ISO 9001:2015 The Process Based Quality Management System Explained.
The process approach to an organisation’s Quality Management System was first introduced in ISO 9001:2000. While the concept of the process-based Quality Management System has not changed, the requirements in the latest standard, ISO 9001:2015, are more specific and easier to understand. This is good news for most organisations as in with previous standards, there is some evidence to say that the process approach was less understood. For your benefit, let us give you a brief overview of what the process approach is.
What is a process approach?
The process approach is a strategy used by management to manage and control processes. It incorporates risk-based thinking and the Plan-Do-Check-Act to provide an understanding of what the core processes in your organisation are and how they fit together.
Organisations use the Plan-Do-Check-Act for:
- Plans for continuous improvement
- When starting a new improvement project
- Defining repetitive work processes
- Verifying and prioritising problems or root causes
- Implementing change
The Key Changes from ISO 9001:2008 to ISO 9001:2015?
The key elements of the process-based Quality Management System such as establish, implement, maintain and continually improve are present in both versions. However, in ISO 9001:2015 there are some key changes that have been introduced below:
- Organisations are required to monitor, measure and use key performance indicators to determine effective operation and controls
- The process approach must be driven by Senior Management and they should communicate this to all their employees and support them to follow a process approach
- The key factor in transitioning to ISO 9001:2015 is the extent to which the process approach has been adopted
Why a Process Approach is so important?
A process approach is of significant importance to an organisation. It links each department together and allows management to control processes throughout the organisation. By using a process approach you will be able to:
- Understand and consistently meet requirements outlined in your Quality Management System
- Indicate where the processes add value to your organisation
- Achieve effective process performance
- Keep improving process performance where necessary
- Place accountability on each employee in each department to meet key performance indicators
- Allow for each department to understand what quality means in terms of customer requirements
A Step by Step Guide to Implementing a Process-Based Approach
- Define what your Quality Management System Processes are:
Organisations are required to define what their own core Quality Management System Processes are. Some of these processes could be:
- How your organisation handles complaints
- The process for internal employee training
- How you manage new customers
- A process for how you manage upcoming audits and inspections
- How you approve new suppliers to your organisation
- Assign roles and responsibilities for the Processes:
Assigning roles and responsibilities for processes will be one of the key factors in the success of your Quality Management System. Organisations should:
- Ask for employee involvement to develop the process-based Quality Management System
- Provide training to employees to ensure that they understand their roles and what they are accountable for
- Provide training for internal auditors to follow processes across all departments
- Document the processes that will provide support to employees which will ensure that they are carrying them out as planned
- Identify risks and opportunities and make plans to address them:
Organisations should determine the risks and opportunities that pertain to their processes, products and services, as well as the Quality Management System. After risks and opportunities are identified, organisations are required to address these.
Conclusion:
Overall a process based Quality Management System is required to be carefully planned and continually improved. The key success factor in your process based Quality Management System will be how it is executed. It is imperative that employees and stakeholders are engaged from the beginning in order to meet customer requirements and enhance customer satisfaction in the future. #WeKnowISO #ISO9001
