ISO 9001:2015 Questions from a recent Webinar Part 3 of 3, Answers by George Hummel, member US TAG to ISO/TC 176


The challenging areas that I see are in 4.1 and 4.2 where more of a business system language moves into the standard. George did point out that this is still a quality standard as opposed to a business standard. The challenge here remains on how to wrap such broad business concepts such as:

·  “The organization shall determine the external and internal issues that are relevant to its purpose and its strategic direction“ to narrow the focus to the areas that “ affect its ability to achieve the intended results of its quality management system.”

·  Narrowing the interested parties to focus on the quality management system.

These requirements, along with the stronger text in 5.1.1, has caused a great deal of confusion in the quality community, as seen in discussion groups, where there is a push toward interpreting ISO 9001:2015 as more of a business standard.


I would appreciate it if George could expand on how ISO 9001:2015 firmly and clearly maintains its identity as a quality management standard as opposed to business management standard.



As was stated in a recent answer, the Scope of the IS focuses the strategic concepts upon the risks and opportunities as they address customer and regulatory/statutory requirements.



When will ISO/TS 16949 be updated to reflect these updates? And is it likely ISO/TS 16949 to have the same implementation dates? 



The automotive sector is (IATF) using ISO 9001:2015 as a base for ISO/TS 16949.  They will announce their timetable.  The dates will most likely be three years from ISO/TS’ publication.



Are there any clauses in ISO 9001:2015 where the current ISO/TS 16949 requirements, Core Tools manuals or Published Customer Specifics Requirements fall short in meeting ISO 9001:2015?



The new requirements, for the most part, are not currently addressed in the automotive documents.  Core Tool manuals are not requirement documents.



Regarding 7.1.5, I've always lamented that Measurement System Analysis (Gauge R & R) was not included in the standard. Has there been discussion of this aspect of Precision of monitoring/measuring Devices within TC 176? (I take the term "valid reliable results" to be supportive of this direction).



It is up to each organization as to how it addresses this requirement.  What matters is that the output of monitoring and measuring be effective.



How do you (others) evaluate the effectiveness of training on employees? This has always been a struggle for our organization.



The organization needs to define the competency needed for each person “doing work under its control that affects the performance and effectiveness of the quality management system.”  When there are deficiencies in the competence needed, the organization must take “action” to address the need.  Any action taken must be evaluated.  A common approach to that evaluation is the change in performance noted as a result.  Does the resulting performance demonstrate that the necessary competence has been achieved? How documented information of evidence is retained is up to the organization.



It seems it will be confusing to keep an existing QMS format when the reference sections have changed. Is it better to make the transition to the new sections for ease of use?



The problem for organizations that use the standard as a format is that the standard changes.  It did in 2000 and has changed again.  It would make more sense for an organization, when planning its quality management system to structure it based upon their business. Thus, if you feel a need to change, now is the time to use your own structure design.

The Final Draft International Standard (FDIS) of ISO 9001:2015 has been published.

The FDIS will help you identify what you need to do to get your quality management system aligned to the 2015 version. 

This is the final stage on the revision journey and means you can be confident that the information contained in the FDIS will be in line with the final version, which will be published in September.
The new 2015 revision is a significant update to the standard, and it’s a great opportunity to make your organization even more effective. The key new areas covered in the standard are:

  • Greater emphasis on building a management system suited to each organization’s particular needs
  • A requirement that those at the top of an organization be involved and accountable, aligning quality with wider business strategy
  • Risk-based thinking throughout the standard makes the whole management system a preventive tool and encourages continuous improvement
  • Less prescriptive requirements for documentation: the organization can now decide what documented information it needs and in what format
  • Alignment with other key management system standards through the use of a common structure and core text

With a comprehensive suite of services and support material, IQC can help you embed this new management system into your organization, so you can start to see the results as quickly as possible.

For more information on the revisions, contact Seth at 937-673-3732 or

The Top 5 Revisions in ISO 9001:2015

ISO 9001 has undergone major revisions for 2015.  Revisions akin to the 2000 version of the Standard.  This is the first major set of changes since that year!  What do organizations implementing or transition have to consider with the fall 2015 publication?

1.    Clause 0.6 in the Introduction section of the draft ISO 9001:2015 standard is titled, "Compatibility with other Management System Standards." It notes that ISO 9001:2015 has adopted the new high-level structure developed by ISO to improve the alignment of all of its management system standards (ISO 14001, ISO 22000, ISO 27001, etc.) The high-level structure is defined in Annex SL of the ISO Directives and provides common:

· Clause sequence

· Text

· Terminology

The ISO 9001:2015 requirements are defined in an order that is consistent with organizational planning and process management:

· Context of organization and its system and processes (Clause 4)

· Leadership, policy, and responsibilities (Clause 5)

· Processes for planning and considering risks and opportunities (Clause 6)

· Processes for support, including resources, people, and information (Clause 7)

· Operational processes related to customers, products, and services (Clause 8)

· Processes for performance evaluation (Clause 9)

· Processes for improvement (Clause 10)


2.    Context of the organization

Understanding an organization and its context, and the needs and expectations of interested parties, is central to maintaining a business. Section 4.1 of the revision requires an organization to determine "external and internal issues that are relevant to its purpose and its strategic direction."

After they are determined, the organization is to monitor those internal and external issues. The clause further requires an assessment of the organization’s ability to achieve the intended results of its QMS. The tool most capable of supporting compliance to section 4.1 is a SWOT or strengths, weaknesses, opportunities, and threats analysis. Another tool, the balanced scorecard, is also a likely candidate. Both are products of business, not necessarily quality management.

At its face, "business thinking" is a welcome addition to the standard, addressing a long-standing complaint that ISO 9001 is not understood as a business system with an output of quality.


3.    Planning for the QMS

Clause 6.1, "actions to address risks and opportunities," is perhaps the single-most talked about addition to the standard. Clause 6.1 weaves together previous elements 4.1 and 4.2, understanding the context of the organization, and the needs and expectations of interested parties by requiring that analysis of these issues become actionable risk-based plans, targets and goals.

The accompanying note to section 6.1.2 provides excellent guidance in this regard, saying "Options to address risks and opportunities can include: avoiding risk, taking risk in order to pursue an opportunity, eliminating the risk source, changing the likelihood or consequences, sharing the risk or retaining risk by informed decision."

There is no mention of preventive action in ISO 9001:2015; it is expressed through the phrase "risk-based thinking." Clauses 6.1.1 and 6.1.2 continue the theme of borderless business and quality system planning and management. The risk-based thinking approach in ISO 9001:2015 is basic: After you know your challenges, develop appropriate plans and monitoring methods to mitigate the risk of inaction or incorrect in these defined areas.

4.    Organizational knowledge

Clause 7.1.6 ushers in the discipline of knowledge management through the requirement that "the organization shall determine the knowledge necessary for the operation of its processes and to achieve conformity of products and services." The point is that knowledge—what, how, when and often why—is required to generate consistent and conforming products.

Furthermore, the right people need access to this knowledge to create this desired outcome. Organizational knowledge management requires analysis and planning that are unique to each organization to balance the typical blend of competent people no longer requiring tools—such as work instructions—against those who do.

5.    Applicability

In ISO/DIS 9001:2015, Clause 4.3, determining the scope of the QMS, you will no longer find references to the term "exclusions." Instead, it’s up to the organization to decide which elements do not apply.

The choice to disregard a requirement is not allowed, however, if it pertains to normal operations.  Furthermore, the text states, "If any requirement(s) of this international standard cannot be applied, this shall not affect the organization’s ability or responsibility to ensure conformity of products and services." The issue of applicability is tied to whether your organization is capable of producing consistent, conforming product.

There are other changes that organizations will need to consider:

·       There is no longer a requirement for a Quality Manual

·       “Product” is now “Products and services”

·       The title “Management Representative” is gone, because:

·       Management Responsibility has been revised to Leadership

·       There is no longer a requirement for 6 documented procedures

·       Document & Record Control is now Control of Documented Information

·       The Process Approach is now mandatory

·       “Outcomes Matter” – the emphasis is upon performance, not compliance

                         .        The use of ISO 9000:2015 for definitions.