Introduction to ISO 9000:2000

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ISO 90012000
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Objective
Introduce the concept of new ISO 9001 Standard
Highlight important areas and changes of the new
standard
Briefly introduce the system requirements of the
new standard
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What is ISO 9001 2000
2nd revision of Quality Management System
Requirement Standard from International
Organization for Standards
Replacement for previous ISO 9001 / 9002 and 9003
standards of 1994
Introduced considerable conceptual changes
Applicable to all types of Organizations with
possible permissible omissions of certain
requirements
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New ISO 9001
QMS
Management Responsibility
Resource management
Measurement, analysis improvements
Product Realization
Continual Improvement cycle
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ISO 90012000 Model
Continual Improvement of the Quality Management
System
Quality Management System
5.Management Responsibility
8. Measurement Analysis and Improvement
6. Resource Management
CUSTOMERS
CUSTOMERS
Satisfaction
7. Product Realization
Requirements
Product
Consumption
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Principles of new standard
Leadership
Customer focus
Mutual beneficial supplier relationship
Involvement of people
Based on eight quality management principles
Factual approach to decision making
Process approach
System approach to Management
Continual improvement
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Principles of new standard

• Customer focus
• Organization depends customers
• Understand current future customer needs.
• Meet / exceed customer expectations

• Leadership
• Leaders establish purpose direction of the
  organization
• Should create maintain environment to achieve
  organizations objectives

• Involvement of People
• People of all levels are essence of an
  organization
• Their full involvement for organizations benefit

Process approach Desired results are achieved
more efficiently when activities and resources
are managed as process
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Principles of new standard
System approach to Management Identifying,
understanding and managing interrelated process
as a system contributes to the organizations
effectiveness efficiency
Continual improvements Continual improvement of
the organizations overall performance should be
a permanent objective of the organization
Factual approach to decision making Effective
decisions are based on the analysis of data and
information

• Mutually beneficial supplier relationships
• An organization its suppliers are
  interdependent
• Mutually beneficial relationship enhances the
  ability of both to create value

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Expectations of the new Standard
Avoid the application of systems that are
separate from the organizations business process
Enable the development of a Quality system that
is fully integrated into the normal operations of
organizations business
Enable Continual improvements of the system for
enhanced customer satisfaction
Enable compliance to statutory regulatory
requirements
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Important changes
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Process approach
Process definition Set of interrelated or
interacting activities which transforms inputs
into outputs
Ensure continual improvements
Do it for all value adding processes
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Process approach Continual improvements of
Process
Understandings meeting requirements PLAN
PDCA Cycle
Processes in terms Of Added Value DO
Continual improvements of Processes based on
objective measurements ACTION
Measure results of process Performance and
effectiveness - Objective Measurements CHECK
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E.g. - Purchasing Process

• Outputs
• Receipt of Material on right condition
• Right Quality Right Quantity
• Right Time

• Performance Measurements
• Delivery status On-time, On spec, NCP etc
• Supplier evaluation

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System Requirements / Structure of the Standard
4 Quality Management System
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4 - Quality management system
Identification of processes required
Continual improvements
4.1 General requirements
Criteria and methods to ensure Operation
control
Monitoring and Measuring of processes
Availability of information resources for
operation control
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4 - Quality management system
4.2 Document requirements
Quality Policy
Quality Objectives
Quality Manual
Procedures required by the Standard
Procedures required for planning, operation
control of Organization activities
Records
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5 - Management Responsibility
5.1 Management commitment
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5 - Management Responsibility
Top Managements commitment
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5 - Management Responsibility
Evidence must be provided to show that the
Management is committed to the above requirements
Auditors could speak to and audit Top Management
(E.g. MD / Directors) to establish their
commitment to the management system
New Development
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6 - Resource Management
6.1 Provision of resources
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6 - Resource Management
Resource Management
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6 - Human Resources
Enhanced
6.2 Human Resources
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7 - Product Realization
7.1 Planning of product realization
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7 - Product Realization
7.1 Planning of Product realization
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7 - Product Realization
7.2 Customer related processes (Sales)
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7 - Product Realization
7.3 Design and Development (Product)
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7 - Product Realization
7.4 Purchasing Purchasing is done in controlled
manner to ensure that purchased products conforms
to specific requirements
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7 - Product Realization
7.5 Production and service provision Manufacturing
/ service provision under controlled condition
to ensure conformity of product
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7 - Product Realization
7.6 Control of monitoring and measuring
devices Control and Calibration of equipments
used for monitoring, inspection and testing
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8 - Measurement, analysis and improvement
8.1 General
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8 - Measurement, analysis and improvement

• To demonstrate
• Conformity of the product
• Conformity to QMS requirements
• Continually improvements and the effectiveness of
  the system

• 8.1 - To demonstrate
• Conformity of the product
• Conformity to QMS requirements
• Continually improvements and the effectiveness of
  the system

• 8.2 - Monitoring and Measurements
• Customer satisfaction / perception
• Internal audits - conformity planned
  arrangements of QMS and ISO9001
• Monitoring and measurements of processes to
  determine / demonstrate ability of processes to
  achieve required results
• Monitoring and measurements of product
  Conformity to product requirements

• 8.3 - Control of NCP
• To assure that NCP products are identified and
  controlled to prevent unintended use / delivery

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8 - Measurement, analysis and improvement
8.4 - Analysis of data Collection and
analysis of data generated through QMS activities
to verify suitability, effectiveness and
continual improvement of the system

• Analysis shall provide information related to
• Customer satisfaction / perception
• Conformity to specs, requirements
• Trends of processes and products
• Opportunities for preventive actions
• Suppliers

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8 - Measurement, analysis and improvement

• 8.5 - Improvements
• Continual Improvements
• QMS needed to be continually improved

• Corrective action
• Actions to prevent recurrence of NCP, NCR etc
• Includes reviews, determination of causes, need
  of action, implementation of action, review of
  action and maintenance of relevant records

• Preventive action
• Actions against potential non conformities to
  avoid their occurrence
• Includes identification of potential non
  conformities, cause, need for action,
  implementation of action, review of action and
  maintenance of records

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Criteria for measurements
System performance
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Criteria for measurements
Processes
Products
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Pros and Cons
More business oriented. Less procedure oriented
Company wide involvement
Mutual benefit to all interested parties
Customer focus than product focus
Continual improvements
Less emphasis on documentation
Demanding more resources ??
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Challenges in implementing new standard
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ISO 90012000 Transition Process
4th visit
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Thank You