Iso 9001 2015 presentation
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1 ISO 9001:2015 ISO 9001:2015 A Major Revision of Quality Management TÜO Egypt LLC: 1164 St. Building number 5, Morabaa El Wozara, Masaken Sheraton, Cairo - Egypt Mobile +20. 12 224 046 25 Fax +20. 2 227 398 26 email: [email protected]
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Transcript of Iso 9001 2015 presentation
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ISO 9001:2015ISO 9001:2015A Major Revision of Quality Management
TÜO Egypt LLC: 1164 St. Building number 5, Morabaa El Wozara, Masaken Sheraton, Cairo - EgyptMobile +20. 12 224 046 25 Fax +20. 2 227 398 26 email: [email protected]
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TÜO Egypt LLC: 1164 St. Building number 5, Morabaa El Wozara, Masaken Sheraton, Cairo - EgyptMobile +20. 12 224 046 25 Fax +20. 2 227 398 26 email: [email protected]
ISO 9001 MilestonesISO 9001 Milestones
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CONTENT OF PRESENTATION Key Changes ISO 9001:2008 -> ISO 9001:2015 Why the change? The Quality Documentation Involvement of the Management Goods and Services Terminology The Process-based Approach Risk-based Thinking The New High Level Structure in ISO How to get ready!
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Why the change?Why the change?ISO standards are reviewed regularly, every 5 – 7 years!ISO 9001:2015 will follow the new common structure for management standards.Organizations that use multiple Management System Standards are increasingly demanding a common format and language that is aligned between those standards!
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Key Changes in ISO 9001:2015Key Changes in ISO 9001:2015
• Abolishment of a Quality Manual• Role of the Management Representative• Process Based Approach
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All future management standards will have common high level structures, text, terms, and definitions!
A new common ISO format benefits organizations with integrated management systems, like QMS, EMS, and ISMS.
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The Quality Manual The Quality Manual No longer a requirement in the revised standard! The new standard requires the identification and
interaction of processes – risk based approach/preventive action
“Documented Information” as required by the standard may make use of any choice of media
“Documented Evidence” constitutes now the quality records of the company.
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Management RepresentativeManagement Representative No more management representative/quality
manager – “process owners” are responsible for the implementation of awareness and action.
Creation of a “High Level Structure”. Understanding the needs of the organization and its
stakeholders to ensure viable long-term business success – defining the internal and external requirements of an organization.
Integration of QMS requirements into business processes.
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Management Review Input
The organization’s management shall review the organization's quality management system at
predefined intervals, to ensure its continuing suitability, adequacy, and effectiveness!
This guarantees the management‘s direct involvement in the process of quality enhancement.
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“Goods and services”
Replacing “products”. New term to make the standard
more generic and thus more applicable to service organizations.
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The Management System – A Preventive The Management System – A Preventive ToolTool
Process based approach and the importance of Process based approach and the importance of knowledgeknowledge
Implement, maintain and audit the value-added activities. PDCA cycle requiring risk-based thinking (risk assessment
and risk management) for establishing, maintaining and continually improving the quality management system
Determination of risk to conformity of goods and services and to customer satisfaction
Knowledge as a resource Determine the knowledge necessary for the operation of the
QMS and its processes to be maintained, protected and made available as necessary
Foresee the need for changes in knowledge and the risk of not acquiring it in a planned and timely manner.
Understanding opportunity as positive risk!TÜO Egypt LLC: 1164 St. Building number 5, Morabaa El Wozara, Masaken Sheraton, Cairo - EgyptMobile +20. 12 224 046 25 Fax +20. 2 227 398 26 email: [email protected]
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The Purpose of the Process ApproachThe Purpose of the Process Approach
The purpose of the process approach is to enhance an
Organization’s effectiveness and efficiency in achieving
its defined objectives. This means enhancing customer
satisfaction by meeting customer requirements!
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What is “risk-based thinking”? What is “risk-based thinking”? Something we all do automatically and often subconsciously! Concept of risk > always implicit in ISO 9001 Risk-based thinking • is already part of process approach • makes preventive action part of the routine Risk-based thinking can also help identify opportunities = positive risk
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Risk Based Thinking = Preventive ActionRisk Based Thinking is everybody’s business!Risk Based Thinking is not just the responsibility of the administration!Risk Based Thinking must become a crucial part of the organization’s culture!
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How and why is risk addressed in ISO How and why is risk addressed in ISO 9001:2015?9001:2015? Main objectives of ISO 9001: • “To provide confidence in the organization’s ability to consistently provide customers with conforming goods and services” • To enhance customer satisfaction” The concept of “risk” relates to the uncertainty in achieving those objectives!
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Integrating Process Approach + Risk Based Thinking with the PDCA
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The new High Level StructureThe new High Level StructureThe revision of ISO 9001 creates a so-called
“High Level Structure” using identical, mutually applicable terms and definitions
to be used in future standards!
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The “High Level Structure” 1.Scope 2.Normative reference 3.Terms and definitions 4.Context of the organization 5.Leadership 6.Planning 7.Support 8.Operation 9.Performance evaluation 10.Improvement
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High Level Structure (Part 1)High Level Structure (Part 1)1. Scope2. Normative references3. Terms and definitions4. Context of the organization
4.1 Understanding of the organization and its context 4.2 Understanding the needs and expectations of interested parties 4.3 Determining the scope of the XXX management system 4.4 XXX management system
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High Level Structure (Part 2)High Level Structure (Part 2)5. Leadership
5.1 Leadership and commitment 5.2 Policy 5.3 Organizational roles, responsibilities and authorities
6. Planning 6.1 Actions to address risks and opportunities6.2 XXX objectives and planning to achieve them
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High Level Structure (Part 3)High Level Structure (Part 3)7. Support
7.1 Resources 7.2 Competence 7.3 Awareness 7.4 Communication 7.5 Documented information 7.5.1 General 7.5.2 Creating and updating 7.5.3 Control of documented information
8. Operation 8.1 Operational planning and control
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High Level Structure (Part 4)High Level Structure (Part 4)9. Performance evaluation
9.1 Monitoring, measurement, analysis and evaluation 9.2 Internal audit 9.3 Management review
10. Improvement10.1 Nonconformity and corrective action10.2 Continual improvement
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The New ISO 9001 QMS StructureThe New ISO 9001 QMS Structure
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What you can do to prepare yourself for the new standard?
1. Educate yourself and your team!2. Identify gaps between current and future
requirements!3. Plan the implementation of the new requirements!4. Let us assist you along the way!
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Contact the TÜO Team to get started!
TÜO Egypt LLC: 1164 St. Building number 5, Morabaa El Wozara, Masaken Sheraton, Cairo - EgyptMobile +20. 12 224 046 25 Fax +20. 2 227 398 26 email: [email protected]
TÜO Egypt LLC: 1164 St. Building number 5, Morabaa El Wozara, Masaken Sheraton, Cairo - EgyptMobile +20. 12 224 046 25 Fax +20. 2 227 398 26 email: [email protected]
