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General Overview of

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ISO 10005:1995: QM-Guidelines ... Stand-alone. Common vocabulary and underlying principles. Common process approach ... Does not establish product requirements ... – PowerPoint PPT presentation

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Title: 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.
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