ISO 9001 - 2008 Quality Management Systems
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Transcript of ISO 9001 - 2008 Quality Management Systems
Eng R. L. Nkumbwa-2010 Copperbelt University1
ISO 9001 - 2008 Quality Management
Systems
Eng R. L. Nkumbwa-2010 Copperbelt University2
Agenda
General Introduction
Quality Management Principles
Process Approach
Compatibility with Other Management Systems
Eng R. L. Nkumbwa-2010 Copperbelt University3
Introduction
ISO recently released the latest revision: ISO 9001 – 2008.
This part of the training session will cover an introduction to the ISO standard, 2008.
Eng R. L. Nkumbwa-2010 Copperbelt University4
Overview
ISO 9001:1994 was the last revision prior to the 2000 release and now we have the 2008 version.
The standard tells a company what they have to do, but not how to do it.
Eng R. L. Nkumbwa-2010 Copperbelt University5
Advantages of Becoming ISO Certified (QMS) Our customers want it Reduce expenses/variability – Optimization of
costs and resources Lower costs and shorter cycle times through
effective use of resources Focused and prioritized improvement
opportunities Repeat business and referrals Performance advantage through improved
organizational capabilities
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Vocabulary
ISO - International Organization for Standardization
QMS - Quality Management System
Supplier Organization Customer
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CAPA – Corrective Action and Preventive Action
PMT – Process Management Team
Process – any activity or set of activities, that uses resources to transform inputs to outputs.
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General
ISO 9000 describes fundamentals of a QMS.
ISO 9001 specifies the requirements for a QMS.
ISO 9004 provides guidelines to consider for the QMS.
ISO 19011 provides guidance for auditing QMS and Environmental Systems.
Eng R. L. Nkumbwa-2010 Copperbelt University9
General (Cont’d) Adoption of a quality management system should be a
strategic decision of an organization.
The QMS requirements specified in the standard are complimentary to requirements for products.
This standard can be used by internal and external parties.
The quality management principles stated in ISO 9000 and ISO 9004 have been taken into consideration during the development of this standard.
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Quality Management Principles
Eight quality management principles have been identified that can be used by top management to lead the organization towards improved performance.
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Quality Management Principles (Cont’d)
Customer focus
– Organizations depend on their customers and therefore should understand current and future customer needs, should meet customer requirements and strive to exceed customer expectations.
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Quality Management Principles (cont’d)
Leadership
– Leaders establish unity of purpose and direction of the organization. They should create and maintain the internal environment in which people can become fully involved in achieving the organization’s objectives.
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Quality Management Principles (cont’d)
Involvement of people
– People at all levels are the essence of an organization and their full involvement enables their abilities to be used for the organization’s benefit.
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Quality Management Principles (cont’d)
Process Approach
– A desired result is achieved more efficiently when activities and related resources are managed as a process
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Quality Management Principles (cont’d)
System approach to management
– Identifying, understanding and managing interrelated processes as a system contributes to the organization’s effectiveness and efficiency in achieving its objectives.
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Quality Management Principles (cont’d)
Continual Improvement
– Continual improvement of the organization’s overall performance should be a permanent objective of the organization.
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Quality Management Principles (cont’d)
Factual approach to decision making
– Effective decisions are based on the analysis of data and information
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Quality Management Principles (cont’d)
Mutually beneficial supplier relationships
– An organization and its suppliers are interdependent and a mutually beneficial relationship enhances the ability of both to create value.
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Process Approach
Determining the needs and expectations of customers and other interested parties
Establishing the quality policy and objectives of the organization
Determining the processes and responsibilities necessary to attain the quality objectives
Determining and providing the resources necessary to attain the quality objectives
Eng R. L. Nkumbwa-2010 Copperbelt University20
Process Approach (Cont’d)
Establishing methods to measure the effectiveness and efficiency of each process
Applying these measures to determine the effectiveness and efficiency of each process
Determining means of preventing nonconformities and eliminating their causes
Establishing and applying a process for continual improvement of the quality management system
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Model of a Process-based Quality Management System
ManagementResponsibility
ResourceManagement
Measurement,Analysis andImprovement
ProductRealization
Customers(and otherinterestedparties)
Requirements Product
Customers(and otherinterestedparties)
Satisfaction
Input Output
Continual Improvement ofthe quality management system
Key Value -added activities Information flow
NOTE: Statements in parentheses do notapply to ISO 9001
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Compatibility With Other Management SystemsThis International Standard had been
aligned with ISO 14001: 2004 to enhance compatibility
Does not include requirements specific to other management systems, but enables organizations to integrate other systems (such as environmental, OHSA, or financial mgmt.)
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Key Changes to the 2008 StandardCustomer Satisfaction must be measured
Outsourced processes– Must be able to demonstrate control over
process– Must be in quality manual and other public
documents
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Key Changes to the 2008 Standard (Cont’d)Process Management
– PMT (Process Mgmt. Team) that meets regularly– Process map that shows steps and functions– Customer driven measures– Training and Communication Plan– Methods for monitoring and measuring– Methods for solving problems (CAPA)
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Key Changes to the 2008 Standard (Cont’d) Structure of a QMS
– Communicate to rest of company– How much documentation is enough?
Customer Property – Must have process for controlling.
Internal Auditing – has changed, special training required.
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Summary
ISO 9001 : 2008 is a process approach system.
This standard is aligned to work with other management systems.
Other processes (such as out sourcing) must be controlled.