ISO 9001:2015 – Changes that We Already Know

outsource-auditingAlthough many of us are anxiously awaiting the 2015 ISO 9001, we are aware of one important change that eliminates one long-standing source of frustration. In previous years it was noted that the management system standards of various ISO standards appeared to have the same overarching goal but the language and specific details were different. This subtle difference has been a cause of confusion for organizations and auditors alike.

For example, the Document Control sections of ISO 9001 and 14001 are very similar but are addressed with different perspectives. To comply with each standard, you must understand, interpret and implement the relevant standard. Because they are very similar, it is easy to become confused. The 2015 version of ISO 9001 will contain management system sections that will be consistent throughout all of the standards.

Although there have long been standards for developing and revising standards, creating a consistent structure throughout several standards has never before been achieved. A description of the consistent structure for management system standards and requirements for common processes is described in detail in Annex SL of ISO 9001.

The elements that seem to have the most commonality lie in the supporting processes such as document control, record management, training, and corrective action. Because all of these functions are essential to the success of any business, they should be easy to define. Therefore, when the newly unified ISO management system standards are developed, all of the various ISO standards will be required to adopt them.

The guidelines for standard revision outlined in the ISO Annex SL have been used to develop ISO 27001 and ISO 14001 and it is currently being used for the revision of ISO 9001. The ISO standards are currently in committee draft form. If it were not for the great number of changes that need to be made to accommodate the unified management system standards, it would appear that the 2015 changes are quite substantial.

In summary, the noteworthy changes include the unified structure and content of management system sections throughout ISO standards as well as badly needed organic content changes to the ISO 9001, the nature of which remains unknown. Current drafts indicate that the changes will be significant however because the ISO 9001 revision is still in process, any proposed changes will not be certain until the draft is finalized.

In our next few articles, we will be outlining the changes to the structure of the ISO 9001 standard, as well as changes to the content of the common requirements and processes. Stay tuned! And in the meantime, if you have specific questions about these upcoming changes and how they might affect your organization, just ask.

Upgrading to ISO 13485 from ISO 9001