Procedure for Context of the Organization

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 XXX Quality Management System.

3. REFERENCE DOCUMENTS

3.1 XXX Quality Manual,

4. TERMS & DEFINITIONS
IP- Interested Parties
R-Risk
O-Opportunity
SOP- Standard Operating System

5. RESPONSIBILITY AND AUTHORITY

The Management Representative (MR) and HOD’s 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 XXX 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, labor union leadership may be identified as an interested party, but that does not mean QMS documents and policies must be developed related to them.
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 the interested party, or maybe concerns derived from the party that impacts 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, labor 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

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

7. RETAINED DOCUMENTED INFORMATION

7.1 Internal issues(QMS F 015)
7.2 External issues(QMS F 016)
7.3 Pest Analysis (QMS F 017)
7.4 SWOT Analysis (QMS F 018)
7.5 Porter’s 5 Forces (QMS F 019)
7.6 Needs and expectations of Interested Parties (QMS F 020)
7.7 Steps to derive the scope of the organization (QMS F 021)