On this page, we will explain in detail, the ISO 9001 clauses in plain English. As an introduction, here are the salient elements of these ISO 9001 clauses in plain English.
Introduction to ISO 9001 Clauses in plain English
Context – What are the internal and external elements affecting the business? Who are the people involved who therefore have an interest in the business?
Leadership – Do the leaders of the business have the vision to implement a strategy to grow their business? Who will they work with to achieve their goals?
Planning – What are the risks and opportunities for this business, and what is being done to ensure the sustainability of the business? What are the goals of the business, and how are you keeping track to ensure optimal performance in all areas of the business?
Support – How are you ensuring that all employees are performing at their best potential?
Operations – What activities do you, and your staff engage in to succeed in your industry? This relates to your sales and operational processes. And how are you making sue that you delivering a high-quality service to your clients?
Evaluation – How are you monitoring that what you intended to do is being done?
Improve – Here is where we implement the improvements suggested by all the above elements, and other improvements suggested based on mistakes done by the business (no matter how much you improve, there will still be mistakes..).
The aim of this post about the ISO 9001 Clauses in plain English is aimed at people seeking to learn more about ISO 9001. If you’d like help in following the process to get ISO 9001 certified, click here to get a quote.
Clause 4 – About your organization
ISO 9001 is a quality management system that has been around since 1987. The latest update of the standard, done in 2015, had a greater emphasis on the environment in which the company works. Businesses are working in a fast-paced environment, that is why some ISO 9001 consultants are outdated. The first important ISO 9001 Clause of the standard talks about the context of the organization. Here we need to establish a suitable understanding of the unique circumstances of the company. This means that we will define what is important for the company, and set the stage for what elements of the business are more critical. These critical elements must be included in the quality management system.
This relates to both the internal and external factors of the company. Internal factors refers to everything that is within the company, including
- the building through the company operates
- the product itself
- the performance of the company
- operation and factors such as the the processes involved in the delivery of the service to the customer
- and anything that the company has direct control over.
External factors include elements within the market that are relatively out of our control. This means that we cannot take decisions to impact the future of these elements. The issues listed might still have an effect on the business. External issues include
- economic factors such as Forex and inflation
- social factors like the unemployment rate and education levels
- political factors such as political instability and the local infrastructure
- new technologies entering the markets
- market factors such as competition the market share and similar products and services including customer trends and supplier relationships
- legal & statutory factors that’s coming into through new legislation
There are multiple tools and systems that we can use to evaluate internal and external issues relating to a company. Examples of these tools include:
- SWOT analysis for internal issues
- Pestle analysis for external issues
At this stage, thriving companies would be wise to invest in a strong business plan. The business plan, which is a document that includes the strategies and tactics that the company will employ to achieve goals. This will surely highlight everything that is needed for internal and external issues.
ISO 9001 Clause 5 – Leadership
On the page on why I am back to ISO 9001 consulting, I identified 2 types of people. There are those who want to improve and those who want to get ISO 9001 certified in the fastest, easiest way possible.
If you are looking for the easiest way to get certified, all you need to know is that an ISO 9001 auditor will need to find evidence of your involvement in the QMS.
This can simply be done by you signing a couple of documents which would make it same like you are involved in the QMS.
If you are willing to improve and thrive in your business, you won’t need to do anything more than what you’re doing for the section. This section within the ISO 9001 Clauses requires leaders of organisations to actively take control in growing their business. This is done through business strategies and communication during annual reports and management meeting minutes.
Goals and objectives are the signs of an active leader within a company.
The standard calls these quality objectives however they are not necessarily relating to quality. anything that has been discussed and the previous section (context of the organisation), and that actually needs to be measured to be improved, must have a goal.
Actively working to achieve those goals then it means that they are in compliance with the standard because they are taking an active role in the running of the quality management system whose sole purpose is to ensure a continuous feedback for ideas for improvement, and the execution of the projects behind those ideas.
Clause 6 – QMS Planning
In line with Clause 4, of the ISO 9001 Clauses continues to emphasize on the factors that could possibly affect the company both positively and negatively. In this section we must list the risks and opportunities relating to the business and take action on them.
- Identify and prioritise risks 4.4.1
- Address the most critical risks 5.1.2
- Ensure that the actions implemented for each risk did achieve the intended result 6.1.1
- Integrate actions to address risks into the processes 6.1.2
- Control those risks identified the 8.1
- Evaluate effectiveness of actions on risks 9.1.3
- Review effectiveness on actions on risks 9.3.2
- Improve the quality management system based on risk 10.3
Notice from the above mentions of the section , it seems that only risk is mentioned. I encourage you you too always considered opportunities so that you will not only be maintaining your business, but you’ll also be growing it.
This shows that the first three ISO 9001 Clauses tied together beautifully. We are giving the tools to determine the internal and external factors that could affect the business. We are reminded to consider the risks and opportunities relating to the business. And finally leadership is given the responsibility to ensure that the company has goals to work for and that solid business strategies are set and implemented.
ISO 9001 Clause 7 – Support
It’s evident that the wording of this standard is designed to cater for top management, for you. The clause speaks about the support you will need to achieve the goals of the company.
More specifically this clause speaks about the resources you will need and this is split into 3 main clauses. These are the people, infrastructure, and the environment for the operation of the processes.
People – the provision of the necessary stuff that is effectively trained to perform the job as per their job description within the organisation chart.
Infrastructure – to provide the buildings, the tools and any supporting services including IT and communication that is required for the provision of the service.
Environment – providing a place that is safe to work for both the people and the quality of the product.
ISO 9001 Clause 8 – Operation
It is a long-held belief that for an organisation to get ISO 9001 certification the company must map out all of its processes. However that is not the case.
Seek and record evidence that your organisation has determined the designed it’s processes to meet the requirements of the customer.
When designing a process it is important to include the inputs, outputs, resources, controls, criteria and processes.
Most importantly in this clause a smart business people, we should ensure to map specific processes that need active monitoring. This will be defined in clause 6 where we talk about the risks & opportunities and in clause 5 when we define goals of the business.
Clause 8.1 operational planning and control is about creating processes. Specifically, those that are critical to delivering a product that meets specified customer requirements and and expectations. This means that we must be sure to have a systematic way in which we can consistently deliver high quality service to our clients. This is done by:
- Determining the quality objectives for the product
- Determining requirements for the product
- Identify the processes required
- Establish the processes required
- Identify the documents needed to run the process
- Identify the resources needed to run the process
- Maintaining and retaining documented information relating to the delivery of the product
This clause also includes an element of performance evaluation. Here we are encouraged to obtain the customer views and perceptions to clearly understand what what the people who have used our product have to say.
Clause 9 – Performance Evaluation
This clause encourages us to think of ways in which will be measuring what we have defined in our goals. Let’s take an example with customer feedback. In that case, we need to have a way in which that information can be made available.
Moreover the standard goes on on to make it a requirement to have a standard to process this information. We need to define how we will identify, collect and analyse the data relating to information we get from both internal and external sources.
ISO 9001 Clause 10 – Improvement
Is explained that are two types of people who would want to get ISO 9001 certified. Those who want to improve and those who are in it simply for the certificate.
For those who simply want the certificate this clause is simply redundant. this is because they do not understand the importance of continual improvement and they are not committed to making small sacrifices now to achieve better results in the future.
On the other hand, those who have a will to improve will clearly understand the benefit of the clause. Here we are encouraged to not be passive about improvement, but rather to take a systematic approach towards the collecting of our ideas for improvement, and to find a way in which we can implement those ideas.
Achieving ISO 9001 certification through the help of a consultant, or through internal work as a matter of fact, is useless if considered as a one-time project. ISO 9001 certification should be seen as the Foundation of improvement, it is is like you have just graduated.
Right after you finish your thesis and you get the certification in your hand you feel like you have mastered the topic that you have studied. As an employer you know that that is very far from the truth. Newly graduates have much to learn about how to actually implement of what they’ve been taught in university, as required in industry. They need to work hard to learn from others and they need to do their best to deliver results.
The same goes with your company. Once you get ISO 9001 certification, you still need to work hard to actually improve your company has a continuous journey that will never end as long as the business is still running.
As a final note the iso 9001 standard closes off with an important section, probably the most important. It is a well-known fact that only those who try do not make mistakes. You are now within the magical world of never-ending improvement. And so you and your team are bound to make mistakes. Which is completely normal.
Nonconformities might sound like a complicated word but it’s only means ‘when something goes wrong’. So whenever something wrong happens inside the company either there’s a mistake, or it’s a complaint, or anything else, that is an nonconformity.
If you’ve read the entire text above, you’d know that naturally the standard with required a standardized way in which non-conformities will be handled.
The above has been my interpretation of explaining the ISO 9001 clauses in plain English. If you’d like more information, feel free to get in touch now. I’d love to give you a quote for ISO 9001 certification in Malta.
From the above ISO 9001 Clauses in plain English, it can be seen that the current version of the ISO 9001 standard has been created in a way that encompasses most of the important elements of the business plan. Click this link if you’d like to get more information about the mandatory documents required for ISO Certification by a marketing company.
If you’d like to get a quote for ISO Certification, feel free to get in touch. We’d love to help.