ISO 9001:2015 Released.
The new ISO 9001:2015 standard, Quality Management Systems – Requirements, and ISO 9000:2015 standard, Quality Management Systems – Fundamentals and Vocabulary, have been released globally by ISO and are now available to purchase from national standards bodies. The price for ISO 9001:2015 is U.S. $173; ISO 9000:2015 is U.S. $240.
The release of ISO 9001:2015 and ISO 9000: 2015 is the culmination of a long revision process that started as soon at the last version was released in 2008. For more information on ISO’s standards revision process, see our related FAQs here.
ISO 9001:2015 positions the new version of the standard as an integral part of an organization’s efforts toward the broader aim of sustainable development and promotes it as a tool for improving an organization’s overall performance. It encourages more internal and external stakeholder focus as part of the adoption of a risk-based approach to quality management and emphasizes the importance of adopting a quality management system (QMS) as a strategic decision for an organization. In addition to renaming and repositioning some QMS activities, other significant new requirements have been introduced.
The “context” of an organization (or its ‘business environment’) refers to the combination of internal and external factors and conditions that can have an effect on an organization’s approach to its products and/or services. As a result, consideration of an organization’s context must now be an element of the QMS design and implementation process.
Risks and opportunities
A vital part of the planning and implementation of a QMS is a new requirement to identify the risks and opportunities that can potentially affect the operation and performance of the QMS, as well as the corresponding “proportionate” actions to address them.
Top management is now required to demonstrate a greater direct involvement in the organization’s QMS, and the absence from ISO 9001:2015 of the need for a specific management representative is partly an attempt to ensure that ownership of an organization’s management system is not simply focused on one individual. There is now a focus on leadership rather than just management of the QMS.
The terms “documented procedure” and “record” used in ISO 9001:2008 have both been replaced throughout ISO 9001:2015 by the term “documented information.” This is defined as “information that is required to be controlled and maintained by an organization,” though it’s up to each organization to determine the level and type of documentation necessary to control its own QMS.
Other QMS requirements
There are also other changes to QMS requirements, including:
- Proposed specific requirements for organizations in relation to the execution of a process approach when planning, implementing, and developing a QMS
- Identification of the competence necessary for personnel doing work that affects its quality performance
- Identification and maintenance of the knowledge needed to ensure that an organization can achieve conformity of products and services
- A risk-based approach to ascertain the type and extent of controls suitable to all types of external provider
Structure and terminology
ISO 9001:2015 adopts the clause structure specified in Annex SL, which is now the required framework for all new and revised ISO management system standards. ISO imposed the Annex SL structure on ISO 9001:2015 to help ensure that ISO 9001:2015 is aligned with other management systems standards. Annex SL structure is intended to present QMS requirements in a more consistent, rational manner and not simply offer a template for the elements of an organization’s QMS.
It’s important to note that for those organizations that already have an ISO 9001-compliant QMS, there is no requirement to change their existing QMS procedure, document structure, or the terminology they use to mirror that specified in ISO 9001:2015.
ISO 9001:2008 transition
Organizations that are already certified to ISO 9001:2008 will have three years from formal publication of ISO 9001:2015 in which to transfer to the new version of this standard. Because ISO 9001:2015 was released on September 23, this transition period would end in September 2018.
ISO 9001:2015 and ISO 9000:2015 are available in the United States from the American National Standards Institute (ANSI). ANSI is offering a discounted Quality Management Systems package that combines the ISO 9001:2015 and ISO 9000:2000 standards for $201 – a $212 savings over purchasing them separately.
Here’s a list of some national standards bodies where ISO 9001:2015 and ISO 9000:2015 can be purchased:
For other countries, visit ISO’s member body directory here.
Our thanks to SGS Certification Services for their assistance with this article.
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