The ISO 9001 standard provides a framework for a facility's quality management system (QMS). There are several new themes presented in the ISO 9001:2015 standard that were not included in the last version of the standard (ISO 9001:2008). The new standard also brings a significant restructuring to the standard since it now follows the same overall high-level structure of other ISO management systems (called “Annex SL” format).

 

There are two main aspects of upgrading an existing ISO 9001 system conforming to the ISO 9001:2008 standard. First, the facility needs to restructure the existing documentation to fit the Annex SL format. For most of the elements contained in the 2008 standard, there are similar sections in the 2015 standard (e.g., customer focus, communications, internal audits, management review, etc.). However, some of the sections may be more difficult to map to the new standard, so it is beneficial to utilize a cross reference chart to help connect each section of the 2008 standard to the 2015 standard[1]. An example of this is the Planning of Production Realization (Element 7.1) in the 2008 standard, which matches most closely to the Operational Planning and Control (Element 8.1) in the 2015 standard.

 

The second aspect of upgrading a facility's QMS is to address the new content or themes presented in the 2015 standard. One way to efficiently identify the 'gaps' between a facility's current system and the new standard is to perform a gap analysis. During this analysis, a facility should focus on the new themes presented in the 2015 standard including: addressing the context of the organization (Elements 4.1 and 4.2), planning actions to address risks and opportunities (Element 6.1), planning and controlling changes (Elements 6.3 and 8.5.6, and evaluating performance (Element 9.1). The new standard also requires a more in-depth description of top management's role and responsibilities in demonstrating leadership and commitment to the QMS (Element 5.1).

 

Addressing the new content may involve creating and developing new documentation and processes that meet the themes of the new standard. However, facilities should also consider existing documentation and procedures that may already address the new themes. For example, facilities that have implemented a business continuity or contingency plan could find content related to addressing business risk that would be useful for addressing risk management in the QMS. Risk management related to quality risks such as identifying alternate raw material suppliers or implementing natural disaster protocols may likely be found in existing facility documentation. 

 

The 2015 standard addresses the context of the organization in two ways, including understanding external and internal issues related to the QMS and the needs and expectations of interested parties.  The standard does not provide a specific structure to address these new elements. Therefore, the facility has flexibility in determining how to address the internal/external issues and needs of interested parties. A risk management approach may be useful to outlining these issues, where first a facility would identify the internal and external issues affecting quality. This may include corporate requirements, customer specifications, or market pressures. Once the issues are identified, the facility can rank the need for risk mitigation and available mitigation options. A similar approach can be developed for understanding the needs and expectations of interested parties which may include customers, employees, regulatory agencies, the general public, or neighbors in the vicinity of a manufacturing plant. Ultimately, the facility will need to demonstrate that the context of the organization has been considered and that the information related to issues and interested parties is monitored and reviewed.

 

Implementing a management of change (MOC) procedure is also a common process that may already exist at a facility. A MOC procedure can be useful to control changes proposed at a facility that may affect product quality, thus assuring that the objective of the change is achieved. The purpose of the procedure would be to trigger an evaluation of the ramifications of the change and alert the appropriate staff of the changes. The ISO standards have hinted at controlling change in past standard versions; however, the 2015 standard specifically calls out handling changes in two separate elements (Element 6.3 Planning of Changes and 8.5.6 Control of Changes). Therefore, a facility may choose to comply with these elements by implementing a MOC procedure that addresses quality changes.

 

Most ISO 9001 registration bodies have provided facilities with a three year grace period for upgrading to the new standard. Since the new standard was issued in September 2015, facilities will see the window for upgrading their systems begin to close in 2017 and 2018.  Therefore, it is prudent to identify necessary upgrades now since system upgrades can often take several months to devise and implement.

 

For more information related to the changes in the ISO 9001:2015 standard, contact Ms. Aimee Andrews at aandrews@trinityconsultants.com.

 


 

[1] https://committee.iso.org/files/live/sites/tc176sc2/files/documents/ISO%209001%202015%20-%20Implementation%20guidance%20docs/ISO9001_2015_Correlation_Matrices.docx (Accessed on September 26, 2017)