Part 1 of 2: In this two-part series, manufacturers will learn what they need to know about updates to ISO standards. Part 1 deals with ISO 9001. Part 2 in the November/December issue of Today’s Motor Vehicles will deal with the automotive-specific ISO/TS 16949.
Those familiar with the ISO 9001 quality management certification understand that the standard is updated on a regular basis. This happens in order to keep the standard timely and relevant, adding content and context throughout the years to address new and emerging quality management challenges. Organizations across a range of industries are now working beyond the 2008 version of the standard, evaluating and adopting the 2015 version. While some changes may be considered minor, such as terminology and nomenclature, others represent revised or wholly new ways of doing things.
Following are some of the significant changes found in ISO 9001:2015 from the previous version of the standard, along with some discussion of what those changes mean.
1. Documented procedures are no longer required
You may decide that it’s helpful to do so, but your organization is no longer required to keep a physical quality manual on site. It could be useful to digitize this content and keep it on your company’s website, either on a private intranet or even on the public page.
2. Organizations no longer need to assign a management representative
Quality is a team sport and sometimes delegation to one staffer can lead to information silos. This is closely related to number 4 below.
3. The preventive action clause no longer exists
This has been transitioned to a focus on risk-based thinking; it requires the organization to give consideration to both positive and negative issues, conditions, and outcomes.
4. There is an increased level of responsibility for top management
Linked to number 2, the standard is seeking more involvement and oversight from top managers. This also supports the new focus on risk-based thinking, as the leadership of the certified organization often bears the responsibility for failures.
5. The number of auditable clauses increased from 5 to 7
Review the standard to ensure you know what can and will be audited.
In addition to these key changes, it’s also important to keep in mind the calendar for this transition. The timeline for moving from 2008 to 2015 is aggressive, particularly when considering the number of significant changes between the versions.
Your ISO 9001:2008 certification will remain in effect until Sept. 15, 2018. If your organization is already certified to the 2008 standard, your certification body is being directed to have you certified to the 2015 standard by the end of 2017 to avoid delays and bottlenecks. It is likely that most, if not all, certification bodies will cease certifying to the 2008 version sometime in 2017.
Another key point is ensuring that management, in collaboration with your quality team, are aware of the differences between ISO 9001:2015 and any recent or upcoming revision to other quality standards you may be certified in, particularly TS 16949. We’ll be covering the coming revisions to the TS 16949 standard in the next article in this series; but in the meantime, remember that changes to the ISO 9001 standard do not necessarily remove similar requirements for the TS 16949 standard. One specific example is the fact that while ISO 9001 has removed the management representative requirement, TS 16949 has not.
Smithers Quality Assessments
About the author: Gretchen Merriman is general manager of Smithers Quality Assessments in Akron, Ohio. She holds auditor credentials for ISO 9001, ISO 14001, SN 9000, and AS 9100. She can be reached at 330.762.4231 x1403 or email@example.com.