ISO 9001:2015 – Newsletter – Issue 17



Issue 17 – Clause 5.3:  Organizational Roles, Responsibilities and Authorities


ISO 9001:2015…

Clause 5.3: Organizational Roles, Responsibilities and Authorities


What’s new in Clause 5.3?… In our last Newsletter (ISO 9001:2015 Newsletter Issue 16) we discussed the topic of “Quality Policy”, and now here in Clause 5.3 we address the area of “roles, responsibilities and authorities”.
Note 1: This Clause does NOT include a requirement for “documented information”.
Note 2: I’ve had some readers email me to ask “Where do I get the content for these Newsletters?”.   That’s simple… it’s from working in the field with both my Clients and with their ISO Certification Bodies.  A lot of hands-on experience comes from conducting numerous gap audits, where the requirements of the Standard have to be interpreted and applied to each unique situation.  Combining a Gap Audit with ISO 9001 Essentials Training, has become our most popular request from our Newsletter readers (…more details on this, as well as other training, can be found below).


The new numbering format… 

Element 4 – Context of the organization
Element 5 – Leadership
Element 6 – Planning
Element 7 – Support
Element 8 – Operation
Element 9 – Performance evaluation
Element 10 – Improvement


Clause 5.3 Organizational Roles, Responsibilities and Authorities consists of zero (0) Sub-Clauses.

What’s new in this Clause is what is missing from it – namely there is no longer a requirement to appoint a QMS Management Representative.  This situation is very similar to the removal of the requirement for a Quality Manual, and once again I suggest you carefully re-consider before eliminating this role.

As I mentioned back in an earlier Newsletter (ISO 9001:2015 Newsletter Issue 5), the Management Representative role can provide an important focal point for many “quality related activities” within an organization, such as taking ownership of the internal audit process, coordinating audits with outside Customers, as well as handling external regulatory/accreditation bodies, to mention just a few.

Keep in mind that your QMS could erode over time if no one is specifically identified and assigned to look after it.  I’d recommend that the role of “Management Representative” be maintained but that it become a rotating responsibility amongst the Top Management team members, and that it is re-assigned every two years max.  This provides a few advantages, such as: a) it satisfies the intent of the ISO 9001:2015 Standard of distributing QMS responsibilities; b) it recognizes that everyone shares the commitment to “Quality” within the organization; and c) every member of Top Management eventually gains a much better appreciation of all that is involved in maintaining a QMS.

Other wording that is new within Clause 5.3 is the phrase “...ensure that roles, responsibilities and authorities are… understood within the organization“.  This implies that Top Management will ensure that it is understood “who” is responsible for “what” within the Quality Management System.  If this new requirement is not addressed properly it will surface during audit interviews where conflicting responses are received from auditees when asked about who makes the final decision on quality related issues.

Other then the above comments, Clause 5.3 is mostly a repeat of requirements from the earlier 2008 edition.



Be sure to watch for our next Newsletter issue where we will cover another section of ISO 9001:2015…


PS: Don’t forget to look at the Q&A section below for some final thoughts…


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Need Training?

ISO 9001:2015 Essentials + Gap Audit

This combines the ISO 9001:2015 Essentials Session with a Gap Audit – This approach is used to assist organizations in launching their transition efforts for this new ISO Standard. This event accomplishes two things: a) it provides education on the new ISO 9001:2015 Standard for your key personnel (i.e. internal auditors; etc.), by highlighting the differences from the 2008 version; and b) assesses the gap from where you are today to where you need to be to achieve compliance to this new ISO Standard. Training certificates covering education on the new ISO 9001:2015 Standard, as well as issuing of a Gap Audit Report for distribution to your Top Management, are the two deliverables from this event. On a final note, a closing meeting can be arranged with key individuals so they can hear first hand the results of the Gap Audit that was performed.  PS: We’ve also done this session with just the QMS Management Rep attending, which allowed them to quickly get up to speed on this new Standard, as well as to see how much of an effort the transition will be… and of course they receive their own Training Certificate as part of this event.  This also allowed them to avoid traveling offsite to get the training they needed anyways, as evidence for their Certification Bodies.


Internal Process Auditing for ISO 9001:2015

The two (2) day Internal Process Auditing for ISO 9001:2015 Session (also covers requirements in ISO 19011) is focused on a process approach to auditing with the objective being not only to assess conformance of the quality management system, but also to uncover process improvements during an audit. This goes hand in hand with the process auditing requirements found within ISO 19011 and the process approach covered in ISO 9001:2015, which promotes continual process improvement throughout this Standard. An enhanced checklist is developed, and there will be workshops throughout, to reinforce learning, as well as a live, practice audit. If you are looking to meet the ISO 9001:2015 internal audit requirements and to “raise the bar” for your internal audit program then this is the course you should consider.



Q:  How do you perform a gap audit for Clause 5.3 of ISO 9001:2015?

A:  For Clause 5.3, a Gap Audit checklist should cover these areas:

–  Has Top Management retained the role of QMS Management Representative?  If not, how have they ensured that the responsibilities, previously held by that position, were assigned, communicated and understood by all employees?  How was the transition of responsibilities handled?  Interview the person who last held the QMS Management Representative role for their input, and interview others to see if they were made aware of this change.
–  Ask Top Management “who is currently assigned to manage the internal audit process”?
–  Ask Top Management “who is currently assigned to coordinate the external audit conducted by the ISO Registrar”?
–  How has Top Management ensured that “roles, responsibilities and authorities”, for all of the QMS activities, are understood by all employees within the organization?

(Make sure to interview more than one person and obtain examples for the items listed above)


Until next time…

Tim Renaud

Helping Business Professionals Reduce Risk and Remove Waste!