Free Training Course -Foundations of Quality Management System (QMS) According to ISO 9001-2015 - module (3)- Context of Organization.
In Foundations of Quality Management System - module (1)show the history of ISO revisions and fundamental concept in ISO 9001:2015 and
module (2) explain Process Approach and PDCA Cycle.
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.
good effort
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