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Get ISO 9001 certified fast – gives a full overview of each of the clauses within the standard as an overview of everything that needs to be considered when implementing ISO 9001. It does not have information about which clauses are being references.
These clauses give an overview of the management system. The two most worthy concepts to learn are the scope of the organization (including whether or not to include design). And the concept of terms & definition.
Clause 4 – Context of the organization
This section is about setting up the foundation for the management system. It is about defining the ‘context’ in which the organization works. Key Concepts to learn are:
- Products and services offered by the company, and how these create the key processes of the organization
- Interaction of processes (including the key processes and the supporting processes of the management system)
- Interested parties who have varying requirements that must be catered for within the management system – this will help us define who our company is serving, and what they are expecting from us.
- Internal and External Issues as created through a SWOT & PESTLE Analysis
Clause 5 – Leadership
The most important resource in an organization is its people. And the way to optimize the effectiveness of employees is through strong leadership. Key concepts to learn are:
- Setting up a quality policy for your ISO management system (quality, environmental, OH&S)
- Real tactics that can be used by leaders to show that they are actively managing their team to drive improvement through the management system
- Only required in ISO 45001, however, makes sense to implement in all management systems is the process that workers are being directly involved in the improvement of the organization
- How are roles assigned and communicated throughout the organization, to ensure that everyone knows what their role within the company (vis-a-vi the management system) is?
Clause 6 – Planning
This clause is about ensuring that the business has a defined strategy. Directly linked to information found within the business plan, this clause talks about:
- The identification and assessment of risks & opportunities
- The process to manage the projects for the implementation of the risks & opportunities
- Considering the full requirements (specific requirements & compliance requirements) when evaluating risks & opportunities
- Coming up with Quality Objectives – definition + examples to act as the guidance for the vision of the organization
- The processes of planning action to achieve management system objectives
Clause 7 – Support
This clause refers to supporting processes that are required to run the process. For example, if going to work is ‘the process’, ‘driving to work’ is a supporting process. This is because driving to work has to be done to accomplish the actual process. Therefore here you must learn about:
- Internal and external communication with the various stakeholders of the organization
- Systems in place to gather ‘organizational knowledge‘ – This information would be used to store vital lessons learned by employees over time.
- How to make sure that people are aware of the goals of the organization, particularly through ISO 9001:2015 roles and responsibilities.
- The process that the organization has in place to ensure that it allocates its staff to meet the requirements.
- And a system to ensure that people running a process have the required competencies for ISO 9001
- How to ensure that the right work environment is provided to the employees
- How to ensure optimal performance of monitoring and measuring equipment
- How to ensure that infrastructure required for the running of the management system is well maintained
Clause 8 – Operation
This section deals with the business processes that are required to deliver the product or service to the customer. These processes are what our clients pay us for. Here you must learn:
- How to communicate with the customer in relation to information relating to the product/service inquiries
- The process that the company runs to determine the requirements of customers. And how does the organization make sure that it has the ability to meet these requirements (before issuing a quote)?
- What documented information is amended when there is a change in customer requirements or in product specifications?
- If applicable, how does the company handle the design & development procedure as per ISO 9001 standard?
- How does the company approve, and evaluate the performance of their suppliers?
- What information is given to the suppliers when we are purchasing products/services, and how do we confirm that the information is correct?
- How does the organization keep documented information that defines the operational processes of the company, including:
- traceability of information and physical products
- safeguard external property
- preservation of process outputs
- requirements for post-delivery activities
- control the changes for production or service provision, to ensure continuing conformity with specified customer requirements
- How do we know that the product has been delivered as required by the customer and that therefore we can release the product/service?
- How are non-conformities handled?
Clause 9 – Performance Evaluation
One of the benefits of ISO 9001 certification is that management will lead by data (not by hunches). This is only possible if the organization collects data relating to:
- customer satisfaction through evaluating the perception of the customer after purchasing and consuming your product/service
- Internal audits – through which the processes of the management system are evaluated to ensure continual conformity to the procedures defined within the standard
- The process that the company uses to gather, and analyze data and information resulting from all measurement systems within the organization.
- The management review meeting is where the performance evaluation is discussed, and where a decision regarding the appropriate actions for improvement are agreed upon.
Clause 10 – Improvement
And finally, the standard recognizes that performance evaluation without action is useless. The last section is about implementing the improvements agreed. It is important to know:
- How corrective actions and non-conformities are handled through corrective and preventive actions (CAPAs)
General information about ISO
From the various ISO Management Systems available, here you can learn about Which ISO Certification is best for your company.
ISO 9001 has been around since 1987. On this page, you will read about What is the current ISO 9001 Standard.
What the main Benefits of ISO 9001 certification?
Business Process Improvement
During the COVID-19 Pandemic, we were all forced indoors. Here’s a quick post I wrote for Service business working from home – Tips for 2020
Implementing ISO 9001 in your business
My story about why I had decided to be an ISO Consultant in Malta back in 2014, and why I had decided to stop. And what made me return to the field of continual improvement.
Even though it is a standard, some consultants just don’t seem to be following a structured Process to get ISO 9001 Certified. Here you will read about all the steps to achieve certification.
Choosing a certification body is the final step to achieving ISO. Here you can read about the process of choosing, and appointing a certification body (after you’ve implemented your Management System).
Examples by industry
Here you can read about all documentation required when implementing ISO 9001 for a Marketing Agency
Linking the procedures and documentation required for Good Distribution Practise (GDP) Certification in Malta, with ISO 9001 Certification.
ISO 9001 Training Courses – Conclusion
We hope that you have enjoyed the above information and free ISO 9001 Training Courses. If you’d like more information, feel free to get in touch.