QMS ISO 9001:2008
Introduction to QMS 9001:2008
and system auditing
QMS ISO 9001:2008
Mohsen Mersal
QC manager
Siemens Wind Power
QMS ISO 9001:2008
Management systems
QMS ISO 9001:2008
ISO 9001:2008, Quality
ISO 14001:2004, Environment
OHSAS 18001, Health & safety
QMS ISO 9001:2008
Management systems Why?
QMS ISO 9001:2008
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Competition
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Legislation
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Product quality
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Production stability
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Economy
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CSR
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Continuous improvement
QMS ISO 9001:2008
How is a management system built?
Deming´s PDCA
QMS ISO 9001:2008
QMS ISO 9001:2008
QMS ISO 9001:2008
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Documentation
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Management responsibility
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Resource management
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Product realization
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Measurement, analysis and improvement
QMS ISO 9001:2008
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Documentation
Policy and objectives
Procedures
Manual
Records
QMS ISO 9001:2008
http://www.vestas.com/Files//Filer/EN/Policies/Quality
_and_Health_Safety_Policy.pdf
QMS ISO 9001:2008
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Management responsibility
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Commitment to development and implementation
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Communication
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Customer focus
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Policy
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Responsibility
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Management review
QMS ISO 9001:2008
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Resource management
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Competence
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Infrastructure
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Work environment
QMS ISO 9001:2008
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Product realization
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Planing, requirements to product
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Customer related processes
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Customer communication
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Design and development, inputs & outputs
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Purchasing
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Identification & traceability
QMS ISO 9001:2008
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Measurement, analysis and improvement
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Customer satisfaction
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Internal audit
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Monitoring & measurement of processes
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Control of nonconforming product
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Analysis of data
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Improvement
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Corrective actions
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Preventive actions
QMS ISO 9001:2008
Auditing
QMS ISO 9001:2008
Definition
An audit is an evaluation of a person, organization, system,
process, enterprise, project or product.
QMS ISO 9001:2008
An audit seeks to provide only reasonable assurance
that the statements are free from material error. Hence,
statistical sampling is often adopted in audits
QMS ISO 9001:2008
Quality audits are essential to:
Verify the existence of objective evidence showing conformance to
required processes
Assess how successfully processes have been implemented, for
judging the effectiveness of achieving any defined target levels
Providing evidence concerning reduction and elimination of
problem areas and are a hands-on management tool for achieving
continual improvement in an organization.
QMS ISO 9001:2008
Audit types
QMS ISO 9001:2008
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Internal
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System/certification
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Customer
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Management
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Process
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Supplier assessment
QMS ISO 9001:2008
Auditors
QMS ISO 9001:2008
External auditor
An independent firm engaged by the client subject to the
audit
Internal auditor
Employed by the organizations they audit
QMS ISO 9001:2008
Setting up and performing an audit
QMS ISO 9001:2008
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What do I need to do?
Where should I start?
What requirements will need to be met?
How much time is it going to take?
QMS ISO 9001:2008
Guidance
ISO 190011
QMS ISO 9001:2008
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Authority for the audit program
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Establishing the audit program
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Implementing the audit program
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Monitoring and reviewing the audit program
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Improving the audit program
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Competence and evaluation of auditors
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Audit activities
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Plan Do Check Act
QMS ISO 9001:2008
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planning and scheduling
❍ team leader and auditor competence
❍ team composition
❍ how to carry out the audit
❍ how to carry out follow-up audits
❍ keeping records
❍ how to monitor performance
❍ reports to senior management on how well the audit program is
QMS ISO 9001:2008
Check lists
●Audit report and findings
●Positive, minors, majors & improvements
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