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ISO 9001 is the international standard that specifies requirements for a quality management system (QMS). Organizations use the standard to demonstrate the ability to consistently provide products and services that meet customer and regulatory requirements. It is the most popular standard in the ISO 9000 series and the only standard in the series to which organizations can certify.
ISO 9001 was first published in 1987 by the International Organization for Standardization (ISO), an international agency composed of the national standards bodies of more than 160 countries. The current version of ISO 9001 was released in September 2015.
ISO 9001 is based on the plan-do-check-act methodology and provides a process-oriented approach to documenting and reviewing the structure, responsibilities, and procedures required to achieve effective quality management in an organization. Specific sections of the standard contain information on topics such as:
Specific sections of the standard contain information on topics such as:
Changes introduced in the 2015 revision are intended to ensure that ISO 9001 continues to adapt to the changing environments in which organizations operate. Some of the key updates in ISO 9001:2015 include the introduction of new terminology, restructuring some of the information, an emphasis on risk-based thinking to enhance the application of the process approach, improved applicability for services, and increased leadership requirements.
ISO 9001 helps organizations ensure their customers consistently receive high quality products and services, which in turn brings many benefits, including satisfied customers, management, and employees.Because ISO 9001 specifies the requirements for an effective quality management system, organizations find that using the standard helps them:
"It has been my experience, with several companies, that the culture change associated with ISO implementation is multilayered. The first and most obvious benefit is quality awareness
"This quality awareness does not fade away easily. Even those who offer strong resistance to change learn to respect and very much appreciate all the practical value in a good quality management system."
ISO 9001 also provides financial benefits, such as cost savings.
In Nevada, the Clark County School District used ISO 9001 to save $174 million over 10 years in actual expenditures and cost avoidance. More than 3,000 employees were trained to the standard, enabling three critical components of the system’s success: training, communication and respect, and efficiency.
Read other ISO 9001 case studies to see the performance benefits of using the standard.
Oscar Combs summarizes results of a Harvard Business School study comparing 916 organizations that have adopted ISO 9001 and 17,849 non-adopters. As Combs explains, the “business benefits” enjoyed by the ISO 9001 organizations included higher rates of survival and growth, increased wages, reduced waste, enhanced productivity, and improved health and safety performance.
Organizations and individuals that use ISO 9001 are encouraged to transition to the 2015 revision as soon as possible. However, the International Accreditation Forum (IAF) and the ISO Committee on Conformity Assessment (CASCO) have agreed to a three-year transition period from the publication date of ISO 9001:2015.
Whether you are beginning your ISO 9001 journey or transitioning to the 2015 revision, your first step is to purchase a copy of ISO 9001:2015.
ISO 9001 is the only standard in the ISO 9000 series to which organizations can certify. Achieving certification means that an organization has demonstrated the following:
Certification to the ISO 9001 standard can enhance an organization’s credibility by showing customers that its products and services meet expectations. In some instances or in some industries, certification is required or legally mandated.
The certification process includes implementing the requirements of ISO 9001:2015 and then completing a successful registrar’s audit confirming the organization meets those requirements.
Organizations should consider the following as they begin preparing for an ISO 9001 quality management system certification:
ISO 9001:2015 applies to any organization, regardless of size or industry. More than one million organizations from more than 160 countries have applied the ISO 9001 standard requirements to their quality management systems.
Organizations of all types and sizes find that using the ISO 9001 standard helps them:
All organizations that use ISO 9001 are encouraged to transition to ISO 9001:2015 as soon as possible. This includes not only organizations that are certified to ISO 9001:2008, but also any organizations involved in training or certifying others.
Guidance on transitioning to ISO 9001:2015 can be downloaded from the International Accreditation Forum (IAF).
QACS is an accredited certification body which provides International Organization for Standardization (ISO) management system certification and inspection services to organisations globally.
QACS is accredited by IAS (International Accreditation Service) USA to audit and certify organisations to ISO 9001.
QACS is also accredited by QASL Independent accreditation to audit and certify organisations to ISO 9001.
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