02 Procedure For Context of The Organization

LOGO ISO 9001:2015
Company Name Quality System Procedure
PROCEDURE FOR CONTEXT OF THE ORGANIZATION

Procedure No: XXX/PRO/02 Rev No: 1.0 Rev. Date: dd/mm/yyyy
1. SCOPE
The purpose of this procedure is to define how the company’s Strategic Direction is
developed by senior management through the identification of interested parties, issues of
concerns, risks and opportunities.
2. PURPOSE
This procedure applies to all the activities within the scope of the Best Enterprises Quality
Management System.
3. REFERENCE DOCUMENTS
3.1 Best Enterprises Quality Manual,
4. TERMS & DEFINITIONS

IP- Interested Parties
R-Risk
O-Opportunity
SOP- Standard Operating System
BE – Best Enterprises
5. RESPONSIBILITY AND AUTHORITY

The Management Representative (MR) and in-charge of all departments are responsible for
the effective implementation of this procedure.
6. DETAILS OF PROCEDURE
6.1. Interested Parties

6.1.1 “Interested parties” are those stakeholders who receive our Products or Services
Processes., who may be impacted by them, or those parties who may otherwise have a
significant interest in our company. The interested parties applicable to Best Enterprises
are listed in the Risk and Opportunity register, along with the reason for their inclusion.
This includes both internal and external parties.
6.1.2 The identification of an interested party does not necessarily bring that party into the
scope of the QMS; for example, labour union leadership may be identified as an interested
party, but that does not mean QMS documents and policies must be developed related to
them.
PREPARED BY VERIFIED BY APPROVED BY

K.THANGAMANI M.PRABAGARAN M.PRABAGARAN
Confidential: For Internal Use Only Page 1 of 3

LOGO ISO 9001:2015

6.1.3 Properly planning a change by applying risk-based thinking can help to avoid negative
consequences such as rework or cancellation or postponement of service; it can also result
in positive consequences such as reduction of nonconforming outputs; or reduced incidents
of human error
6.2 Issues of Concern

6.2.1 For each interested party, the related issues of concern shall be identified in the Risk
Register. These issues may reflect direct concerns of the party (for example, customers are
concerned about the quality of products or services they purchase) or they may be indirect
concerns. Such concerns may impact on the interested party, or maybe concerns derived
from the party that impact on the company.
6.2.2 Issues may be either internal or external, depending on whether the interested party
is internal or external. In addition, a certain type of party may have both internal and
external concerns.
6.2.3 When attempting to identify internal concerns, it may be useful to consider service
concerns, employee concerns, etc.
6.2.4 When attempting to identify external concerns, it may be useful to consider concerns
arising from competition, society and culture, labour relations, statutory and regulatory
issues, supply chain, economic issues, etc.
6.3 Risk and Opportunity

6.3.1 Management will then identify risks and opportunities related to the issues of concern
within the Risk and Opportunity register.
6.3.2 Within the Risk register, each risk and opportunity will be noted, along with the
primary process involved.
6.3.3 Management will then determine a treatment method for each risk or opportunity.
Risks are managed to reduce their likelihood and severity, while opportunities are
managed to increase their likelihood and benefits. Blended issues may require more
complex treatment.
6.3.4 Where a risk is determined to be treated, these must then be entered into the Risk
and Opportunity Register.
6.3.5 Opportunities are managed via the Opportunity in Risk Register
6.4 Strategic Direction


LOGO ISO 9001:2015

6.4.1 From the information above, CEO devises a “strategic direction” which is documented
in the records of management review.
7. RETAINED DOCUMENTED INFORMATION

7.1 Internal issues (QMS F 012)
7.2 External issues (QMS F 013)
7.3 Pest Analysis (QMS F 014)
7.4 SWOT Analysis (QMS F 015)
7.5 Porter’s 5 Forces (QMS F 016)
7.6 Needs and expectations of Interested Parties (QMS F 017)


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What are the interested parties identified in the procedure?

What are the interested parties identified in the procedure?

What issues are considered when identifying risks and opportunities?

What issues are considered when identifying risks and opportunities?

LOGO ISO 9001:2015

Company Name Quality System Procedure

PROCEDURE FOR CONTEXT OF THE ORGANIZATION

4. TERMS & DEFINITIONS

5. RESPONSIBILITY AND AUTHORITY

6.1. Interested Parties

PREPARED BY VERIFIED BY APPROVED BY

Confidential: For Internal Use Only Page 1 of 3

PROCEDURE FOR CONTEXT OF THE ORGANIZATION

6.2 Issues of Concern

6.3 Risk and Opportunity

6.3.5 Opportunities are managed via the Opportunity in Risk Register

6.4 Strategic Direction

Confidential: For Internal Use Only Page 2 of 3

PROCEDURE FOR CONTEXT OF THE ORGANIZATION

7. RETAINED DOCUMENTED INFORMATION

PREPARED BY VERIFIED BY APPROVED BY

Confidential: For Internal Use Only Page 3 of 3

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