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Objective
Introduce the concept of new ISO 9001 Standard
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Replacement for previous ISO 9001 / 9002 and 9003 standards of 1994
Applicable to all types of Organizations with possible permissible omissions of certain requirements
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General requirements
Resource management
QMS
General requirements
Product Realization
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
http://www.kwaliteg.co.za - ISO 9000:2000 explained
Product
Consumption
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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
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Continual improvement of the organizations overall performance should be a permanent objective of the organization
Continual improvements
Enable the development of a Quality system that is fully integrated into the normal operations of organizations business
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Important changes
Criteria
Main focus
Previous version
Products
New Version
Customer satisfaction
Approach
Product requirements
20 quality elements
Requirements specified by customer / organization
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
Ensure continual
improvements
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Process approach
Continual improvements of Process
Understandings & meeting requirements PLAN
PDCA Cycle
Purchasing Procedure
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
3/30/2013 http://www.kwaliteg.co.za - ISO 9000:2000 explained 13
Management Commitment
Planning
General
Customer focus
Quality policy
Analysis of data
Management Reviews
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Continual improvements
4.1 General
requirements
Monitoring and Measuring of processes Availability of information & resources for
Criteria and
methods to ensure Operation & control
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Quality Objectives
Quality Manual
Records
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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 5.7 Management Review
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5 - Management Responsibility
Development, implementation and continually improvement of QMS Establishment of
Quality Policy Quality Objectives
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 6.2 Human Resources 6.3 Infrastructures 6.4 Work Environment
General
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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
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Enhanced
6 - Human Resources
Competent on the basis of appropriate education, skill and experience
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
Design planning Design inputs Design outputs Design review Design verification Design validation
Control Validation of processes Identification & traceability Customer property Preservation of product
Customer communication
Design Changes
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7 - Product Realization
Quality objectives of Products Specs
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7 - Product Realization
Identification of Customer / Market requirements
Specified by customer Requirements taken for granted Statutory / Regulatory requirements
Review of requirements related product prior to acceptance / commitment to customers - ability to meet customer requirements
7 - Product Realization
Planning
Effective & efficient Expectations of interested parties EHS
7.3
Design and Development (Product)
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
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7 - Product Realization
Product characteristics (Specs) Procedures and work instructions
Process validation
Identification and traceability Customers property Material supplied by customers e.g.. 3rd party blending
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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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Continual improvements
Corrective action
Preventive action
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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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System performanc e
Processes
Products
Inspection and testing of incoming, in process and final product Product verification Product validation
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Encouragement
New ISO
Communication
1st visit
2nd visit
3rd visit
4th visit
2 years
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Thank You
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