Module 4:

Gontext of the Organisation

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Module a: Gq{94frof the
Organisation
I Quality Management
Systems - An lntroduction
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I An ISO 900'l :20'15 Based

Quality Management System
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Perform a nce:EnaluEtio n

Duration: 30 minr.rtes including Activity 5

Objectives:
. Understand Clause 4 - Context of the Organisation

Slides: 38 - 40

Activities:
Activity 5 - Context of the Organisation, page 50

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This section is intended to provide insight into the purpose and objectives of
the organisation, i.e. why it exists.

Whereas some aspects of this section were implied in the previous version of
ISO 9001, the section expands upon those requirements, ensuring the quality
management system is truly integrated into the organisation's business
processes.

Experience has shown that too many organisations address the standard but
don't integrate their quality management system into their organisation, so it
ends up being a separate system. These explicit requirements encourage
people to have a single, effective management system.

An organisation is required to identify, analyse and determine how external

and internal issues can impact its ability to achieve the expected outcomes of
the quality management system. External issues to be considered could be
changes in the competitive landscape, economic issues, environmental
issues, legal requirements, regulatory issues, and technological changes,
regardless of whether they are domestic or global. lnternal issues could be
related to the culture, beliefs, values or principles inside the organisation.

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UNDERSTAND THE ORGANISATION

This represents the purpose and strategic direction of the organisation's
management system - why the organisation is here.

The organisation needs to determine its relevant issues, both lnternal and
external, that have an impact on what it is trying to achieve, its intended
outcomes.

Notes 1 ,2 and 3 add context to this requirement.

iffi4.1Understandingtheorganisationanditscontexti
The organisation shall determine external and internal issues i

that are relevant to its purpose and its strategic direction and
that affect its ability to achieve the intended result(s) of its
quality management system.
The organisation shall monitor and review information about these external
and internal issues.

NOTE 1: Issues can include positive and negative factors or conditions for
consideration.

NOTE 2: Understanding the external context can be facilitated by considering

issues arising from legal, technological, competitive, market, cultural, social
and economic environments, whether international, national, regional or local.

i ruOff 3: Understanding the internal context can be facilitated by considering

i issues related to values, culture, knowledge and performance of the
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UNDERSTAND NEEDS & EXPECTATIONS OF
INTERESTED PARTIES
This implies that the quality management system will have to account for
much more than just the customer's needs. lt might need to address the
requirements of shareholders/owners, management, employees and possibly
even the public in some organisations.

While it could be interpreted that the organisation defines the customer as the
only interested party for the purposes of quality, this section opens the system
up for much broader application.

fre 4.2 Understanding the needs and expectations of

gd interested oarties
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requirements, the organisation shall determine:
a) the interested parties that are relevant to the quality management system;
b) the requirements of these interested parties that are relevant to the quality
management system.
The organisation shall monitor and review information about these interested
parties and their relevant requirements.

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Objective:

An organisation is required to identify, analyse and determine how external

and internal issues can impact its ability to achieve the expected outcomes of
its quality management system.

Task:

ln your team review the list of organisations provided below and identify
potential internal and external issues that must be considered.

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lnternet Based Sales

Organisation

Bank

Large Public Hospital

Manufacturer of Car
Components

Waste Management Com pany

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 NOTES

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DETERMINE THE SCOPE OF THE QUALITY
MANAGEMENT SYSTEM
The scope of the quality management system should be determined
considering the external and internal issues and interested parties.

The scope is to be made available in "documented information" and stated in

terms of "products and services" with the processes and organisation needed
to deliver them.

4.3 Determining the scope of the quality management

system
The organisation shall determine the boundaries and
applicability of the quality management system to establish
its scope.
When determining this scope, the organisation shall consider:
a) the external and internal issues referred to in 4.'1 ;

b) the requirements of relevant interested parties referred lo in 4.2',

c) the products and services of the organisation.
The organisation shall apply all the requirements of this lnternational
Standard if they are applicable within the determined scope of its quality
management system.
The scope of the organisation's quality management system shall be
available and be maintained as documented information. The scope shall
state the types of products and services covered, and provide justification for
any requirement of this lnternational Standard that the organisation
determines is not applicable to the scope of its quality management system.
Conformity to this lnternational Standard may only be claimed if the
requirements determined as not being applicable do not affect the
organisation's ability or responsibility to ensure the conformity of its products
and services and the enhancement of customer satisfaction.

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 QUALITY MANAGEMENT SYSTEM AND ITS
PROCESSES
This clause covers all the requirements that need to be included in the quality
management system, including the processes to be covered.

The final point relating to "documented information being maintained and

retained only to the e{ent necessary" is extremely important as many
organisations have made the assumption that the Standard requires the
organisation to meticulously document all their processes.

4.4 Quality management system and its processes

4.4.1 fhe organisation shall establish, implement, maintain and
continually improve a quality management system, including the
processes needed and their interactions, in accordance with the
requirements of this lnternational Standard.
i The organisation shall determine the processes needed for the quality
i management system and their application throughout the organisation, and
i shall:
i a) determine the inputs required and the outputs expected from these
processes;
b) determine the sequence and interaction of these processes;
c) determine and apply the criteria and methods (including monitoring,
measurements and related pedormance indicators) needed to ensure the
effective operation and control of these processes;
d) determine the resources needed for these processes and ensure their
ava ilability;
e) assign the responsibilities and authorities for these processes;
f) address the risks and opportunities as determined in accordance with the
requirements of 6.'1 ;

g) evaluate these processes and implement any changes needed to ensure

that these processes achieve their intended results
rh) improve the processes and the quality management system.

4.4.2To the extent necessary, the organisation shall: i

a) maintain documented information to support the operation of its processes;

i

b) retain documented information to have confidence that the processes are i

being carried out as planned. i

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