ISO 9001:2000
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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 Management Responsibility
General requirements
Resource management
QMS
Measurement, analysis & improvements
General requirements
Product Realization
Continual Improvement cycle April 24, 2007
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ISO 9001:2000 – Model Continual Improvement of the Quality Management System
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CUSTOMERS
Requirements
Quality Management
8. Measurement
6. Resource Management
Analysis and Improvement
Satisfaction
CUSTOMERS
5.Management Responsibility
System
7. Product Realization Ikhwandy properties/Introduction to ISO 9001:2000
Product
Consumption
5
Principles of new standard Customer focus Mutual beneficial supplier ip relationsh
Factual to approach decision making
eight n o d e s a B quality ent managem principles
nt Involveme of people
Process approach Continual ent improvem
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p
Leadershi
System to approach en Managem t
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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 organization’s objectives
Involvement of People
•People of all levels are essence of an organization •Their full involvement for organization’s benefit
Process approach
Desired results are achieved more efficiently when activities and resources are managed as process April 24, 2007
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Principles of new standard System approach to Management
Identifying, understanding and managing interrelated process as a system contributes to the organization’s effectiveness & efficiency
Continual improvements
Continual improvement of the organization’s 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 April 24, 2007
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Expectations of the new Standard Avoid the application of systems that are separate from the organization’s business process
Enable the development of a Quality system that is fully integrated into the normal operations of organization’s business
Enable Continual improvements of the system for enhanced customer satisfaction
Enable compliance to statutory & regulatory requirements
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Important changes Criteria
Previous version
New Version
Main focus
Products
Customer satisfaction
Approach
20 quality elements
Value adding processes
Product requirements
Requirements specified by customer / organization
+ Statutory & regulatory requirements
Involvement of people What to do, When, Whom & How + Why it is to be done to do Improvements
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Maintain the system requirements
Ikhwandy properties/Introduction to ISO 9001:2000
Continual improvements should be achieved
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Process approach Process definition Set of interrelated or interacting activities which transforms inputs into outputs
Identify the processes
Identify the Inputs & outputs
Identify the Interactions to other processes
Establish measurin g criteria
Ensure continual improvements
Do it for all value adding processes April 24, 2007
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Process approach – Continual improvements of Process Understandings & meeting requirements PLAN
Processes in terms Of Added Value DO
PDCA Cycle
Continual improvements of Processes based on objective measurements ACTION
Measure results of process Performance and effectiveness - Objective Measurements CHECK April 24, 2007
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E.g. - Purchasing Process Inputs • Required item / quantity / date • Applicable specs • Supplier source • Suppliers capability to meet our requirements
Purchasing Procedure
Interactions to
•Storage •Inspection and Testing •Manufacturing •Finance
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 April 24, 2007
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System Requirements / Structure of the Standard 4 Quality Management System
General requirements Documentation Requirements
5 Management Responsibility
Management Commitment Customer focus
6 Resource Management
Provision of resources Human resources
7 Product Realization
Planning
General
Customer related processes
Monitoring & measurement
Quality policy Infrastructures Planning
Work environment
Responsibility, authority & communication
8 Measurement Analysis & improvement
Design & development
Control of NCP Analysis of data
Purchasing Improvements Production & service provision
Management Reviews April 24, 2007
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4 - Quality management system Identification Continual
of processes
improvements
required
4.1 General Criteria and
requirements Monitoring and
methods to ensure
Measuring of
Operation & control
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 April 24, 2007
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5 - Management Responsibility 5.1 Management commitment
5.2 Customer focus
5.3 Quality policy
5.4 Planning
5.6 Responsibility authority & communicate
Quality objectives
Responsibility & authority
QMS planning
Management representative Internal communication
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5.7 Management Review
General Review inputs Review outputs
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5 - Management Responsibility Development, implementation and continually improvement of QMS Establishment of •Quality Policy •Quality Objectives
Top Management’s commitment
Identification of Customer requirements
•Appointment of Management Representative •Conducting Management Reviews
Communication of importance of •Regulatory & statutory requirements •Meeting customer requirements •Quality Policy & Quality objectives •Responsibilities & authorities
•Providing required resources April 24, 2007
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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
6.2
Provision of resources
Human Resources
6.3 Infrastructures
6.4 Work Environment
General
Competence, awareness & training
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6 - Resource Management Resources required to Implementing, monitoring & continual improvements Enhance Customer satisfaction by meeting customer requirements
Human Resources Resource Managemen t
Infrastructures Infrastructures needed to achieve product conformity
Work environment Work environment needed to achieve product conformity April 24, 2007
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Enhanced
6 - Human Resources Competent on the basis of appropriate education, skill and experience
Define competencies for people performing work affecting product quality
6.2 Human Resources
Provide training or actions
Evaluate effectiveness of the training / actions
Employees should aware importance of the activity being performed April 24, 2007
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7 - Product Realization 7.1
7.2
7.3
7.4
7.5
7.6
Planning of product realization
Customer related processes
Design and development
Purchasing
Production & service provision
Control of monitoring measuring devices
Purchasing process
Control
Identification of customer requirement
Design planning Design inputs
Review of customer requirement
Design outputs
Customer communication
Design verification
Design review
Purchasing information Verification of purchased products
Design validation
Validation of processes Identification & traceability Customer property Preservation of product
Design Changes April 24, 2007
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7 - Product Realization Quality objectives of Products – Specs
Processes, procedures to realize product
7.1 Planning of Product realization
Verification, validation, monitoring, inspection and testing of product
Record to demonstrate conformance
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7 - Product Realization Identification of Customer / Market requirements •Specified by customer •Requirements taken for granted •Statutory / Regulatory requirements
7.2 Customer related processes – (Sales)
Review of requirements related product prior to acceptance / commitment to customers - ability to meet customer requirements
Effective communication with customer in relation to •Product information •Sales order handling •Customer feedback •Customer complaints April 24, 2007
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7 - Product Realization Planning •Effective & efficient •Expectations of interested parties •EHS
7.3 Design and Development – (Product)
Design inputs and outputs
Review and verification, validation and control of changes •Accuracy •Potential hazards & faults •Corrections •Evaluations against lessons learned April 24, 2007
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7 - Product Realization Degree of control depends on effects of subsequent processes and effect on final product
7.4 Purchasing Purchasing is done in controlled manner to ensure that purchased products conforms to specific requirements
Supplier evaluation
Verification of purchased product – Inspection and testing
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7 - Product Realization Product characteristics (Specs)
Procedures and work instructions
Suitable equipments to manufacture. Monitoring and inspection & testing
7.5 Production and service provision Manufacturing / service provision under controlled condition to ensure conformity of product
Product release, delivery and post delivery
Process validation
Identification and traceability Customers property Material supplied by customers – e.g.. 3rd party blending April 24, 2007
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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
8.2
General
Monitoring & measurements
8.3 Control of non conforming product
8.4
8.5
Analysis of data
Improvement
Customer satisfaction
Continual improvements
Internal audits
Corrective action
Measurement of processes
Preventive action
Measurement of product
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8 - Measurement, analysis and improvement To demonstrate 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 April 24, 2007
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Criteria for measurements –Satisfaction surveys for customers and other interested parties •Feedback on products •Customer & market requirements
System performanc e
–Financial measurements •Prevention cost •Non conforming / failure cost •Lifecycle cost Self assessment
–Internal audits •Effectiveness & efficiency of processes •Opportunities for improvements •Use of data / information •Effective & efficient use of resources •Adequacy, accuracy and performance of measurements •Relationships with customers/ suppliers/ other interested parties April 24, 2007
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Criteria for measurements
Processes
–Process capability / process validation –Reaction time –Cycle time / throughput (Capacity) –Utilization of technology –Waste reduction –Cost reduction
Products
–Inspection and testing of incoming, in process and final product –Product verification –Product validation
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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 Management Support
Encouragement
New ISO
Communication
Other employee Support April 24, 2007
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ISO 9001:2000 Transition Process
1st visit
2nd visit
3rd visit
4th visit
Review of QMS & Product realization
Review of Measurement, analysis & improvements
Review of Management responsibilit y
Review of Resource management
2 years
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Thank You
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