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By Curtis Lopez, Missouri Enterprise Project Manager

The new revision of ISO 9001 is scheduled to be released in the 4th quarter of 2015, and the now available Final Draft International Standard (FDIS) contains some significant changes that may seem minor on the surface, but will have deep impact on how manufacturers adopt and adhere to the standard in the future.  ISO/FDIS 9001:2015 is of course still subject to change prior to its release, but it does give a strong indication of what is coming.

A genuine concern is that some manufacturers may breathe an initial sigh of relief when they note the new ISO/FDIS 9001 standard seems to eliminate the traditional “clerical” role where a quality team (or individual) is responsible for maintaining the ISO paperwork.  However, a deeper understanding of the new revisions reveals that companies will have to decide for themselves what documents they need to support their Quality Management Systems (QMS).  They’ll carry the responsibility for establishing, implementing and maintaining their own tools for measurement and documentation.

In a nutshell, it’s no longer going to be a matter of “delegating to the quality department”.  Rather, manufacturers will need to incorporate QMS into their overall strategic direction, with top level managers playing a key role in supporting and ensuring the integration of quality at every level of their organization.  The so called “C-Level” leaders (CEO’s, CFO’s, etc.) will have more responsibility and accountability for managing qualify efforts in their company; they’ll need to extend or identify key success factors and key performance indicators (KPI’s), and incorporate their SWOT Analyses to identify strengths, weaknesses, opportunities and threats, in order to define the context of their organizations.  Top management will need to take a supportive and proactive approach towards quality in their company.  The coming revision seeks to help companies understand that “quality” is not just an obscure concept involving checklists and paperwork, it’s an integral part of a manufacturer’s overall business and operational system, a part of their strategic direction. 

Another important area of change coming in ISO 9001:2015 is related to structure and terminology.  The ultimate goal is to have consistency among the various ISO standards overall, so companies can more easily integrate the standards they need into their corporate culture, making them integral to the way a company does business.  For example, “documentation and records” will become “documented information”; “work environment” will change to “environment for the operation of processes”; “purchased product” will now be referred to as “externally provided products and services” and so on.  As the various ISO standards are revised over time, all will move towards this alignment of terminology.

A simple examination of these terminology adjustments illustrates another fundamental paradigm shift in the coming ISO 9001 revisions for 2015:  QMS will focus more heavily on external factors.   ISO/FDIS 9001 proposes the requirement that organizations implementing a QMS must examine and understand how outside factors can influence their quality efforts, and ensure the organization has effective plans to address risks and opportunities, integrate them into their QMS processes and evaluate and measure their effectiveness.  It’s a risk-based approach to maximize an organization’s ability to achieve objectives in a systematic, ongoing manner that is integral to the overall strategic plan.

ISO 9001 Auditors will be looking for many of the same things they have for years, but critical additional areas of focus will be:

  • What is top-level and middle management looking at on an ongoing basis?
  • How is management measuring key internal and external factors that can impact their ability to conduct business at the highest level of quality and efficiency?
  • How has the organization integrated their business systems with their QMS to ensure the functions operate together, rather than as operational islands?

Stay tuned to the coming revisions to ISO 9001, due later in 2015.  Don’t be deceived into thinking you can loosen up your documentation and internal measurement standards.  Do understand that more of the onus is going to be on you, with top level executive management playing a critical role is integrating their business systems and their QMS into their overall strategic direction.  Realize that ISO 9001 auditors will be looking at much more than ever before, with an emphasis on measuring how QMS has permeated the organization from the top down.  Auditors will be looking to see that “the company gets it”, not just “the quality staff” at the company.  Some of the changes that seem fairly subtle may in fact cause the bigger headaches, so before you make any changes, it would be a good idea to consult with an ISO 9001 expert as the new revisions become reality.