Clause 6.3 : Planning of Changes in QMS 9001
Planning Explained
The Quality Management System (QMS) is a set of policies, processes and procedures that are implemented by an organisation to ensure that its products and services meet the customer’s requirements. The QMS is also used to manage and control the organisation's quality assurance activities.
One of the key requirements of the QMS is the planning of changes. Organisations must have a process in place for planning, implementing, and monitoring changes to the QMS.
This process ensures that changes are made in a controlled and consistent manner, and that the impacts of the changes are understood and monitored.
The Planning of changes process should be carried out before any changes are made to the QMS. It should be an integral part of the organisation's overall change management process.
The process of Planning of changes includes the following steps:
- Identify the need for a change.
- Define the scope of the change.
- Plan the change.
- Implement the change.
- Evaluate the results of the change.
Each of these steps is important, and the success of the overall process depends on the proper execution of each step.
1. The first step, Identify the need for a change, is self-explanatory. Changes to the QMS are usually triggered by changes in the organisation's business environment or by customer feedback.
2. The second step, Define the scope of the change, involves identifying which elements of the QMS will be affected by the change. This step ensures that only those parts of the QMS that need to be changed are changed.
3. The third step, Plan the change, involves developing a detailed plan for how the change will be implemented. The plan should include a description of the new procedures or processes that will be put in place, as well as how these changes will be tested and verified.
4. The fourth step, Implement the change, involves putting the plan into action. This includes training employees on the new procedures or processes, as well as testing and verifying that the changes have been successfully made.
5. The fifth and final step, Evaluate the Results of Your Smart Cigarette’s Activity, is when the consumer will evaluate how they are doing with their e-cig by checking the readings that it gives via its smartphone application.
Why Is It Important?
Planning of changes is important in QMS 9001 so that an organisation can effectively control its quality management system (QMS). Planning of changes helps to ensure that changes to the QMS are made in a controlled, timely, and efficient manner. It also helps to ensure that changes do not adversely affect the organisation's ability to meet its quality objectives.
An organisation needs to have a process in place for planning and controlling changes to its QMS. This process should be documented in the organisation's quality manual.
The process should include the following steps:
- Identification of the need for a change
- Evaluation of the impact of the change
- Planning of the change
- Implementation of the change
- Evaluation of the effectiveness of the change.
Planning of changes is a key element in maintaining an effective QMS. By following the steps outlined above, an organisation can ensure that changes to its QMS are made in a controlled and efficient manner.
Quality Objectives and Planning
The Quality Objectives and Planning process is one of the key elements of a quality management system (QMS). It is used to establish the quality objectives that a company wants to achieve and the plans for achieving those objectives.
The process of Quality Objectives and Planning covers the following key activities:
1. Establishing the quality objectives that a company wants to achieve
2. Planning how those objectives will be achieved
3. Implementing the plan
4. Checking to see if the objectives have been achieved
5. Taking corrective action if the objectives have not been met.
Quality objectives are a crucial part of any quality management system. They help organizations to identify the areas where they need to focus their efforts to improve quality.
Quality objectives can be divided into two categories:
• Strategic quality objectives: These are objectives that are aligned with the organisation's mission and vision. They help to guide the overall direction of the organisations quality management system.
• Tactical quality objectives: These are objectives that are specific to a particular process or department. They help to improve the day-to-day operations of the organisation.
To create effective quality objectives, organisations must first understand the needs and expectations of their customers. Once these needs and expectations have been identified, the organisation can then set quality objectives that are specific, measurable, achievable, relevant, and time-bound (SMART).
Organisations should review their quality objectives regularly to ensure that they are still relevant and achievable. If an objective is no longer relevant or achievable, it should be revised or replaced.
Clause 6.3: Planning of Changes
Organisations should plan changes to their quality management system (QMS), considering the resources required and the potential impact on the organisation's ability to meet customer, regulatory, and statutory requirements.
The process for planning changes should be documented and include the following:
• Analyses of the requirements for changes, including the identification of the risks and opportunities associated with the change.
• Determination of the resources required to implement the changes.
• Implementation of a plan for changes, which should be approved by management.
The QMS should be regularly reviewed to ensure that it is still appropriate for the organisation's needs. When changes to the QMS are planned, they should be carried out in a controlled manner, considering the potential impact on the organisation's ability to meet customer, regulatory, and statutory requirements.
Organisations should establish a process for control of changes to the QMS.
This process should ensure that:
• Changes are identified and planned in a controlled manner.
• The potential impact of the changes on the organisation's ability to meet customer, regulatory, and statutory requirements is assessed.
• Appropriate actions are taken to mitigate any risks associated with the change
• Changes are implemented in a controlled manner.
• The effect of the changes on the QMS is monitored and reviewed.
