Awareness Program on
QMS - ISO 9001:2015 Standard
by
Key perspectives
ISO 9001 needs to change, to:
§ adapt to a changing world
§ reflect the increasingly complex environments in which organizations
operate
§ provide a consistent foundation for the future
§ ensure the new standard reflects the needs of all relevant interested
parties
§ Ensure alignment with other management system standards
2
ISO 9000 standards for QMS
ISO
ISO
Annexes A & B for 10012
10012
information only Measurement
Quality management
systems - Fundamentals
ISO ISO
& vocabulary 9000: Audits 19011
2015
Guidelines
Managing for the
sustained success of
ISO ISO Quality management
systems -
an organisation – 9004: 9001:
Requirements
A QMS approach 2009 2015
Technical …as needed
Reports
(e.g. ISO/TR 10013)
3
Key feature changes
10-clause structure and core text for all Management System Standards (MSS)
More compatible with services and non-manufacturing users
§ Clearer understanding of the organization’s context is required “one size doesn’t
fit all”
Process approach strengthened/more explicit
Concept of preventive action now addressed throughout the standard by risk
identification and mitigation
The term documented information replaces the terms document and record
Control of externally provided products and services replaces purchasing/
outsourcing
Increased emphasis on seeking opportunities for improvement
Management Principles got changed
4
Relationship with other management system standards
► Adoption of “high level structure” has enabled:
l ISO to improve alignment among its international standards for management systems
(Annex A of this standard provides key elements of ‘high level
structure”)
l Level of risk may vary between various processes and the context of the organization
l This standard defines requirements in an order that is in line with organizations’
planning and process management. i.e.,
• Understanding the context of the organization. Its quality management system &
processes (Clause 4)
- Leadership, policy and responsibilities (Clause 5)
• Processes for planning & consideration of risks and opportunities (Clause 6)
• Processes for support, including resources, people and information (Clasue 7)
• Operational processes related to customers, products and services ( Clause 8)
• Processes for performance evaluation (Clause 9)
• Processes for improvement (Clause 10)
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Beneficial changes to ISO 9001
Enhanced leadership involvement in the management
system
Risk-based thinking
Simplified language, common structure and terms
Aligning QMS policy and objectives with the strategy of
the organization
6
Potential benefits to the user
Focus on achieving planned results
Flexibility for documented information
Improved risk control
Better process control leading to improved results
Improved customer satisfaction
Customer retention and loyalty
Improved image and reputation
Greater credibility
7
Quality Management Principle
ÜCustomer focus
ÜLeadership
ÜEngagement of people
ÜProcess approach
ÜImprovement
ÜEvidence-based Decision making
ÜRelationship Management
8
Process approach
• Consistent and predictable results are achieved when activities are managed
as processes.
• Process Approach=systematic definition and management of processes and
their interactions… to achieve intended results
Controls
(e.g.procedure)
(e.g.procedure) Process Process
A C
Input Process Output
Activities Process Process
+
Resources B D
9
Model of a process based QMS
4.1,4.2 &4.3
Context & Scope
Improvement
Leadership
4.4 QMS-General & Process
Approach
Customer
& Other
relevant Performance Customer
Planning evaluation
Interested Satisfaction
parties
Products &
Services
Products
& Services
Operations
Input Output
Requirements Satisfaction
Support Processes
10
PDCA Cycle
ACT – incorporate PLAN - the process
improvements as (Extent of planning depends
necessary on RISK)
DO – carryout the process
OUTPUTS
INPUTS
CHECK – monitor/measure
process performance
Schematic representation of a single process within the system
11
Risk Assessment
12
Risk Assessment
§ Balance risks and opportunities
Analyse and prioritize your risks
what is acceptable?
what is unacceptable?
Plan actions to address the risks
how can I avoid, eliminate or mitigate risks?
Implement the plan; take action
Check the effectiveness of the action; does it work?
Learn from experience; improve
13
Risk Assessment
14
Structure of ISO 9001:2015
1 Scope 2 Normative references 3 Terms and definitions
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 quality management system
4.4 Quality management system and its processes
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 opportunities
6.2 Quality objectives and planning to achieve them
6.3 Planning of changes
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Structure of ISO 9001:2015
7 Support
7.1 Resources
7.2 Competence
7.3 Awareness
7.4 Communication
7.5 Documented information
8 Operation
8.1 Operational planning and control
8.2 Requirements for products and services
8.3 Design and development of products and services
8.4 Control of externally provided processes, products and services
8.5 Production and service provision
8.6 Release of products and services
8.7 Control of nonconforming outputs
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Structure of ISO 9001:2015
9 Performance evaluation
9.1 Monitoring, measurement, analysis and evaluation
9.2 Internal audit
9.3 Management review
10 Improvement
10.1 General
10.2 Nonconformity and corrective action
10.3 Continual improvement
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Plan Do Check Act
4 9
5 6 7 8 10
Context of Performance and
Leadership Planning Support Operation Improvement
organization Evaluation
4.1 7.1 9.1 10.1
5.1 6.1 8.1
Understanding context Resources Monitoring, General
Leadership and Actions to address risks Operational planning and
commitment control measurement, analysis
and opportunities
7.1.2 and evaluation
4.2 People
Interested parties 5.2
10.2 Nonconformity
Policy 6.2 See next slide
9.1.2 and corrective action
Quality objectives and 7.1.3
Infrastructure Customer satisfaction
4.3 planning
Scope 5.3
Organizational roles,
responsibilities and 7.1.4 10.3
6.3 Environment for the 9.1.3 Continual improvement
4.4 authorities Planning of changes
operation of processes Analysis and evaluation
QMS
7.1.5 9.2
Monitoring and measuring Internal audit
resources
9.3
7.1.6 Management review
ISO/TC 176/SC 2/ N1282
Organizational knowledge
7.2
Competence
7.3
Awareness
7.4
Communication
7.5
Documented information
18
Any Question?
19
THANKS
