

• There must be procedures for the proper
  identification and tracing of the product, and
  the components that make up a product, during all
  stages of production, delivery, and installation.

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4.9 Process Control

• There must be procedures for the production,
  installation, and servicing of a product or
  service, where the absence of such procedures
  would adversely affect quality.
• Controlled conditions must be maintained.
• Procedures should include
• Compliance to standards,
• Monitoring and verification, and
• Workmanship.

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4.10 Inspection and Testing

• There must be identification of WHEN inspection
  and testing is required.
• Includes peer reviews as well as formal tests.
• When may include
• Receipt of material.
• Various stages during the process.
• Upon release or post-installation.

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4.11 Control of Inspection, Measuring and Test
Equipment

• There must be procedures to control, maintain,
  and calibrate all inspection, measuring, and
  testing equipment.
• Records must be maintained.
• Test equipment includes Test Data.

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4.12 Inspection and Test Status

• There must be the ability to show the status of
  inspection and test of all products during all
  stages of production.
• Identification by suitable means to indicate
  conformance or non-conformance.

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4.13 Control of Nonconforming Product

• There must be procedures to ensure the proper
  control of all nonconforming products.
• This control includes identification,
  documentation, evaluation, segregation,
  disposition, and notification to all functions
  concerned.
• Re-work must be re-inspected.

!
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4.14 Corrective and Preventive Action

• Procedures for handling problems, bugs, and
  complaints, including receipt, documentation of
  the correction, controls, and communication.
• Procedures for proactively preventing problems,
  including analysis, documentation, feedback, and
  review.
• Root Cause analysis performed on all problems.

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4.15 Handling, Storage, Packaging, Preservation,
Delivery

• There must be documented procedure for the proper
  handling, storage, packaging, preservation, and
  delivery of the product or service.
• Ensure that once it meets requirements, it stays
  that way.

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4.16 Control of Quality Records

• There must be procedures for the proper
  identification, collection, indexing, access,
  storage, and disposition of quality records.
• Quality records are the ...artifacts that
  demonstrate conformance to specified
  requirements, and the effective operation of
  the quality system.

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4.18 Training

• There must be procedures for the
• Identification of training needed by which
  individuals.
• Provision of this required training.
• Records that the training has been received.
• Internal courses are taken care of by PRISM and
  ESEE. External courses and contractor training
  must be recorded manually by the manager through
  TRAINREC or hard-copy records.