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
 4.4 QMS and Processes
First we shall define the
processes needed to
meet the requirements
The policy of our
Customers requirements

for the provision of

Customers
organization is to create
products and services.
value for the customers
Requirements for these
at competitive price.
processes are given in
clause 8
 4.4 QMS and Processes
8.2 Requirements for products
and services
Customers requirements
A sales process is a set of activities
for selling a product or service:
planning the sale, initial contact,

8.2.1 Customer communication

8.2.3 Review of requirements
related to products and services
8.2.4 Changes to requirements
for products and services
Customers
need assessment, presentation,
meeting objections, follow-up …

Sales
 4.4 QMS and Processes
8.3 Design and development of products
and services
Customers requirements
Design and development is
the process of creating a
new product and services

8.3.2 Design and development planning,

Customers
8.3.3 Design and development inputs, to be sold by an
8.3.4 Design and development controls, organization to its
8.3.5 Design and development outputs, customers.
8.3.6 Design and development changes

Sales Design
 4.4 QMS and Processes
Purchasing is engaged in buying
anything you can not produce
within the organization, and
8.4 Control of externally provided
Customers requirements

out-sourcing is something you

Customers
processes, products and services
could produce yourself, but
8.4.1 General
choose not to due to capacity
8.4.2 Type and extent of control
or commercial considerations.
8.4.3 Information for external
providers

Sales Design Purchasing

Suppliers

Sub-contractors
 4.4 QMS and Processes
8.5 Production and service provision
8.5.1 Control of production and
An organization must carry out
service provision
the activities to provide products
8.5.2 Identification and traceability
Customers requirements

or services under controlled

Customers
8.5.3 Property belonging to customers
conditions. These include work
or external providers
instructions, suitable equipment,
8.5.4 Preservation
activities controlling product
8.5.5 Post-delivery activities
release, delivery and post-
8.5.6 Control of changes
delivery...

Production &
Sales Design Purchasing
service provision

Maintenance
Suppliers

Sub-contractors
 4.4 QMS and Processes
The release of products and
services to the customer shall
not proceed until the planned
Customers requirements

arrangements have been

Customers
satisfactorily completed, or
approved by a relevant
authority or by 8.6 Release of
the customer. products and services

Production &
Sales Design Purchasing
service provision

Maintenance
Suppliers

Sub-contractors
 4.4 QMS and Processes

The organization shall ensure that outputs that do

Customers requirements

not conform to their requirements are identified

Customers
and controlled to prevent their unintended
use or delivery.

8.7 Control of nonconforming

outputs

Production &
Sales Design Purchasing
service provision
?

Maintenance
Suppliers

Sub-contractors
 4.4 QMS and Processes
The organization shall determine,
provide and maintain the
Customers requirements

infrastructure necessary for the

Customers
operation of its processes to
achieve conformity
of products and services.
7 Support
7.1.3 Infrastructure

Production &
Sales Design Purchasing
service provision
?

Maintenance
Suppliers

Sub-contractors
 Interested parties
4.4 QMS and Processes
The process of
management of the
company
Customers requirements

Customers
4.2 Understanding the
needs and
expectations of
interested parties
5.1.2 Customer focus

Production &
Sales Design Purchasing
service provision
?

Maintenance
Suppliers

Sub-contractors
 Interested parties
4.4 QMS and Processes
The process of
management of the
company
Customers requirements

Customers
9.1.2 Customer satisfaction
The organization shall
monitor customers'
perceptions of the degree to
which their needs and
expectations have been
fulfilled.

Production &
Sales Design Purchasing
service provision
?

Maintenance
Suppliers

Sub-contractors
 Interested parties
4.4 QMS and Processes
The process of 5.2 Policy
management of the 6 Planning
company
Customers requirements

Customers
Production &
Sales Design Purchasing
service provision
?

Maintenance
Suppliers

Sub-contractors
 Interested parties
4.4 QMS and Processes
The process of 7.1 Resources: The
management of the organization shall
company determine and provide
the resources needed
Customers requirements

Customers
7.1.2 People for the QMS
7.1.3 Infrastructure
7.1.4 Environment
7.1.5 Monitoring and measuring
7.1. 6 Organizational knowledge

Production &
Sales Design Purchasing
service provision
?

Maintenance
Suppliers

Sub-contractors
 Interested parties
4.4 QMS and Processes
The process of
Monitoring of the
management of the
operating costs of
company
the system.
Customers requirements

Customers
7.1.2 People
7.1.3 Infrastructure Accounting
7.1.4 Environment
7.1.5 Monitoring and measuring
7.1. 6 Organizational knowledge Not ISO 9001:2015
requirement

Production &
Sales Design Purchasing
service provision
?

Maintenance
Suppliers

Sub-contractors
 Interested parties
4.4 QMS and Processes
The process of
management of the
company
Customers requirements

Customers
7.1.2 People
7.1.3 Infrastructure Accounting
7.1.4 Environment
7.1.5 Monitoring and measuring QA
7.1. 6 Organizational knowledge

Production &
Sales Design Purchasing
service provision
?

9.1 Monitoring, measurement, analysis and evaluation

Maintenance
9.1.2 Customer satisfaction Suppliers
9.1.3 Analysis and evaluation
9.2 Internal audit Sub-contractors
9.3 Management review
10 Improvement
 Interested parties
4.4 QMS and Processes
The process of
management of the
company
Resources
Customers requirements

Customers
7.1.2 People
7.1.3 Infrastructure Accounting
7.1.4 Environment
7.1.5 Monitoring and measuring QA
7.1. 6 Organizational knowledge

Production &
Sales Design Purchasing
service provision
?

Legend: Maintenance
Value adding processes Suppliers
Supporting processes
Sub-contractors
External parties
Monitoring, inspection, maesuring
 QMS Interaction Chart
Leadership and
1
management

2
17
Project
16
manage-
Customer (requirements, needs and expectations)

15 ment

11
Human resources

Customer (satisfaction)
12 Quality 10
management
Finance resources
13 14
Accounting
IT management (outsourced)

C
B

3.2
5

3 Product 4 Design & Production,

6 9
planning, sales development, inspection and
and marketing purchasing testing
8
7
3.1

Suppliers
Sequence and interaction of processes
 4.4 QMS Example cont.
Process inputs and outputs
Nr. Description
1 Market requirements
2 Business plan, Quality policy, quality objectives
3, Customers orders
3.1 Proposals, Contracts
3.2 Design and development support to sales and marketing
4 Customer requirements
5 Product
6 Product inspection and test documentation
7 Production documentation, purchase orders
8 Purchased products, prototypes from vendors
9 Tested prototypes and documentation
10 Customer satisfaction data
11 Reporting of quality related information (nonconformities statistics, status of corrective
actions, management review reports, audit reports, risk reports (FMEA, FTA …)
12 Quality related information from processes
13 Accounting information from processes
14 Accounting reports
15 Customer requirements, project change requests
16 Project deliverables
17 Project progress reports
A Human, financial and IT resources
B Information about quality and accounting
C Project management information (tasks, schedules, deliverables)