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Implementaion of Iso

The document discusses several aspects of understanding and determining the context of an organization's quality management system. It describes how an organization should identify external and internal issues, monitor relevant information, and understand how these factors affect the goals of the QMS. It also addresses understanding the needs and expectations of interested parties, determining the scope of the QMS, and establishing processes and responsibilities.

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SAM KUMAR
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75 views5 pages

Implementaion of Iso

The document discusses several aspects of understanding and determining the context of an organization's quality management system. It describes how an organization should identify external and internal issues, monitor relevant information, and understand how these factors affect the goals of the QMS. It also addresses understanding the needs and expectations of interested parties, determining the scope of the QMS, and establishing processes and responsibilities.

Uploaded by

SAM KUMAR
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as DOCX, PDF, TXT or read online on Scribd
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NEW

4.1 “Understanding the organization and its context”

Organization shall:

 Determine external and internal issues that are relevant to purpose and strategic
direction and that affect ability to achieve the intended result(s)
of QMS.

 Monitor and review the information about these external and internal issues.

External context includes*

 Cultural, social, political, legal, regulatory, financial, technological, economic,


natural and competitive environment, whether international, national, regional or
local;

 Relationships with, and perceptions/values of external stakeholders

Internal context includes*

 Corporate culture;

 Governance, organizational structure, roles and accountabilities;

 Policies, objectives, and strategies

 Resources (capital, time, people, processes, systems technologies);

 Information systems, information flows and decision making


Processes (both formal and informal)
NEW

4.2 “Understanding the needs and expectations of interested parties”

The organization shall

 Determine- the interested parties that are relevant to the QMS,

 Determine -the related requirements of these interested parties that are relevant
to the QMS”

 Monitor and review the information about these interested parties and their
relevant requirements

 ISO 9001:2015 focuses attention on those interested parties that can impact the
organization’s ability consistently provide conforming products and services
NO
4.3 Determining the scope of the QMS CHANGE

The organization shall determine the boundaries and applicability of the QMS to
establish its scope.

Must consider
 The external and internal issues referred to in 4.1,
 The requirements referred to in 4.2
 Products and services provided.

ISO/DIS 9001:2015 includes comments that:

 All requirements are applicable


 If a requirement cannot be applied, it must

 Not affect the ability to provide conforming product


 Be justified NO
CHANGE
4.4 Quality management system and its processes
“Establish, implement, maintain and continually improve the QMS, including the
processes needed and their interactions, in accordance with the requirements of this
International Standard”.

(This is key to maintaining the “process approach”, which will now


be embedded in ALL ISO management system standards)

Organizations shall determine: NEW

 Inputs required and outputs expected from the QMS processes;


 Criteria methods, including measurements and related performance
indicators needed to ensure the effective operation and control;
 Assignment of the responsibilities and authorities for these processes;
 Risks and opportunities and plan and implement appropriate actions to address
them
NEW
5.1 Leadership and commitment

“Top management shall demonstrate leadership and commitment with respect to the
quality management system by

 Taking accountability of the effectiveness of the QMS;


 Ensuring policy and objectives are compatible with strategic direction
 Ensuring the quality policy is communicated, understood and applied
 Ensuring integration of the QMS requirements into business processes
 Promoting awareness of the process approach
 Communicating importance of effective quality management and of conforming to
the QMS requirements;
 Ensuring that the system achieves its intended results
 Engaging, directing and supporting persons to contribute to the effectiveness
Of the QMS;
 Promoting continual improvement
 Supporting other relevant management roles to demonstrate their
leadership as it applies to their areas of responsibility.”

Top management is also required to ensure that:

 Customer requirements and applicable statutory / regulatory requirements are


determined and met;
 The risks and opportunities that can affect conformity of products and services
and the ability to enhance customer satisfaction are determined and addressed;
 The focus on consistently providing products and services that meet
customer and applicable statutory and regulatory requirements is
maintained;
 The focus on enhancing customer satisfaction is maintained.

NO
5.2 Quality Policy
CHANGE

“Top management shall establish a quality policy that:

 Is appropriate to the purpose of the organization,


 Provides a framework for setting quality objectives;
 Includes a commitment to satisfy applicable requirements, and
 Includes a commitment to continual improvement of the quality management
system.
NEW
The quality policy shall

 Be available as documented information


 Be communicated within the organization
 Be available to interested parties, as appropriate

5.3 Organizational roles, responsibilities and authorities

Top management shall assign the responsibility and authority for...........


NEW

 Ensuring that the processes are delivering their intended outputs;

 Reporting on the performance of the quality management system, on


opportunities for improvement and on the need for change or innovation, and
especially for reporting to top management;

This is typically what we would expect from NO


the “Management Representative”, though CHANGE
this name is no longer used
NEW
6.1 Actions to address risks & opportunities

“determine the risks and opportunities that need to be addressed to


 give assurance that the QMS can achieve its intended result(s)
 prevent or reduce undesired effects
 achieve continual improvement.

Plan:
a) Actions to address these risks and opportunities, and
b) How to

 integrate and implement these actions into the QMS processes


 evaluate the effectiveness of these actions.”

Actions taken to address risks and opportunities shall be proportionate to the potential
impact on the conformity of products and services.

NOTE
Options can include: avoiding risk, taking risk in order to pursue an opportunity,
eliminating the risk source, changing the likelihood or consequences, sharing the risk,
or retaining risk by informed decision.

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