Tips for approaching Clause 4 ‘Context of the Organisation’ in ISO 9001:2015
With many organisations considering implementing ISO 9001:2015, we take a look at the new clause 4, ‘Context of the Organisation’. The Context of the Organisation refers to how a business is run and sets a requirement for organisations to identify relevant interested parties (e.g. Customers, Suppliers, Employees and Industry Regulators) that may impact upon their organisation and their Quality Management System Below are some simple steps that you can take to determine the ‘Context of your Organisation.’
- Keep it simple
A simple approach is the most effective one and organisations should not over complicate what the Context of their Organisation is. Start with identifying what you do and then tell people. Then consider what internal and external issues can have an impact on your strategic objectives and your Quality Management System.
- Internal issues: Identify them and determine how they affect your organisation’s products, services and your interested parties
- External Issues: Identify them and determine how they affect your organisation’s products, services and interested parties
- Identify your interested parties and their requirements
- Review and Monitor internal and external issues and interested parties regularly
- Perform a SWOT Analysis
The SWOT (Strengths, Weaknesses, Opportunities and Threats) analysis is a very useful tool for analysing the internal and external issues and opportunities for your organisation. Organisations can determine what issues they can and cannot control and implement plans to deal with the ever changing needs and requirements of interested parties.
What you will find in the SWOT analysis?
- Strengths – Your organisations advantages and core competencies i.e. what do you excel at?
- Weaknesses – Your organisations disadvantages and weaknesses i.e. what can you improve?
- Opportunities – The current external trends and how you can take advantage of them
- Threats – Insights on external factors that may have an impact on your organisation in a negative fashion
- More on a SWOT Analysis here.
- Outline the Strategic direction of your organisation
The strategic direction for your organisation will be documented in your vision and mission statements. This will include the plans and actions you have put in place to work towards this vision for your organisation.
For ISO 9001:2015, you must align quality with your organisation’s strategic direction. As your organisation grows this will pose many challenges for quality relating to new products, new customers, new employees, new regulations, new processes and new risks. It will be important that your organisation determines the processes and procedures to put in place to assist with these challenges now and into the future.
- Determine what your regulatory requirements are
Another activity required in determining the context of your organisation is to establish what are the regulatory requirements that are applicable to your organisation? You will need to ensure that you have processes in place to allow you to meet your customer requirements. One of the best ways to approach this is through customer feedback from surveys, interviews and reports. Understanding your customers is one of the key drivers in how you plan to improve quality in the future.
These simple and helpful steps will provide you with a guide to determining the context of your organisation. You can also download our ISO 9001:2015 Transition Guide for FREE. If you still require assistance, please contact us and we will be happy to assist you achieve your certification.
