ISO 9001 Clause 5 - Leadership (as a Process?)

[Solitude]

I work for a company who are not currently ISO9001 certified, but we have very recently started working towards certification to ISO9001:2015. This is because the MD and Senior Management team think that it is right for the business, and a number of potential and new customers are requesting this.

I had a visit from a key customer in the week who stated that there should be a business process clearly defined for Leadership. I do not agree with the auditor.

My take on it is that for clause 5.1.1 - General, we can demonstrate that the Leadership is fulfilling the requirements of a) - j) with objective evidence which could be verified through audit activity.

For 5.1.2 - Customer Focus point a), the specification provided as part of the design process along with the technical file for our CE mark meets this requirement.
Point b) is addressed through our risks and opportunities register
Point c) we monitor and measure customer facing metrics, track repeat business and are looking ta introducing customer surveys.

For 5.2, there is a quality policy in evidence that meets the requirements defined, and this is communicated and there is evidence that people are aware of this and understand it.

For 5.3, we have an organizational chart, job descriptions and process documents which define the requirements of a) to e).

Has anyone got any thoughts on the need for a Leadership process document? I am struggling to see the need, but the customer auditor was adamant that one was required. Am I missing something? Thank-you.

 

[Jane_S]

Hello!

I had to check the ISO 9001:2015 after I read your post.
To answer to your question - there's no requirement to have a documented process/procedure on Leadership (to be honest, for me it is hard to imagine how it could look like). There are different ways how to comply with the requirements of ISO 9001:2015.

For example, in my company we just document our quality policy together with the Top Management's commitment in the quality manual (which minus the procedures and work instructions consists of like 3 pages which mostly cover the "Leadership" part). Of course the revision of 2015 doesn't require to have a documented quality manual anymore, but it doesn't mean that you should throw it away and are forbidden to establish one if necessary.

As for the quality objectives - those a set during annual management review and all the employees are informed about them (they ale placed on the board, for example).

All employees have seen the Quality manual and there are training (if you can call it like that) records referencing the Quality manual. Hence after the previously mentioned 3 pages are read and understood all employees know what is the quality policy of the company, who sets objectives and what does the QMS mean and why it is necessary. Which means the quality policy and all the other leadership stuff is known and understood throughout the organization.

So in general: one way is to cover the 5.1. of ISO 9001:2015 is through quality manual (for the things which are set in stone) and annual management review (for the things that can change and have to be evaluated - like the effectiveness of QMS)

 

[Solitude]

Thanks Jane. I was struggling to see how the process would look like in my mind too to be honest.
What you have suggested is along the lines of my thoughts and what we are looking to do to meet the requirements.

 

[howste]

Looking at the definition of a process may help to decide if it makes sense:

set of interrelated or interacting activities that use inputs to deliver an intended result

If you look at leadership as a noun (group of leaders), then it's probably not a process. If you look at leadership as a verb (act of leading) then you might have a process.

I've seen MANY organizations that have a process named Management Review or similar. This could just as easily be called Leadership. The inputs to the process consist of information and metrics from all of the other QMS processes. The intended result would be improvement of those processes, achieving objectives, profitability, etc. This is a process that oversees all of the other processes and determines decisions, actions, and resources to be applied throughout the organization.

All of these activities are required and need to be done. Ultimately, your organization decides what processes you need to carry them out and how you'll define them.

 

[Kronos147]

FWIW, we have defined the following core processes for our small machine shop:

-Management
-Production
-Purchasing
-Customer Related Processes
-Inspection & Compliance


I would answer a customer\auditor that Leadership is a 'sub-process' of Management, based on the Context of the Organization being we are a small machine shop, with 5 core processes and sub-processes identified underneath.

 

[Solitude]

Thanks @Howste. I agree with what you say, and looking at the definition as a noun or a verb helps. We have a Management Review process with inputs, activity and outputs. We have a documented QMS including a policy and a customer monitoring process. I think that I am going to argue that we do not need a standalone Leadership process, and give him the evidence we have that shows we meet the requirements defined within section 5 of the standard.

 

[Solitude]

FWIW, we have defined the following core processes for our small machine shop:

-Management
-Production
-Purchasing
-Customer Related Processes
-Inspection & Compliance


I would answer a customer\auditor that Leadership is a 'sub-process' of Management, based on the Context of the Organization being we are a small machine shop, with 5 core processes and sub-processes identified underneath.

Thanks @Kronos. I agree that leadership is part of the management process. I will post my Process Interaction map later today, as I think it may be too detailed, e.g. we have a series of management processes.

 

[Alienraver]

I have lumped our management process into the Support Process. Our support process includes things like high level quality, IT, Leadership (Management) and Safety. Which as a manufacturing facility are all supporting the major process of production. There are others, we have a total of 6 CORE processes for our business, about 185 employees.

 

[Kronos147]

Sounds manageable to me.

Nice!

 

[Coury Ferguson]

I have lumped our management process into the Support Process. Our support process includes things like high level quality, IT, Leadership (Management) and Safety. Which as a manufacturing facility are all supporting the major process of production. There are others, we have a total of 6 CORE processes for our business, about 185 employees.

Good job on that. Management is a Supportive Process. Management/Leadership makes decisions for the organization, that can affect interested parties and should be identified somewhere, in my opinion.

I like what you did with that.