ISO-9001-2015-Management-Review-B.ppt

1. Terms and Concepts
• Context of the organization
– Combination of internal and external factors
and conditions that can have an effect on an
organization's approach to its products,
services and investments and interested
parties.
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2. Annex SL
• High-level structure developed
by the Joint Technical
Coordination Group (JTCG),
• All ISO technical committees
who develop management
system standards in future will
use this as their blueprint.
• Designed to align format, text,
terms and definitions
• It still gives standards
developers flexibility to
integrate their technical topics
and requirements.
Clause 1 Scope
Clause 2 Normative
References
Clause 3 Terms and
Definitions
Clause 4 Context of the
Organization
Clause 5 Leadership
Clause 6 Planning
Clause 7 Support
Clause 8 Operation
Clause 9 Performance
Evaluation
Clause 10 Improvement
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3. Model of a process-based quality management
system, showing the links to the clauses of the
International Standard (DIS)
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4. ISO 9001:2015 Structure
4 Context of
the
organization
5 Leadership 10 Improvement
6 Planning for the
quality management
system
7 Support 8 Operations 9 Performance
and evaluation
Understanding
of the
organization
and its context
Understanding
the needs and
expectations
Of interested
parties
Scope of
management
systems
QMS
Leadership
and
commitment
Quality policy
Organizational
roles,
responsibilities
and
authorities
Action to
address risk
and opportunity
Quality
objectives
Planning of
changes
Resources
Competence
Awareness
Communication
Documented
Information
Release of
products and
services
Operations
planning
and control
Determination
of requirements
for products
and services
Design and
development of
products and
services
Control of
externally
provided
products and
services
Production and
service
provisions
Control of non-
conforming
process
outputs,
products and
services
Monitoring,
measurement.
analysis and
evaluation
Internal audit
Management
review
Nonconformity
and corrective
action
Continual
Improvement
Plan
Do
Check Act
General
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5. 4. Context of the Organization
4.1 Understanding the organization and its
context
4.2 Understanding the needs and
expectations of interested parties
4.3 Determining the scope of the QMS
4.4 Quality management system
4.4.1 General
4.4.2 Process Approach
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6. 5. Leadership
5.1 Leadership and commitment
5.1.1 Leadership & commitment with
respect to QMS
5.1.2 Leadership & commitment with
respect to customers
5.2 Policy
5.3 Organizational roles, responsibilities and
authorities
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7. 6. Planning
6.1 Actions to address risks and
opportunities
6.2 Quality objectives and planning to
achieve them
6.3 Planning of changes
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8. 7. Support
7.1 Resources
7.1.1 General
7.1.2 Infrastructure
7.1.3 Process Environment
7.1.4 Monitoring and measuring devices
7.1.5 Knowledge
7.2 Competence
7.4 Awareness
7.5 Communication
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9. 7. Support
7.5 Documented information
7.5.1 General
7.5.2 Creating and updating
7.5.3 Control of documented information
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10. Documentation Structure
• Level 1: Policies
– Quality Policy
• Level 2: Procedures
– Defines who will do what and
when
• Level 3: Work Instructions
– Defines how the work will be
completed
• Level 4: Records
– Shows evidence of
compliance to the standard or
customer requirements
Level 1
Level 2
Level 3
Level 4
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11. General – Documented
Information
The organization’s quality management
system shall include
a) documented information required by
this International Standard;
b) documented information determined by
the organization as being necessary
for the effectiveness of the quality
management system.
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12. General – Documented
Information (Cont.)
The extent of the quality management
system documented information can differ
from one organization to another due to:
• The size of the organization and type of
activities
• The complexity of processes and their
interaction
• The competence of personnel
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13. Documented Information
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14. Documented Information
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15. 8.Operation
8.1 Operational planning and control
8.2 Determination of market needs and
interactions with customers
8.2.1 Customer communicaton
8.2.2 Determination of requirements related to
products and services
8.2.3 Review of requirements related to
products and services
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16. 8.Operation
8.3 Design and development of products
and services
8.3.1 General
8.3.2 Design and development planning
8.3.3 Design and development inputs
8.3.4 Design and development controls
8.3.5 Design and development outputs
8.3.6 Design and development changes
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17. 8.Operation
8.4 Control of externally provides products
and services
8.4.1 General
8.4.2 Type and extent of control of external
provisions
8.4.3 Information for external providers
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18. 8.Operation
8.5 Production and service provision
8.5.1 Control of production and service provision
8.5.2 Identification and traceability
8.5.3 Property belonging to customers or
external providers
8.5.4 Preservation
8.5.5 Post delivery activities
8.5.6 Control of changes
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19. 8.Operation
8.6 Release of products and services
8.7 Control of nonconforming process
outputs, products and services
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20. 9. Performance Evaluation
9.1 Monitoring, measurement, analysis, and
evaluation
9.1.1 General
9.1.2 Customer satisfaction
9.1.3 Analysis and evaluation
9.2 Internal audit
9.3 Management review
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21. 10 Improvement
10.1 General
10.2 Non conformity and corrective action
10.3 Continual Improvement
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22. Questions?
?
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23. Quality Policy
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24. Quality Policy
Top management shall establish, review and maintain a
quality policy that
a) is appropriate to the purpose and context of the organization;
b) provides a framework for setting and reviewing quality objectives;
c) includes a commitment to satisfy applicable requirements;
d) includes a commitment to continual improvement of the quality
management system.
The quality policy shall:
a) be available as documented information;
b) be communicated, understood and applied within the organization;
c) be available to relevant interested parties, as appropriate.
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25. Quality Objectives
The organization shall establish quality objectives at relevant functions,
levels and processes.
The quality objectives shall:
a) be consistent with the quality policy,
b) be measurable;
c) take into account applicable requirements;
d) be relevant to conformity of products and services and the
enhancement of customer satisfaction;
e) be monitored;
f) be communicated;
g) be updated as appropriate.
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