ISO 9001:2015 is an international standard dedicated to Quality Management Systems (QMS). It outlines a framework for improving quality and a vocabulary of understanding for any organization looking to provide products and services that consistently meet the requirements and expectations of customers and other relevant interested parties in the most efficient manner possible. The QMS is the aggregate of all the processes, resources, assets, and cultural values that support the goal of customer satisfaction and organizational efficiency. First published in 1987, the latest iteration (ISO 9001:2015) replaces ISO 9001:2008.

ISO 9001:2015 doesn’t dictate what an organization’s objectives should be or how to achieve them. In other words, it doesn’t tell anyone how to run their business. It’s a flexible standard that allows each organization to define for itself what its objectives and adherence to the standard ought to be. ISO 9001:2015 defines the guiding principles that can be used to create efficiencies by aligning and streamlining processes throughout the organization, in an effort to bring down costs, create new opportunities, meet regulatory requirements, and help organizations expand into new markets in which clients demand ISO 9001 certification (the last of which is increasingly crucial for businesses working in or with the public sector or serving as suppliers in automotive or private OEM (Original Equipment Manufacturer) scenarios).

ISO does not perform certifications to ISO 9001:2015. Instead, organizations engage an independent certification body to audit their QMS implementation against the ISO requirements. Organizations of any size can certify to this standard, including smaller ones with no dedicated Quality resources.

Why a new version?

ISO regularly reviews all standards to ensure they are up-to-date and continue to be relevant for the needs of organizations around the world. The last major revision of ISO 9001 was in 2008. While that might not seem like such a long time ago, the exponential increase in the availability of technology, products, and services for consumers, as well as the size and complexity of the global supply chain, have meant that ISO needed to make 9001 meet several new requirements. Customer demands on products and services, and the impact on the brand reputations of those companies that can meet them, grow each day, and ISO 9001 needed to meet these enhanced expectations.

Important Dates

ISO 9001:2015 was published in September 2015 and is already the most widely adopted standard in the history of standards. To help the more than 1 million companies that have certified to ISO 9001:2008 move to the new standard, ISO has set in place a three-year transition period during which ISO 9001:2008 certification will remain valid. This transition will expire in September 2018. It is important to note that after 2018, those companies that were certified ISO 9001:2008 and have not certified to ISO 9001:2015 will lose their ISO 9001 certification until they recertify to the new standard.

Many people have heard the term “ISO standard” and wondered what ISO is and how it became the guardian of standardization. ISO (from Greek isos meaning “equal”) is the “International Organization for Standardization,” a non-governmental organization based in Geneva, Switzerland. It is dedicated to developing voluntary standards that ensure product safety and quality while encouraging innovation in a global marketplace. ISO dates from 1947, after a meeting at the Institute of Civil Engineers in London at which delegates from 25 countries met to coordinate international standards for industrial manufacturing

ISOs fundamental mission is to provide common specifications, terms, standards, and units of measurement to organizations around the world. ISO does not provide certification or conformity assessment. Rather, it facilitates global trade and innovation to allow every organization in every sector from around the world to have a  common  language  and common expectations for everything from technology and manufacturing to food safety, healthcare, and agriculture. ISO standards benefit organizations at the environmental, economic, and societal level and help developing countries meet the United Nations Sustainable Development Goals through the ISO Action Plan for Developing Countries, a program that provides technical courses to assist developing countries in meeting international standards. ISO has published more than 22,000 standards since its first published standard in 1951.

ISOs overall mission is built on the following core initiatives for its members:

  • Strengthening the links between standardization and public policy by providing thought leadership and promoting awareness of best practices.
  • Identifying and building national standardization strategies by applying best practices.
  • Ensuring the efficient operation of their organizations while managing financial
  • Sustainability and risk.
  • Ensuring participation of, and collaboration with, key stakeholders in all standardization projects.
  • Increasing adherence to Good Standardization Practices (GSP) among standards experts in every national organization and evaluating all processes to determine their alignment with the World Trade Organization (WTO) Technical Barriers to Trade (TBT) Agreement.

ISO consists of 161 standards bodies from around the world, with 776 technical committees and subcommittees. The annual General Assembly is the overall authority for the Principal Officers, Development Committees, Technical Management Board, and various other committees and subcommittees. ISO works in partnership with the International Electrotechnical Commission (IEC) and the International Telecommunication Union (ITU) as part of the World Standards Cooperation (WSC), and with the World Trade Organization to use international standards to reduce trade barriers. ISO collaborates with over 700 international, regional, and national organizations and provides pedagogical material to educational institutions around the world from primary to university levels.

ISO technical committees determine the strategy for creating standards in accordance with the needs of specific markets. The technical committee creates the initial draft and then shares it with other members for comments, discussion, and revision. Developing a new standard from proposal to publication typically takes about three years and adheres to the following key principles:

  • ISO develops standards in response to requests from industry stakeholders or to meet clear market demands.
  • ISO develops standards based on the opinions of international experts. The technical committee then decides the scope and content for the standards.
  • ISO develops standards according to a process that includes multiple stakeholders including consumer associations, academics, NGOs, and the public sector.
  • ISO develops standards based on consensus and accounts for all feedback and requests for revisions.

ISO 9001:2015 and its complementary management standards are based on the following seven Quality principles.

PrincipleDescription
Customer FocusCustomer focus means exceeding customer expectations and providing satisfaction and value with every customer interaction. It requires an organization to link every business objective to customer needs and to recognize that customers are those that have both direct and indirect relationships with an organization.
LeadershipLeadership must commit to ensuring the availability of all resources for Quality projects and to providing positive role models through active participation, proactive communication of vision and strategy, and an organization-wide engagement with a Culture of Quality.
Engagement of PeopleOrganizations must engage and empower competent and motivated workers while encouraging everyone to contribute and collaborate.
Process ApproachA process approach recognizes that processes must be part of a unified and consistent system that produces predictable results, illuminates elements that require improvement, and addresses all risks that have an impact on process outcomes.
ImprovementAn ongoing dedication to improvement reacts to changes in external and internal conditions to create new opportunities by focusing on root-cause determination and preventative and corrective actions.
Evidence-Based Decision MakingMaking decisions based on statistical evidence provides greater objectivity, effectiveness, and efficiency to an organization and makes it easier to review results for ongoing improvement.
Relationship ManagementOrganizations must account for and manage relationships with all vendors, partners, and suppliers to understand the constraints, opportunities, and risks for each.