We had such an incredible response to iso 45001 in 45 minutes so after many requests here comes our next new series iso 9001 in 90 minutes.

Welcome to iso 9001 in 90 minutes in this segment we’re going to be looking at clause 4 – the context of the organisation.

In clause 4 1 we need to understand the organisation and its context we do that by identifying internal and external issues be it positive or negative that could impact the organisations ability to achieve its intended results.

Examples of internal and external issues that could affect your organisation, such as old infrastructure, unskilled staff.

Or from a positive perspective you could have a culture of innovation new product development you could have good leadership and good financial management all of those would benefit your organisation and possibly enhance your quality management system’s ability to achieve the intended results.

Examples of external issues, suppliers and material availability do you have good suppliers? do you have multiple suppliers? are materials for your products and services readily available?

Recession, could impact your financial viability as an organisation. How competitive is the market that you operate in, is it highly competitive or not?

So up until now you’ve heard me use the term intended results so these are some of the intended results of your quality management system when properly and effectively implemented is the ability to consistently meet customer and regulatory requirements for your products and services. Also the ability to enhance customer satisfaction. Address risks and opportunities relative to the context and objectives of your organisation, but also to demonstrate conformity to your QMS. So clause 4.1 looks at those issues that could affect your organisation and its ability to achieve those intended results, identifying them now helps you to consider them during the development of your QMS

Clause 4.2 looks at the needs and expectations of interested parties. First off you need to define who are interested parties, now if you have a look at the diagram on the right hand side there we identify interested parties as being both internal and external so examples of interested parties could be employees contractors suppliers visitors shareholders the regulator and customers to name but a few.
Then once we’ve identified the interested parties we need to define what are their needs and expectations examples of that could be relative to your products your services, the quality of those products and services, the cost of your products and services, the time it takes to manufacture and deliver, warranties guarantees, the profitability of your company, compliance, again to name but a few. The whole idea behind identifying interested parties and their needs and expectations is to determine which of those requirements are then going to be relative to your QMS so that you can consider those issues as you develop your quality management system.

Moving on to clause 4.3 here’s where you define the scope of your quality management system. Here after considering the issues identified in clause 4.1 the context of the organisation and clause 4-.2the needs and expectations of interested parties, then define the scope of your quality management system taking into consideration the products and services that are created by your organisation. Then also consider the iso 9001 standard and all the requirements that are applicable and consider exclusions and justifications. Your scope statement and the applicability of your quality management system must be available as documented information

if we have a look in clause 4.4,  we’re talking about your quality management system. You’re required to establish implement maintain and continually improve your QMS. Also consider your processes their interactions, inputs and outputs, operational criteria, resources and availability, responsibilities and authority and also evaluate and improve your QMS.

Having a look at your quality management system these are some of the the tools that you could utilize to demonstrate conformity to clause 4. Here I  would develop a process for clause 4 entitled organisational context, you could do this in your quality manual. You would define the context of the organisation, examples of some of the tools that we would use such as the discovery register where we identify all of our activities products services customers suppliers materials etc, we also create various different organograms to demonstrate the roles responsibilities and authorities within the organisation.

Within our clause 4 process we would define clause 4.1 requirements, we would define how we identify internal and external issues and we then have a tool called the QMS organisational context register, which identifies all of those internal and external issues we also use the same register to record the who are our interested parties, what are their needs and expectations. We then document the scope within this process or our quality manual and we also include the interrelationship of processes diagram in clause 4.4. So there you have it an overview of clause 4 of iso 9001 in 90 minutes