Issue 50 – Clause 7.2: Competence
Clause 7.2: Competence
What’s the intent of Clause 7.2?… In our last Newsletter (ISO 9001:2015 Newsletter Issue 49) we discussed the topic of “resources”, and now here in Clause 7.2 we address the area of “competence”. The intent of this Clause is to make sure that once you’ve assigned a “person” to a role or job, that you ensure that “person” remains competent. As I said in my previous Newsletter, if Sub-Clause 7.1.2 asked you to “put round pegs into round holes”, then Clause 7.2 wants you to ensure they continue to fit as time moves on. Often what occurs is that either the job responsibilities evolve over a period of time, or the “person’s” abilities/behaviours change as time progresses… which could end up with a situation where “round pegs are trying to fit into square holes”.
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, gap audits and internal 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 7.2 Competence consists of zero (0) Sub-Clauses…
The requirements within this sub-clause are essentially asking the organization to ensure they assign “competent” people to the tasks they are asked to perform, and then make sure they stay “competent”. Within Part [a] is asking organizations to start by first deciding what the competency requirements are for a particular job/role. Notice that they’ve introduced the word “performance” into this requirement, asking organizations to maintain the performance of the QMS through the assignment of roles to “competent” personnel. Notice also the use of the wording “persons doing work under its control”. This supports what I said in the previous Newsletter, under Clause 7.1.2, about the fact that ALL persons who affect quality are within the scope of these requirements. Part [b] then goes on to ask the organization to ensure that whoever they assign to the role possesses the competency requirements determined in Part [a]. Part [c] then says that if a gap in competency arises, that actions will be taken to close the gap, and then a follow-up done to make sure the gap is closed. Part [d] of this sub-clause asks you to maintain documented information as evidence of competency requires records of education, training, skills and experience, as well performance review documentation, where applicable.
Many organizations will use their existing performance review processes to address all of the requirements within this sub-clause. For those “persons” who are not included as part of a formal performance review process, they can be addressed through observation of their job performance by their immediate Supervisor or Manager. The difficulty of course is in those circumstances when “documented information” is not available for an informal process of observing the work of subordinates.
Keep in mind that way back in the year 2000 revision of the ISO 9001 Standard the word “competent” was used to replace the word “qualified” which was previously used. At that time there was much debate as to how to define the word “competent”, which in the end, most ISO Registrars decided it was “however the organization defined it as”… and this still holds true today.
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 7.2 of ISO 9001:2015?
A: For Clause 7.2, an Audit Checklist should cover these areas:
– How does the organization determine the level of competency necessary for the persons involved in carrying out the activities defined in the QMS? Where is this defined for each role/job function?
– How does the organization ensure that these persons remain competent over time?
– Is competency defined based on appropriate education, training or experience?
– If a gap in competency arises, how is this gap closed? How is the effectiveness of these actions assessed?
– Has the organization retained documented information as evidence of competency?
(Make sure to interview more than one person and obtain examples for the items listed above)
Until next time…
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