Issue 19 – Clause 6.2: Quality objectives and planning to achieve them
ISO 9001:2015…
Clause 6.2: Quality objectives and planning to achieve them
What’s new in Clause 6.2?… In our last Newsletter (ISO 9001:2015 Newsletter Issue 18) we discussed the topic of “risks and opportunities”, and now here in Clause 6.2 we address the area of “quality objectives”.
Note A: This Clause does include a requirement for “documented information”.
Note B: The content for these Newsletters comes from working in the field with my Clients, and with their ISO Certification Bodies. I gain a lot of hands-on experience 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 6.2 Quality objectives and planning to achieve them consists of two (2) Sub-Clauses as listed below:
6.2.1 [no title] The organization shall establish quality objectives…
6.2.2 [no title] When planning how to achieve its quality objectives…
Sub-Clause 6.2.1 – The lead off sentence starts off by being very similar to the requirements in the 2008 version but adds that these Quality Objectives should also be established for “relevant processes”, which is something new. Many organizations already have objectives in place for processes, in addition to measurements for individual functions or departments. You can recognize these “process” objectives because they are the metrics that not one single Manager can control, but rather depends on various functional areas to perform effectively, an example of which would be on-time delivery to the Customer.
Parts [a] through [e] within this sub-clause outline requirements that are not really different from 2008, asking that the Quality Objectives: be consistent with the Quality Policy; be measurable; that they take into account any applicable requirements; be relevant to the conformity of products/services and to the enhancement of Customer satisfaction; and be monitored. However parts [f] and [g] asks that you communicate the Quality Objectives, and that you keep them updated. In many organizations this is often accomplished during monthly or quarterly business scorecard review meetings.
Finally they make sure that there is no confusion by telling you to maintain your Quality Objectives as “documented information”. All of the requirements found in Clause 6.2 add some teeth to what I’ve always said is a critical section within the ISO 9001 Standard because it drives your quality performance.
The following was taken from a previous Newsletter and I think it’s worth repeating… How should Quality Objectives be developed? Are they the same as Business Objectives? Let me start with the second part of the question. Yes, Quality Objectives can be identical to the Business Objectives, or they can be a sub-set of them. Business Objectives are generated from the key words found within an organization’s Mission Statement. If you state that you want to be the market leader in your industry then you need to set a measurable objective (and an action plan) that will get you there. This is the same approach that you should use with your QMS by ensuring that your Quality Objectives flow directly from the key words within your Quality Policy statement. So if your Quality Policy says something like “…we make sure Customers are always satisfied, by being on-time every time…” then you would need two quality objectives, one for the level of Customer Satisfaction you want to achieve, and another objective for the on-time delivery performance that you are striving towards.
Sub-Clause 6.2.2 – Parts [a] through [e] definitely adds new depth to the topic of Quality Objectives by asking “Who”, “What”, “When” and “How”. They want to know what will be done to achieve each Quality Objective (and what resources will be needed to do it); Who is responsible for each Quality Objective; When each Quality Objective will be achieved; and how the status of each Quality Objective will be tracked and assessed. This level of detailed requirements will ensure that you are clearly stating how you will manage to achieve your Quality Objectives within your organization.
This new ISO 9001:2015 Standard is attempting to achieve more “business alignment”, and Clause 6.2 is another good example of that.
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.
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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.
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Q: How do you perform a gap audit for Clause 6.2 of ISO 9001:2015?
A: For Clause 6.2, a Gap Audit checklist should cover these areas:
– Does the organization have Quality Objectives?
– Are they established for different processes within the QMS?
– How were the Quality Objectives developed?
– Are there Quality Objectives for services provided to Customers? Examples?
– How are the Quality Objectives communicated?
– How are the Quality Objectives updated?
– Has the organization established what will be done to achieve each Quality Objective?
– Has the organization established what resources will be needed for each Quality Objective?
– Has the organization established who is responsible for each Quality Objective?
– Has the organization established when each Quality Objective will be achieved?
– Has the organization established how each Quality Objective will be evaluated?
(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!