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Quality Management Systems -
Requirements based on
ISO 9001:2015[E]
ISO 9001:2015 AWERENESS
FOR
MANAGEMENT & STAFF
BY
WINYANA TRANSFORMATIONS
Copyright, WINyana Transformation PLC,
April,2020
1
Chaminda Karunanayake
-Director Business
Development –
(MSc Herriot Watt, MBA-USQ, PhD
candidate (Sri Jaya))
Isuru Denagamage
-Marketing & Brand
Executive
(BSc (Hons) in Agriculture, PGdip
Marketing (SLIM) )
Sugath Hettiarachchi
-Director System
implementation-
(DOSH, DQA, Lead Auditor EMS,QMS,
OHMS, BSc-Colombo)
Madusha Sewwandi
-QA & Project Lead-
(HND-Food Science)
Asheni Silva
-Compliance Specialist-
(LLB-UK, LLM-Candidate)
In House Team
Pravinda Bhagya
-Consultant-
BSc, MSc, PhD(Candidate-Aus)
Copyright, WINyana Transformation PLC,
April,2020
2
Our Experience
Copyright, WINyana Transformation PLC,
April,2020
3
Project team-introduction
Why Quality and Endorsement
ISO 9001 Structure and Content
References
Content
1
2
3
4
4
Copyright, WINyana Transformation PLC,
April,2020
5
ISO 9001:2015 is an international
standard dedicated to Quality
Management Systems (QMS).
The QMS is the aggregate of all the
processes, resources, assets, and
cultural values that support the goals of
customer satisfaction and
organizational efficiency.
Introduction to ISO 9001: 2015
Copyright, WINyana Transformation PLC,
April,2020
4
6
6
7 5
6. Performance
Evaluation
ISO 9001:2015 QUALITY MANAGEMENT SYSTEM
PRINCIPLES
1
7
6 5
2
3
3
4
2
2. Leadership 3. Planning
4. Support
1
1. Context of the
Organization
5. Operations
7.
Improv
ement
Copyright, WINyana Transformation PLC,
April,2020
7
Copyright, WINyana Transformation PLC,
April,2020
8
Copyright, WINyana Transformation PLC,
April,2020
PDCA
9
Copyright, WINyana Transformation PLC,
April,2020
10
High Level Structure of ISO-X
Copyright, WINyana Transformation PLC,
April,2020
11
Copyright, WINyana Transformation PLC,
April,2020
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
Clause 4: Context of the organization
12
Copyright, WINyana Transformation PLC,
April,2020
5.1 Leadership &
Commitment
5.2
Quality
Policy
5.3
Organization
al Roles ,
Responsibilit
ies &
Authorities
13
Clause 5: Leadership
Copyright, WINyana Transformation PLC,
April,2020
Planning
6.1 Actions to
address risks &
opportunities
6.2 Quality
objectives &
planning to
achieve
6.3 Planning
of changes
Clause 6. Planning
14
Copyright, WINyana Transformation PLC,
April,2020
Support
7.1 resources
7.2
Competence
7.3 Awareness
7.4
communication
7.5
Documented
Information
Clause 7: Support
15
Copyright, WINyana Transformation PLC,
April,2020
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
16
Clause 8 : Operation
Copyright, WINyana Transformation PLC,
April,2020
Performance
Evaluation
9.1 Monitoring,
measurement,
analysis and
evaluation
9.2
Internal
Audit
9.3
Managemen
t Review
17
Clause 9: Performance evaluation
Copyright, WINyana Transformation PLC,
April,2020
Continual Improvement
10.3
Continual
improvement
s
10.2
Nonconformi
ty and
corrective
action
10.1
General
18
Clause 10: Continual Improvement
Copyright, WINyana Transformation PLC,
April,2020
19
Benefits of ISO 9001:2015
• Become more cost-efficient
• Improved risk management
• Increased credibility and competitiveness
• Lower costs and shorter cycle times through effective use of resources
• Enhanced customer satisfaction and improved customer loyalty
• Increased revenue and market share
• Improved communication, planning and administration process
Copyright, WINyana Transformation PLC,
April,2020
20
FUNDAMENTAL REASONS FOR EXISTENCE OF AN ENTERPRISE
KEY
DRIVING
FORCES
Profitability
Expanded Market share
Long term survival
Service to Society
Copyright, WINyana Transformation PLC,
April,2020
21
ESSENTIAL FACTORS FOR SURVIVAL AND GROWTH OF AN
ENTERPRISE
> High Quality
> Increased Productivity
> Cost Effectiveness
> Efficiency
Quality is the key to productivity,
profitability, survival and growth
Copyright, WINyana Transformation PLC,
April,2020
22
Quality – WHY ?
 Unprecedented interest in Quality both on the part of
Industry & trade and Society in General.
 Rapid changes in technology, environment, economic
aspects, trade patterns.
 Abundance of product variety, complexity, innovativeness.
Copyright, WINyana Transformation PLC,
April,2020
23
Inputs
Process
(a value-adding
set of activities)
Outputs
Resources
What is a process?
Copyright, WINyana Transformation PLC,
April,2020
24
Corporate Operating Philosophy
VISION
MISSION
QUALITY POLICY
QUALITY OBJECTIVES
Copyright, WINyana Transformation PLC,
April,2020
25
Copyright, WINyana Transformation PLC,
April,2020
26
INTERESTED PARTIES
CUSTOMERS
SHAREHOLDERS
EMPLOYEES
SUPPLIERS
PUBLIC
Copyright, WINyana Transformation PLC,
April,2020
27
No. 20, Kothalawala Avenue, Colombo 04.
info@winyana, support@isoconsultancy.lk
011 2576616 , 0777 169339, 071 600 4411
Copyright, WINyana Transformation PLC,
April,2020

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ISO 9001 Presentation for management dan staff