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Lecture Outline
• ISO• ISO 9000 Series of Standards• ISO 9001: 2000 Overview• ISO 9001: 2008• ISO 9003: 2004 Overview
What is ISO?
• Greek word “ISOS”• International Organization for Standardization• Worldwide network of the national standards institutes
157 Member Nations• Promotes international standards in various fields to
facilitate the worldwide exchange of goods & services• Non-governmental organization: members are not, as is
the case in the UN, delegations of national governments • Published three documents which outline requirements
for a Quality Management System ISO 9000 Quality System Standards
Quality Management System
• QMS approach encourages organizations to analyze customer requirements, define processes that contribute to the achievement of a product that is acceptable to customer, and keep these processes under control.
• It provides the confidence to the organization and its customers that it is able to provide products that consistently fulfill requirements.
Quality Management Principle
• “A Quality Management Principle is a comprehensive and fundamental rule or belief, for leading and operating an organization, aimed at continually improving performance over the long term by focusing on customers while addressing the needs of all stakeholders.”
ISO/TS 176/SC 2/N 376
What is ISO 9001:2000?
ISO 9001:2000 is an international
standard for implementing a quality management system
ISO 9001:2000 sets out how a company can
establish an effective quality management system to meet its
stakeholders’ needs
ISO 9001:2000 sets out how a company can
establish an effective quality management system to meet its
stakeholders’ needs
Why Use ISO 9001:2000?
ISO 9000:2000 - Fundamentals and Vocabulary
Provides an introduction to Quality Management Systems (QMS) and vocabulary
ISO 9001:2000 - Requirements Specifies requirements for a QMS where
capability to provide product that meets customer and regulatory requirements needs to be demonstrated
ISO 9004:2000 - Guidelines for Performance Improvement
Provides guidance on using an established QMS to further enhance customer satisfaction and product/service quality
IS0 9000:2000 Series of Standards
ISO 9001 Requirements
• Model for Use in Design, Development, Production, Installation & Servicing
• Use: Where a Supplier’s Capability to Design & Supply
Conforming Product Needs to be Demonstrated• Applicable When:
Design is Required & Products Reqts are Stated in Performance Terms, or they Need to be Established
• Aimed at Achieving Customer Satisfaction by Preventing Nonconformity at all Stages from Design to Servicing
ISO 9002 Requirements
• Model for QA in Production, Installation & Servicing• Use:
Where a Supplier’s Capability to Supply Conforming Product to an Established Design Needs to be Demonstrated
• Applicable When: Specified Requirements are Stated in Terms of an
Established Design or Specification• Aimed at Achieving Customer Satisfaction by
Preventing Non-conformity at All Stages from Production to Servicing
ISO 9003 Requirements
• Model for QA in Final Inspection & Test• Use:
Where a Supplier’s Capability to Detect & Control the Disposition of Any Product Nonconformity During Final Inspection & Test Needs to Be Demonstrated
• Applicable When: Conformance to Specified Requirements is to
be Assured by the Supplier Solely at Final Inspection & Test
1. Customer focus
2. Leadership
3. Involvement of people
4. Process approach
5. System approach to management
6. Continual improvement
7. Factual approach to decision making
8. Mutually beneficial supplier relationship
Eight Quality Management Principles
CONTINUAL IMPROVEMENT OF THE QUALITY MANAGEMENT SYSTEM
CONTINUAL IMPROVEMENT OF THE QUALITY MANAGEMENT SYSTEM
Measurement, analysis and improvement
Measurement, analysis and improvement
ProductProductInput Output
Management responsibility
Resource management
Resource management
Clause 5
Clause 6 Clause 8
Clause 7
Customers
Requirements
Product
realization
Customers
Satisfaction
Value adding activitiesInformation flow
Introduction to ISO 9000:2000
1. Scope
1.1 General
1.2 Application
2. Normative reference
3. Terms and definitione.g., Supplier Organization Customer
ISO 9001:2000 Requirements
Possibility to reduce scope
No 9002 or 9003
Can reduce the scope of requirements related to “product realization”
May not exclude any requirement that affects ability to provide product and/or service that meets customer and regulatory requirements
Permissible Exclusions
• To meet the requirements you must: Document Implement Maintain Continually improve effectiveness
4 Quality Management System
4 Quality Management System
4.1 General requirements Processes, interaction, improvement
4.2 Documentation requirements General Quality manual Control of document Control of records
5 Management Responsibility
5.1 Management commitment
5.2 Customer focus5.3 Quality policy5.4 Planning
Objectives Management system
5.5 Responsibility, authority and communication
Top management emphasis Management representative
Includes promotion of customer requirements throughout the organization
Internal communication5.6 Management review
Lists of inputs and outputs Recommendation for improvement Action items expected Records
5 Management Responsibility
6 Resource Management
6.1 Provision of resources to improve processes and enhance customer satisfaction
6.2 Human resource Determine competence Provide training or other action Evaluate effectiveness of action
6.3 Infrastructure Buildings, workspace, utilities Process equipment Support services
6.4 Work environment Manage conditions of environment to
achieve product requirement conformance
7 Product Realization
7.1 Plan and develop the processes Include product objectives, relevant
processes and resource, appropriate test and validation
7.2 Customer related processes Customer requirement - stated and
implied Statutory and regulatory Product requirements and changes Organization ability Communication with customers
7.3 Design and development Planning, inputs, outputs, systematic
reviews, verification and validation, control of changes
7 Product Realization
7.4 Purchasing Supplier evaluation and selection Relevant purchasing information Verification of purchased product
7.5 Production and service provision Controlled conditions including product
characteristics, work instructions, suitable equipment, measuring devices, and system
Release, delivery and post delivery activities
Validation of processes when no other method
Identification and traceability of product and it’s status
Care of customer property Preservation of product
Includes constituent parts
7 Product Realization
7.6 Control of monitoring and measuring devices Calibrated where necessary Adjusted and readjusted Identifies status Safeguarded from invalid adjustment Protected from damage or deterioration
8 Measurement, Analysis, and Improvement
8.1 General Plan and implement Measurement and monitoring processes
To demonstrate product conformity, system conformity and continually improve the QMS
8.2 Monitoring and measurement Customer satisfaction
Perception of fulfillment Internal planned audit, etc.
Auditors independent of their own work Processes
Demonstrate achievement of planned results Product
Monitor and measure characteristics Conformity with acceptance criteria Waivers / concessions
8 Measurement, Analysis, and Improvement
8.3 Control of nonconforming product Elimination, concession, preclude
intended use
8.4 Analysis of data Customer satisfaction Product and process requirements and
trends Suppliers
8.5 Improvement Continually improve effectiveness
of the system Corrective action Preventive action