QMS_ISO 9001_Awareness

1. ISO 9001:2015
“Orientation and Risk-Based Thinking
approach on Management”
1

2. ISO 9001:2015 Awareness (Risk-Based)
2
Introduction on ISO 9001:2015
Requirements of ISO 9001:2015
Risk-Based Thinking Approach on
Management
Q&A

3. 3
Introduction
on ISO
9001:2015

4. Introduction
4
The ISO 9001 is the world’s most popular Quality Management
System standard and is all about focusing on how to keep
customers satisfied and other interested parties, whatever sector
or industry you operate in, from Manufacturing to Service-
oriented companies.
Companies that work to adopt the principles of quality
management have benefited from more efficient ways of
working, better cost control and fast and more effective
implementation or work practices.
This presentation includes some details about ISO 9001:2015
making it work for your and department & business processes.

5. 5
ISO
?
 A Word
- Greek word “isos”, which means “equal” or
“equivalent”
 An Acronym
- Short name for International Organization
for Standardization (ISO, instead of IOS)
 A Federation
- Worldwide federation of national standards
bodies (member bodies)

6. The Development of Quality Management
Quality is focus on
separating good and
bad items without
feedback to the
Operation process
Final Inspection
Quality develops during
the Operation process
Enhanced inspection and
extended to the operation
process and prevention
Quality is clearly defined,
planned & supervised
Commitment of management,
participation of employees &
step by step improvements
6

7. Total Quality Management Philosophy:
“Doing the right things right, the first time, on
time, all the time”

8. 1. Customer requirements
2. Government mandate
3. Management’s own initiative

9. 1. An international recognized series of quality system standards followed by
a company to do their business well.
2. Adopted by many countries as national standards for the design,
manufacture, sales and servicing of a product.
3. Checklist of doing business on a world-class level.
4. Allows the company to use the standard as an important tool, and a
standard framework for continuous improvement
ISO 9001:2015 – Requirements
ISO 9000:2015 – Fundamentals and Vocabulary
ISO 9004:2018 – QMS – Guidance to Achieved Sustained Success

10. Quality Management is defined as management
with regard to quality.
Note 1: Quality management can include establishing
- quality policies and
- quality objectives, and
- processes to achieve these quality objectives through quality
planning, quality assurance, quality control, and quality
improvement.

11. Main Feature of the ISO 9001:2015
11
7 Quality Management Principles
1. Customer Focus
2. Leadership
3. Engagement of People
4. Process Approach
5. Improvement
6. Evidence-based decision making
7. Relationship Management

12. ISO/TC
176/SC
2/
N1267
12
Date: 6
•Process Approach
•PDCA – Plan-Do-Check-Act
Basic Concept / Framework of
ISO 9001:2015

13. Model of Process-Based QMS of
ISO 9001:2015

14. PROCESSES
(Transformation)
INPUTS OUTPUTS
RESOURCES
CONTROLS
Customers
Regulations,
Customers,

15. PDCA in ISO 9001:2015 Structure
4 Context of
the
organization
5 Leadership 6 Planning 7 Support 8 Operation
9
Performance
evaluation
10
Improvement
Understanding
of the
organization
and its context
Expectations of
interested
parties
Scope of
management
system
QMS ind its
processes
Leadership and
commitment
Policy
Roles
responsibilities
and authorities
Actions to
address risk and
opportunity
Quality
objectives
Planning of
changes
Resources
Competence
Awarness
Communication
Documented
information
Operations
planning and
control
Requirements
for products
and services
Design and
development
Production and
service
provision
Monitoring,
measurement,
analysis and
evaluation
Internal audit
Management
review
General
Nonconformity
and corrective
action
Release of
products and
services
Control of
nonconforming
outputs
Continual
improvement
PLAN DO CHECK ACT
Control of
externally
provided
processes,
products and
services

16. Representation of the structure of ISO
9001:2015 Standard in the PDCA cycle
Quality Management System (4)
Support &
Operation
(7,8)
Plan Do
Check
Act
Organization
and its context
(4)
Customer
requirements
Needs and
expectations of
relevant
Intersted
parties (4)
Leadership
(5)
Planning
(6)
Performance
evaluation
(9)
Improvement
(10)
Customer
satisfaction
Results of
the QMS
Products and
services
Reference: ISO 9001:2015 Figure 2

17. Organization Organization
Orientation of the Organization towards the Customer
Customer Customer

18. Sales
Planning
Purchasing Service
Service
Distribution
Personnel
Planning
Management
by Objectives
Resource
Planning
Quality
Assurance
Maintenance Information
Management
Process Types:
- Management-Oriented Processes (MOP)
- Customer-Oriented Processes (COP)
- Support – Orientated Processes (SOP)

19. Contents
ISO 9001:2015
0 Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Context of the organization
5 Leadership
6 Planning
7 Support
8 Operation
9 Performance evaluation
10 Improvement

20. Contents
0 Introduction
0.1 General
0.2 Quality management principles
0.3 Process approach
0.4 Relationship with other management system standards

21. 0.3 Process approach
P
Process owner is
responsible for planning
and assuring results.
Risk based
thinking is part
of the process
approach!

22. 0.3 Process approach
P D
People in process are
executing planed
activities

23. 0.3 Process approach
P D C
Results are checked
before products and
services are delivered
to customer.

24. 0.3 Process approach
P D C
A
Customer
internal or
external
If any nonconformities in products,
services or process are detected, they are
analyzed and corrective actions are
performed to eliminate nonconformities.
feedback

25. 0.3 Process approach
P D C
A
Customer
We are monitoring customers’ perception
of the degree to which their needs and
expectations have been fulfilled, and
acting upon the results in order to
improve their satisfaction.
Customer
satisfaction
A
Products
and/or
services
feedback
feedback

26. 0.3 Process approach
P D C
A
Customer
First of all customer
requirements, needs
and expectations are
gathered and analyzed.
Customers’
satisfaction
A
Products
and/or
services
Requirements,
needs and
expectations
A
feedback
feedback
feed forward

27. 0.3 Process approach
P D C
A
Customer
Process owner
shall align process
goals to company
goals …
Customers’
satisfaction
A
Products
and/or
services
Requirements,
needs and
expectations
A
Business
plan

28. A
0.3 Process approach
P D C
A
Customer
… process owner shall
ensure process to meet
applicable statutory
and regulatory
Requirements, …
Customers’
satisfaction
Products
and/or
services
Requirements,
needs and
expectations
A
Business
plan
Statutory &
Regulatory
requirements

29. Requirements
of other
processes
A
0.3 Process approach
P D C
A
Customer
…
… and coordinating
his/hers plans to plans of
other processes.
Customers’
satisfaction
Products
and/or
services
Requirements,
needs and
expectations
A
Business
plan
Statutory &
Regulatory
requirements

30. Requirements
of other
processes
A
0.3 Process approach
P D C
A
Customer
Customers’
satisfaction
Products
and/or
services
Requirements,
needs and
expectations
A
Business
plan
Statutory &
Regulatory
requirements
Measurements of process effectiveness

31. Requirements
of other
processes
A
0.3 Process approach
P D C
A
Customer
Customers’
satisfaction
Products
and/or
services
Requirements,
needs and
expectations
A
Business
plan
Statutory &
Regulatory
requirements
Measurements of process effectiveness
Measurement of
process efficiency
Resources
planned
Resources
used
Goals planned Goals achieved

32. Requirements
of other
processes
A
0.3 Process approach
P D C
A
Customer
Customers’
satisfaction
Products
and/or
services
Requirements,
needs and
expectations
A
Business
plan
Statutory &
Regulatory
requirements
Measurements of process effectiveness
Measurement of
process efficiency
Resources
planned
Resources
used
Goals planned Goals achieved
NCR
CSI

33. Quality management systems –
Requirements
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
The scope of the organization's quality
management system shall be available
and be maintained as documented
information.
Described in terms of:
• Products and services
• Main processes involved
• Sites where processes are
operated

34. QA
Accounting
Customers
Production &
service provision
Suppliers
Sales
4.4 QMS and its processes
Customers
requirements
Design Purchasing
Sub-contractors
Maintenance
?
The process of
management of the
company
7.1.2 People
7.1.3 Infrastructure
7.1.4 Environment
7.1.5 Monitoring and measuring
7.1. 6 Organizational knowledge
Resources
Value adding processes
Supporting processes
External parties
Monitoring, inspection, maesuring
Legend:
Interested parties

35. QMS Interaction Chart
Leadership and
management
Project
manage-
ment
Human resources
Finance resources
IT management
Product
planning, sales
and marketing
Design &
development,
purchasing
Production,
inspection and
testing
Customer
(requirements,
needs
and
expectations)
Customer
(satisfaction)
Quality
management
Accounting
(outsourced)
Suppliers
1
2
3 4
5
6
7
8
9
10
11
12
13 14
15
16
17
C
B
A
3.1
3.2
Sequence and interaction of processes

36. Quality management systems –
Requirements
5 Leadership
5.1 Leadership and commitment
5.2 Policy
5.3 Organizational roles, responsibilities and authorities

37. Quality management systems –
Requirements
6 Planning
6.1 Actions to address risks and opportunities
6.2 Quality objectives and planning to achieve them
6.3 Planning of changes
In Clause 4: the
organization is required
to determine risks that
can affect its ability to
meet objectives”
In Clause 5: top
management are
required to commit to
ensuring Clause 4 is
followed
In Clause 6: the
organization is required
to plan and take action
to address risks and
opportunities
In Clause 8: the
organization is required
to have processes which
identify and address
risk in its operations
In Clause 9: the
organization is required
to consider risks and
opportunities when
determining what
needs to be monitored,
measured, analyzed and
evaluated
In Clause 10: the
organization is required to
improve by responding to
changes in risk and
opportunities

38. 6.2 Quality objectives and planning to achieve them
We are going to show how
QMS operates on strategic
and operational level using
PDCA approach.
Each management level is
using its’ own PDCA loop.
Both loops are connected
and synchronized by
information exchange.

39. QMS
P
D
C
A
Top management Process owners
Plan: establish the objectives of the
system and its processes, and the
resources needed to deliver results
in accordance with customers'
requirements and the
organization's policies;

40. QMS
P
D
C
A
Top management Process owners
Do: implement what
was planned;

41. QMS
P
D
C
A
Top management Process owners
Check: monitor and (where applicable)
measure processes and the resulting
products and services against policies,
objectives and requirements and report
the results;

42. QMS
P
D
C
A
Top management Process owners
Act: take actions to improve
performance, as necessary.

43. QMS
P
D
C
A
Top management Process owners
Quality policy
Business plan with
quality objectives
Target values
Action plan
8.1
6.1 and 6.2
5.2
8.1
Top management shall
establish, implement
and maintain a quality
policy and establish quality
objectives at relevant
functions, levels and
processes needed for the
quality management
system.
Actions
6.1
SWOT
Quality plan

44. QMS
P
D
C
A
Top management Process owners
Quality policy
Business plan with
quality objectives
Target values
Action plan
8.1
6.1 and 6.2
5.2
8.1
The organization
shall plan actions to
address these risks
and opportunities.
Actions
6.1
SWOT
Quality plan

45. QMS
P
D
C
A
Top management Process owners
Quality policy
Business plan with
quality objectives
Managing organization
according to Quality policy
and objectives
Target values
Action plan
Operations as planned
8.1
8.2 to 8.5
6.1 and 6.2
5.2
8.1
The organization shall
plan, implement and
control the processes
needed to meet
the requirements for the
provision of products
and services
Actions
6.1
SWOT
Quality plan

46. QMS
P
D
C
A
Top management Process owners
Quality policy
Business plan with
quality objectives
Managing organization
according to Quality policy
and objectives
Target values
Action plan
Operations as planned
Check
Control of
nonconformities
Corrective
actions
Analyzing
data
Nonconformance
Internal audits
8.1
8.2 to 8.5
9.2
8.7
9.1.3
10.2
8.6
6.1 and 6.2
5.2
8.1
Check
Customers
The organization shall implement
planned arrangements, at
appropriate stages, to verify
that the product and service
requirements have been met and
control nonconforming output.
Actions
6.1
SWOT
Quality plan

47. QMS
P
D
C
A
Top management Process owners
Quality policy
Business plan with
quality objectives
Managing organization
according to Quality policy
and objectives
Management review
Analyzing results and action
taking
Target values
Action plan
Operations as planned
Check
Customers
Control of
nonconformities
Corrective
actions
Analyzing
data
Nonconformance
Internal audits
8.1
8.2 to 8.5
9.2
9.1.2
8.7
9.1.3
10.2
8.6
6.1 and 6.2
5.2
9.3
8.1
Quality plan
Check
6.1
9.3.3
Top management shall
review the organization's
QMS, at planned
Intervals.
Actions
6.1
SWOT

48. QMS
P
D
C
A
Top management Process owners
Quality policy
Business plan with
quality objectives
Managing organization
according to Quality policy
and objectives
Management review
Analyzing results and action
taking
Target values
Action plan
Operations as planned
Check
Customers
Control of
nonconformities
Corrective
actions
Analyzing
data
Nonconformance
Internal audits
8.1
8.2 to 8.5
9.2
9.1.2
8.7
9.1.3
10.2
8.6
6.1 and 6.2
5.2
9.3
8.1
Quality plan
Check
9.3.3
Actions
6.1
SWOT

49. Practical
example
Company
owners
Top management Process owners Project manager and experts
Quality policy
CHECK
ACT
DO
Business plan with
quality objectives
Process plan
Appr
oval
Approved
business plan
OK
Work according to
plan
Checking
monthly
Analyzing results Monthly
Quarterly
Action plan
Targets
Work according to
plan
Checking
Customer
Customer satisfaction
feedback
Analysis of customer
perception of quality
Work according to
plan
Annual
report
Checking
Quarterly
Auditing
Audit
report
Corrective &
preventive
actions
Non
conformance
NOT
OK
Annual management review
Prototype production
(vendor)
Checking
Non
conformance
Checking
Non
conformance
Analysis
of NC
A
C
A
C

50. Quality management systems –
Requirements
7 Support
7.1 Resources
7.2 Competence
7.3 Awareness
7.4 Communication
7.5 Documented information

51. Quality management systems –
Requirements
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

52. Quality management systems –
Requirements
9 Performance evaluation
9.1 Monitoring, measurement, analysis and evaluation
9.2 Internal audit
9.3 Management review

53. Dashboard
Customers
Customers
Orders
Design
Suppliers
Products
and /or
services
Resources
planned
Performance
goals
Effectiveness=
Goals planned
Goals achieved
Efficiency =
Resources used
Resources Planned
Sales
Purcha-
sing
Production
and service
provision