Understanding ISO 9001:2015 QMS
The major purposes of an organization is to identify and meet the needs
and expectations of its customers and other stakeholders and to gain competitive advantage. One of the strategies
it might use to achieve these goals is to employ universally recognized business tools to improve the effectiveness
and efficiency of its capabilities.
ISO 9001:2015 is a powerful business tool that organizations may use to
achieve this. Organizations use ISO 9001 to
achieve goals and objectives related to meeting customer, stakeholder and regulatory requirements and
enhancing customer satisfaction.
While the focus is on quality management, the ISO 9001 business model may be applied just as well to manage the
entire organization. The standard embodies business concepts and principles universally recognized and applied for
sound business management. As such, ISO 9001 is a strategic management tool that when used correctly can act
as a starting point towards achieving sustained business success.
As a strategic tool, it can be used as the framework to integrate other
strategic activities related to sales and marketing; technology; and product, service and process design and
development; corporate environment, structure, culture and governance; product and service realization, delivery
and support; facility and asset management, etc. it can also be integrated
with other business management systems such as environmental management system (EMS) and occupational health
and safety (OHS).
The various parts of an
organization’s management system, including its QMS, can be integrated as a single management system. The
objectives, processes and resources related to quality, growth, funding, profitability, environment,
occupational health and safety, energy, security and other aspects of the organization can be more effectively
and efficiently achieved and used when the QMS is integrated with other management systems.
success can be achieved by
developing growth and improvement programs and initiatives that add value by addressing the present
and longer term needs of its
that include customers, end-users, investors/ shareholders
(owners), people employed by the organization, external
regulatory bodies, lending institutions, unions, partners, interest groups and communities.
What this means is that the organization must take a long-term outlook to attaining business success as well
as addressing a broader scope of stakeholder requirements, needs and expectations, not just its immediate
customers. In pursuing ISO 9001 certification and undertaking longer term improvement initiatives, it
must seek to
achieve a balance between its economic-financial interests and those of the social and ecological environment that
it operates in. The goals and objectives that it seeks to achieve must also strike a balance between incremental
improvement and breakthrough accomplishments.
The QMS that you develop
for your organization (based on meeting the applicable requirements of this ISO 9001 standard) must comprise of interacting processes and activities which to some extent can be
predetermined, but at the same time must be flexible and adaptable to the complexities of your business context.
The ability to change may sometimes require innovation to achieve breakthrough improvements.
Your organization must
understand its internal and external context and identify the needs and expectations of relevant interested
parties. This information must be used to develop your QMS to achieve organizational sustainability. Although
often appearing to be comprised of similar processes, each organization and its QMS are unique.
The processes of your QMS
can be defined, measured and improved. These processes interact to deliver results consistent with your
organization’s objectives and cross functional boundaries. Some processes can be critical while others are not.
People collaborate within a
process to carry out their daily activities. Some activities are prescribed and depend on an understanding of
the objectives of the organization, while others are not and react to external stimuli to determine their nature
Every organization has
quality management activities, whether they have been formally planned or not. ISO 9001 provides requirements on
how to develop a formal system to manage these activities. It is necessary to determine activities which already
exist in the organization and their suitability regarding the context of the organization. ISO 9001 along with
guidance from ISO 9000 and ISO 9004 can be used to assist the organization to develop a cohesive QMS. I will
make many references to information from these standards to give you a solid understanding of ISO 9001.
A formal QMS provides a
framework for planning, executing, monitoring and improving the performance of quality management activities.
The QMS does not need to be complicated; rather it needs to accurately reflect the needs of the
A QMS is a dynamic
system that evolves over time
through periods of improvement. QMS planning is not a static activity, but an ongoing process. Plans
evolve as the organization learns and adapts to its changing environment. Your QMS planning must take into
account all quality activities of your organization and ensure that all applicable requirements of ISO 9001 are
addressed. The plan is implemented upon approval.
It is important for your
organization to regularly monitor and evaluate both the
implementation of QMS planning and the performance of the QMS. Carefully considered indicators facilitate these
monitoring and evaluation activities. Auditing is a means of evaluating the effectiveness of the QMS, in order
to identify risks and to determine the fulfillment of requirements. In order for audits to be effective,
tangible and intangible evidence needs to be collected. Actions are taken for correction and improvement based
upon analysis of the evidence gathered. The knowledge gained could lead to innovation, taking QMS performance to
Your QMS must be able to
identify risks and pursue opportunities to improve its processes, products and services in order to achieve and
enhance customer satisfaction. ISO guidance documents suggest that many issues such as innovation, ethics, trust
and reputation could be regarded as parameters within the QMS.
It is important to state here that ISO 9001 certification must not be the ultimate goal of QMS implementation. Your
primary long-term focus must be to improve the effectiveness
and efficiency of the organization for the benefit of all its relevant stakeholders. Obtaining certification must be considered as just a
stepping stone in this journey. Organizations that understand and follow this approach will get the most benefit
from QMS development and implementation.
The potential benefits from implementing a QMS based on ISO 9001 include:
The ability to consistently provide product and
services that meet customer and applicable statutory and regulatory requirements;
Facilitation opportunities to enhance customer
Addressing risks and opportunities associated
with its context and objectives;
The ability to demonstrate conformity to
specified quality management requirements.
These benefits will be discussed in ample detail as we cover the various clauses of the standard.
This article is an extract from my eCourse "Understanding ISO
This eCourse shows you how to easily and effectively IMPLEMENT all the requirements of this