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

Question:

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.

 

Answer:

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.

 

Question:

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

 

Answer:

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.

 

Question:

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?

 

Answer:

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

 

Question:

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).

 

Answer:

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.

 

Question:

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

 

Answer:

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.

 

Question:

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?

 

Answer:

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.