Quality Management Systems -

Requirements based on
ISO 9001:2015[E]

ISO 9001:2015 AWERENESS

FOR
MANAGEMENT & STAFF
BY
WINYANA TRANSFORMATIONS

Copyright, WINyana Transformation PLC,

1
April,2020
 In House Team
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 Madusha Sewwandi
-Director System -QA & Project Lead-
(HND-Food Science)
implementation-
(DOSH, DQA, Lead Auditor EMS,QMS,
OHMS, BSc-Colombo)
Asheni Silva Pravinda Bhagya
-Compliance Specialist- -Consultant-
(LLB-UK, LLM-Candidate) BSc, MSc, PhD(Candidate-Aus)
Copyright, WINyana Transformation PLC,
2
April,2020
Our Experience

Copyright, WINyana Transformation PLC,

3
April,2020
Content

1
Project team-introduction

2 Why Quality and Endorsement

3
ISO 9001 Structure and Content

4 References

Copyright, WINyana Transformation PLC,

4
April,2020
 Introduction to ISO 9001: 2015
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.

Copyright, WINyana Transformation PLC,

5
April,2020
ISO 9001:2015 QUALITY MANAGEMENT SYSTEM
6. Performance
5. Operations
Evaluation
4. Support

7.
Improv
3
ement 7 6 5 4

6 5
7 1 2
PRINCIPLES
4
1 3
2
1. Context of the 2. Leadership 3. Planning
Copyright, WINyana Transformation PLC,
Organization April,2020 6
Copyright, WINyana Transformation PLC,
7
April,2020
Copyright, WINyana Transformation PLC,
8
April,2020
PDCA

Copyright, WINyana Transformation PLC,

9
April,2020
High Level Structure of ISO-X

Copyright, WINyana Transformation PLC,

10
April,2020
Copyright, WINyana Transformation PLC,
11
April,2020
Clause 4: Context of the organization

4.1 Understanding the

Organization and its
context

4.2
4.4 4. Context of Understanding the
Quality Management the needs and expectations
system Organization of interested parties

4.3
Determining the scope of
the quality management
system
Copyright, WINyana Transformation PLC,
12
April,2020
Clause 5: Leadership

5.2
Quality
Policy

5.1 Leadership &

Commitment

Copyright, WINyana Transformation PLC,

13
April,2020
Clause 6. Planning
6.1 Actions to
address risks &
opportunities

Planning
6.2 Quality
6.3 Planning objectives &
of changes planning to
achieve

Copyright, WINyana Transformation PLC,

14
April,2020
Clause 7: Support

7.1 resources

7.5
Documented 7.2
Information Competence

Support

7.4
7.3 Awareness
communication

Copyright, WINyana Transformation PLC,

15
April,2020
Clause 8 : Operation
8.1 Operational
planning and
control
8.7 Control of 8.2
nonconforming Requirements
outputs for products
and services

Operation 8.3 Design and

8.6 Release of
development
products and
of products
services
and services

8.4 Control of
8.5 externally
Production provided
and service processes ,
provision products and
services
Copyright, WINyana Transformation PLC,
16
April,2020
Clause 9: Performance evaluation

9.1 Monitoring,
measurement,
analysis and
evaluation

Performance
9.3 Evaluation 9.2
Managemen Internal
t Review Audit

Copyright, WINyana Transformation PLC,

17
April,2020
Clause 10: Continual Improvement

10.2
Nonconformi
ty and 10.1
corrective General
action
10.3
Continual
improvement
s

Continual Improvement
Copyright, WINyana Transformation PLC,
18
April,2020
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,

19
April,2020
FUNDAMENTAL REASONS FOR EXISTENCE OF AN ENTERPRISE

Profitability

KEY Expanded Market share

DRIVING
FORCES

Long term survival

Service to Society

Copyright, WINyana Transformation PLC,

20
April,2020
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,

21
April,2020
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,

22
April,2020
What is a process?

Process
Outputs
Inputs (a value-adding
set of activities)

Resources

Copyright, WINyana Transformation PLC,

23
April,2020
Corporate Operating Philosophy

VISION

MISSION

QUALITY POLICY

QUALITY OBJECTIVES

Copyright, WINyana Transformation PLC,

24
April,2020
Copyright, WINyana Transformation PLC,
25
April,2020
INTERESTED PARTIES

CUSTOMERS

SHAREHOLDERS
PUBLIC

SUPPLIERS EMPLOYEES

Copyright, WINyana Transformation PLC,

26
April,2020
 011 2576616 , 0777 169339, 071 600 4411

info@winyana, support@isoconsultancy.lk

No. 20, Kothalawala Avenue, Colombo 04.

Copyright, WINyana Transformation PLC,

27
April,2020