02 ISO 9001 2015 Awareness & Transition
02 ISO 9001 2015 Awareness & Transition
02 ISO 9001 2015 Awareness & Transition
2 TUV ME │ QM 001 - ISO 9001:2015 Awareness Training │ REVISION 01│ ISSUE DATE 28.12.2015
Objective and Aim of this course:
To understand
3 TUV ME │ QM 001 - ISO 9001:2015 Awareness Training │ REVISION 01│ ISSUE DATE 28.12.2015
Contents:
▪ History of ISO 9001
▪ Why ISO 9001:2015 version has been issued?
▪ The main changes in ISO 9001:2015
▪ Quality management system principles
▪ Risk management vs ISO 9001:2015
▪ Context of the organization
▪ Leadership
▪ Planning for the quality management systems
▪ Support
▪ Operation
▪ Performance evaluation
▪ Improvement
4 TUV ME │ QM 001 - ISO 9001:2015 Awareness Training │ REVISION 01│ ISSUE DATE 28.12.2015
History of ISO 9001
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What is new? The main changes in
ISO 9001:2015
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7 Quality management principles
Customer focus
Leadership
Engagement of people
Process approach
Improvement
Relationship management
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.
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Risk management
▪ Risk definition
Risk
Effect of uncertainty on an expected result
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Risk management
▪ Reason for risk based thinking (as per ISO)
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Risk management framework
identify and treat
risks
risk can be
internal or external
integrate risk
management in to
the culture
risk management
should be an
ongoing process
responsibility
shall be assigned
this is a
preventive
measure
better to define
and document
this is
everyone's
responsibility
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Example of risk associated with processes
Purchase process
Risk
Analysi
s Risk evaluation
(Option Respo
Process Risk (R) /
al) How to address risk nsibili Monitoring
Steps opportunity (O)
ty
Unacce
L S Accept
pt
What Who When How
Purchase
1- Planning
of purchase
- Insufficient
supplies (R)
M H
--- 1- selecting a different
sources of supplies (as a
manager
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Key terminology
‘Documented Information’
“retain documented information as evidence of …. “ – Record
‘ensure’ - the responsibility can be delegated, but not the accountability to make
sure that it is performed.
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Key terminology
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High level Structure of ISO 9001:2015
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Structure of ISO 9001:2015 – in PDCA Cycle
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4. Context of the organization
• Legal, • Values
• Technological, • Culture
• Competitive • Knowledge
• Market, • Performance
• Cultural,
• Social
• Economic Environment
- Owners,
- Customers,
- Competitors,
- Employees,
- Bankers,
- Union,
- Supplier etc.
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4. Context of the organization
Boundaries Applicability
Consider:
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4. Context of the organization
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5. Leadership
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5. Leadership
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5. Leadership
5.2 Quality Policy
- Top management shall establish, Review and Maintain
Available to relevant
Provide framework for setting interested parties as
quality objectives appropriate
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5. Leadership
5.3 Organizational roles, responsibilities and authorities
Top management shall
assign Responsibility,
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6. Planning for the quality management system
Assurance to
quality Prevent, or reduce, Achieve continual
management undesired effects Improvement
system
Proportionate
actions - Integrate and implement in QMS & Evaluate the effectiveness
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6. Planning for the quality management system
6.2 Quality objectives and planning to achieve them
Establish quality objectives at relevant functions, levels and processes and
maintain documented information
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6. Planning for the quality management system
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7. Support
7.1 Resources
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7. Support
7.2 Competence
Determine the necessary competence of person(s)
doing work under its control that affects its
performance of QMS,
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7. Support
7.3 Awareness
Persons doing work under the
organization’s control shall be aware of:
Implications of
Their
Relevant Quality not conforming
Quality Policy contribution to
objectives to QMS
QMS
requirements
7.4 Communication
When to communicate
Determine the
communication Whom to communicate
How to communicate
External Who communicates
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7. Support
7.5.1 General
▪ The documented information of the organizational QMS shall included:
- Required by this International standard
- Determined by the organization
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7. Support
7.5.2 Creating and updating
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7. Support
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8. Operation
▪ The organization shall plan, implement and control the processes and implement
action for risk and opportunities by:
- Determining requirements for the product and services
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8. Operation
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8. Operation
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8. Operation
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8. Operation
8.3.1 General
The organization shall establish, implement and maintain a design and development
process that is appropriate to ensure the subsequent provision of products
and services
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8. Operation
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8. Operation
8.3 Design and development of products and services
Apply control
Incorporation based on ability
into products
and services
Criteria for
Control externally evaluation
provided
Provided directly
processes, Selection
to customer
products or
service when,
Monitoring
Providing
process or part
of process Re-evaluation
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8. Operation
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8. Operation
8.5 Production and service provision
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8. Operation
8.5 Production and service provision
- Statutory & Regulatory requirements
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8. Operation
8.6 Release of products and services
- Shall implement the planned arrangements at appropriate stages
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8. Operation
Take appropriate action – during or after service provision, after delivery of product
How to deal?
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9. Performance Evaluation
9.1.1 General
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9. Performance Evaluation
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9. Performance Evaluation
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9. Performance Evaluation
9.2 Internal audit
9.2.1 The organization shall conduct internal audits at planned interval to ensure
quality management system
a) confirms to:
Organization’s own requirements & Requirements of the standard
b) is effectively implemented and maintained
9.2.2 The organization shall plan, establish and maintain audit programme and
shall take into consideration of:
- Frequency?
- Importance of processes concerned
- Methods?
- Changes affecting the organization
- Responsibilities?
- Results of previous audits - Planning requirements?
- Reporting?
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9. Performance Evaluation
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9. Performance Evaluation
9.3 Management review
Conduct at planned interval & Consider; The output shall include decision
- Status of actions from previous review and action related to;
- Changes in external and internal issue
- Opportunities for
- Information on the performance & improvement
effectiveness of the QMS including trends in:
- customer satisfaction & feedback - Any need for changes to
- Extent which quality objectives met QMS, including resource
- Process performance & conformity of needs
product and service provision
- nonconformities and corrective actions
- monitoring and measurement results
- audit results
- performance of external providers
- adequacy of resources
- Effectiveness of action taken to address risk
and opportunities
- Opportunities for improvement
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10. Improvement
10.1 General
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10. Improvement
10.2 Nonconformity and corrective action
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10. Improvement
10.3 Continual improvement
Suitability
Effectiveness of QMS
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