What’s New In ISO 9001:2015
On September 23, 2015 ISO released the latest revision to the ISO 9001 Standard. So now that the world’s most popular and widely utilized quality management standard has been formally released to the public, I thought it would be a good time to give you a brief explanation of the changes and what effect those changes will have on organizations and the people who have the responsibility of implementing, managing and auditing the new standard.
Let me give you a little history…
ISO 9001 has been around since the early eighties and has evolved as business needs and requirements change over time. The most recent version of the standard, ISO 9001:2008 has been in effect for the past seven years and was due for a makeover.
ISO 9001:2015 builds on the foundation of the previous versions of the standard to better guide businesses and organizations in achieving quality products and services, by streamlining processes, focusing on continuous improvement efforts and placing a greater emphasis on management responsibility and risk identification.
ISO 9001 has long been a valuable tool for businesses and organizations to adopt a process approach and create effective quality management systems and processes that improve efficiency and provide confidence to potential clients that a standardized level of quality will be met. ISO 9001:2015 maintains this emphasis on a process approach while also stressing the importance of proactive and strategic planning.
So what are some of the changes included in the new 2015 revision of the standard?
While many of the concepts from the 2008 version of the standard remain, there are some significant changes and additions to the 2015 version which we will take a closer look at right now:
- One of the more obvious changes to the 2015 revision will be in the look and structure of the standard itself. In an effort to maintain consistency across multiple ISO management systems, the latest revision takes on the new Annex SL format that is shared by other standards such as ISO 14001 Environmental Management Systems (both the IS0 14001 and new ISO 9001:2015 share the same clause structure) to allow organizations the ability to implement and integrate multiple management systems more easily and effectively.
- Another major addition to the ISO 9001:2015 revision is the incorporation of risk based thinking within the management structure of the organization. This is not to be confused with a standalone risk management procedure, but the incorporation of risk awareness and identification throughout the system as a whole. Top management are now required to develop processes that allow foresight and planning for possible risk factors that may have a negative impact on process and performance as well as identify and take advantage of possible opportunity. With the addition of risk based thinking, the section addressing preventive action (Sub-clause 8.5.3 in ISO 9001:2008) has been deemed redundant and therefore removed from the 2015 revision.
- Greater Emphasis on Leadership and Management Commitment – The new standard is intended to promote integration and alignment with business processes and strategies. With this integration, top management now have more responsibility in taking on a proactive role in the health and promotion of the quality management system. The requirement for a single point of contact or management representative regarding the QMS has been removed and a new section on leadership has been added to better emphasis a greater involvement from the leadership team.
Along with the major structure and concept changes that are prominent in the new ISO 9001:2015 revision, there are some additional changes that many people familiar with the ISO 9001:2008 version will notice almost immediately.
- No Mention of a Quality Manual – One of the biggest omissions to the new standard is the requirement for an organization to maintain a documented Quality Manual. Organizations that wish to continue this practice and maintain a quality manual outlining its QMS are welcome to do so, however it is no longer required by the standard.
- “Product and Service” – Another notable change is the replacement of the term “product” with “product and services” which is intended to better address service based organizations.
- “Documented Information” – Along with the change in the term “product” the 2015 revision also replaces the common terms “documents” and “records” with “documented information”. The new standard is less prescriptive on when and where this documented information is required and how and organizations should manage this.
This is not an exhaustive list of amendments to the new version of the standard, but a high level look at the new content and structure of the newly released standard.
So what does this mean for the ISO 9001:2008 version of the standard and the organizations that are currently certified to or following this standard?
The new ISO 9001:2015 standard has been formally released for public consumption and implementation. However, organizations are not expected to be compliant to the new changes immediately. Starting the day the new standard was released, organizations have been granted a 3 year transition period before compliance to the new standard is required for those that maintain certification to ISO 9001:2008. So don’t throw out your copy of the existing 2008 standard just yet!
Organizations and quality professionals are urged to become familiar with the new requirements and perform gap analysis of their current system to determine the steps required for eventual implementation of the new 2015 revision by September 2018.
While quality personnel and auditors are still required to be proficient in the 2008 standard it is important to be proactive in learning the requirements of the 2015 revision in order to understand the concepts and requirements and better assist their clients and organizations with the transition process.