ISO 9001:2000
- 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
- ISO 9000:2000 explained
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
- ISO 9000:2000 explained
New ISO 9001
QMS
Resource
management
Measurement,
analysis &
improvements
Product
Realization
Management
Responsibility
Continual Improvement cycle
General requirements
General requirements
- ISO 9000:2000 explained
ISO 9001:2000 – Model
CUSTOMERS
CUSTOMERS
Quality Management
System
Responsibility
7. Product
Realization
6. Resource
Management
8. Measurement
Analysis and
Improvement
Requirements
Satisfaction
Continual Improvement of
the Quality Management System
Consumption
Product
- ISO 9000:2000 explained
Principles of new standard
Based on eight quality management principles
Leadership
Process approach
Involvement of people
System approach to Management
Continual improvement
Factual approach to decision making
Mutual beneficial supplier relationship
Customer focus
- ISO 9000:2000 explained
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
- ISO 9000:2000 explained
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
- ISO 9000:2000 explained
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
- ISO 9000:2000 explained
Important changes
+ Why it is to be done
What to do, When, Whom & How to do
Involvement of people
Continual improvements should be achieved
Maintain the system requirements
Improvements
+ Statutory & regulatory requirements
Requirements specified by customer / organization
Product requirements
Value adding processes
20 quality elements
Approach
Customer satisfaction
Products
Main focus
New Version
Previous version
Criteria
- ISO 9000:2000 explained
Process approach
Process definition
Set of interrelated or interacting activities which transforms inputs into outputs
Ensure continual improvements
Identify the processes
Do it for all value adding processes
Establish measuring criteria
Identify the Interactions to other processes
Identify the Inputs & outputs
- ISO 9000:2000 explained
Process approach –
Continual improvements of Process
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
Understandings &
meeting requirements
PLAN
- ISO 9000:2000 explained
. - Purchasing Process
Performance Measurements
Delivery status – On-time, On spec, NCP etc
Supplier evaluation
Outputs
Receipt of Material on right condition
Right Quality Right Quantity
Right Time
Purchasing
Procedure
Interactions to
Storage
Inspection and Testing
Manufacturing
Finance
Inputs
Required item / quantity / date
Applicable specs
Supplier source
Suppliers capability to meet our requirements
- ISO 9000:2000 explained
Provision of resources
Human resources
Infrastructures
Work environment
6 Resource Management
General requirements
Documentation Requirements
Planning
Customer related processes
Design & development
Purchasing
Production & service provision
Management Commitment
Customer focus
Quality policy
Planning
Responsibility, authority & communication
Management Reviews
5 Management Responsibility
8 Measurement Analysis & improvement
System Requirements / Structure of the Standard
4 Quality Management System
7 Product Realization
General
Monitoring & measurement
Control of NCP
Analysis of data
Improvements
- ISO 9000:2000 explained
4 - Quality management system
General
requirements
Identification
of processes
required
Criteria and
methods to ensure
Operation & control
Availability of
information &
resources for
operation & control
Monitoring and
Measuring of
processes
Continual
improvements
- ISO 9000:2000 explained
4 - Quality management system
Quality Policy
Quality Objectives
Quality Manual
Procedures required by the Standard
Procedures required for planning, operation & control of Organization activities
Records
Document requirements
- ISO 9000:2000 explained
5 - Management Responsibility
Responsibility authority & communicate
Planning
Management commitment
Customer focus
Management Review
Quality policy
Quality objectives
QMS planning
General
Review inputs
Review outputs
Internal communication
Management representative
Responsibility & authority
- ISO 9000:2000 explained
5 - Management Responsibility
Development, implementation and continually improvement of QMS
Communication of importance of
Regulatory & statutory requirements
Meeting customer requirements
Quality Policy & Quality objectives
Responsibilities & authorities
Appointment of Management Representative
Conducting Management Reviews
Providing required resources
Establishment of
Quality Policy
Quality Objectives
Identification of Customer requirements
Top Management’s commitment
- ISO 9000:2000 explained
5 - Management Responsibility
New
Development
Evidence must be provided to show that the Management is committed to the above requirements
Auditors could speak to and audit Top Management (. MD / Directors) to establish their commitment to the management system
- ISO 9000:2000 explained
6 - Resource Management
Work Environment
Infrastructures
Human Resources
General
Competence, awareness & training
Provision of resources
- ISO 9000:2000 explained
6 - Resource Management
Resources required to
Implementing, monitoring & continual improvements
Enhance Customer satisfaction by meeting customer requirements
Human Resources
Infrastructures
Infrastructures needed to achieve product conformity
Work environment
Work environment needed to achieve product conformity
Resource Management
- ISO 9000:2000 explained
6 - Human Resources
Enhanced
Competent on the basis of appropriate education, skill and experience
Define competencies for people performing work affecting product quality
Provide training or actions
Evaluate effectiveness of the training / actions
Employees should aware importance of the activity being performed
Human Resources
- ISO 9000:2000 explained
7 - Product Realization
Control of monitoring measuring devices
Control
Preservation of product
Validation of processes
Identification & traceability
Customer property
Production & service provision
Verification of purchased products
Purchasing process
Purchasing information
Purchasing
Design planning
Design inputs
Design outputs
Design review
Design Changes
Design validation
Design verification
Design and development
Planning of product realization
Identification of customer requirement
Review of customer requirement
Customer communication
Customer related processes
- ISO 9000:2000 explained
7 - Product Realization
Quality objectives of Products – Specs
Processes, procedures to realize product
Verification, validation, monitoring, inspection and testing of product
Record to demonstrate conformance
Planning of Product realization
- ISO 9000:2000 explained
7 - Product Realization
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
Identification of Customer / Market requirements
Specified by customer
Requirements taken for granted
Statutory / Regulatory requirements
Customer related processes – (Sales)
- ISO 9000:2000 explained
7 - Product Realization
Design inputs and outputs
Review and verification, validation and control of changes
Accuracy
Potential hazards & faults
Corrections
Evaluations against lessons learned
Planning
Effective & efficient
Expectations of interested parties
EHS
Design and Development – (Product)
- ISO 9000:2000 explained
7 - Product Realization
Supplier evaluation
Verification of purchased product – Inspection and testing
Degree of control depends on effects of subsequent processes and effect on final product
Purchasing
Purchasing is done in controlled manner to ensure that purchased products conforms to specific requirements
- ISO 9000:2000 explained
7 - Product Realization
Product characteristics (Specs)
Procedures and work instructions
Suitable equipments to manufacture. Monitoring and inspection & testing
Product release, delivery and post delivery
Process validation
Identification and traceability
Customers property
Material supplied by customers – .. 3rd party blending
Production and service provision
Manufacturing / service provision under controlled condition to ensure conformity of product
- ISO 9000:2000 explained
7 - Product Realization
Control of monitoring and measuring devices
Control and Calibration of equipments used for monitoring, inspection and testing
- ISO 9000:2000 explained
8 - Measurement, analysis
and improvement
Monitoring & measurements
Analysis of data
Improvement
Control of non conforming product
Measurement of product
Internal audits
Customer satisfaction
Measurement of processes
Corrective action
Preventive action
Continual improvements
General
- ISO 9000:2000 explained
8 - Measurement, analysis
and improvement
To demonstrate
Conformity of the product
Conformity to QMS requirements
Continually improvements and the effectiveness of the system
- 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
- Control of NCP
To assure that NCP products are identified and controlled to prevent unintended use / delivery
- To demonstrate
Conformity of the product
Conformity to QMS requirements
Continually improvements and the effectiveness of the system
- ISO 9000:2000 explained
8 - Measurement, analysis
and improvement
- 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
- ISO 9000:2000 explained
8 - Measurement, analysis
and improvement
- 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
- ISO 9000:2000 explained
Criteria for measurements
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
Financial measurements
Prevention cost
Non conforming / failure cost
Lifecycle cost
Self assessment
Satisfaction surveys for customers and other interested parties
Feedback on products
Customer & market requirements
System performance
- ISO 9000:2000 explained
Criteria for measurements
Inspection and testing of incoming, in process and final product
Product verification
Product validation
Process capability / process validation
Reaction time
Cycle time / throughput (Capacity)
Utilization of technology
Waste reduction
Cost reduction
Products
Processes
- ISO 9000:2000 explained
Pros and Cons
More business oriented. Less procedure oriented
Company wide involvement
Mutual benefit to all interested parties
Customer focus than product focus
Demanding more resources ??
Continual improvements
Less emphasis on documentation
- ISO 9000:2000 explained
Challenges in implementing new standard
Communication
Management Support
Other employee Support
New ISO
Encouragement
- ISO 9000:2000 explained
ISO 9001:2000
Transition Process
2 years
Review of QMS & Product realization
Review of Measurement, analysis & improvements
Review of Management responsibility
Review of Resource management
1st visit
2nd visit
3rd visit
4th visit
- ISO 9000:2000 explained
Thank You
- ISO 9000:2000 explained
