General Overview of

1
General Overview of

• ISO 90002000 Standards

2
Quality Redefined

• Most important factor for national
  competitiveness
• Directly influences standard of living
• Attitude of mind to give and take the best
• Every resource is vital irrespective of quantity
  and price

3
ISO 9000 Today

• Over 450,000 certifications worldwide and more in
  the process
• Reviewed every five years
• Last revision to 1987 standards was done in 1994
• Revision by ISOs technical committee TC 176
  Published on 15, Dec 2000

4
ISO 9000 Family

• ISO 90002000 QMS-Fundamentals and vocabulary
• ISO 90012000 QMS-Requirements
• ISO 90042000 QMS-Guidelines for performance
  improvements
• ISO 19011 Guidelines on quality and
  environmental management systems auditing

5
ISO 9000 Family

• ISO 100051995 QM-Guidelines for quality plans
• ISO 100061997 QM-Guidelines to quality in
  project management
• ISO 100071995 QM-Guidelines for configuration
  management
• ISO/DIS 10012-1 QA requirements for measuring
  equipments-Part 1 Metrological confirmation
  system for measuring equipment
• ISO 10012-21997 QA requirements for measuring
  equipments-Part 2 Guidelines for control of
  measurement of processes

6
ISO 9000 Family

• ISO 100131995 Guidelines for developing quality
  manuals
• ISO/TR 100141998 Guidelines for managing the
  economics of quality
• ISO 100151999 QM-Guidelines for training
• ISO/TS 169491999 QS-Automotive
  suppliers-Particular requirements for the
  application of ISO 90011994

7
The Consistent PairISO 90012000 ISO 90042000

• ISO 90012000
• Addresses QMS requirements that help demonstrate
  capability to meet customer needs
• Only standard for certifying a QMS

• ISO 90042000
• For designing a comprehensive QMS addressing
  needs of all interested parties
• Beyond ISO 9001

8
The Consistent PairISO 90012000 ISO 90042000

• Stand-alone
• Common vocabulary and underlying principles
• Common process approach
• Consistency supports transition beyond ISO 9001
• Identical structure and sequence
• Promotes enhanced synergy
• Aids efficiency and effectiveness
• Facilitates user-friendly introduction of QMS
• Enables alignment of QMS to operations

9
Main Features

• Increased focus and emphasis on
• Top management commitment
• Customer satisfaction
• Organizational processes
• Introduces continual improvement concepts
• Aids respond to changing customer needs
• Stimulates efficiency and improves competitiveness

• Based on eight quality management principles
  reflecting best management practices
• Continuity, compatible with 1994 version
• Covers activities that assure customers that
  needs are being met

10
Structure, Sequence, Application

• Structure
• Four Main Sections
• Management responsibility
• Resource management
• Product realization
• Measurement, analysis and improvement

• Sequence
• Process orientation
• Logical sequence
• Requirements
• Guidelines

11
Top Management Resources

• Top management
• Increased emphasis includes commitment to
• Develop/improve QMS
• Customer focus
• Consider statutory and regulatory requirement
• Establish measurable objectives at relevant
  functions and levels

• Resources
• Top management to provide make available
• Evaluate training effectiveness
• Provide relevant information
• Internal/external communication
• Facility needs
• Human/physical factors of work environment

12
Others

• Continual improvement
• Defines complete cycle to improve the
  effectiveness of QMS
• Documentation
• Instead demonstrate effective operation
• Customer satisfaction
• Monitoring info on customer as measure of system
  performance
• Application
• Concept of exclusions
• Customize specific needs

13
QMS Assist in Enhancing Customer Satisfaction

• Encourage analysis of customer requirements
• Define processes to achieve acceptable product
• Controls processes
• Provides framework for continual improvement

• Increases probability of enhancing satisfaction
  of all interested parties
• Provides confidence on ability to provide product
  that consistently fulfill requirements

14
QMS v/s Product Requirements

• ISO 9001 specifies QMS requirements
• Generic
• Applicable regardless of product category
• Does not establish product requirements

• Product requirements specified by customer,
  regulation, self are found in
• Technical specifications
• Product standards
• Process standards
• Contracts
• Regulations

15
Steps to Develop, Implement, Maintain Improve
QMS

• Determine need expectations
• Establish quality policy and objectives
• Determine processes responsibilities to attain
  quality objectives
• Determine provide resources to attain quality
  objectives
• Establish methods to measure effectiveness
  efficiency of process

• Apply measures to determine process effectiveness
  efficiency
• Determine means to prevent eliminate
  nonconformities
• Establish apply process for continual
  improvement of QMS

16
Process approach

• Systematic identification and management of
  processes employed within an organization and
  particularly the interactions between such
  processes

17
Process Approach
18
Quality Policy Objectives

• Provides focus to direct the organization
• Determines desired results
• Aids in applying resources
• Quality policy provides framework to establish
  review quality objectives

• Quality objectives to be consistent with
• Quality policy
• Commitment to continual improvement
• Meeting quality objectives
• Should be measurable
• Positively impacts satisfaction confidence of
  interested parties

19
Role of Top Management

• Establish, maintain and promote policy
  objectives
• Ensure focus on customer requirements
• Ensure process implementation
• Ensure resource availability

• Ensure effective, efficient QMS is established,
  implemented maintained
• Regular review of QMS
• Decide on actions regarding
• Policy, objectives
• QMS improvement

20
Value of Documentation

• Documentation should be a value-adding activity
• Documentation contributes to achievement of
• Conformity to customer requirements
• Continual improvement
• Repeatability and traceability
• Objective evidence
• Evaluation of effectiveness suitability of QMS

21
Types of QMS Documents

• Quality manuals provides consistent info about
  QMS
• Quality plans describe application of QMS
  to specific product, project or contract
• Specifications states requirements
• Guidelines states recommendations or
  suggestions
• Provides info on HOW to perform
  activities/processes consistently e.g. documented
  procedures, work instructions, drawings
• Records provides objective evidence of
  activities performed or results achieved

22
QMS Evaluation

• Ask Qs for each process
• Identified defined?
• Responsibility assigned?
• Procedures implemented and maintained?
• Effective in achieving desired results?

• Scope and range of evaluation activities
• Audits on QMS
• Review of QMS
• Self assessment of QMS
• Audit systematic, independent documented
  process for obtaining audit evidence evaluating
  it objectively to determine the extent to which
  audit criteria are fulfilled

23
Continual Improvement

• Aims at increasing probability of enhancing
  satisfaction of all interested parties
• Analyze evaluate current situation
• Identify areas establish objectives for
  improvement
• Identify, evaluate, select implement solutions
• Measure, verify, analyze evaluate results
• Determine whether or not objectives are met
• Formalize changes identify scope for further
  improvement

24
Role of statistical techniques

• Helps understand variability
• Measure, describe, analyze, interpret, model
• Nature, extent, causes
• Aids problem solving and prevention
• Improves effectiveness and efficiency
• Improves use of data for decision-making
• Promotes continual improvement

25
Quality Management Principles

• Defined in ISO 90002000
• Basis for performance improvement and
  organizational excellence
• Derived from collective international experience
  and knowledge
• Specific challenges determine nature of
  application

• Customer focus
• Leadership
• Involvement of people
• Process approach
• System approach to management
• Continual improvement
• Factual approach to decision making
• Mutually beneficial supplier relationships

26
Quality Management System

• 4.1 General requirements
• 4.2 Documentation requirements
• 4.2.1 General
• 4.2.2 Quality Manual
• 4.2.3 Control of documents
• 4.2.4 Control of Record

27
Management Responsibility

• 5.1 Management Commitment
• 5.2 Customer focus
• 5.3 Quality policy
• 5.4 Planning
• 5.4.1 Quality Objectives
• 5.4.2 Quality management system planning

28
Management Responsibility

• 5.5 Responsibility, authority and communication
• 5.5.1 Responsibility and authority
• 5.5.2 Management Representative
• 5.5.3 Internal communication
• 5.6 Management review
• 5.61 General
• 5.6.2 Review input
• 5.6.3 Review output

29
Resource Management

• 6.1 Provision of resources
• 6.2 Human resources
• 6.2.1 General
• 6.2.2 Competence, awareness and training
• 6.3 Infrastructure
• 6.4 Work environment

30
Product Realization

• 7.1 Planning of product realization
• 7.2 Customer related processes
• 7.2.1 Determination of requirements related to
• the product
• 7.2.2 Review of requirements related to the
• product
• 7.2.3 Customer communication

31
Product Realization

• 7.3 Design and development
• 7.3.1 Design and development planning
• 7.3.2 Design and development inputs
• 7.3.3 Design and development outputs
• 7.3.4 Design and development review
• 7.3.5 Design and development verification
• 7.3.6 Design and development validation
• 7.3.7 Control of design and development changes

32
Product Realization

• 7.4 Purchasing
• 7.4.1 Purchasing process
• 7.4.2 Purchasing information
• 7.4.3 Verification of purchased product

33
Product Realization

• 7.5 Production and service provision
• 7.5.1 Control of production and service
• provision
• 7.5.2 Validation of processes for production and
  service provision
• 7.5.3 Identification and traceability
• 7.5.4 Customer property
• 7.5.5 Preservation of product
• 7.6 Control of monitoring and measuring devices

34
Measurement, Analysis and Improvement

• 8.1 General
• 8.2 Monitoring and measurement
• 8.2.1 Customer satisfaction
• 8.2.2 Internal audit
• 8.2.3 Monitoring and measurement of
• processes
• 8.2.4 Monitoring and measurement of
• product

35
Measurement, Analysis and Improvement

• 8.3 Control of non-conforming product
• 8.4 Analysis of data
• 8.5 Improvement
• 8.5.1 Continual improvement
• 8.5.2 Corrective action
• 8.5.3 Preventive action

36
ImplementationStep 1

• Identify the goals to be achieved. Typical goals
  may be
• Be more efficient and profitable
• Produce products and services that consistently
  meet customer requirements
• Achieve customer satisfaction
• Increase market share
• Maintain market share
• Improve communications and morale in the
  organization
• Reduce costs and liabilities
• Increase confidence in the production system

37
ImplementationStep 2

• Identify what others expect of the organization.
• These are the expectations of interested parties
  (stakeholders) such as
• Customers and end users
• Employees
• Suppliers
• Shareholders
• Society

38
ImplementationStep 3

• Obtain information about the ISO 9000 family.
• For general information, read the information in
  this material.
• For more detailed information, see ISO 90002000,
  ISO 90012000 and ISO 90042000
• For supporting information, implementation case
  studies and news of ISO 9000 developments
  worldwide refer appropriate and authentic sources

39
ImplementationStep 4

• Apply the ISO 9000 family of standards in the
  organizations management system.
• Decide if the organization is seeking
  certification that its quality management system
  is in conformance with ISO 90012000 or if it is
  preparing to apply for a national quality award.
• Use ISO 90012000 as the basis for certification
• Use ISO 90042000 in conjunction with your
  national quality award criteria to prepare for a
  national quality award

40
ImplementationStep 5

• Obtain guidance on specific topics within the
  quality management system. Topic-specific
  standards are
• ISO 10006 for project management
• ISO 10007 for configuration management
• ISO 10012 for measurement systems
• ISO 10013 for quality documentation
• ISO/TR 10014 for managing the economics of
  quality
• ISO 10015 for training
• ISO/TS 16949 for automotive suppliers
• ISO 19011 for auditing

41
ImplementationStep 6

• Establish current status of the organization,
  determine the gaps between its quality management
  system and the requirements of ISO 90012000.
• One can use one or more of the following
• Self assessment
• Assessment by an external organization

42
ImplementationStep 7

• Determine the processes that are needed to supply
  products to customers.
• Review the requirements of the ISO 90012000
  section on Product Realization to determine how
  they apply or do not apply to the organizations
  quality management system including
• Customer related processes
• Design and/or development
• Purchasing
• Production and service operations
• Control of measuring and monitoring devices

43
ImplementationStep 8

• Develop a plan to close the gaps identified in
  Step 6 and to develop the processes determined in
  Step 7. Identify actions needed to close the
  gaps, allocate resources to perform these
  actions, assign responsibilities and establish a
  schedule to complete the needed actions.
• Carry out the plan. Proceed to implement the
  identified actions and track progress to your
  schedule
• Undergo periodic internal assessment.

44
ImplementationStep 9

• Identify whether the organization needs to
  demonstrate conformance.
• An organization may need or wish to show
  conformance (certification/registration) for
  various purposes, for example
• Contractual requirements
• Market reasons or customer preference
• Regulatory requirements
• Risk management
• To set a clear goal for internal quality
  development (motivation)

45
ImplementationStep 10

• Undergo independent audit. Engage an accredited
  registration/certification body to perform an
  audit and certify that the organizations quality
  management system complies with the requirements
  of ISO 90012000.
• Continue to improve business. Review the
  effectiveness and suitability of your quality
  management system. ISO 90042000 provides a
  methodology for improvement.