ISO 9001:2015 –

how to use TRIZ for QMS design and

improvement
© 2015 Andrej Trebar
 PDCA in ISO 9001:2015 Structure
PLAN DO CHECK ACT

4 Context of 9
10
the 5 Leadership 6 Planning 7 Support 8 Operation Performance
Improvement
organization evaluation

Understanding Leadership and Actions to Resources Operations Monitoring, General

of the commitment address risk and planning and measurement,
organization opportunity Competence control analysis and Nonconformity
and its context Policy evaluation and corrective
Quality Awarness Requirements action
Expectations of Roles objectives for products Internal audit
interested responsibilities Communication and services Continual
parties and authorities Planning of Management improvement
changes Design and review
Documented
Scope of development
information
management
system Production and Control of
service externally
provision provided
QMS ind its
processes processes,
Release of products and
products and services
services

Control of
nonconforming
outputs
 Representation of the structure of ISO
9001:2015 Standard in the PDCA cycle
Quality Management System (4)

Organization
and its context Support &
(4) Operation
(7,8)

Plan Do Customer
satisfaction

Performance Results of
Customer Planning Leadership
requirements
evaluation (9) the QMS
(6) (5)

Products and
Act Check services

Improvement
Needs and (10)
expectations of
relevant
Intersted
parties (4) Reference: ISO 9001:2015 Figure 2
 Which inventive principles are most effective
Quality Management System (4) 6,19,20,24,26

Organization 12,14,15,,25,
and its context 28,24,32,40 Support &
(4) Operation 7,8,13,15,17,18,21,22,
(7,8) 27,29,30,31,35,36,38

Plan Do Customer
satisfaction
3,5,9,10,11,3
1,33,34,40
Performance Results of
Customer Planning Leadership
requirements
evaluation (9) the QMS
(6) (5)

Products and
Act Check services
1,2,4,5,9,10,15,16,
Improvement 22,23,24,33,37,39,40
Needs and (10)
expectations of
relevant All 40 inventive
Intersted principles
parties (4) Reference: ISO 9001:2015 Figure 2
 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
 Contents
0 Introduction
0.1 General
0.2 Quality management principles
0.3 Process approach
0.4 Relationship with other management system standards
 Risk based
0.3 Process approach
thinking is part
of the process
approach!
Process owner is
responsible for planning
and assuring results.

P
0.3 Process approach

People in process are

executing planed
activities

P D
0.3 Process approach

Results are checked

before products and
services are delivered
to customer.

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

P D C

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

Products
and/or
P D C services

feedback
A
feedback Customer
A satisfaction
 0.3 Process approach
First of all customer
requirements, needs Customer
and expectations are
gathered and analyzed. Requirements,
feed forward
A needs and
expectations

Products
and/or
P D C services

feedback
A
feedback Customers’
A satisfaction
 0.3 Process approach

Customer
Requirements,
Business
plan A needs and
expectations

Products
and/or
P D C services

A
Customers’
Process owner A satisfaction
shall align process
goals to company
goals …
 0.3 Process approach

Customer
Requirements,
Business
plan A needs and
expectations

Products
Statutory & and/or
Regulatory P D C services
requirements

A
Customers’
… process owner shall
ensure process to meet
A satisfaction

applicable statutory
and regulatory
Requirements, …
 0.3 Process approach

Customer
Requirements,
Business
plan A needs and
expectations

Products
Statutory & and/or
Regulatory P D C services
requirements

Requirements A
of other
Customers’
processes
…
A satisfaction

… and coordinating
his/hers plans to plans of
other processes.
 0.3 Process approach
Measurements of process effectiveness

Customer
Requirements,
Business
plan A needs and
expectations

Products
Statutory & and/or
Regulatory P D C services
requirements

Requirements A
of other
Customers’
processes
A satisfaction
 0.3 Process approach
Measurements of process effectiveness
Goals planned Goals achieved

Customer
Measurement of
process efficiency Requirements,
Business
plan A needs and
expectations
Resources Resources
planned used
Products
Statutory & and/or
Regulatory P D C services
requirements

Requirements A
of other
Customers’
processes
A satisfaction
 0.3 Process approach
Measurements of process effectiveness
Goals planned Goals achieved

Customer
Measurement of
process efficiency Requirements,
Business
plan A needs and
expectations
Resources Resources
planned used
Products
Statutory & and/or
Regulatory P D C services
requirements
NCR

Requirements A
of other CSI
Customers’
processes
A satisfaction
 Using TRIZ to detect N.C.
Worsening
Nonconforming
Measurements of process effectiveness
features
product is
Goals planned Goals achieved
produced here
Customer
Measurement of
process efficiency Requirements,
Business Nonconforming
plan A product is
needs and
not
expectations
Resources Resources detected here
planned used
Products
Statutory & and/or
Regulatory P D C services
requirements
NCR

Requirements A
of other CSI
Customers’
processes
A satisfaction

Improving Improving speed

features and productivity
Use 39×39 matrix for inventive principles
 Using 39×39 matrix
Worsening features
Improving #31 Harmful factors acting #37 Complexity of a
features developed by an object control

#9 Speed 2, 24, 35, 21 3, 34, 27, 16

#39 Capacity / 35, 22, 18, 39 12, 17, 28, 24

Productivity
Example: situation as-is

Metal chips are falling into the lathe.

Metal chips are jamming the lathe

performing added value operation.

Metal chips are removed by operator.

This is not value added operation.
Identification of free resources

GRAVITY

Gravity field is:

• free,
• reliable,
• doesn’t need
maintenance.

Gravity field can be

used to remove metal
chips from machine.
 Using 39×39 contradiction matrix
Worsening feature
Improving #31 Harmful factors acting
feature developed by an object

#9 Speed 2, 24, 35, 21

Inventive
principle

Remove metal Use gravity field Change process – Skip manual

Action chips from the to remove metal turn the lathe removal of metal
system chips upside down chips
Example: situation to-be

Turn the lathe upside down.

Metal chips will be falling out of the

system by gravity. This is effective use
of gravity field (available for free) for
removing metal chips.

Metal chips are collected periodically

for recycling.