Issue 47 – Clause 6.2: Quality objectives and planning to achieve them
Clause 6.2: Quality objectives and planning to achieve them
What’s the intent of Clause 6.2?… In our last Newsletter (ISO 9001:2015 Newsletter Issue 46) we discussed the topic of “Risks & Opportunities”, and now here in this Clause we address “Quality Objectives”. The intent of Clause 6.2 is to have the organization put some meat into the Quality Policy (Clause 5.2) by giving life to all of the key words within that statement. If the Quality Policy is the goal of the quality management system (QMS), then the Quality Objectives is the road-map of how to get there.
Note A: This Clause DOES include requirements for “documented information”.
Note B: As some of you already know, 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 training workshops and gap audits, where the requirements of the Standard have to be interpreted and applied to each unique situation. A popular training request is our on-site Internal Process Auditor Training for ISO 9001:2015 since you will need to do a complete round of internal audits to the new Standard prior to your external upgrade audit. On that note, some organizations are opting to use an outside resource to assist with their internal audits in order to meet deadlines (…more details on this service, as well as the training sessions we offer, 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 – This sub-clause begins by asking your organization to establish what your Quality Objectives will be for the relevant functions, levels and processes within your business.
Parts [a] through [e] within this sub-clause outline requirements 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. 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.
The requirements within this sub-clause are definitely adding teeth to the previous version of the ISO 9001 Standard. Most companies shouldn’t have much trouble dealing with part [e] (how the results will be evaluated) since this will happen as part of the monthly or quarterly reviews of the business objectives (balanced scorecard reviews or KPI reviews). Part [d] (when the objective will be completed) is usually tied directly to the fiscal year end of the company, while part [c] (who will be responsible) is usually clear by the “initials” next to each Objective. Parts [a & b] (what will be done and what resources are needed) are the more challenging requirements since many companies don’t have a “plan” on Jan 1st to achieve each Objective. Another way to handle this is to show that in Months 1 to 12, when an Objective turns “red” (not meeting target), that a “plan” is developed by the person whose “initials” are beside it, as to how they intend to turn it back into “green“, along with identifying what resources they will use to accomplish do this.
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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For cost effectiveness, the Internal Audit function can be outsourced to an external experienced auditor on a periodic basis. This will provide an independent and objective assessment to management, of where process issues may exist, along with identifying opportunities for improvement. It will also provide the evidence needed to satisfy the Internal Audit requirements in the ISO Standards. We have used two different approaches with this service: a) We conduct the entire audit ourselves, or b) We act as the lead auditor, and along with your Team of internal auditors, we complete the entire audit together. This latter approach allows your people to receive guidance and direction from an experienced lead auditor while at the same time maintaining significant involvement in the internal audit process.
This Documentation Development Training Workshop for ISO 9001:2015 Session is intended to be a very interactive, hands-on session (hence the name Workshop) where your QMS documentation will be created/revised, with guidance from an experienced facilitator. This type of session can help launch your transition efforts by getting a lot accomplished within a compressed time-frame. If your organization has already begun the re-write then this session can be used to validate what you’ve accomplished so far, or if you haven’t yet begun, it can be the catalyst to get things started (…which is usually the hardest part). Deciding how to move from your current QMS structure into a new one can be a daunting task and this session can help you navigate through it. A copy of a sample Quality Manual (re-iterating the “shall” requirements found within the ISO 9001:2015 Standard) will be provided to each participant. As always, our focus will be on how to develop a simplified and streamlined quality management system, that helps to drive improvement in your business.
The two (2) day Internal Process Auditing for ISO 9001:2015 Training Session 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.
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.
Q: How do you perform an audit for Clause 6.2 of ISO 9001:2015?
A: For Clause 6.2, an Audit Checklist should cover these areas:
– Does the organization have Quality Objectives? Are they documented?
– Are they established for different functions, levels, processes within the QMS?
– How were the Quality Objectives developed?
– Are there Quality Objectives for services provided to Customers? Examples?
– Are the Quality Objectives consistent with the Quality Policy? How?
– Are the Quality Objectives measurable?
– Do the Quality Objectives take into account Customer requirements? How?
– Do the Quality Objectives take into account other requirements? How?
– How do the Quality Objectives reflect conformity of products? Conformity of services?
– Are the Quality Objectives relevant to the enhancement of Customer satisfaction?
– How are the Quality Objectives monitored?
– 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…
Helping Business Professionals Reduce Risk and Remove Waste!