ISO 9001:2015 Quality Management Systems Standard

Hand reaching to ISO 9001:2015 graphic for quality management system requirements and certification / accreditation.

ISO 9001:2015 – Quality Management Systems – Requirements is available on the ANSI Webstore. Read on to learn more about this international standard and the changes made to the latest version, which remains current.

Standardization seeks to unite industries via shared practices, but ISO 9001 helps unite the world. With core requirements essential to enacting, maintaining, and improving a quality management system, ISO 9001 is the world’s most popular standard. In fact, there have been over 1 million certifications issued to the quality management systems standard worldwide.

ISO 9001:2015 specifies the requirements for a quality management system. With a process-based approach, the international ISO standard utilizes the Plan-Do-Check-Act (PCDA) model to enable continual improvement. This standard helps organizations consider their context in relation to their quality management system and the role of top leadership. It details planning, support, operation, and performance operation.

The benefits of such a quality management system are plentiful, as they can help consistently provide products and services that meet the needs of interested parties, enhance customer satisfaction, adequately address risks and opportunities, and demonstrate conformity.

Which Organizations Need ISO 9001?

The requirements in this standard are set to be nonprescriptive and general by ISO, meaning that ISO 9001:2015 can be used by any organization, regardless of industry, size, or scope, whether they are a massive corporation or a small start-up. Such a quality management system, according the to the standard PDF, is useful for any organization that needs to demonstrate its ability to consistently provide products and services that meet customer satisfaction and aims to enhance customer satisfaction through the application of the system.

Changes to ISO 9001:2015

The current edition of the ISO standard for management system standards requirements, ISO 9001:2015, revises the 2008 version of the same document. In all, this was a sizable revision, and its changes reflect the pattern that we have witnessed with revisions of other ISO management systems standards since.

One of the most substantial changes to ISO 9001:2015 is compliance with Annex SL (now known as Annex L), which contains a high-level structure written specifically to better harmonize all ISO management systems standards. In short, the Annex L serves as a blueprint for management systems standards so they can be integrated together within the same organization.

Furthermore, the 2015 edition of ISO 9001 was changed to better consider risk-based thinking. Between the 2008 and 2015 revisions of the quality management standard, a direct link was established between quality management and risk management. Since implementing quality management comes with some level of uncertainty, an understanding of that uncertainty can help in creating preventive controls that keep the quality management system from deviating from expected results.

ISO 9001:2015 also places an emphasis on the involvement of top leadership to carry out the success of the quality management system. In the 2008 edition, organizations were able to set a “management representative,” who could be a member of the organization’s leadership or an avatar of sorts for management. The 2015 edition removed the possibility for a management representative, instead encouraging leadership to be active throughout all points of the process, from planning to continual improvement.

In addition to these major alterations, ISO 9001:2015 was written to be less prescriptive than its predecessor was. Therefore, its requirements are more generic and are easy to apply to different organizations.

ISO 9001 vs. ISO 9000

It should be noted that ISO 9001 should not be confused with ISO 9000. “ISO 9001 definitions” are standardized in the ISO 9000 document, a companion standard that covers terms and definitions. Since quality management systems are used in a variety of industries, some terms might not have the same meaning across-the-board.

ISO 9000:2015 was revised alongside ISO 9001:2015.

Other ISO 9000 Quality Management Standards

Numerous documents in the ISO 9000 series help implement and support a robust quality management system for any organization. These includes ISO 9004:2018 – Guidance to Achieve Sustained Success, ISO/TS 9002:2016 – Quality Management Systems, and ISO 9001:2015 for Small Enterprises – What to Do?, among others.

For the ease and simplicity of standards users, ANSI has bundled many ISO 9000 standards together at a discounted price. Some standards packages in the quality management series include:

ISO 9000 Collection 1

ISO 9000 Collection 2

Quality Management Package

ANAB Accreditation for Quality Management Systems Certification Bodies

While these additional documents help support the establishment, maintenance, and continual improvement of a quality management system, many organizations seek out certification to ISO 9001 to demonstrate that their quality management system meets the requirements of the standard—over 1 million organizations have been certified, in fact.

How do you know if the certification provided by certification bodies can be trusted? This is where accreditation comes into play. The ANSI National Accreditation Board (ANAB) accredits management systems certification bodies, like those that issue ISO 9001 certifications, to demonstrate credibility. This confidence, in turn, transfers down to organizations seeking certification, as it lets them know which bodies can be trusted.

You can search for ISO 9001 certification bodies accredited by ANAB here.

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