ORGANISATIONAL P-400-A

nd
CONTEXT 2 Jan, 2018

1.0 Purpose/Scope

1.1 The purpose of this procedure is to ensure that the context of SSITL and the needs and
expectations of interested parties are understood.

1.2 The procedure applies to the external and internal issues that can affect the Quality
Management System (QMS).

2.0 Responsibilities and Authorities

2.1 The Managing Director has the prime responsibility and approval authority for this procedure.

2.2 Top management is responsible to determine the relevant external and internal issues that
affect the ability to achieve the intended result(s) of the QMS and that can impact on the planning of the
QMS.

3.0 References and Definitions

3.1 Reference

3.1.1 This document addresses clause 4 of the ISO 9001:2015 standard covering, Context of the
organization.

3.2 Definitions

3.2.1 Top management: Person or group of people who directs and controls an organization at the
highest level.

3.2.2 Context of the organization: Combination of internal and external factors and conditions that can
have an effect on an organization.

4.0 Resources

4.1 As outlined in the procedure P-710 for Resource management

5.0 Instructions

5.1 To fully understand the organization and its context, SSITL determines the external and internal issues
that are relevant and that affect the ability to achieve the intended results of the QMS.
5.2 To completely understand the needs and expectations of interested parties, SSITL identifies
the relevant interested parties, determines, monitors and reviews the requirements that are relevant to
the QMS.
5.1.1 The interested parties are identified by the Quality team / ISO steering committee. Their
expectations and needs and the impact or potential impact on the ability to consistently provide
products and services that meet customer and applicable statutory and regulatory requirements
are considered.

5.1.2 Interested parties may be customers, owners, and people in the organization, suppliers, unions,
bankers, partners or society that may include competitors or opposing pressure groups.

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 ORGANISATIONAL P-400-A
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CONTEXT 2 Jan, 2018

5.2 In support of Top management, the QMS documentation provides for an understanding of the
requirements and of the international standard as a whole.

5.2.1 As related to this procedure, the following combines the relevant external and internal factors
and conditions to complete an activity loop from leadership through continual improvement
where:

 P-500 demonstrates leadership and commitment to the QMS

 P-600 determines the issues that impact on the planning of the QMS

 P-710 covers the management of resources

 P-810 details the operational planning and control

 P-910 ensures the monitoring, measurement, analysis and evaluation

 P-1010 outlines a process for improvement.

5.3.2 The flow diagram FD-440-001 provides a graphical representation of the interactions of the
processes.

5.4 To determine and establish the scope of the QMS, SSITL determines the boundaries and applicability of
the QMS and considers the external and internal issues, the requirements of relevant interested parties,
the requirements that can be applied, and the products and services of the company.

5.4.1 The scope is available and maintained as documented information stating the products and
services covered by the QMS.

The scope of the QMS is as follows:

To include the scope.

5.4.2 SSITL applies all the requirements of ISO 9001:2015 when they are applicable within the
determined scope of the QMS.

5.4.3 Conformity to ISO 9001:2015 may only be claimed if the requirements determined as not being
applicable do not affect the organization’s ability or responsibility to ensure the conformity of its
products and services and the enhancement of customer satisfaction.

5.4.4 For any instance where a requirement cannot be applied, justification is documented.

SSITL has determined that the following requirement(s) is/are not applicable to the operations at
this site: _________________________________________________________.
For example, if you are a manufacturer of toys, a requirement that does not apply may be:
Clause 8.5.5 for post-delivery activities does not apply to the company. Customer feedback has
shown that conformity to post-delivery services is achieved with the initial delivery activities.
5.5 To establish, implement, maintain and improve the QMS, SSITL determines the processes
needed and their interaction and application throughout the company. The processes are identified on
the QMS-Process identification worksheet, form F-440-001.

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 ORGANISATIONAL P-400-A
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CONTEXT 2 Jan, 2018

5.5.1 This process approach provides for the management of the quality system and its processes
through the application of a “Plan-Do-Check-Act” continual improvement methodology, and a
focus on “Risk-Based-Thinking” that lead to the prevention of undesirable outcomes.

5.2.2 In support of Top management, the planning procedures P-600, Planning for the Quality
management system and P-810, Operational planning and control are established to further
detail the processes.

5.2.3 In support of Top management, the procedure P-930 for Management review is used to
evaluate the performance of the QMS.

5.3 SSITL maintains and controls documented information to support the operation of processes
and retains documented information needed to provide confidence and evidence that the processes are
being carried out as planned.

5.3.1 The documented information collectively describes the QMS where a pyramid-shape
documentation structure provides for:

 Tier I - Manual

 Tier II - Procedures

 Tier III - Work Instructions

 Tier IV - Quality Records

5.6.2 The procedure P-750 for documented information is established to control documentation and to
retain records.

6.0 Forms and Documented Information

6.1 Forms / Flow diagram

6.1.1 F-440-001 QMS-Process identification worksheet

6.1.2 FD-440-001 Process interactions flow diagram

6.2 Documented information / Related processes

6.2.1 P-500 Leadership

6.2.2 P-600 Planning for the quality management system

6.2.3 P-710 Resource management

6.2.4 P-750 Control of documented information

6.2.5 P-810 Operational planning and control

6.2.6 P-910 Monitoring, measurement, analysis and evaluation

6.2.7 P-930 Management review

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6.2.8 P-1010 Improvement

7.0 Revision History

Rev Date Section Paragraph Summary of change Authorized by

A 2 Jan, 18 Initial issue

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