PRINCIPLES OF ISO 9001:2015

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Seven Quality Management Principles

CUSTOMER FOCUS
LEADERSHIP
ENGAGEMENT OF PEOPLE
PROCESS APPROACH
CONTINUAL IMPROVEMENT
FACTUAL APPROACH TO DECISION MAKING
RELATIONSHIP MANAGEMENT

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 What Is A Process?

Definition: ISO 9000 Quality Management systems –

Fundamentals and Vocabulary provides the following definition:

Process is set of interrelated or interacting

activities which transforms inputs into outputs

 Note 1: Inputs to a process are generally outputs of other

processes
 Note 2: Processes in an organization are generally planned
and carried out under controlled conditions to add value

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 Understanding the Process

Schematic Representation of a PROCESS

EFFECTIVENESS
OF PROCESS =
Ability to achieve
PROCEDURE desired results
(“Specified way to carry out an activity or a (Focus of ISO
process” - may be documented or not) 9001)

Input PROCESS Output

PRODUCT
(Includes (“Set of interrelated
or interacting activities”) (“Result of a process”)
Resources)

MONITORING AND EFFICIENCY OF

MEASUREMENT OPPORTUNITIES PROCESS =
(Before, during and after the process) Results achieved
vs Resources used
–
(Focus of
ISO 9004)

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 Classical Process Model

The following Figure describes this basic approach

of inputs and outputs.

OUTPUT
INPUT Customer who has a
Customer who has a need need met

INPUT Step 1
OUTPUT
Step 2 Step 3 Step 4 Step 5

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 Understanding the Process Approach

MANAGEMENT
INPUT ACTIVITIES OUTPUT
•Transformed Resources
ENABLERS
•Resources being Transformed
•Resources being used to
Transform

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 Understanding the Process Approach

INPUTS

• Customer Inputs - Quality / Cost / Delivery

Requirements

• Business Inputs - Business Plan / Departmental /

Group Targets

• Legal Inputs - Legislative & Regulatory

Requirements 7
 ISO 9001:2015 – Model
Continual Improvement of
the Quality Management System
(4)
Needs & Expectations
of Relevant
Interested Parties
(7) Support
(4) Organisation &
Its Context (8) Operation

CUSTOMERS
CUSTOMERS

Quality Management

Satisfaction
(5) (9) Performance
(6) Planning Leader- Evaluation
ship

System

Customer (10)
Product Consumption
Requirements Improvement
Typical Network of Interacting Processes

A P
C D Input E Output E
PROCESS E

AA PP
Input A CC DD
PROCESS A
Output A
AA PP Input C Input D Output D
CC DD PROCESS C PROCESS D

AA PP Output CAA PP
Input B CC DD CC DD
PROCESS B
Output B
AA PP Input F Output F
CC DD Internal PROCESS F
Internal
Customer Customer
AA PP
CC DD Feedback

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 Understanding the Process Approach

IDENTIFICATION AND MANAGEMENT

OF PROCESSES WITHIN AN
ORGANISATION (INTERACTION
BETWEEN PROCESSES) IS THE
PROCESS APPROACH

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 Example of Classical Process Model

P
Purchase Despatch Daily A
Order / Plan from Prodn. C
Delivery Marketing Plan K
Schedule M I
C N
A PROD
U G
R
S P
K
T P S
E
O C T
T
M O
I MTLS
E R
N
R E
G
S

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Customer Oriented Processes
1. Market Analysis / Customer Requirements
2. Enquiry Handling / Bid / Tender
3. Customer Order
4. Product & Process Design
5. Product & Process Verification / Validation
6. Production
7. Delivery
8. Payment
9. Warranty / Service
10.Customer Feedback
Note that Key Processes (COPS) are typically found in
Section 7 of ISO 9001
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 Support Processes

1. Storage
2. Purchasing
3. Inspection & Testing
4. Training
5. Maintenance
6. Logistics
7. EDP

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 Management Processes

1. Internal Audit
2. Management Review
3. Resource Provision
4. Continual Improvement
5. Communication

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