Clause 4- context of organisation.

        CONTEXT OF ORGANISATION

Context of organisation  basically  works on the analysis  of risk and opportunity  by top management  of the organisation in Oder to achieve the objectives  of the QMS.  It has been divided  into four subcluses by ISO 9001-2015  for better understanding.

4.1                              Understanding the organisation and its context 

4.2                              Understanding the need and expectations of interested parties.

4.3                              Determining scope of quality management system.

4.4                              Quality management system and its processes.

CLAUSE NO.-4 context of the organisation

clause no4.1>understanding context of organisation-The  organization  shall  determine  external  and  internal  issues  that  are  relevant  to  its  purpose and its strategic direction and that affect its ability to achieve the intended result(s) of its quality management system.

The organization shall monitor and review information about these external and internal issues.

NOTE 1       Issues can include positive and negative factors or conditions for consideration.

NOTE 2 Understanding the external context can be facilitated by considering issues arising from legal, technological, competitive, market, cultural, social and economic environments, whether international, national, regional or local.

 

NOTE 3 Understanding the internal context can be facilitated by considering issues related to values, culture, knowledge and performance of the organization.

clause no4.2> understanding the need and expectation of interested parties:- the organization’s ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements, the organization shall determine:

a>                 the interested parties that are relevant to the quality management system;

b>              the requirements of these interested parties that are relevant to the quality management system.

The organization shall monitor and review information about these interested parties and their relevant requirements.

 

   clause no-4.3>Determining the scope of the quality management system

The organization shall determine the boundaries and applicability of the quality management system  to establish its scope.

When determining this scope, the organization shall consider:

a>                 the external and internal issues referred to in 4.1;

b>             the requirements of relevant interested parties referred to in 4.2;

c>                the products and services of the organization.

The organization shall apply all the requirements of this International Standard if they are applicable within the determined scope of its quality management system.

The scope of the organization’s quality management system shall be available and be maintained as documented information. The scope shall state the types of products and services covered, and provide justification for any requirement of this International Standard that the organization determines is not applicable to the scope of its quality management system.

Conformity to this International Standard 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.

 

      Clause no. 4.4>  Quality management system- The organization shall establish, implement, maintain and continually improve a quality management system, including the processes needed and their interactions, in accordance with the requirements of this International Standard.

The organization shall determine the processes needed for the quality management system and their application throughout the organization, and shall:

a>             determine the inputs required and the outputs expected from these processes;

b>                determine the sequence and interaction of these processes;

c>            determine and apply the criteria and methods (including monitoring, measurements and related performance indicators) needed to ensure the effective operation and control of these processes;

d>                determine the resources needed for these processes and ensure their availability;

e>                 assign the responsibilities and authorities for these processes;

f>               address the risks and opportunities as determined in accordance with the requirements of 6.1;

g>                 evaluate these processes and implement any changes needed to ensure that these processes achieve their intended results;

h>              improve the processes and the quality management system.

To the extent necessary, the organization shall:

a)                 maintain documented information to support the operation of its processes;

b)                retain documented information to have confidence that the processes are being carried out as planned.