ISO 9001:2015 Requirements Clause 0.1 – Purpose of the Standard
The major purpose of the ISO 9001 requirements for 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.
The ISO 9001:2015 QMS standard is a powerful business tool that organizations may use to achieve this. Organizations implement and use ISO 9001 requirements 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, ISO 9001 requirements 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.
Sustained business 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 interested parties that include customers, end-users, investors/ shareholders (owners), people employed by the organization, external providers, 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 and execution.
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 requirements 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 higher levels.
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 requirements include:
a. The ability to consistently provide product and services that meet customer and applicable statutory and regulatory requirements;
b. Facilitation opportunities to enhance customer satisfaction;
c. Addressing risks and opportunities associated with its context and objectives;
d. 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 9001:2015″.
This eCourse shows you how to easily and effectively IMPLEMENT all the requirements of this Standard.