Iso9000 2000

ISO 9001:2000
3/30/2013
http://www.kwaliteg.co.za - ISO 9000:2000 explained
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
3/30/2013
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
3/30/2013
New ISO 9001

Management Responsibility
General requirements
Resource management
QMS
Measurement, analysis & improvements
General requirements
Product Realization
Continual Improvement cycle

3/30/2013 http://www.kwaliteg.co.za - ISO 9000:2000 explained 4
ISO 9001:2000 Model

Continual Improvement of the Quality Management System
5.Management Responsibility
CUSTOMERS
CUSTOMERS
Quality Management
Satisfaction
6. Resource Management
System
8. Measurement
Analysis and Improvement
Requirements
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7. Product Realization
Product
Consumption
Principles of new standard
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Organization depends customers Understand current & future customer needs. Meet / exceed customer expectations
Customer focus
Leaders establish purpose & direction of the organization Should create & maintain environment to achieve organizations objectives
Leadership
People of all levels are essence of an organization Their full involvement for organizations benefit
Involvement of People
Process approach
Desired results are achieved more efficiently when activities and resources are managed as process

System approach to Management
Identifying, understanding and managing interrelated process as a system contributes to the organizations effectiveness & efficiency
Continual improvement of the organizations overall performance should be a permanent objective of the organization
Continual improvements
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
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
3/30/2013
Important changes
Criteria
Main focus
Previous version
Products
New Version
Customer satisfaction
Approach
Product requirements
20 quality elements
Requirements specified by customer / organization
Value adding processes

+ Statutory & regulatory requirements
Involvement of people Improvements
What to do, When, Whom & How + Why it is to be done to do Maintain the system requirements 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
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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

E.g. - Purchasing Process

Inputs
Required item / quantity / date Applicable specs Supplier source Suppliers capability to meet our requirements
Purchasing Procedure
Storage Inspection and Testing Manufacturing Finance
Interactions to
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
System Requirements / Structure of the Standard

4 Quality Management System 5 Management Responsibility 6 Resource Management 7 Product Realization 8 Measurement Analysis & improvement
General requirements Documentation Requirements
Management Commitment
Provision of resources Human resources Infrastructures
Planning
General
Customer focus
Customer related processes Design & development Purchasing
Monitoring & measurement Control of NCP
Quality policy
Planning Work environment Responsibility, authority & communication
Analysis of data
Improvements Production & service provision
Management Reviews
4 - Quality management system

Identification of processes required
4.1 General
requirements
Monitoring and Measuring of processes Availability of information & resources for
Criteria and
methods to ensure Operation & control
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
5 - Management Responsibility
5.1 Management commitment 5.2 Customer focus 5.3 Quality policy 5.4 Planning 5.6 Responsibility authority & communicate 5.7 Management Review
Quality objectives QMS planning
Responsibility & authority Management representative

Internal communication
General Review inputs Review outputs
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Development, implementation and continually improvement of QMS Establishment of
Quality Policy Quality Objectives
Top Managements commitment
Identification of Customer requirements
Communication of importance of Appointment of Management Representative Conducting Management Reviews

Regulatory & statutory requirements Meeting customer requirements Quality Policy & Quality objectives Responsibilities & authorities
Providing required resources

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 6.2 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
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

7 - Product Realization
7.1 Planning of product realization 7.2 Customer related processes 7.3 Design and development 7.4 Purchasing 7.5 Production & service provision 7.6 Control of monitoring measuring devices
Identification of customer requirement
Design planning Design inputs Design outputs Design review Design verification Design validation
Purchasing process Purchasing information Verification of purchased products
Control Validation of processes Identification & traceability Customer property Preservation of product
Review of customer requirement
Customer communication
Design Changes
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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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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
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
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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Product characteristics (Specs) Procedures and work instructions
7.5 Production and service provision
Suitable equipments to manufacture. Monitoring and inspection & testing
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
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 8.2 Monitoring & measurements 8.3 Control of non conforming product 8.4 Analysis of data 8.5 Improvement
Customer satisfaction Internal audits
Corrective action
Measurement of processes Measurement of product
Preventive action
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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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8.4 - 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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8.5 - 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
Criteria for measurements

Satisfaction surveys for customers and other interested parties Feedback on products Customer & market requirements
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
System performanc e
Criteria for measurements

Process capability / process validation Reaction time Cycle time / throughput (Capacity) Utilization of technology Waste reduction Cost reduction
Processes
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

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
3/30/2013
38
Thank You
3/30/2013
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ISO 9001:2000

http://www.kwaliteg.co.za - ISO 9000:2000 explained

Highlight important areas and changes of the new standard

Briefly introduce the system requirements of the new standard

http://www.kwaliteg.co.za - ISO 9000:2000 explained

What is ISO 9001: 2000

Introduced considerable conceptual changes

http://www.kwaliteg.co.za - ISO 9000:2000 explained

New ISO 9001

Measurement, analysis & improvements

Continual Improvement cycle

ISO 9001:2000 Model

Principles of new standard

http://www.kwaliteg.co.za - ISO 9000:2000 explained

Principles of new standard

Principles of new standard

Factual approach to decision making

Mutually beneficial supplier relationships

Expectations of the new Standard

Enable Continual improvements of the system for enhanced customer satisfaction

Enable compliance to statutory & regulatory requirements

http://www.kwaliteg.co.za - ISO 9000:2000 explained

Value adding processes

Involvement of people Improvements

http://www.kwaliteg.co.za - ISO 9000:2000 explained

Identify the processes

Identify the Inputs & outputs

Identify the Interactions to other processes

Establish measurin g criteria

Do it for all value adding processes

http://www.kwaliteg.co.za - ISO 9000:2000 explained

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

E.g. - Purchasing Process

Storage Inspection and Testing Manufacturing Finance

System Requirements / Structure of the Standard

General requirements Documentation Requirements

Provision of resources Human resources Infrastructures

Customer related processes Design & development Purchasing

Monitoring & measurement Control of NCP

Planning Work environment Responsibility, authority & communication

Improvements Production & service provision

4 - Quality management system

operation & control

http://www.kwaliteg.co.za - ISO 9000:2000 explained

4 - Quality management system

Procedures required by the Standard

Procedures required for planning, operation & control of Organization activities

Quality objectives QMS planning

Responsibility & authority Management representative

General Review inputs Review outputs

http://www.kwaliteg.co.za - ISO 9000:2000 explained

Top Managements commitment

Identification of Customer requirements

Communication of importance of Appointment of Management Representative Conducting Management Reviews

Providing required resources

http://www.kwaliteg.co.za - ISO 9000:2000 explained

Competence, awareness & training

http://www.kwaliteg.co.za - ISO 9000:2000 explained

Define competencies for people performing work affecting product quality

6.2 Human Resources

Provide training or actions