by Lorri Hunt
Author’s note: ISO 9001:2015 is still in the revision process. Information in this article should not be used by organizations to make changes to their quality management system or for legal agreements. Information in this article will be useful in helping organizations understand the level of change that is coming.
The International Organization for Standardization (ISO) recently published the first committee draft (CD) of the next revision to ISO 9001. Although there is still a long way to go in the process, keeping current on what is happening with the standard is important to organizations that use ISO 9001 as the foundation of their quality management system (QMS).
The biggest change to users is the structure. Both the 1987 and 1994 versions of ISO 9001 used a “20 element” model that had familiarity to manufacturing industries. In the year 2000, ISO 9001 transitioned from the 20 element model to a process approach model based on a structure of five clauses. This structure was used for both the 2000 and 2008 versions of the standard.
The ISO Technical Management Board has adopted a standardized format and common core text for use in all new and revised ISO management system standards, to promote greater ease of use for organizations that seek to integrate the requirements of (for example) ISO 9001, ISO 14001, and ISO 50001 into a single, coherent system. This standardized format is referred to as Annex SL. Table 1 compares the clause titles of ISO 9001:2008 to the clause titles in the proposed version of ISO 9001:2015.
Table 1: Annex SL Compared to ISO 9001:2008
|Annex SL||ISO 9001:2008|
|4 Context of organization||4 Quality management system|
|5 Leadership planning||5 Management responsibility|
|6 Planning||6 Resource management|
|7 Support||7 Product realization|
|8 Operation||8 Measurement, analysis, and improvement|
|9 Performance and evaluation|
Although there is not an ISO 9001 requirement for an organization to develop its quality management system and document architecture using the structure of ISO 9001, many organizations choose to do so because it is easier to understand and maintain compliance as well as demonstrate compliance to external parties. As a result, many organizations structured their QMS around the ISO 9001:2008 structure.
Organizations that see the structural change in ISO 9001:2015 might be overwhelmed. Before making any structural changes to your QMS, it’s important to consider the opportunities and issues associated with making such a change. Any change should add value. Making a change for the sake of aligning your QMS with a structure of any kind adds unneeded cost and overhead to the organization.
To avoid making a structural change, organizations can cross-reference their existing procedures and methods of compliance against the requirements in the revised standard. It’s anticipated that the revised version of ISO 9001 will include a cross-reference of existing requirements in ISO 9001:2008 to ISO 9001:2015.
If an organization chooses to make a structural change, it should focus on creating a structure that is unique from any standard or governing document and is easy to change. For example, don’t change document numbers, but create a filter in your QMS that aligns documents with whichever standard you are using. This method can meet the needs of the organization and be more cost effective in the long term.
Organizations can expect to see other requirements change in the standard as well. It’s highly likely that there will be changes to the specific requirements in the ISO 9001:2015 CD. However, it’s likely that some of the general themes of the revision will carry through until publication. Some of these themes include:
- More generic. There has been feedback that the standard is difficult to apply to certain types of industries, specifically the service industry. For that reason, the language in the standard is being modified to make ISO 9001 easier to use for these types of industries. Currently, the CD of ISO 9001:2015 uses the phrase, “goods and services,” instead of “product” when specifically referring to the deliverables.
Another proposed change to make the standard more generic revolves around some of the requirements that were focused on manufacturing industries. Specifically, the clauses related to 7.1.5, Monitoring and measuring devices (previously clause 7.6), and 8.5, Development of goods and services (previously clause 7.3). Both of these clauses included specific requirements for demonstrating compliance. These specific requirements have been removed or made more general to make the clauses easier to implement for all industries.
- Context of the organization. The required high-level structure and identical text requires the management system standard to have clauses related to 4.1, Understanding the organization and its context, and 4.2, Understanding the needs and expectations of interested parties. These requirements, while new in the text of the standard, were included in 0.1, General, in ISO 9001:2008, which indicated that the QMS is influenced by the environment that the organization is in, including changes and risks. The new language may cause confusion to users, but the intent is basically the same. One of the concerns with the core text relates to the term, “interested parties.” The interpretation for this phrase is that there is no new requirement to ensure that goods and services meet the requirements of interested parties because this would go beyond the scope of the QMS. It’s anticipated that steps will be taken in future drafts to make this distinction more clear.
- Process approach. Both the 2000 and 2008 versions of ISO 9001 promoted the use of the process approach in organizations’ QMS. The requirements in 4.4.2, Process approach (previously clause 4.1), include specific requirements for adopting the process approach. However, one might argue that these specific requirements go outside the boundaries of making the standard more generic. The balance between improving the requirements for the process approach while maintaining generic requirements is critical as the standard advances.
- Risk and preventive action. The CD for ISO 9001 does not use the term, “preventive action.” This is consistent with the core text from Annex SL. The language in the standard looks at how an organization determines the risks and opportunities that need to be addressed for an effective QMS. Clause 6.1, Actions to address risks and opportunities, includes requirements to make sure that the QMS can achieve its intended outputs. It also addresses taking action appropriate to the potential effect of conformity to goods and services. This requirement is consistent with traditional requirements of preventive action. This change better aligns the standard with current management philosophies because “managing risks” is typically the language that leadership uses when making decisions about the organization.
- Documented information. The terms “documents” and “records” have been used since the original version of ISO 9001. The core text required by Annex SL adopts the terminology, “documented information.” The business world and the technology used to run it has changed significantly. It’s important for the standard to move forward and be consistent with those business changes. In the past, documents and records relied on paper evidence. Today, the manner in which we control information is typically electronic and the line between documents and records is more seamless. There will be challenges to organizations because the standard no longer differentiates between the terms “document” and “record,” and it instead uses “documented information” in both instances.
Now that the ISO 9001 revision has reached the CD level and comments have been submitted and reviewed by the working group experts, the standard will advance through the following stages:
- Draft International Standard (DIS). Once the CD is approved for circulation as a DIS, it will be submitted by ISO’s Central Secretariat in Geneva for a formal ballot of the SC 2 participating members (July 2014).
- Final Draft International Standard (FDIS). Once the DIS has been approved, it will move on to the publication stage. The document is finalized by the staff in Geneva and submitted for a final ballot to the SC 2 participating members. This stage is generally considered to be a simple check for editing errors and only minor changes and edits can be made (February 2015).
- International Standard (IS). After approval of the FDIS, the document is published and provided to member bodies for national adoption purposes. In the United States, the American Society for Quality (ASQ) normally adopts these standards as American National Standards as a part of the American National Standards Institute (ANSI) national adoption process (December 2015).
It’s important to note that the final publication of the standard relies on its successful advancement at each specific stage. Estimated dates may shift based on progress and results of ballots. During this timeframe, the International Accreditation Forum will develop any specific guidelines for how organizations that are certified to ISO 9001 will transition to the revised standard. Until the final draft of the standard is published, organizations should not make any change to their QMS based on the content of the CD alone.
About the author
Lorri Hunt is president of Lorri Hunt and Associates Inc. She has been implementing quality management systems in diverse organizations such as Honeywell, the Department of Energy, and small businesses since 1994. She is an active member of the U. S. Technical Advisory Group to ISO Technical Committee 176. She currently serves as the head of delegation for ISO/TC 176/SC 2. In this role, she is responsible for overseeing the development of consensus positions for the United States related to ISO 9001 and 9004. She is a U.S. expert and task group monitor for the next revision to ISO 9001, which is currently planned for 2015. She also served as the international deputy task group leader to the ISO 9001:2008 amendment. She is also the co-author of The Insiders’ Guide to ISO 9001:2008, published by Paton Professional.