What is ISO 9001:2015 – Quality management systems?
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.
Who should use the ISO 9001:2015 – quality management systems revision?
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:
- Organize processes
- Improve the efficiency of processes
- Continually improve
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).
What topics does ISO 9001:2015 cover?
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:
- Requirements for a quality management system, including documentation of a quality manual, document control, and determining process interactions
- Responsibilities of management
- Management of resources, including human resources and an organization’s work environment
- Product realization, including the steps from design to delivery
- Measurement, analysis, and improvement of the QMS through activities like internal audits and corrective and preventive action
Looking for a longer introduction to the ISO 9001 standard and the process approach?
Read these popular open-access articles from QP magazine:
ISO 9001 Made Easy
The Process Approach to QMS in ISO 9001 and 9004
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.
See a collection of featured resources providing more details on ISO 9001, including materials you can use to prepare for the transition to ISO 9001:2015.
How do I get started with ISO 9001:2015?
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.
What are the benefits of ISO 9001?
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:
- Organize a QMS
- Create satisfied customers, management, and employees
- Continually improve
"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," ASQ senior member Bud Salsbury writes on ASQ’s Ask the Experts blog. "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.
ISO 9001:2015 as a “business management tool”
In an article for ASQ’s QP magazine, 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.
“ISO 9001 offers more than quality benefits. The standard should be thought of as a business management tool an organization can use to drive value, improve its operations and reduce its risks.”
- Oscar Combs, Standard Wise
Achieving ISO 9001 certification
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:
- Follows the guidelines of the ISO 9001 standard
- Fulfills its own requirements
- Meets customer requirements and statutory and regulatory requirements
- Maintains documentation
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.
As Bill Aston explains in an Expert Answers column for ASQ’s QP magazine, organizations should consider the following as they begin preparing for an ISO 9001 quality management system certification:
- Registrar’s costs for ISO 9001 registration, surveillance and recertification audits
- Current level of conformance with ISO 9001 requirements
- Amount of resources that the company will dedicate to this project for development and implementation
- Amount of support that will be required from a consultant and the associated costs
Read "What’s the cost?" for a checklist you can use to assess the costs of certifying to ISO 9001.
ASQ does not issue ISO 9001 certification.
"For many organizations, once certification is achieved, there is an attitude that no more effort is needed to improve the QMS. Such an attitude is contrary to both the explicit requirements of ISO 9001 and its intent."
- Charles A. Cianfrani and John E. "Jack" West, ISO 9001:2008 Explained & Expanded
Training in the ISO 9001 standard
Training can provide an opportunity to review the ISO 9001:2015 standard and apply quality management principles in a practice environment.
Professionals responsible for developing, implementing, auditing, and managing an ISO quality management system or quality professionals interested in updating their documented ISO 9001-based QMS can take ISO 9000 training courses, which include courses focused on ISO 9001 and quality management systems. Additionally, organizations looking to improve employee performance and employees looking to continually improve will also find ISO 9000 training relevant.
Previous versions of ISO 9001
Originally published in 1987, ISO 9001 underwent revisions in 1994, 2000 and again in 2008. The latest revision was published in September 2015.
As John E. "Jack" West, Lorri Hunt, Nigel H. Croft, and Alka Jarvis write in an article for QP magazine:
- ISO 9001:1994 included changes to significantly improve the clause on control of design and development, and to provide several other clarifications. The 1994 series also slightly modified the role of ISO 9002 and 9003….
- The ISO 9001:2008 revision can be thought of as an amendment to clarify issues that had been raised during the application of ISO 9001:2000. It included several changes to the text but no additional requirements.
Read an article in ASQ’s QP magazine for details on the changes that took effect in the revision from ISO 9001:2008 to ISO 9001:2015.
Organizations certified to the ISO 9001:2008 standard will have a three-year period to transition to ISO 9001:2015. When the transition period ends in September 2018, ISO 9001:2008 certificates will no longer be valid. Organizations looking to start their transition to the 2015 revision can purchase a copy of ISO 9001:2015.
Why did you look up ISO 9001:2015?
Please let us know what resources your organization needs to support its ISO 9001 efforts. If you would like a reply, please include an email address.