2017

STANDARDS OUTLOOK

Small Change, Big Impact

Clause 5.3 of ISO 9001:2015 offers new benefits

by Paul Palmes

You might easily overlook a small item in clause 5 of the 2015 revision of ISO 9001.

The clause appears to be much the same as in earlier revisions—so much so that seasoned ISO 9001 veterans could miss it. They might simply nod their heads and instead concentrate on the more dramatic changes we’ve all been discussing and analyzing over the past several years as the ISO 9001 standard progressed through several drafts:

  • Strengthening leadership requirements (clause 5.1.1).
  • Adding risk-based thinking and context of the organization (clauses 6.1 and 4).
  • Eliminating traditional documentation requirements, but requiring documented information (found throughout the new standard).
  • Linking nonconformance and corrective action (clause 10.2).

But there is another change, the one in clause 5, which could have immense impact. It might appear to some as an omission, similar to the loss of preventive action. This seemingly small revision, however, is actually the result of careful consideration and much discussion regarding the fact that many organizations have traditionally installed their quality management systems (QMS) as accountable to, but still separate from, the business processes and goals of the organization.

ISO 9001:2015, notably in clause 5.1.1, adds several prescriptive requirements for top management to demonstrate leadership and commitment to the QMS, beginning with accountability for its effectiveness. On the other hand, a traditionally structured QMS places this responsibility on quality departments, quality managers and their staffs, much in the same mold as design or purchasing managers are responsible for the effectiveness of their departments.

By assigning the responsibility for QMS effectiveness to top management, it will no doubt be a functionally shared responsibility of both top management and the quality department. This strikes at the heart of the oft-heard lament that top management is too often distant in its support of a QMS. Clause 5.1.1, therefore, is a structural change, knitting together top management and an organization’s QMS.

The second structural change in clause 5 is not as obvious, but carries similar positive aftershocks if implemented to your QMS’s advantage. It is that the title of management representative is gone. ISO 9001:2000 and ISO 9001:2008 required that a single individual be appointed to represent the QMS. Previously, clause 5.2.2 stated that "top management shall appoint a member of the organization’s management who, irrespective of other responsibilities, shall have responsibility and authority that includes:

  • Ensuring that processes needed for the QMS are established, implemented and maintained,
  • Reporting to top management on the performance of the QMS and any need for improvement.
  • Ensuring the promotion of awareness of customer requirements throughout the organization."1

In contrast, clause 5.3 of ISO 9001:2015 no longer requires QMS responsibilities and reporting be in the hands of a single representative but simply that they be assigned. This is a small change, perhaps, but one with the potential for huge improvement opportunities because clause 5.1.1 directly places top management within the QMS, and clause 5.3 now asks that members of top management assign others—not necessarily a single individual—to help them.

Roles and responsibilities

ISO 9001:2015, clause 5.3 on organizational roles, responsibilities and authorities, says, "Top management shall ensure that the responsibilities and authorities for relevant roles are assigned, communicated and understood throughout the organization. Top management shall assign the responsibility and authority for:

  1. Ensuring that the QMS conforms to the requirements of this international standard.
  2. Ensuring that the processes are delivering their intended outputs.
  3. Reporting on the performance of the QMS and on opportunities for improvement (see subclause 10.1) to top management.
  4. Ensuring the promotion of customer focus throughout the organization.
  5. Ensuring that the integrity of the QMS is maintained when changes to the QMS are planned and implemented."2

Of course, it’s entirely possible the same management representative is simply assigned to each of these QMS responsibilities, but for those organizations recognizing the requirement to expand top management participation via clause 5.1.1, the current delegation opportunities in clause 5.3 make it possible for several members of top management to maintain key organizational roles within the QMS.

It’s not difficult to imagine the positive impact that delegating oversight to several key members of the management team would have on the effectiveness of a QMS, given the importance of assignments defined in this clause.

The requirement to demonstrate leadership and commitment in clause 5.1.1 can be partially achieved by assuming roles of responsibility and authority in clause 5.3. For those who maintain the traditional approach of continuing with a single management representative, clause 5.3 is the smallest of changes because the standard clearly allows the organization to assign these responsibilities and authorities any way it sees fit.

Were it not for other clauses in the 2015 revision that require business and quality to work in greater coordination, the logic of just maintaining the management representative would be clear. But the door has been widened in clause 5.3 to allow for a team, in contrast to a single person, to direct what actually is a wide, inclusive and crucial set of requirements. 

Applying these changes

For those transitioning to ISO 9001:2015 or seeking certification for the first time, the simplest way to imagine how this widened door can be of benefit is relatively straightforward. Begin by placing the two most obvious clauses—5.1.1 and 5.3—alongside each other and connect the requirements of one against the other.

Several opportunities to provide tangible evidence of top management leadership and commitment to a QMS (clause 5.1.1) become evident when some of these same requirements also are mentioned either directly or indirectly in clause 5.3.

For example, subclause 5.3b on "ensuring that the processes are delivering their intended outputs" is quite close to 5.1.1 on "ensuring that the quality management system achieves its intended results."

If processes in a system are not performing as expected, the entire system is challenged. But imagine the extent to which combining clause 5.1.1 and clause 5.3’s requirements might be beneficial, especially by ensuring a host of activities in the QMS are carried out and regularly reported among top management.

When top management demonstrates QMS responsibilities and authorities, it can and will be helpful, especially for those who initially thought clause 5.3 represented just a small change.

Improved and meaningful involvement of top management requires the opening of a wider door than you might have first realized.


References

  1. International Organization for Standardization, ISO 9001:2008—Quality management systems—Requirements, clause 5.2.2.
  2. International Organization for Standardization, ISO 9001:2015—Quality management systems—Requirements, clause 5.3—Organizational roles, responsibilities and authorities.

Paul Palmes is principal consultant with Business Systems Architects Inc. He is chairman of the U.S. Technical Advisory Group to the International Organization for Standardization, Technical Committee 176 (ISO/TC 176), and also chairman of ISO/TC 176, subcommittee 1, responsible for ISO 9000:2015. He is the author of Process Driven Comprehensive Auditing, second edition (ASQ Quality Press, 2009), and The Magic of Self-Directed Work Teams (ASQ Quality Press, 2006).



subclause 5.3b on "ensuring that the processes are delivering their intended outputs" is quite close to 5.1.1 on "ensuring that the quality management system achieves its intended results." was missed even in the recent training I took. This was overall a great article to ensure we are continually improving.

--Cynthia Camble, 11-02-2016


Demonstrates the relationship of changes, and subtly provides insight into possibilities for strengthening quality into an integrated stream.
--Leanne Whalen, 11-02-2016


I don't see these as strong enough words to really change current attitudes toward the QA organization in a small to medium company.
The roles will not change. However if it would state that purchasing, manufacturing, engineering, production control are the team members and are name as a quality counsel and give some specific duties
--Frank Feher, 02-17-2016


In a brief way very well established relationship among clauses Thanks
--Varinder, 02-16-2016


Excellent article pointing out a critical but not obvious criterion. This type of requirement is often overlooked, leading to a performance that is less than it could or should be. Paul has provided an important service to the standard and to quality.
--William Stimson, 02-16-2016

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