Free Quality Management System Course - module (3)- Context of Organization
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Free Quality Management System Course - module (3)- Context of Organization

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Free Training Course -Foundations of Quality Management System (QMS) According to ISO 9001-2015 - module (3)- Context of Organization.


In this module we will discuss context of organization.



- Context of organization and risk-based thinking.


Clause 4 of ISO 9001:2015 states that the organization to assess itself regarding the organization’ context and how his context may affect the QMS.


Organization need to study:

  • Influences of various elements on the organization
  • How elements reflect on the QMS
  • Risk and opportunities regarding the business



The standard does not mandate for understanding the context of the organization. However, there are few logical steps & milestones as per below:



- Identifying internal and external issues.

Define internal and external issues that relevant to its purpose and its strategic direction and affect to its ability to achieve the intended results of its QMS.

1         

- Internal context.

An organization internal context is the environment in which it aims to achieve its objectives. For example:
  • The company culture
  • Objectives and goals
  • Complexity of the products
  • Flow of processes
  • Organization knowledge
  • Size of the organization


- External context.

An organization external context is the environment which influences the organization. 

External contexts include:
  • Markets
  • Customers
  • Regulatory bodies & government organization
  • Social
  • Economic environment
  • Technology advancement

- Understanding the needs and expectations of interested parties.

Depending on the nature of the business there will be a lot of different interested parties. Most general examples are:
  • Partners
  • Clients
  • Suppliers
  • Employees


After identifying the interest party’s standard require to determine their requirements regarding your QMS.

You can imagine all these different groups have different requirements regarding the QMS. For example, one client can be more important because he will make a big part in handing over. so, his needs and expectations need to be met to keep this client.

Once you know what the requirements are then we can star configuring QMS according to the requirements and this will help in implementation of the effective QMS.


The clause 4.2 of the standard requires these analyses to be conducted. However, it does not require to document them.

- Determining the scope of the QMS.

The scope is important because it sets the boundaries of the QMS and it is included in the ISO 9001 certificate.

To define the QMS scope you should take in consideration what your company want to achieve. As well as results of previous analysis of issues and interested parties.

Additionally, you should consider the activities of your organization and activities of other organizations such as associates, partners, or outsourcing companies and how those activities related and how do they depend on each other.

For example, if analysis of internal issues of a small company with only one location show that the organizational structure is simple and organizational culture is easily adaptive to changes. This is indication that the whole company and all its operations can be in the QMS scope.

Or, in large company if the analysis of interested parties and their requirements show that the big client requires that the product deliver to him are produce according ISO 9001 then the company can include in the scope only facilities and production wise that produce about mentioned product. May be after certain periods are extend the scope to other processes as well.

The standard requires that the processes be documented. Typically, on the QMS scope document or statement includes information’s such as services and products company provides, location, etc.

- Quality management system and its processes.

Including:

  • Inputs required and outputs expected from each process.
  • Sequence and interaction of these process
  • Criteria and methods for effective operation and control of process
  • Resources needed for process
  • Responsibility and authorities for these processes.
  • Risk & opportunities in accordance with requirements
  • Evaluate the processes and implement any changes needed
  • Improve the process and QMS.















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