Title: General Overview of
1General Overview of
2Quality 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
3ISO 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
4ISO 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
5ISO 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
6ISO 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
7The 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
8The 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
9Main 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
10Structure, Sequence, Application
- Structure
- Four Main Sections
- Management responsibility
- Resource management
- Product realization
- Measurement, analysis and improvement
- Sequence
- Process orientation
- Logical sequence
- Requirements
- Guidelines
11Top 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
12Others
- 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
13QMS 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
14QMS 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
15Steps 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
16Process approach
- Systematic identification and management of
processes employed within an organization and
particularly the interactions between such
processes
17Process Approach
18Quality 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
20Value 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
21Types 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
22QMS 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
23Continual 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
24Role 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
25Quality 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
26Quality 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
27Management 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
28Management 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
29Resource 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
30Product 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
31Product 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
32Product Realization
- 7.4 Purchasing
- 7.4.1 Purchasing process
- 7.4.2 Purchasing information
- 7.4.3 Verification of purchased product
33Product 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
34Measurement, 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
35Measurement, 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
36ImplementationStep 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
37ImplementationStep 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
38ImplementationStep 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
39ImplementationStep 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
40ImplementationStep 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
41ImplementationStep 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
42ImplementationStep 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
43ImplementationStep 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.
44ImplementationStep 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)
45ImplementationStep 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.